Global Medical Device Podcast powered by Greenlight Guru

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach to whether or not this technology should be regulated?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the pros and cons of 3D printing in the medical device industry and key considerations manufacturers should make with regard to this technology. Some of the highlights of this episode include:Although additive manufacturing and 3D printing are often used interchangeably, Mike explains that 3D printing is a very broad category with at least a dozen different technologies under that category, including additive manufacturing.FDA describes 3D printing as, “a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete.”Classic or traditional manufacturing is more subtractive than additive. What if the intended patient population is for one person, can a clinical trial be performed for validation? Additive manufacturing poses regulatory and quality challenges.FDA has sought input from the medical device industry, manufacturers, healthcare providers and facilities to explore appropriate regulatory approaches for Point-of-Care (PoC) 3D printing of medical devices.For example, Mike discusses that the regulation of today was not intended for 3D printing face masks and other protective gear. The lack of regulation should not hold back manufacturers from getting products on the market and through FDA.FDA, as well as Mike, recommends software certification for people using 3D printing in a controlled environment to make safe and effective products.Memorable quotes from this episode:“There’s been now about 100, a little more, medical devices that have come through the FDA onto the market that have been 3D printed.” Mike Drues“The phrase, ‘additive manufacturing,’ comes from the fact that many of these technologies, certainly not all, but many of them are based on layer-by-layer-by-layer technology.” Mike Drues“Additive manufacturing is 3D printing, but not all 3D printing is additive manufacturing.” Jon Speer“There’s two ways you can do a validation. One way is to validate the product. The way we do clinical trials today is we essentially validate the product, but the other way we can do a validation is to validate the process.” Mike Drues“The blending of tech and med device, it’s scary on one hand, but it can be exciting, as well. I’m looking forward to seeing how this impacts and hopefully improves our health care in the world.” Jon SpeerLinks:FDA - 3D Printing of Medical DevicesFDA - Technical Considerations for Additive Manufactured Medical Devices GuidanceFDA’s Role in 3D PrintingFDA - Process of 3D Printing Medical DevicesFDA - 3D Printing Medical Devices at the Point of Care: Discussion PaperFDA - Classify Your Medical DeviceFDA - The 3Rs of 3D Printing: FDA's RolePART 820 - Quality System Regulation (QSR)Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

How does a quality management system (QMS) and regulatory factors impact fundraising, pre-money valuation, market access, and commercialization for medical device companies?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Cristiano Fontana, founder and CEO of ThreeBridges.ThreeBridges is a consulting firm that provides business development advisory services for startups, distribution companies, and subject matter experts (SMEs) in the global medtech market. Also, Cristiano is a co-founder of CrossBay Medical, Inc., and partner of IStarter and ClubDealOnline. Some of the highlights of this episode include:When someone evaluates and/or values a company, QMS and regulatory impacts fundraising rounds and pre-money valuation by asking for backup evidence as well as understanding business models and financial motives.Cristiano describes the common paths that startups and entrepreneurs take when considering valuation. Start with a clear idea of the entire journey to create a reliable and consistent business plan.Cristiano’s fundraising strategy is knowing how much money is needed for different stages and consistently targeting the ideal investor (tier 1 or 2).When approaching investors, expect a lot of ‘no’s’ from investors, but you only need one, ‘yes.’ It’s a learning process to identify QMS/regulatory inconsistencies related to fundraising and pre-money valuation.Medical device companies may face specific challenges, such as demand, expertise, and selecting investors. Also, know about regulatory approval, debt, and reimbursement and mitigate risk, generate cash flow, and grow with a QMS.There are several differences when it comes to fundraising in the United States compared to the European Union (EU), including the amount of equity/money in the market and investors’ expectations of how a company is managed.Cristiano offers advice on the dilution of funds and company ownership. Consider how the money will be used and the actual versus relative numbers of valuation.Memorable quotes from Cristiano Fontana:“Come up with a business plan that is reliable as far as a business plan can be reliable.”“You need a deep understanding of your business model, your market potential, your value position, so that you understand what really is the potential of the product.”“Many times, people are not succeeding in fundraising or are delaying the time for getting their money because they’re not targeting the right people.”“You need, also, to show that you know what a QMS is, you have that in place already, and it is really efficient and well managed. Having something that is well structured that is tailor made but is well recognized on the market that is working.”Links:ThreeBridgesCristiano Fontana on LinkedInEU Medical Device Regulation (MDR)FDA - Pathway to ApprovalISO 13485Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

Colombia represents an untapped destination for early feasibility, first-in-human clinical research for companies to first enter the Latin American market and sell medical devices.  In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Julio Martinez-Clark, CEO and co-founder of Bioaccess, about early feasibility studies in Latin America.Since 2010, Julio has supported more than 100 Medtech opportunities to design and operationalize successful clinical trial, regulatory, and market access strategies in Colombia and other countries in Latin America. Some of the highlights of this episode include:Julio is a big believer in the potential for medical device companies in Latin America. He explains how U.S. Medtech companies can succeed in Latin America with early feasibility clinical trials and market access entry initiatives.Latin America is a good location to conduct easy feasibility clinical trials because U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.More companies are coming to Columbia because it is difficult, expensive, and time consuming to recruit patients in the United States and achieve regulatory approval at the FDA.Although the FDA implemented its Early Feasibility Studies (EFS) Program several years ago, it does not work well. Trials are still expensive, and it’s still difficult to recruit patients in the United States.Patients and physicians in the United States and those in Latin America tend to share a similar culture when it comes to their health and lifestyle.However, there are challenges for companies in Columbia, such as language barriers. Documents for regulatory approval need to be translated into Spanish.Columbia’s reputation has evolved into a knowledgeable country for companies to visit, feel safe/comfortable, and find patients to conduct trials for quality data.Memorable quotes from Julio Martinez-Clark:“U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.”“The struggle that these companies go through is immense. They find it very difficult, very expensive, and time consuming to recruit patients in the United States, not to mention the regulatory approval at the FDA.”“The Early Feasibility Studies Program that they implemented about seven, 10 years ago, it hasn’t really worked because of the dynamics of the U.S. system. Trials are still expensive and it’s still difficult to recruit patients in the United States.”“It’s really a bargain to buy services from a hospital in a country like Columbia.”“These companies are, in essence, looking for fast regulatory approval, ease of patient recruitment, and cost savings.”Links:BioaccessJulio Martinez-Clark on LinkedInOECDPacific AllianceFDA - Early Feasibility Studies (EFS) ProgramISO 13485True Quality 2022The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Ken Zalevsky, Certified CyberSecurity Leader and CEO of Vigilant Ops, about software bill of materials (SBOMs) and cybersecurity in the medical device industry.Ken has collaborated with the FDA, U.S. Department of Homeland Security (DHS), and National Telecommunications and Information Administration (NTIA) on cybersecurity initiatives, including cyber simulation exercises, industry guidance documents, and SBOMs. Ken’s written work advises medical device manufacturers on cybersecurity best practices and coaches hospitals on handling record numbers of breaches.Some of the highlights of this episode include:Ken defines an SBOM as a list of software components that compose any system, application, or device. In health care, medical devices are computer-based systems with software components.Engineers may know all about software and security, but not with medical devices and SBOMs. Medical device manufacturers are familiar with safety and efficacy in a regulated industry and may need to overcome software challenges.Most medical device software teams don’t build everything that is in a medical device. Scope appropriately because third-party components may involve risk.Safety is not the same as security, but both should be included early in the product life cycle. Cybersecurity standards include authorization, authentication, and encryption versus safety recalls, use cases, and vulnerabilities.SBOMs are not evergreen documents. They need to be maintained and updated regularly to act, react, and take action.Health care is the primary target for hackers over other verticals and the response time in health care has always been the slowest. Today, it takes about 160 days for a healthcare organization to discover a security breach. Memorable quotes from Ken Zalevsky:“A detailed list of those software components is really the essence of an SBOM.”“At the heart of it, the idea and the purpose of the SBOM is to give that transparency into software components that are utilized in medical devices.”“Most software companies, especially medical device software teams, don’t build everything that’s in the device. They take components from other third parties and there’s risk associated with those components.”“You can’t blame it all on the hospital because the hospital has no idea what’s running in those devices.”“Providing that transparency, understanding what you’re deploying on your network, just is common sense.”Links:Medical Device Security Made Easy - InSight Platform by Vigilant OpsSBOM - National Telecommunications and Information Administration (NTIA)NTIA - Minimum Elements For a Software Bill of MaterialsFDA - Guidance Documents (Medical Devices and Radiation-Emitting Products)FDA - Medical Device OverviewAAMI TIR57: Principles for medical device security - Risk managementThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give users what they want and need to safely use it as intended.In this episode of the Global Medical Device Podcast Etienne Nichols talks to Abbas Dhilawala, a cybersecurity and SaMD expert with Galen Data, about a new approach to cybersecurity and usability for SaMD companies to ensure products are both secure and user-friendly.Abbas has 18 years of experience developing enterprise-grade software for the medical device industry and is well-versed with technology, industry standards, and the privacy of data.Some of the highlights of this episode include:Usability and human factors testing standards exist. However, there’s no standard approach to follow for cybersecurity. Abbas’s approach is to obtain user feedback as soon as possible for SaMD to still be secure and user-friendly.Different kinds of users in the healthcare spectrum can be trained to use SaMD, including hospital staff and patients - depending on their level of trust and understanding of technology.Potential Pitfalls: Classification and credential layers, such as permissions and passwords, can put the security burden on the users but leads to the need for risk assessment/management for possible harm. Biometrics: Cutting-edge technology, such as fingerprint, eye, and face scanning is not as secure, reliable, or consistent, but it’s getting better. Always have a backup plan.Key Takeaway: There’s a lot of push on cybersecurity, but don’t take away the convenience or the usability aspect. Find a way to balance both usability and cybersecurity.Memorable quotes from Abbas Dhilawala:“Ultimately, if you make the product in a way that’s hard to use, you can be secure. If nobody uses it, it doesn’t really matter.”“There’s lots of standards, just no harmonization.”“What can you do to minimize stress? Health care is already a stressful environment.”“The fundamental layer of security is to know who the user is.”“Having standards is a nice thing because then you can develop tooling around that.”Links:Galen Data (Schedule a Demo)FDA - GuidancesFDA - CybersecurityHIPAATrue Quality 2022The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

How many COVID tests have you taken at home, in hospitals, or at drive-thru clinics? Are you sick and tired of the long wait times to access the tests you need? Do you worry about whether you followed the instructions correctly or not? Does it take too long to process results - only to get false positives or negatives? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Jeremy Stackawitz, CEO of Senzo Health about his company's focus on improving current testing product offerings through better performance. Jeremy has more than 20 years of experience in the healthcare industry and Senzo Health is an in vitro diagnostics and point-of-care company working on COVID-19 technology. Some of the highlights of this episode include:Positive vs. Negative Test Results: Jeremy discusses the pros and cons of COVID testing by using lateral flow products to increase the time to results and improve performance. Supply and Demand Constraints: Senzo Health’s reason for being is to offer a better test that resonates with end-users, government contractors, healthcare providers, and others.Main Barrier: Lateral flow tests are simple, but the technology and performance is limited. However, these tests could be good tools to use to monitor your own health, are relatively inexpensive, user-friendly, and fast.Data: With new technologies, Jeremy gains confidence and believes in Senzo Health’s products because of data generated and shared with investors, regulatory bodies, and other people in the industry.Healthcare reform: People are genuinely interested in having an active role in managing their health care and know the system is broken. It makes more sense to bundle tests, take in one place, get results fast, and develop a treatment plan. Mitigate Risk: Make decisions based on priorities, different technologies, and limitations. It takes the right technology, team, and vision - know when to pivot.Memorable quotes from Jeremy Stackawitz:“Our test is 10,000 times more sensitive than the dozen or so current offerings that you can buy.”“People have realized, ‘Wow, these could be really good tools for me to use to monitor my own health, they’re relatively inexpensive, they’re fast.’”“With new technologies, what gives you confidence is seeing data and then seeing data in other people’s hands.”“I think our problem will be not so much finding a home for the technology, it’s going to be prioritizing what the best match for what our technology can deliver and the unmet needs in various markets.”Links:Jeremy Stackawitz on LinkedInSenzo HealthFDA - Emergency Use Authorization (EUA) PathwayFDA - 510(k) PathwayTeladocTheranosGreenlight Guru AcademyTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared mission. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Dan Purvis, CEO and co-founder of Velentium, about building quality-centric, life-changing products for the medical device space.Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. Its staff does meaningful work on clients’ behalf to bring products to market.Some of the highlights of this episode include:Dan describes quality through culture as a way to move beyond compliance to get true buy-in and engagement throughout your organization.Quality through culture is like a three-legged stool consisting of people, business, and quality. The three legs must work together and learn from mistakes.Dan’s definition of quality depends on industry. In the medical device space, quality aligns with risk and safety. A risk-based approach is needed to understand the harm that will ultimately happen to someone using your device.Compliance obviously matters, as much as safety. A medical device could be fully compliant and still unsafe, or it could be fully safe and not compliant.Team Effort: A high-performing organization needs a dedicated leader and excellent talent. If you’re teachable, there’s always hope. Also, even if you can’t hire perfectly, you can fire perfectly.The culture of quality management can be considered a partnership or the police. Create a process, not a problem for people to conduct reviews.Instill quality and get people to say ‘yes’ by creating and crafting a culture-forward company for people to be ready for anything at any time.Dan wrote the book, 28 Days to Save the World, which details how Velentium partnered with a small medical device company and large vehicle manufacturer to increase emergency ventilator production.Memorable quotes from Dan Purvis:“In our space, quality really, really aligns itself well with risk and safety.” “Quality - it really is driving your organization towards perfection. That doesn’t mean perfect people. That doesn’t exist. We’re all fallible. But how have I created the processes, the thinking, and ultimately, the culture that gives us the best shot at removing risk and creating devices that are not only ethical and helpful to people but safe for the long haul.”“You could be fully compliant, and still unsafe. You could be fully safe, and not compliant, and so compliance obviously matters. You can’t go to market with non-compliant devices because you’ll get shut down, and you should be shut down.”“The only rules in this company should be rules that are inspiring.”Links:VelentiumDan Purvis on LinkedIn28 Days to Save the World by Dan PurvisQuality Is Free by Philip B. CrosbyISO 13485 - Medical DevicesFDA - Medical Device OverviewBrian Tracy - Motivational SpeakerTurning the Flywheel by Jim CollinsZen and the Art of Motorcycle MaintenancePaycheck Protection Program (PPP)FDA - Corrective and Preventive Actions (CAPA)True Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

Are you passionate about human-centered design and how it relates to health care? Patients deserve a high quality experience when bringing medical devices into their home. They want a product that they can use and want to use, without sacrificing any elements that would otherwise exist in a clinical setting. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Dylan Horvath, Founder, President, and Chief Product Officer at Cortex Design.Dylan has a degree in Systems Design Engineering and founded Cortex Design to be a firm that fosters human connection, improves health outcomes, and allows people to do things that they couldn’t do before.Some of the highlights of this episode include:Dylan describes design as a tool for understanding how people react and relate to technology. The design of those experiences should create empathy and fit in with a person’s lifestyle and their experience.When people bring home and use a new medical device or product, it should not be a completely foreign object. There should be familiarity with it already because it has features that exist in the person’s cultural landscape.When developing new medical products, engineers and scientists use different human-led design activities to get something to fit in someone’s home design.When designing a product, it’s important for engineers and scientists to understand that they may not be the audience. Ultimately, they’re designing the product for those that are going to use the product.Objects tell people how to interact with them. Unexpected behaviors and accordances signify improvements to bad design. Even small changes early on in the design process can have a big impact on user experience.Adding risk management methodologies to a product design/development approach and decision-making process is to use economic, regulatory, and market constraints to accurately assume, define, and validate user needs.The role beauty plays in medical products and devices is subjective, but there is beauty in well-functioning devices. The thing that is beautiful is when something considers how it appears and how it lives with the people that have it.Design only works within the constraints in which both manufacturability and aesthetic perception are successful. You can’t get away with one or the other.Memorable quotes from Dylan Horvath:“Design is a tool for understanding how people react to a technology and how people relate with technology, and specifically the design of those experiences so that we can empathize and create products that fit in with a person’s lifestyle and fit in with their experience.”“The challenge when developing medical products is the people and the skill sets and the activities that engineers and scientists typically go through to develop a new product can be very different from the types of activities that you go through to try and get something to fit in someone’s home.”“People design their environments, unknowingly, to sort of fit with the image that they want to project about themselves.”“When you’re designing a product, if you’re designing it for yourself, you can guarantee one sale.”“I really got interested in medical systems because of the opportunity for improving lives. That’s our philosophy to this day.”Links:Dylan Horvath on LinkedInCortex DesignFDA - Medical Device OverviewGreenlight Guru Acquires CanvasGT: A Fire(less)side ChatTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations?In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is passionate about bringing products to market in a safe, effective, and efficient manner. Some of the highlights of this episode include:In the medical device industry, De Novo refers to something new and innovative.  When you have an idea that has not been done before and is not substantially equivalent, then the De Novo pathway may be the right choice.The De Novo process is not as commonly used as the 510(k) pathway. The rate of innovation compared to incrementals tends to not be as often.Rob describes the pros and cons of the De Novo pathway. Some people think it requires extra work and higher submission fees, but it’s an opportunity to work with the FDA to create and regulate a new product category that may be copied.The De Novo pathway takes longer to review than 510(k) submissions due to risk management activities. It’s worth it to be the first innovative leader in the field.Think, prepare, and plan for different scenarios and conflicting messages when choosing a pathway to avoid pitfalls, such as analysis paralysis.Don’t compromise core technology and features when making a product/device. Focus on quality without sacrificing compliance to improve quality of life.Work together and collaborate to understand the client’s needs and amount of key information to give to the FDA to provide meaningful and quality feedback. Memorable quotes from Rob MacCuspie:“So new, so innovative, so cool, there’s nothing else like that out there - that’s when the De Novo pathway might be the right choice for bringing this to market.”“The real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category and you’re going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future.”“The desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market.”“Sometimes, it’s better to get something out there that helps and then get the full benefit out there a little bit later.”“Don’t be afraid of the De Novo process. It’s actually a really great tool.”Links:FDA - De Novo Classification RequestFDA - Medical Device OverviewFDA - Q-Submission Program GuidanceFDA - 510(k) SubmissionFDA - Premarket Approval (PMA)FDA - Case for QualityRob MacCuspie on LinkedInProxima CROTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA’s Device Good Manufacturing Practice Advisory Committee (DGMPAC).Michelle is on a mission to help smaller companies with regulatory strategy, planning, submissions, audit preparation and remediation, due diligence, quality systems, and compliance.Some of the highlights of this episode include:Why new clients work with Michelle: It’s easy to find a competent regulatory person, but how many are you going to enjoy working with and able to make you laugh when you really feel like crying?Even with the adoption of EU MDR, people are still in denial when it comes to those with certificates that expire in May 2024 and think they still have time to get certificates reissued.Several small companies, as well as large corporations, are choosing to not go to market or withdraw products in the EU because of the lack of value and revenue.The cost, clinical data, and limited number of notified bodies are some of the biggest challenges for those in the EU versus U.S. market.Companies should perform a market analysis to determine if their revenue model will support year-over-year costs and third-party fees to stay in the EU market.The impact to quality in the European healthcare system could turn the U.S. into a destination for medical tourism. It could happen if an analysis is not done by the government or competent authority.A quality management system (QMS) has to have an ISO 13485 certification in the EU. The U.S. doesn’t require a QMS until a product is put into commercialization and meets performances, standards, and expectations.According to Michelle, the five stages of regulatory grief are denial, anger, bargaining, depression, and acceptance.Memorable quotes from Michelle Lott:“If you don’t have a relationship with a notified body yet, you’re already almost too late. You just can’t make any commitments to or marketing plans for the EU right now, in terms of timing.”“The first thing is to do that market analysis, and then, if they decide that Europe is still  something that they want to do, second, you need to get in line with a notified body.”“There’s no such thing as grandfathering underneath the EU.”“There were 18,000 certificates issued under MDD, and only one percent of those have made it all the way through MDR.”“To properly prepare technical documentation, it is truly a cross-functional effort and it’s going to require a lot of very in-depth expertise.”Links:Michelle Lott on LinkedInRegulatory + Quality Assurance (leanRAQA)leanRAQA - Free GuidesRAQA Today PodcastFDA - Device Good Manufacturing Practice Advisory Committee (DGMPAC)European Union - Medical Device Regulation (EU MDR)ISO 13485FDA - Quality Management System Regulation (QMSR)True Quality 2022The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezers touched the side. Neurophysiology is a lot like that game.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Shawn Regan, CEO and Co-founder of Rhythmlink International, at the South Carolina Biosciences (SCBIO) Conference.From startup to industry leader, Rhythmlink is a company that designs, manufactures, and distributes medical devices that physically connect patients to machines to elicit or record neurophysiologic information.  Rhythmlink’s products are used during risky surgeries to help prevent or reduce paralysis, identify tumors, map the nervous system, and monitor brain waves. Its devices were the first of their kind to be cleared by the FDA to work specifically in MRIs.Some of the highlights of this episode include:Shawn describes neurophysiology as electrodes put on or under a patient’s skin to monitor their nervous system in real-time to identify dangerous situations.As a startup, Rhythmlink recognized the need to change from reusable to disposable products. Although the company did not know when that was going to happen in the medical industry, they knew it would and why.Early on, Rhythmlink experienced several challenges as a medical device company. It didn’t have any money, patentable technology, or intellectual property (IP). Co-founders had an idea, figured out how to create it, and bootstrapped it. Collaborating with the FDA 20 years ago was easy and straightforward. Rhythmlink wanted to know how to submit a 510(k) to get FDA clearance.Rhythmlink’s electrodes can be put on and left on during an imaging study to allow the brain to be monitored more often, which results in much better clinical information quicker and consistently to find and treat dangerous situations.Rhythmlink decided to automate some of its products because shipping rates changed, led to higher quality products, and customers liked the products better.Rhythmlink makes its products in China and sells its products in the United States, European Union (EU), and nine other countries.Cost-Benefit Analysis: Rhythmlink’s regulatory strategy is to identify all the different regulatory requirements for all the different countries the company wants to be in and make sure there is enough of a market to be worthwhile.Memorable quotes from Shawn Regan:“If you remember the game operation when you touch the side and the nose buzzes and goes off, it really is a lot like that.” “With our electrodes, the ability to put the electrodes on once and keep them on and leave them on during an imaging study allows the brain to be monitored more often.” “You get much better clinical information quicker and consistently all the time. So, you’re able to find those dangerous situations and then treat them.” “For our products, not every country has made the switch from reusables to disposables. All of the products that we make are disposable products, none of them are reusable at this point.” Links:RhythmLinkShawn Regan EmailSouth Carolina Biosciences Organization (SCBio)South Carolina Research Authority (SCRA)FDA - Medical Device OverviewCenters for Medicare & Medicaid Services (CMS)Plan, Do, Check, Act (PDCA) CycleEuropean Union Medical Device Regulation (EU MDR)EU Medical Devices Directive (MDD)The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices because incidents have become more frequent, severe, and impactful. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, Director of Product Security at Velentium and author of Medical Device Cybersecurity for Engineers and Manufacturers.Chris has more than 30 years of experience developing and securing medical devices for device manufacturers and collaborates with regulatory and standardization agencies to present, clarify, and systemize tools, techniques, and processes that enable the creation of secure medical devices.Some of the highlights of this episode include:Although the FDA understands the importance of updating cybersecurity guidance, it should tie the documents to real standards from ISO and EU MDR, rather than only referencing consensus standards for global harmonization.To make secure medical devices, a standard cybersecurity requirement needs to be created for manufacturers to do it the same way based on research and tools.During the development portion of the product life cycle, manufacturers need to identify threats. However, if there is not a workable requirement and the developer does not know what to do or not do, then nothing is done but ignored.Manufacturers have to look for the vulnerabilities or end-root cause of all exploits and threats during development. Vulnerabilities occur during the design, implementation, and use of third-party software components.Software Bill of Materials (SBOMs) need to be readable and consumable. An asset management system needs to be built in to address risk mitigation.When buying medical devices, health delivery organizations (HDOs) want SBOMs, support, and other cybersecurity expectations included in contracts.Find out what you need to do to create secure medical devices. At the very least, look at it as a competitive advantage in the industry.Memorable quotes from Chris Gates:“I want something that’s workable, something that’s harmonized.” “What you have to look for are the vulnerabilities or the end-root cause of all exploits and threats.” “We want SBOMs. We want people to talk to. In case of a breach, we want some help.” “Take a look at what you need to do to be a good corporate citizen and create secure medical devices. At the very least, look at it as a competitive advantage in the industry.” Links:VelentiumMedical Device Cybersecurity for Engineers and ManufacturersFDA - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsFDA - Quality Management System Regulation (QMSR)International Organization for Standardization (ISO)European Union - Medical Device Regulation (EU MDR)Protecting and Transforming Cyber Healthcare (PATCH) ActSupply Chain - Cybersecurity and Infrastructure Security Agency (CISA)NIST Special Publication (SP) 800-161, Supply Chain Risk Management Practices for Federal Information Systems and OrganizationsSoftware Bill Of Materials - National Telecommunications and Information AdministrationSoftware Bill of Materials - CISAOWASP CycloneDX Software Bill of Materials (SBOM) StandardCycloneDX Tool CenterInternational Open Standard (ISO/IEC 5962:2021) - Software Package Data Exchange (SPDX)MedcryptCyber BOM (SBOM) Management - CybellumSBOM Use Case - RKVSTThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achieve operational readiness in a manufacturing setting.CAI is a professional service provider that helps medical device companies get their quality products to market through operational readiness. The company provides expertise to get products out the door and qualified in a safe, effective, and cost-efficient manner.Some of the highlights of this episode include:CAI utilizes integrative services to identify clients’ needs to achieve operational readiness. Then, operational excellence is the end goal. Most CAI agents are Project Management Professional (PMP) qualified through Project Management Institute (PMI). Patrick encourages and recommends people to attain PMP certification to enhance their degree of success.Patrick describes the steps of a solid project management process. It includes planning, integration, and execution.The earned value calculation is where every action item is shown a direct correlation to the amount of money spent. Basically, you are getting more or equal to what you paid.If a small company with 2-5 employees is not ready to use or formalize a project management process, Patrick advises people to invest in education and training. The project manager is a hub of communication. Always keep everything accurate to create a sense of security for having everything that will be needed. Memorable quotes from Patrick Hayes:“Everybody strives for operational excellence, but yes, a strong package with operational readiness is the key.”“In a project, especially with startups, I’d say there’s no such thing as over communicating.”“Anything in the medical device industry directly affects, correlates, and supports the public. It’s a huge market and it’s a very important market.”“Never make any shortcuts to your quality.”Links:Patrick Hayes on LinkedInCAISouth Carolina Bio Conference (SCBio)FDA - Medical Device OverviewProject Management Institute (PMI)PMP CertificationPMI - Roles, Responsibilities, and Resources (Responsible, Accountable, Consulted, and Informed - RACI Chart)Earned Value CalculationLinkedIn LearningTrue Quality 20 22Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Adam Steadman, Chief Commercial Officer for SMART-TRIAL, about best practices⁠—not shortcuts⁠—to bridge the gap between medical devices and clinical data.SMART-TRIAL is an Electronic Data Capture (EDC) company that provides software as a service (SaaS). The EDC software generates, collects, and manages data used in clinical studies.Some of the highlights of this episode include:EDC is a newer concept or discipline for the medical device industry. Compared to the pharmaceutical space, automation from the clinical trial perspective has been a bit slower because of smaller sample sizes.Post-market surveillance activities are driven by EU MDR. In Europe, medical device companies are now being forced to prove to the world that their device continues to be effective against its peers and new products getting to market.Pre- and post-market data is to get medical devices to market and continue to be adopted, reliable, effective, and not discontinued due to new products.Another type of data that SMART-TRIAL can capture is related to payors. Does your product show an economic benefit to get reimbursed? It’s difficult to get feedback from those in the field, during tests, and clinical trials. If something’s not working, expect more feedback. If it’s working, you get less.EU MDR has had two significant impacts: the number of notified bodies is still not where it needs to be and it has created rationalization of product SKUs.Decentralization or remote patient care can change data results in clinical trials by using medical devices and technology to work more efficiently. For example, what’s the difference between medical device vs. health/lifestyle product data?Rules are slightly different when developing algorithms and software for medical devices. They’re not written that differently and updated standards are not typically complete overhauls.Memorable quotes from Adam Steadman:“The device industry in terms of automating from a clinical trial perspective has been a little bit slower than the pharma side of things. One of the reasons is we have much smaller sample sizes.”“Technology has gotten to the point now where we can do it efficiently and inexpensively at the same time.”“What’s really happening in Europe now is that you’re being forced to prove to the world that your device continues to be effective against its peers and against other products that are coming out on the market as new products.” “There’s a good reason for regulation. There’s a good reason why we changed the regulations in Europe. We’ve got to have these standards for everyone’s benefit.”“When you’re developing algorithms, when you’re developing software for medical devices, the rules are slightly different and they’re not written that differently.”Links:SMART-TRIALAdam Steadman on LinkedInISO 14155:2020ISO 20916:2019European Union Medical Device Regulation (EU MDR)FDA - Medical Device OverviewFDA - 510(k) ProcessFDA - Premarket Approval (PMA)Quality is Free by Philip B. CrosbyTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will automatically be cleared or approved by FDA. Any medical device company considering MDSAP should be familiar with what the program is and is not.In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Danny Kroo, a medical device consultant and sub-contract lead auditor for several registrars that provides quality management system (QMS) and regulatory affairs services.Listen to Jon, Etienne, and Danny as they help to align expectations about the MDSAP journey so manufacturers can understand both how program works and how it should be leveraged from a regulatory strategy standpoint.Some of the highlights of this episode include:The reaction to requiring MDSAP certification to access and sell medical devices in Canada created price increases and smaller companies were unable to justify changing the notified body or auditing organization.MDSAP provided opportunities and benefitted some distributors by getting and using technical files and documents provided by the original manufacturers.MDSAP satisfies the need for some countries, including the United States and Canada, but some companies in other countries think the approach takes too much time, money, and resources for a single audit.MDSAP involves assigned tasks, questions, and interpretations for seven processes during the single audit. For ISO 13485 certification, there is variability and jurisdictions are not always asked the same questions by all auditors.There should not be any surprises during an audit if companies conform to requirements outlined in regulatory resources, such as guidance documents, FAQs, procedures and forms.The FDA’s MDSAP model and approach should be an easy process, but it depends on your company and the level of maturity of your quality system.Easily find and retrieve tribal knowledge by capturing and organizing it in your company’s quality system in the event of an audit. Memorable quotes from Danny Kroo:“If you do want to sell into a country, especially Canada, you need to have an MDSAP certificate.” “It made things more expensive and it made the barriers for entry much higher.”“What is the purpose of an audit? It’s to see if you conform to the requirements.” “It should be an easy process. It isn’t so easy because some companies’ systems are mature and they go through it quite easily and others are not. It depends on your company, it depends on the level of maturity of your quality system.” “A certain level of tribal knowledge is still there because you have the system.” Links:FDA - Medical Device Single Audit Program (MDSAP)FDA - MDSAP Audit ApproachFDA - MDSAP Audit Procedures and FormsISO 9001ISO 13485:2016European Union Medical Device Regulation (EU MDR)Health CanadaDOCUSYSDanny Kroo on LinkedInDanny Kroo’s EmailTrue Quality 20 22Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old.In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mina Fahim, ​CEO and President of MediView, about bringing augmented reality (AR) medical technology to market.MediView gives clinicians X-ray vision and leverages AR and artificial intelligence (AI) to simplify, democratize, and inform healthcare delivery. Previously, Mina worked at Medtronic, Abbott, Beckman Coulter, and Excelen.Mina is a serial entrepreneur in the medtech and fintech spaces. He approaches his life with a foundation of trust, team, transparency, and track record to encourage collaboration and innovation focused on advancing people’s everyday lives. Some of the highlights of this episode include:MediView solved the problem of how to place a 3-D representation of a patient’s specific anatomy underneath the skin to millimeter accuracy.MediView’s solution enables opportunities for digital health care for minimally invasive procedural guidance and data analytics.MediView’s imaging technology and data feed its platform through a pre-operative or intraoperative scan, such as a CT or MRI, taken of the patient.The scan is communicated to a headset and an algorithm combines/lines up digital AR and physical coordinates to create a 3-D reconstruction that’s put directly into and onto the patient.In the U.S., between physical therapy, loss of productivity, and time off, there’s $120-billion of economic impact due to ergonomic injury of medical imaging.The first therapeutic area and clinical unmet need MediView is targeting is liver and kidney cancer. Only 1 or 2 patients receive a minimally invasive procedure, while the others have to go through chemotherapy or resection.Mina describes the differences of virtual reality (VR) versus AR. VR puts you in a fully digital world, while AR superimposes digital content onto the physical world.MediView’s work culture materializes into the company’s business strategy and model across four functions—trust, transparency, team, and track record. Memorable quotes from Mina Fahim:“We are hardware agnostic. So, we don’t depend, actually, on any one specific headset because of the unique algorithms that we built in.”“We have an algorithm that combines the digital world in AR with the physical world.”“The interventionists are not comfortable taking a needle, sticking it into the abdomen, trying to hit a grape inside of a watermelon blindly to get that tumor ablated.”“We give clinicians imaging modalities they trust and are comfortable with today to validate the new way we’re providing them to practice and exercise medicine.”“If a company’s exit strategy is acquisition, having a robust QMS that someone can look at effectively, efficiently, and simply…that has a mental impact, an emotional impact, a burden impact."Links:Mina Fahim on LinkedInMediViewMedtronicMark GriswoldFDA - Medical Device OverviewCode of Federal Regulations (CFR)The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech.Isabella discusses the necessity of informational meetings and answers some commonly asked questions about them. Sometimes, it is too early to meet with the FDA if you don’t have the information needed to support questions. Some of the highlights of this episode include:Informational meetings are valuable and important for helping medical device professionals and manufacturers build a relationship with the FDA.Informational meetings tend to focus on the early stages of a specific product, technology, or suite of products.Being prepared for informational meetings is beneficial. Rehearse ahead of time and identify pain points according to the FDA.During the informational meeting, pay close attention to what questions the FDA asks as well as address its feedback and suggestions.Some companies do not have or make time and resources available for anything not required, such as informational meetings. However, time and money can be saved in the future by addressing FDA concerns/issues.The FDA is more inclined to attend informational meetings than other meetings because they like learning about new products and technologies.Memorable quotes from Isabella Schmitt:“With FDA, the relationship building from informational meetings is a huge component, and anything relational done with FDA is valuable and important.” “It’s never too early for a pre-sub, but sometimes it is if you don’t actually have the information that you need to support the questions that you’re asking.”“To find them valuable, you need to conduct them in a way that creates the value.”“They like to attend informational meetings because we’re not really asking anything of them and they just get to be nerds again and geek out over the technology.”“If you have a complex product, I would plan to do an informational meeting before pre-subs, just to talk about the product and get FDA to understand it foundationally.”Links:FDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramIsabella SchmittIsabella Schmitt on LinkedInProxima CROM1 MedTechInventing Tomorrow PodcastTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in manufacturing?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols learn the answers to these common questions, and more, about a medical device bill of materials from guest Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box.Mark has more than 30 years of experience in the medical device industry and takes organizations to the next level of quality system, product development, and operational excellence. His vision, experience, and hands-on leadership drive best practices in quality system processes and project management.Some of the highlights of this episode include:The FDA and ISO quality system requirements include design controls, which have a direct correlation to BOMs.The Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) are parts associated with design controls. Mark explains the difference between the three to build a product.For BOMs, there needs to be one source of the truth and everything else needs to match it. A master document needs to be defined, then other files and records copy and configure the same data.Based on configuration management, BOMs should include several components, such as a unique identifier/part number, description of part, quantity, unit of measure, operations step, assemblies, and reference designators.When building a BOM, define attributes or metadata that accommodate manufacturing and design points of view to avoid confusion.Design a flexible system. If you design for flexibility, then you’ll never have to worry about changing your quality system because it can’t handle a new product.Determine the rules of interchangeability. As products change, remember to change the part number and update the version on the BOM.Who owns the BOM? The medical device manufacturer owns the BOM because they are the approver and own the DMR and DHF.Memorable quotes from Mark Rutkiewicz:“The Bill of Materials, you can also grow it to be a Bill of Documents and a Bill of Operations. All that is sort of what’s required to build a product.”“That’s why there’s multiple documents today. The manufacturing people want to see it this way. The design people want to see it this way. They’re not talking to each other.” “If you design for flexibility, then you’re never going to have to worry about, ‘Oh, I ve got to change my quality system because I got this new product because my quality system can’t handle it.’” “Every digit in the part number means something.” Links:FDA - Quality System (QS) RegulationISO - Quality Management Systems RequirementMark Rutkiewicz on LinkedInMark Rutkiewicz on TwitterInnovizeConsiliso LLCMedical Device Company In A Box: The Case For ConsilisoBill of Materials (BOMs)Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What’s the difference?Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.Some of the highlights of this episode include:The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made or are they a waste of time and money? Good regulation is agnostic of time and technology.Government bodies in different parts of the world want to protect their citizens. Will there ever be global harmonization for quality? Are the most important principles of quality a function of geography? No, quality is quality.The timeline to transition is one year, but companies and inspectors may need or want more time due to a limited number of resources and notified bodies.If a company does what it should do for the safety and efficacy of medical devices, it should really be a tiny or no leap at all to make changes. The only changes are in the paperwork and forms.Medical device professionals should know about ISO 13485. If they do not know about this standard, whether it is required or not, that could be a problem.For those adhering to ISO 13485, if there are new requirements that make sense from a biology and engineering perspective, that’s the way to do something.Memorable quotes from this episode:“They are not going to adopt ISO or any other standards across the board. They’ll take sort of a piecemeal approach, and I think that makes sense.” Mike Drues“When was the last time that the design control guidance was updated since it was created in 1997? The answer is, never. That guidance has remained exactly the same.” Mike Drues“Good regulation is timeless.” George Zack“While it might not be a huge shift, I think it is a step in a direction of many steps toward some sort of global harmonization.” George ZackLinks:ANSI/AAMI/ISO 13485:2016 HandbookNIST's "ABC's of Conformity Assessment"International Medical Device Regulators Forum (IMDRF)ISO 13485:201621 CFR Part 820 - Quality System RegulationFDA - Design Control Guidance for Medical Device ManufacturersFDA - Case for Quality ProgramFDA - Medical Device Single Audit Program (MDSAP)European Union Medical Device Regulation and In Vitro Diagnostic Regulation (EU MDR and IVDR)Mike Drues of Vascular Sciences on LinkedInGeorge Zack of Two Harbors Consulting on LinkedInTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

When developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a patent needed and when is it not?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Neil Thompson, Kevin Buckley, and Stephanie Willerth about intellectual property and why it's important to understand the difference between inventorship and ownership.Some of the highlights of this episode include:At a university, Stephanie describes the process that professors and students follow when they have an idea. Before they publish it, if they think they have something novel and meets the definition for a patent, they file a disclosure.In the private sector, Kevin describes the publishing, patent, and funding process as being very different. To patent a trade secret, it must be incredibly robust and support a very valuable program. Funding for commercial entities or for-profit companies does not include grant monies.On the university side, there is no equivalent to a trade secret but the know-how  in the quest to do research and common sense in licensing agreements. There’s no protection for know-how and only royalties are paid related to patents and in countries where patents are enforced.Roles associated with an IP differ depending on the school and its policies and licensing terms. Restrictive conditions are put on IP and licenses because they know they will be negotiated, applied, and sold. Memorable quotes from this episode:“Do we keep this trade secret or do we patent it? If we’re going to patent it, this better be incredibly robust and it better support some commercial embodiment, some very valuable program. Otherwise, there is no publication.” Kevin Buckley“Some companies do not want their secret sauce—how they’re making a drug, what the drug is—eventually, drugs will be disclosed and basically hidden in a patent application until they go into clinical trials. When the drug is published.” Kevin Buckley“If all you have is trade secrets and you don’t have any patents, you’re not going to be seen as valuable.” Neil Thompson“There’s a big difference between inventorship and ownership.” Kevin Buckley“It’s a lot different if you make something in your garage or if you spend five years making it in your research lab.” Stephanie WillerthLinks:Patent Cooperation Treaty (PCT)Creative Destruction Lab (CDL)Stephanie Willerth on LinkedInNeil ThompsonKevin BuckleyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human factors is one of its most important activities. It serves as a tool to guide development, allowing you to improve your products by turning risk into a value-add type of activity.In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Shannon Hoste, President of Agilis Consulting Group and former lead for the FDA’s Human Factors Team.Shannon explains her philosophy and approach on how the pieces of human factors, risk management, and product development come together. It’s all about user-related risks and making the right design decisions early on during product development.Some of the highlights of this episode include:Human factors is a risk management activity that the FDA and International Organization for Standardization (ISO) requests. It’s all about use-related risk.Risk management helps make design decisions around safety and efficacy, and human factors provide a focused view on user- and use-related risks.The main contributor that companies come across are deficiencies and questions regarding the human factors process, including the use-related risk assessment.Probability and occurrence is challenging for most people. To understand product risk, understand risk is probability and disparity. To know what’s driving human factors, understand what could lead to high-disparity harm or kill someone.Based on user needs and human behavior, risk management helps companies understand users, how they interact with your product, and what can go wrong.Step-by-step process of risk assessment is to identify all tasks, identify what can go wrong, stay focused to build information, and then identify solutions.Product development engineers want their product to be safe and work. Embrace human factors to improve that as a likelihood. Do not resist it.Memorable quotes from Shannon Hoste:“Human factors at its core, at least the regulatory aspect of human factors, is a risk management activity. It’s all about use-related risk.”“All of it is a tool to guide development.”“I need to look at anything that could lead to high-disparity harm, regardless of if it doesn’t happen that often, if it’s going to kill someone, then I want to understand it.”“Engineers really like to solve problems. We’re going to jump in and look for solutions, and I think that the human factors, the user needs work, as well, is all about understanding the problem and not solving it.”Links:Shannon Hoste on LinkedInAgilis Consulting GroupPathway for Patient HealthFDA - Medical DevicesFDA - Human Factors ConsiderationsFDA - Human Factors and Medical DevicesISO 62366 - Medical Devices — Part 1: Application of usability engineering to medical devicesThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medical device industry can always do better through continuous improvement.In this episode of the Global Medical Device Podcast host Jon Speer talks to Mike Drues with Vascular Sciences about quality. Practice what they preach!Jon and Mike share tips on what you can do to improve upon your medical device company’s quality philosophy to ensure that true quality becomes a part of your company’s culture.Some of the highlights of this episode include:Quality is an ambiguous and esoteric word. To most, it means how good or bad something is, which leads to oversimplification and subjectivity.If you cannot measure quality, then you cannot improve it. For quality to be meaningful, it must be defined in less subjective terms, made to be objective, and needs to be measured.In the regulatory and FDA space, quality is not about good or bad, but about consistency. A company can make a consistently good or bad product.The difference between product and process quality depends on understanding acceptance criteria, levels, and specifications involved that need to be followed.Not whom but what is ultimately responsible for quality? Consistency. Appreciate what the word ‘quality’ means and whether what you’re doing is good or bad.Quality management systems (QMS) shouldn’t emphasize checking all boxes to be in compliance, but describe how business is done and how KPIs, objectives, and criteria are measured to demonstrate quality at process/product levels.Memorable quotes from this episode:“The problem I have with that simple explanation is there’s subjectivity involved to that, right? What you think is good or bad, might be completely different to what I think is good or bad.” Jon Speer“For quality to be meaningful, it’s something we have to define in as least subjective terms as we possibly can. We need to make it as objective as we can, but I think we need to measure it to determine whether or not we are actually meeting our definition of quality, whatever that might be.” Jon Speer“Quality is not about good or bad. Quality in the regulatory sense is about consistency.” Mike Drues“From the product perspective, does it work or not? Does it perform as expected? That may be a little bit outside the domain of the quality professional.” Jon Speer“You have culpability and responsibility for quality at some level. It sounds cliche, but I think everyone in the organization should have that opportunity to influence or be a part of quality and influence the decisions that are made.” Jon Speer Links:A Regulatory Gap Analysis of FDA's Systems & PoliciesUltimate Guide to 21 CFR Part 820ISO 13485FDA - Classify Your Medical DeviceFDA - Premarket Notification 510(k)FDA - De Novo Classification RequestFDA - Premarket Approval (PMA)Mike Drues on LinkedInThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense, particularly when tracking abnormal eye movement? In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Scott Anderson, Chief Clinical Officer (CCO) at SyncThink about the groundbreaking work the company is doing in advancing neurological assessments by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.You’ll hear how Scott went from his position as Head of Sports Medicine program at Stanford University, where he was part of a multidisciplinary research collaborative studying the natural history of head injuries. Though the technology was initially developed to aid in concussion protocol and the clinical care of athletes with head injuries, the potential of EYE-SYNC technology is now used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.Some of the highlights of this episode include:SyncThink specializes in neurological assessment by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.Besides concussions, EYE-SYNC technology is used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.Verbal or motor actions are the result of real-time brain function using the eyes to orient yourself to what’s happening and respond in real-time. Neurological deficits in performance occur across one’s lifespan due to disease or impairment.SyncThink’s EYE-SYNC technology has the potential to proactively prevent health problems in the future. It could facilitate the migration of hospital-based care to consumer-based driven care to preserve brain health. If used as a surveillance or monitoring tool, EYE-SYNC can identify improvement in brain function based on medication deployment. It helps clinicians learn to better titrate medication to specific individuals, such as children with ADHD.Scott admits that he faced logistical challenges and obstacles when doing clinical trials to get the first FDA clearance for following concussion patients. Memorable quotes from Scott Anderson:“There’s a whole host of neurological disorders that have a high prevalence of abnormal eye movements associated with it.” “Your eyes actually serve as the window to the brain. It allows you to orient yourself to the things that are happening around you.” “Your brain uses your eyes to select content it wants to interact with.” “Our bread and butter is the software and analytics and the eye tracking measurement, and there’s a whole host of these cases for this.” “As technology evolves, too, as well, there will be, I think, several opportunities in order to accelerate the clinical utility of something like eye tracking for a whole host of neurological conditions.” Links:Scott Anderson on LinkedInSyncThinkFDA - Medical Device OverviewFDA - 510(k) ClearancesQ-CollarThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What is the best way for medical device professionals, early-stage, and established companies to select and engage with contract manufacturers? One medtech expert has a winning formula that he wants to share with listeners of the show. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, founder of Consiliso LLC, and author of Medical Device Company In A Box.As a contract manufacturer himself, Mark brings a wealth of knowledge and insight to his discussion with Jon and Etienne, helping listeners understand how to navigate the selection process for medical device contract manufacturers.Some of the highlights of this episode include:Characteristics to consider when evaluating a contract manufacturer include cost, plant location, services provided, complexity of product, process validation, and available technology.Who’s doing what? Create a quality agreement because the overlap and what’s covered under the contract manufacturer’s and medical device company’s quality management system (QMS) should interact and intermix.There are four levels of risk and criticality when selecting suppliers for contract manufacturing: Zero (office supplies) to Level 3 - what you do is going to directly affect the patient experience.Some contract manufacturers have dedicated auditors to control information. MedAccred is an outsourced organization that conducts audits of medical devices and products.When outsourcing to contractor manufacturers, manual work may be cheaper, but automation provides consistent and better quality products.A master validation plan should set expectations of how to validate the product. Modify plan, release reports, and conduct risk assessment to make a product that meets a spec.Contract manufacturers need to communicate to share knowledge and understanding of what a medical device/product is used for as well as the scope and process controls.Memorable quotes from Mark Rutkiewicz:“You can outsource all these different aspects and that’s all part of contract manufacturing.”“The price of the part and what your volume is going to be is directly related.”“What you do is going to directly affect the patient experience. If you mess up, they might die.”“Contract manufacturers - we just take a little cut. We’re not making huge profits.”Links:Mark Rutkiewicz on LinkedInMark Rutkiewicz on TwitterInnovizeConsiliso LLCMedical Device Company In A Box: The Case For ConsilisoHow to Select a Contract Manufacturer for your Medical Device - White PaperFDA - Device Registration and ListingISO Standards - Sterilization and Validation ServicesMedAccredFailure Mode and Effects Analysis (FMEA) ToolGreenlight Guru AcademyTrue Quality 2022MedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.Some of the highlights of this episode include:Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.The FDA’s 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.The biggest problem with 510(k) is predicate creep. There’s room for improvement because the 510(k) is the workhorse of the medical device industry.Mike advocates for communicating often and early on with the FDA, even though it is not always easy to communicate with the FDA. Mitigate risk with a meeting because there is no way to ensure that the FDA views something as a wellness versus a medical device. The FDA has no formal mechanism to designate something as a wellness device."Change Creep" involves relatively minor changes made without notifying the FDA but through a Letter To File. Incremental and individual changes may be minor, but should not prevent innovation and improvement.A personalized medicine pathway is needed because the FDA does not recommend the custom device exemption (CDE) as the perfect pathway. Personalized medicine is clearly the future for many reasons. Memorable quotes from Mike Drues:“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.”“As we all know, the 510(k) is the workhorse of the medical device industry.”“I’m a huge advocate of communication with the FDA.”“We have tons of regulation already. We don’t need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.”Links:FDA - Corrective Action/Preventative Action (CAPA)FDA - Overview of Device RegulationFDA - Premarket Notification 510(k)FDA - Premarket Approval (PMA)FDA - General WellnessFDA - Case for QualityFDA - Warning LettersFDA - Form 483 FAQFDA - De Novo Classification RequestFDA - Emergency Use Authorization (EUA)FDA - Breakthrough Devices Program (BDP)FDA - Safer Technologies Program (STeP) for Medical DevicesFDA - Custom Device Exemption (CDE)Centers for Medicare and Medicaid Services (CMS)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare?In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA.Some of the highlights of this episode include:EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo, or Premarket Approval (PMA) cleared.Quality versus Quantity: What is worse - not having enough ventilators, diagnostics or more ventilators, diagnostics that don’t work? Both the regulatory and quality burden is higher for companies in the medical device industry.Certain shortcuts are justified in the short-term but not in the long-term. What companies did before for COVID/EUA medical devices is not enough now. Don’t waste the FDA’s time. The EUA needs to be a part of a company’s overall regulatory strategy to determine how it fits into the bigger picture.Memorable quotes from this episode:“For those of you that have products that went through the EUA pathway to get to market, if you want to keep those products in the market post-EUA, there’s things that you should be doing and frankly you should have already been doing them.” Jon Speer “The emergency use authorization or the EUA is one of many pathways to market that medical device companies can use to bring devices onto the market here in the U.S.” Mike Drues “Basically, it’s a very, very special kind of pathway. It is not an approval. It is not a clearance. It’s an authorization.” Mike Drues “If you’re not building a plan, a strategy, and starting to execute that strategy, you’re going to be leaving the market with your products.” Jon SpeerLinks:FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyWebinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?The End of EUA Is Coming SoonFDA - Medical Device OverviewMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.Some of the highlights of this episode include:The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.The UDI is stored in a worldwide central database. Different countries have different requirements. In the United States, medical device manufacturers can use three different types of identifiers (GS1, HIBC, and blood banking). For Bills of Materials (BOMs), it’s important to understand the rules of interchangeability to set medical device products apart and determine whether to assign different codes.A data matrix and quick resource (QR) code are intermixed and both are two-dimensional. Mark explains how to visually tell the difference between the two and the three components required.Integrating UDIs and codes into databases represents levels of complexity that are added to medical devices.The UDI is intended for the hospital user. So, a sellable product needs to have a UDI that can be scanned and validated. When parts are too tiny, the UDI will be placed elsewhere on the product packaging.Memorable quotes from Mark Rutkiewicz:“Every part that you use in the hospital room has a barcode on it.”“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.” “Nobody's really standardized." “You can scan it to make sure that you are using the right product with the right other products and with the right patient.” Links:Mark Rutkiewicz on LinkedInMark Rutkiewicz on TwitterInnovizeConsiliso LLCMedical Device Company In A Box: The Case For ConsilisoFDA - Unique Device Identification System (UDI System)European Union Medical Device Regulation (EU MDR)Medical Device Innovation Consortium (MDIC)ISO 13485 - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about amazing products and technology improving the quality of life. Now, there’s an opportunity to take the most listened to podcast in the medical device industry in a new direction by introducing a second voice to the show to share a variety of contexts and perspectives around the why behind what we do that matters.In this episode Jon is joined by Etienne Nichols, a medical device guru at Greenlight Guru and Jon’s new co-host of the Global Medical Device Podcast. This is a must-listen-to episode, offering details into this exciting news and other key thoughts and observations Jon and Etienne share about the medical device industry.Some of the highlights of this episode include:Etienne is passionate about the medical device industry and decided to join Greenlight Guru to help make things better, such as documentation. Guru Edge: Greenlight Guru is the only medical device system platform for the medical device industry built by actual medical device professionals.Greenlight Guru runs the gamut and covers everything from electrical and mechanical to packaging and production. There’s more medical device experience at Greenlight Guru than at most medical device companies.  In the future, Etienne predicts that data-driven decision making involving patients will be one of the biggest trends or themes in the medical device industry.Jon is anticipating the convergence or blending of technology with everyday devices (i.e., wellness wearables). The lines between what is and is not a medical device are blurry. The COVID pandemic has created opportunities for innovation in healthcare. Wellness, telehealth, and home-use products have become more common and make patients more comfortable.Etienne has experienced highs and lows with the FDA in the past. Now, he appreciates and is thankful for FDA regulations as guardrails, not limitations, that are flexible and open to interpretation. The FDA’s job is to protect and promote the health of U.S. citizens. It not only covers medical devices, but many other areas. It’s an awesome responsibility that encourages collaboration and communication.Memorable quotes from this episode:“When I came to Greenlight Guru, part of what kind of led me here, was the desire for things to be better.” Etienne Nichols“No one guru has all the answers on our team, self included." Jon Speer“I’m excited about all the different ways the medical device industry is going to be improving our lives in the future.” Etienne Nichols“The more data that can be behind a decision, I love that.” Etienne NicholsLinks:Meet a Guru: Etienne NicholsEtienne Nichols on LinkedIn21 CFR Part 820FDA - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Technology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and there’s greater potential for it to be revolutionary, not just evolutionary.In this episode of the Global Medical Device Podcast Jon Speer talks to Jennifer Esposito, Vice President and Managing Director of Magic Leap's Health business unit, about AR in healthcare, explaining what it is and is not, as well as how it compares and contrasts to virtual reality (VR), machine learning (ML), and artificial intelligence (AI).Some of the highlights of this episode include:AR is a relatively new technology that some people don’t quite understand how it is or can be used in healthcare today and in the future. It’s important for people to try Magic Leap’s AR device and platform to expand their thinking of use cases.AR is not the same as VR and other technologies. VR is completely immersive and involves wearing a headset. You can’t see the real world. All you’re seeing is digital content. VR has advantages and limitations.Magic Leap’s AR headset device allows users to not only see the real world, but digital content can be overlayed on top of the real world while maintaining spatial awareness and sensibility.Magic Leap isn’t just about AR, but the convergence of other elements and capabilities, such as AI, 5G, and Internet of Things (IoT). AR is going to be the catalyst that generates additional new sources of data not currently captured.AR is not replacing healthcare providers, doctors, nurses, and others. It augments the clinical workforce to present/provide insights that advance and enhance the practice and expertise of medicine when delivering care.Memorable quotes from Jennifer Esposito:“There are places where the differences between those technologies is actually really important in terms of deciding which one you would use for a certain use case.”“What we’re doing isn’t really just about AR. It is this convergence of these other capabilities.”“Augmented reality is also going to be the catalyst to generate additional new sources of data that we don’t currently have.”Links:Jennifer Esposito on LinkedInMagic Leap: Augmented reality platform for EnterpriseMedical Device Innovation Consortium (MDIC)FDA - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software.The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. Some of the highlights of this episode include:According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.There are a few reasons why the FDA is making CDS software important and its #1 priority. More companies and customers are or want to work and produce products in this space.For now, CDS software is not regulated by the FDA due to limited resources. However, that will change when companies’ products provide wrong or inaccurate information. Nobody or not too many people have been harmed, yet.According to Mike, CDS software provides clinicians as well as patients with information to enhance health and health care. Examples of CDS software include telehealth and AI platforms that ask patients questions about their health.FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person - not by a device or software.Make sure that CDS software properly provides accurate information because there can be major product liability implications if not regulatory ones.Regulated or not, usability testing is a must. What if your software tells patients they don’t have a problem, but actually do, and wait to take care of it? Memorable quotes from Mike Drues:“I’ve got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.”“Right now, much of this is not being regulated by the FDA. The FDA - they’re using their enforcement discretion to not regulate.”“FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.” “As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.”Links:Clinical decision support guidance tops FDA’s agenda for 2022 (Med City News) (Oct. 29, 2021)FDA's 2022 A-list guidance plan hits on software, post-pandemic futureCDRH Guidance: Clinical Decision Support Software (September 2019)FDA - Medical DevicesSoftware as a Medical Device (SaMD)Combination Products Webinarhttps://www.greenlight.guru/webinar/combination-productsGeneral Wellness Device and Wearable Exemption WebinarWebMDMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices.Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user.Some of the highlights of this episode include:Medical device professionals may develop something that they view as perfect, but what matters is what the person or patient using the product thinks of it. Medical devices/software should support people with health issues/problems.Those in the medical device industry and at Custom Medical have a major impact on the quality of life for many people. They can save and improve lives as well as prevent damage by doing their work correctly.Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. They should not have to overcome barriers and adapt to the device. It should be easy to use, safe, and supportive.Determine if you are on track when developing a product by conducting formative evaluations of tasks that need to be done and how they should be done.When done with development, a summative evaluation shows the use of a medical device does not come with any unacceptable risks. It offers proof of use.Opportunities for Improvement: Some mistakes that Michaela has observed include not meeting or listening to users, starting too late, and not conducting formative before summative evaluations for feedback. Memorable quotes from Michaela Kauer-Franz:“It’s not about me being excited about it, but about the user being excited about it. Being able to understand it. I think this is a very valuable insight.”“You have so much impact on the quality of life of so many people. You can save life, you can improve life, you can prevent damage if you do your work right.”“Usability is the translation from the capacity that an expert or user has into a device that is being easily used and intuitive, understood, and safe.”“See usability as something that you have to do constantly. It’s not a one-time activity that you do.”Links:Michaela Kauer-FranzCustom MedicalGreenlight Guru AcademyMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transformation of the spine industry by making outcomes and technologies standardized and reproducible.In this episode of the Global Medical Device Podcast Jon Speer talks to Carlton Weatherby, Vice President and General Manager of Spine and Biologics at Medtronic. Listen to Carlton discuss recent developments in spine and biologics technology at Medtronic, a global healthcare technology leader tackling the most challenging health problems with innovative medical devices that transform patient lives.Some of the highlights of this episode include:The spine business is an untapped opportunity that can impact patients across the globe with technology solutions being developed by Medtronic.Would you rather live with back pain or have surgery? Basic spine surgery has advanced and improved, but there’s still a wide variability in the outcomes based on where patients live, training of the surgeons, and technologies used.Surgeons have more confidence and patients have more confidence in the surgeons as they identify a path to improve the patient’s condition, alleviate their pain, and perform a procedure to achieve greater outcomes.The golden age of medical devices due to innovation has made the regulatory environment more willing to collaborate. Regulators and the medical device industry try to help patients, but agree that there’s still room for improvement.Through partnership, acquisition, and organic development, Medtronic already has the assets and pieces to determine if surgery makes sense for patients.Medtronic has brought new products to the market to replace invasive spine surgery. An open procedure versus a minimally invasive surgery (MIS) takes more time and has more complications.Medtronic is bigger than most, and 80% of medical device companies have 50 or fewer employees. Startups dream about an acquisition. Carlton advises them to start with a clinical value proposition connected to a clinical need for customers.Memorable quotes from Carlton Weatherby:“Spine is very much an untapped opportunity in terms of the impact it can have on patients across the globe with technology solutions like the ones we’re developing.” “It’s still more of an art than a science and that’s where the opportunity lies.” “Areas of technology advancements that we’re making allow us to support our surgeons to instill the confidence that they have going into it and especially their patients.” “When you integrate new technologies, it’s not easy, especially if those technologies don’t talk together. That’s where an ecosystem truly becomes valuable.” Links:Carlton Weatherby on LinkedInMedtronicMedtronic Spine SurgeryMedtronic Minimally Invasive Spine Surgery (MIS+)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Medical device companies must comply with a list of strict requirements throughout the duration of their product's lifecycle. These compliance efforts will be put to the test once an FDA inspection or ISO audit rolls around. As it turns out, there are a few common culprits when it comes to compliance issues for manufacturers.In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rynkiewicz, Vice President of Life Sciences for RA/QA and ASQ Certified Quality Auditor, about the three most common compliance issues and offer answers to questions like, why are the same select areas continuing to cause issues and what’s beyond these recurring compliance issues?Some highlights of this episode include:Based on FDA data, the same issues are the top issues year after year. Are people simply not paying attention to the observations they receive? Are they intentionally not being compliant? Probably not, but then, what are the reasons?FDA does not require medical device companies to share internal audit results that address components of a quality system. Rather than being dishonest, hire an independent, third-party to conduct internal audits. Another issue with internal audits is that only individual components of the quality system are audited. However, when FDA performs an inspection, they inspect the entire quality system - all components combined.The corporate management mindset is to manage complaints and CAPAs. However, the entire process should be built upon having zero complaints. Improve the product, make it safer, make it better quality to not get complaints.The CAPA effectiveness measure is not always effective. Some elements may be good to know, but do not actually measure the effectiveness of CAPAs.FDA audits will find something. Nobody’s perfect, including inspectors. Their ultimate goal is to improve products and safety.Human Behavior: Be honest, transparent, and take a system approach to gain efficiency and true quality culture.Memorable quotes from Tom Rynkiewicz: “Out of just human behavior, they want to help each other. So, they are not brutally honest.”“The second issue about internal audits is they’re auditing individual components of the quality system. When the FDA comes in, they inspect the quality system.”“We all manage our complaints. We manage our CAPAs, and as long as they hit some acceptable threshold, we’re good.”“Shouldn’t the entire process be built upon having zero complaints? The reason we’re doing this is to improve the product, make it safer, make it better quality, so we don’t have to manage complaints.”Links:FDA - Medical DevicesISO 13485 - Medical DevicesFDA - Corrective and Preventive Actions (CAPA)FDA - Case for Quality ProgramFDA - Current Good Manufacturing Practices (CGMP) RegulationsTom Rynkiewicz on LinkedInRaland Compliance PartnersThe Five Behaviors by Patrick LencioniGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What is usability? Human factors? Are they one and the same or different in the medical device industry? When do each apply? Whatever you call it, both are very important in virtually all medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about human factors and usability—two terms used synonymously despite subtle differences—to help you better understand how each function and should be applied.Some of the highlights of this episode include:Mike defines usability or human factors as the user’s ability to use the device in a way that it is intended to be used to get the result it’s intended to get.Jon understands how product development engineers forget that they designed a product based on how they think it should operate, function, and be used.Unfortunately, there are few opportunities for engineers to actually test, use, or implant a product that they developed and designed on actual end users, like cadavers or live animals.The user population has expanded beyond a trained healthcare professional. From a human factors perspective, it doesn’t always make sense or make it easier or complicated for some people to use medical devices.Current FDA guidances that focus on general usability/human factors for medical devices are inadequate. FDA does not differentiate devices that should be used by a trained healthcare professional versus a patient or lay person. Usability is important in virtually all medical devices, but there are some exceptions. However, usability is even more important when medical devices are being used by non-trained medical professionals.FDA now requires usability testing for medical devices because of issues with infusion pumps. However, usability testing should be considered based on risk. Is usability testing needed to put on a BAND-AID® or spit into a tube?There are two types of usability testing: Formative is testing that happens prior to design freeze during the development process. Summative testing occurs after the point of design freeze to ensure that the product can be used as intended.Memorable quotes from this episode:“Usability or human factors is the user’s ability to use the device in a way that it’s intended to be used to get the result that it’s intended to get.” Mike Drues“Those who are designing the product are stuck and convinced that they know the way the product should be used.” Jon Speer“The user population has expanded beyond a trained healthcare professional.” Jon Speer“Usability is important in virtually all medical devices across the board. Not all, there are some exceptions, but virtually all.” Mike DruesLinks:FDA - Applying Human Factors and Usability Engineering to Medical DevicesFDA - List of Highest Priority Medical Devices for Human Factors ReviewFDA - Premarket Notification 510(k)FDA - In Vitro Diagnostics Regulation (IVDR)The Global Medical Device Podcast, Episode 223: Understanding FDA's New Intended Use Rule and its ImplicationsMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project.In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell with Prodct and Christie Johnson with Kasota Engineering and Prodct partner about Greenlight Guru Academy’s new course offering, Introduction to Project Management for Product Development of Medical Devices.Some of the highlights of this episode include:It’s assumed that engineers good at managing projects, getting things done, and working with different resources/team members make good project managers.The gold standard is Gantt charts and waterfall methodologies. They have their place and have done a lot of good, but developers do not have to follow the waterfall method - it’s simply a project management practice and example.There’s an appropriate time and place for PM practices and tools, including the Gantt chart. However, don’t blindly apply learned principles.The wrong time to use a Gantt chart is managing how people do their work. Be vulnerable, open, and trust the professionals to know what they are doing and get their work done.Project planning and management are not the same. Project planning does not equal project management.Follow the Keep It Simple Stupid (KISS) philosophy. Rather than build complex and sophisticated tools, acknowledge that you won’t do it right the first time and put time in to react to what you learn and optimize.Who’s running the show? There’s a lot of overlap and not enough room to redo, learn, and make a product better. Also, a lot of iteration happens between those steps. Give time and respect to making a product stronger.Good project management is perpetual because there is a flow to it. It’s cyclical. Prototype and conduct testing early and often if the schedule allows to define and refine product details.Memorable quotes from this episode:“Starting as an engineer and then moving into quality and approaching things with a 30,000-foot view, you kind of see the whole project and the impact of all the sub-tasks. It’s hard not to want to get involved and make sure that everything that needs to get done does.” Christie Johnson“It will ultimately deliver something. It might deliver it over budget. It might deliver it over time. It might deliver it with a bunch of disgruntled employees who hate going through product development because of the way that the project is being managed.” Devon Campbell“Potentially, too many bells and whistles that it makes it really easy for you to create something that looks really awesome, but it’s really hot garbage.” Devon Campbell“Critical path calculations and analyses through tools is generally meaningless. I don’t believe it whenever I see it because we build these really complex and sophisticated models.” Devon Campbell“There’s a lot of overlap and not enough...room to go back and redo and learn and make the product better. There’s a lot of iteration that happens between those steps.” Christie JohnsonLinks:Introduction to Project Management for Product Development of Medical DevicesMedical Device HQDevon Campbell with ProdctChristie Johnson with Kasota EngineeringThe Critical ChainTheory of ConstraintsWhat is a Gantt Chart?FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)FDA - Quality System Regulation, Part 820Waterfall vs. Agile: Battle of the Product Development MethodologiesX-teams: How to Build Teams That Lead, Innovate, and Succeed by Deborah AnconaDesign Structure Matrix (DSM)Steven D. EppingerGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully understand how it impacts your business and product.In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes accordingly.Some of the highlights of this episode include:Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.EU MDR was supposed to go into effect in May 2020, but due to COVID-19 and other reasons, it was pushed off for a year. Guidance drafts were available in 2014-2015, but only a few hundred companies have made that full transition.According to a survey conducted by RWS, 53% of organizations are impacted by both EU MDR and IVDR, yet only 4% of those organizations admit that the regulations are a top priority.Companies with a medical device should proceed to effectively implement EU MDR or it may cost them their business. Also, refer to the definition of medical device that includes monitoring, prediction, and prognosis.Adnan encourages companies to not underestimate the cost of quality and regulatory. Build it in and know your market. With labeling and packaging, don’t forget about Brexit and associated symbols/marks.Regulations happened to catch up with technological advancements and public safety to become more transparent because patients were traumatized or died due to failure of efficacy in medical devices not being tested appropriately.Memorable quotes from Adnan Ashfaq:“They’ve really had to rethink their entire commercial strategy - whether they want to keep their devices within the European market, whether it’s financially feasible for them to continue doing that, or whether they want to rethink their entire strategy and think globally where their best markets are.”“I think it really boils down to what is the priority, and a lot of businesses don’t actually realize to keep themselves in business that they need to see this as a high priority.”“Regulations are mandatory, they are not optional.”“Don’t underestimate the cost of quality and regulatory and very often, that is done. You have to build it in. You have to know your market.”Links:Adnan Ashfaq on LinkedInWelcome to Simplimedica - Simplifying Device RegulationGuidance - MDCG endorsed documents and other guidance - Public Health - European CommissionEuropean Union Medical Device Regulation (EU MDR)European Union In Vitro Diagnostic Regulation (EU IVDR)RWS - Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulationsEUDAMEDFDA - Software as a Medical Device (SaMD)BrexitGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises.In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in which manufacturers should approach responding to AI requests via the Least Burdensome Flag program from FDA CDRH.Some of the highlights of this episode include:You do have options to push back if you think the FDA’s response or request for more information, data, or testing is overly burdensome or unnecessary.Understand why the FDA is asking you for additional testing or to collect additional data. The FDA should be able to give you a legitimate reason.Despite some trite responses, FDA cannot ask you to do whatever it wants. The FDA must give a specific reason, and then you decide whether to accept or fight against it and wave the least burdensome flag.Informal and formal options include understanding concerns of the agencies and working with review team to come up with a compromise or amicable solution.Escalating the issue is another option with an email or phone call to move things along and voice your concerns. If a compromise cannot be made, document the final product.The goal of the Least Burdensome Flag is to quickly address the FDA’s requests that submitters do not believe are least burdensome or held to a different standard than the legally marketed predicate device.Before throwing the Least Burdensome Flag, you need to meet specific criteria: Try to address concerns with the lead reviewer, limit it to two topic areas, and submit it within 60 calendar days of FDA issuing the request or deficiency letter.The last resort option is taking the issue to court. Tread cautiously because you can win the battle, but lose the war.Memorable quotes from Mike Drues:“Why is FDA asking us to do this additional testing, collect this additional data, whatever? FDA should be able to give you a legitimate reason as to why they’re looking for this information.”“We should respect the FDA, but at the same time, they should respect us.”“The goal of the Least Burdensome Flag is to quickly address FDA requests.” “Whatever we do, that needs to be justified. There needs to be a reason for doing it...needs to be justified based on the biology and engineering.”Links:Developing and Responding to Deficiencies in Accordance with the Least Burdensome ProvisionsFDA/CDRH Webinar - The Least Burdensome Provisions: Concept and Principles510(k) Submission ProcessInvestigational Device Exemption (IDE)ISO 10993 - Biological Evaluation of Medical DevicesCode of Federal Regulations (CFR)Medical Device User Fee Amendments (MDUFA)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.Some of the highlights of this episode include:Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.It takes time, often several years, for companies to transition to new or revised regulations and standards. Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.Some medical device companies have lost their way when it comes to quality, and many believe the quality profession is partly to blame for being driven by tools, not data.Mark describes a do versus don’t do mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.Memorable quotes from this episode:“I think today, we’re also at a very interesting crossroads when it comes to quality. There’s a number of different facets.” Jon Speer“It’s going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert“Once complexity creeps into the system, you’re just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert“A lot of companies, I think their quest is towards compliance.” Jon SpeerLinks:ISO 13485ISO 9001FDA - Medical DevicesFDA - Quality System RegulationEuropean Union Medical Device Regulation (EU MDR)European Union In Vitro Diagnostics Regulation (EU IVDR)Mark Alpert on LinkedInThe Global Medical Device Podcast: Quality - Who, What, When with Christie Johnson from Kasota EngineeringGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.Some of the highlights of this episode include:What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.Memorable quotes from this episode:“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike DruesLinks:FDA UDI Homepage: Unique Device Identification SystemCDRH Guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (July, 2021)FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturersCode of Federal Regulations (CFR)FDA - 510(k) Submission ProcessFDA - Software as a Medical Device (SaMD)FDA - Premarket Approval (PMA)ABILIFYMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.Some of the highlights of this episode include:Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.Memorable quotes from Christie Johnson:“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”“The system that you should implement is the one that your team will use and make it easy.”“It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”Links:Christie Johnson on LinkedInKasota EngineeringNational Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)Devon Campbell with ProdctFDA - Medical DevicesISO 13485Meet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge⁠—a team of medical device professionals with a ton of industry experience.In this episode of the Global Medical Device Podcast Jon Speer talks to Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlight Guru team.Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's MDSP solution can help them achieve ultimate success.Some of the highlights of this episode include:Maryann’s background is in quality systems initiatives, and she has extensive experience with ISO 13485. She loves being a part of audits and truly enjoys defending quality systems.While Maryann has been through numerous ISO 13485 audits, she has experienced only a few FDA inspections. She explains that there’s a whole different level of terror when it comes to the FDA.Maryann was attracted to joining the Greenlight Guru team because of her interest in quality system software. She wanted to help the company sell its software and connect with customers and medical device companies.Maryann shares some of her favorite stories working with companies trying to evaluate their options for quality systems. The best part is customers’ positive reactions during design control matrix and risk matrix demonstrations.The benefits of Greenlight’s QMS include the ability to quickly and easily find and access visually appealing information and data. Ultimately, it helps people get through audits faster and be in compliance.However, Maryann explains how and why EU MDR continues to be a challenge for medical device companies. Compiling records and evidence for submission as well as interconnectivity are just some of the bigger quality issues.If the FDA transitions to the 13485 standard, Maryann believes the medical device industry shouldn’t panic but anticipate it. It would be better to have a harmonized way of auditing and inspecting companies.Memorable quotes from Maryann Mitchell:“I’ve lived and breathed the 13485, 820, all those fun standards, which I love. It’s really exciting and I love being in audits.”“There’s a whole different level of terror when it comes to the FDA, but it was really exciting to be there. Thankfully, I wasn’t in the hot seat for those, but I was in the front room to participate.”“Not just during an audit, but for your own internal quality, it’s just so much easier when your systems are connected, and that’s exactly what Greenlight offers to our customers.”“You should always be audit ready.”Links:Maryann Mitchell on LinkedInISO 13485 - Medical DevicesFDA InspectionsEuropean Union’s Medical Device Regulation (EU MDR)Meet a Guru - Sara AdamsMeet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message.In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Perriello, who previously cofounded MassDevice and now current founder and principal at Circle Hill Life Science Communications, about his unique line of work helping medical device companies learn how to effectively tell their story.Listen to this episode now to learn what your company can and can't say to different target audiences and how to effectively communicate your company’s core message and story so it positively resonates with the listener.Some of the highlights of this episode include:Brad Perriello, alongside fellow journalist Brian Johnson, founded the online medical device business journal MassDevice based on his belief that small businesses and startups drive everything that lead to the biggest outcomes.Although medical device companies know their story best, they do not always effectively tell people their story, what they do, and why they do what they do.Startups telling their story is applicable and important to raise funds, but engineers are not strong narrative writers or speakers. They tend to focus too much on details, which can derail the intended message.A medical device company’s core message and story is the same, but is communicated differently. For instance, investors want to know the ROI, patients want to know if it’s safe and effective, physicians want to know about safety, efficacy, and cost.When hiring outside help with communications, they should be familiar with the medical device industry because the regulatory environment is strictly unique. Be aware of quality systems, design controls, and reimbursement issues.Some things change over time, and some things never change. Find an unmet need and help patients and others by figuring out what they need to hear. Be able to effectively communicate with all audiences.Social media evolves quickly and provides powerful communications tools with massive reach. Companies succeed by having a dedicated team member who knows how to leverage each platform based on the audience.Memorable quotes from Brad Perriello:“These folks know their stories really, really well...but they don’t know how to tell them all the time.”“Through no fault of their own, they’re not really effectively telling people, this is our story, this is what we’re about, and this is why.”“The old adage is that engineers can’t write.”Links:Brad Perriello on LinkedInMassDeviceBrian Johnson of MassMEDIC on LinkedInMedtronicFDA - The Pre-submissionFDA - 510(k) Premarket NotificationGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet.In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device Designation (BDD). Learn what the BDD experience was like and how their team is currently navigating the FDA regulatory process and collecting the necessary clinical data with the hopes of soon placing OsteoBoost on the US market.Some of the highlights of this episode include:More than 50 million Americans are suffering from osteopenia and low bone density. Half of all women will have a fracture from osteopenia and osteoporosis - that’s more than heart attack, stroke, and breast cancer combined.As people get older, especially women, shrinking is a real issue that is usually due to a fracture that causes pain as well as breathing and digestive problems.People with hip fractures have a 20-plus percent mortality rate. Hip fractures are difficult to recover from and a high percentage of people lose their independence.Currently, there are no approved treatments for osteopenia. Basically, your only options are to get enough Calcium and Vitamin D and do high-impact exercise. Give your bones enough stimulation to lessen the decline.There are medications for osteoporosis. However, the side effects, the way they work, and indications for use are for people with osteoporosis.When vs. If: Most people will eventually get osteopenia. Heredity is a factor that influences less dense and smaller bones. Lifestyle matters, such as excessive drinking and smoking or steroid use can have an impact on bone density.Also, if you are an astronaut or go into space, bone loss is accelerated. Evidence from NASA shows that using whole body vibration improves bone density.People must use such a device regularly, it is expensive, and it requires doing nothing for a period of time. Bone Health Technologies is developing OsteoBoost, a more practical and easy-to-use product that leverages whole body vibration.Memorable quotes from Laura Yecies:“Osteopenia is an incredibly common problem, and we have over 50 million Americans suffering from low bone density.”“If you walk around a nursing home, people are there typically for one of two reasons - they have Alzheimer’s or they have a hip fracture.”“Most people will eventually get it.”“There’s a body of evidence from NASA about using whole body vibration essentially to improve bone density. Astronauts lose a lot of bone when they are in space. Their bone loss is accelerated.”Links:Laura Yecies on LinkedInBone Health TechnologiesOsteoBoostU.S. Food and Drug Administration (FDA)FDA: Breakthrough Devices ProgramGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling.Some of the highlights of this episode include:When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.Intended use focuses on a device (what it does, how it works, and what is its mechanism of action). Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat).Why do we need a new rule about intended use? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print.The root cause for the rule relates to manufacturers’ saying or claiming one thing, but inferring and implying another thing. FDA does not regulate, at least not yet, the names of medical devices.Manufacturer's Objective Intent: If manufacturer knows or has knowledge of facts that product, device, or drug would be used for conditions or purposes other than what is advertised/claimed, manufacturer may need to provide adequate labeling.Manufacturers also need to consider product liability and reimbursement implications of a device being used for purposes other than what’s on the label.Memorable quotes from this episode:“When we refer to labeling, at least when I refer to it, I’m not talking about the sticky piece of paper that we stick on a package or in a box that a medical device comes in, nor am I talking about the graphics that go onto that label.” Mike Drues“There have been numerous and continues to be numerous warning letters, recalls, etc, etc, etc, that are strictly related to content or lack thereof or misinformation that’s on labeling.” Jon Speer“FDA does not regulate, at least not yet, the names of medical devices. So, you can embed a claim in the name of your device without it being subject, at least directly, to FDA regulation.” Mike Drues“Don’t just focus on what you say in your labeling, also consider what you don’t say and how you don’t say it.” Mike DruesLinks:FDA finalizes long-awaited intended use ruleFDA Delays Implementing Parts of 'Intended Use' RuleFederal Register’s Regulations Regarding “Intended Uses”FDA - Center for Devices and Radiological Health (CDRH)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors.In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs which are involved with the Greenlight Guru Academic Partner Program. Jon, Renee, and Devin discuss their work together in the program and Renee and Devin share their experiences using the eQMS from Greenlight Guru in the classroom and how it's helping students engage and better understand medical device risk and quality management concepts and practices.Some of the highlights of this episode include:Introducing Greenlight Guru to students has helped them to understand eQMS and how they can take the things they learn in theory and apply them in practice.Biomedical engineers need to be taught design principles, technical writing, and how to conduct tests and case studies with a risk matrix.Students should have a working knowledge and understanding of quality and regulatory affairs to prepare them for real-world application. The traditional approach to teaching risk in an engineer setting is to focus on failure modes and effects analysis (FMEA) and design failure modes and effects analysis (DFMEA). However, this singular approach is not efficient and can leave some medical device risks undetected, resulting in harm.Case studies should include ways to be reasonable, realistic, and helpful in product design and quality systems to think about how other options could fail.It is challenging in capstone design to deal with risk. Capstone courses are overwhelming for students and difficult to teach. Tackle risk in manageable way.Students don’t like doing busy work associated with quality management and risk assessments, but there’s a reason for it: ensuring the safety of people using a device you designed.Memorable quotes from this episode:“Using Greenlight in particular, introducing that to our students has really opened a lot of eyes and doors for our students at understanding what quality management systems look like and how they can take the things they are learning in theory and then apply them in practice.” Renee Rogge“There’s things that our students are getting out of an eQMS platform like Greenlight that they wouldn’t get if we were trying to do a paper-based system. There’s just subtleties and nuances that are built in that we don’t really have to teach. They can learn by experience.” Devin Hubbard“It’s not just a bunch of checkbox things they have to do. It’s critical for the development of the product that they communicate their ideas because someone’s going to pick it up and run with it later.” Renee Rogge“Risk is bigger than just a thing that you do as part of your design. It is a thing that drives your design.” Devin Hubbard“I think it’s easy to make risk boring. I think it’s hard to make risk engaging in a way that is educational for the students.” Devin HubbardLinks:Renee RoggeRose-Hulman Institute of TechnologyDevin HubbardUniversity of North Carolina/NC State - Joint Biomedical Engineering ProgramGuideWire PodcastFDA - Medical DevicesFDA - Design ControlsFDA - 510(k) Premarket NotificationISO 14971: Medical Devices - Application of Risk ManagementGuideWire PodcastGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs.In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and executives make better decisions for teams to achieve greater outcomes.Some of the highlights of this episode include:Learn the must-haves of management reviews, such as inputs, feedback, complaints, reporting, and audits during planned intervals, by following ISO 13485 and FDA 21 CFR Part 820 - Quality System Regulation.How often should management reviews be performed? The industry standard is once a year, but a lot could happen in 12 months. Greenlight Guru recommends management reviews twice a year, especially in the early parts of your business.Internal audits and management reviews are two activities that offer a snapshot in time of the overall picture of the health of your QMS. Then, the management review is a platform to escalate issues.Best practices for a management review include where more research, time, and effort should go. Don’t mistake a management meeting for a review. Pulling off a management review last minute is a lot easier than an internal audit.Your company’s key performance indicators (KPIs) and goals should be put on the agenda as a checkbox activity for the management review. Yet the list of topics/objectives should be discussed to assess how you handle your business.Document any decisions and actions to maintain the suitability, adequacy, and effectiveness of your QMS. In meeting minutes, include an action plan and product improvements related to customer requirements and correct problems.You can share your management review meeting minutes with notified body auditors, but not the FDA.If you have to hurry up and hustle to get data, is it reality data that you need? Is it that important? Automate, divide, and conquer.Memorable quotes from this episode:“The standard is pretty general on how often you should be doing management reviews.” Taylor Brown“Management review is really a platform to escalate issues.” Taylor Brown“Pulling off a management review last minute is a lot easier than trying to pull off all of your internal audits last minute.” Jon Speer“Executive management needs to be aware of and involved with the health of the quality system.” Jon SpeerLinks:ISO 13485 - Medical DevicesFDA - 21 CFR Part 820 Quality System (QS) RegulationTaylor Brown on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru.Listen to this episode to learn about Ryan's professional journey which brought him to Greenlight Guru and how he's helping companies with design of experiments, design controls, contextual inquiry, FDA QSR and ISO 13485 compliance, protocol/report writing, protocol execution, and quality system implementation and maintenance.Some of the highlights of this episode include:Ryan studied biomedical engineering and eventually zoned and honed in on medical device entrepreneurship.After graduating from college, Ryan worked for a startup in Omaha that was a Greenlight Guru customer. Ryan was able to develop a device, get 510(k) clearance, and go to market using Greenlight Guru.Ryan’s first-hand experience with Greenlight Guru not only helped the development of the customer’s product, but boosted Ryan’s personal development as an engineer.To better prepare engineers, reduce the concepts to practice and teach design controls, quality, and regulatory curriculum.Ryan advises engineers to get the knowledge they need to be successful via a foundation of quality. Then, put into practice what you learn to be compliant.Risk Management/Design Controls: Always make sure you know why you are doing things. What’s the purpose? Find value in things and collect feedback.Ryan’s keys to customer success include using Greenlight Guru as a quality system and medical device platform to find early wins and deeper motivation.Memorable quotes by Ryan Behringer:“I love the entrepreneurship element in the medical device space.”“I had the pleasure of developing a device, getting  510(k) clearance, and getting to market utilizing Greenlight Guru. It was really instrumental in our development of the product and kind of my personal development as an engineer - gave me loads of confidence.”“I really enjoy the technical element of things.”“I always make sure that the things I’m doing, I know why I’m doing them. They have a purpose, and I can find value in those things.”Links:Ryan Behringer on LinkedIn21 CFR Part 820 (Quality System Regulation/Medical Device)ISO 13485 - Medical DevicesFDA - 510(k) ClearancesMedical Device HQGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the US, for manufacturers and regulators alike.In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about the opportunities and challenges associated with medical device cybersecurity. Listen as Mike and Jon share their thoughts on the potential ways to eliminate or reduce cyber threats and encourage better cybersecurity practices for medical devices.Some highlights of this episode include:Cybersecurity is an important topic, but why is the FDA concerned about it? It’s important not to over-generalize.For example, identity theft may involve a physical medical device or Software as a Medical Device (SaMD). With that, a person’s personal information such as their credit card number could be stolen. Should not be the FDA’s concern.What about patient privacy? Personal health information or confidential electronic health records are a HIPAA matter - not the FDA’s concern.Cybersecurity related to the safety and efficacy of a medical device, however, is the FDA’s concern.  Safety and efficacy of medical devices is part of FDA’s Center for Devices and Radiological Health (CDRH) mission.Some have seen in the popular press or been told the urban legend around cybersecurity concerns for implantable devices, such as insulin pumps, pacemakers, catheters, and angioplasty (a.k.a. the Johnny Carson Procedure).NIST’s call for position papers/statements covered five areas:Criteria for designating critical software.Initial list of secure software development lifecycle standards, best practices, and other acceptable guidelines.Guidelines outlining security measures that will be applied to the federal government’s use of critical software.Initial minimum requirements for testing software source code.Guidelines for software integrity chains and provenance.The categories above are not new and don’t really relate to cybersecurity. These should be standard operating procedures for companies developing products where cybersecurity and software is applicable.How to minimize or avoid cybersecurity concerns? Join boards/committees to create standards, and determine if there’s a legitimate reason to connect to the internet and communicate with the outside world.Memorable Quotes from this episode:“Safety and efficacy of medical devices is at least a paraphrase of part of the FDA - CDRH mission.” Jon Speer“If there’s a cybersecurity concern that could affect the safety of the device, that is something that FDA could and should be, quite frankly, concerned about.” Mike Drues“I’m a big fan of using regulatory logic.” Mike Drues“None of this is new. These should be standard operating procedures for companies that are developing products where cybersecurity and software is applicable.” Jon SpeerLinks:FDA lays out device cybersecurity efforts as feds look to implement Biden executive orderWorkshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain SecurityResponse to NIST Workshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain SecurityHealth Insurance Portability and Accountability Act (HIPAA)FDA - Center for Devices and Radiological Health (CDRH)U.S. Department of Health and Human Services (HHS)The Terrorist Hack that Shocked America – and Why it Matters (Homeland Episode)Johnny Carson Procedure (Angioplasty)Al GoreInternational Organization for Standardization (IOS)ASTM International - Standards WorldwideUnderwriters Laboratories (UL)Mike Drues of Vascular Sciences on LinkedInGlobal Medical Device Podcast, Episode 164: What is a multiple function device?Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Many medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that compound those challenges? If only there was a solution...In this episode of the Global Medical Device Podcast, Jon Speer talks to Pall Johannesson, CEO and co-founder of Smart-Trial – a digital platform that helps medical device companies manage many, if not all, clinical data activities.Listen to Pall’s story about his solution for managing clinical trials, which has many similarities to that of Greenlight Guru, as he discusses his vision and the problem they're attempting to solve to help manufacturers, as well as patients, save time and money with clinical trial management.Some highlights of this episode include:Pall started Smart-Trial as a solution to solve the problem of the medical device industry being underserved. The technology being used to generate clinical evidence and collecting clinical data in clinical studies was outdated.Smart-Trial empowers medical device manufacturers to be in control of their own clinical evidence. Data is becoming more valuable, so companies need to control and access their own data. EU MDR has increased the need for clinical evidence and ongoing clinical data for products. Pall discusses how some companies adopt and adapt to it by taking advantage of collecting data and clinical evidence early on and doing it well.Pall describes similar challenges in the United States and EU. The MDR has pushed companies toward the United States as far as where to start with your market access and different directions to develop clinical evidence.  Smart-Trial’s products and services streamline the clinical side of things. Pall works with startups to well-established corporate medical device companies. However, the complexity of the device comes with complexity of the studies. Pall agrees that the medical device industry is moving toward integration of AI, machine learning, and other intelligent technology. It’s better to find experienced partners to make smart decisions that benefit manufacturers and patients.A big mistake made by medical device companies is collecting too much data. Start small and be specific. One of the best practices is to involve analysis of clinical evidence by a statistician.  Memorable quotes from Pall Johannesson:“The technology that they were using for generating clinical evidence or basically collecting clinical data in clinical studies was outdated by far.”“We empower medical device manufacturers to be in control of their own clinical evidence. Data is becoming more and more valuable.”“Medical device companies, today and in the future, will have to rely much more on having control and access to their own data.”“The biggest impact is definitely companies that wait too long.”Links:Pall Johannesson - LinkedInSmart TrialEuropean Union - Medical Device Regulation (EU MDR)U.S. Food and Drug Administration (FDA)FDA - 510(k) Premarket NotificationHalo by Greenlight GuruGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the extent and impact of these changes.In this episode of the Global Medical Device Podcast, Jon Speer talks to René Van De Zande with MedEnvoy Global, a specialty solution for European regulatory compliance that offers importer representation services. In addition, René founded EMERGO in 1997, later becoming what's known today as EMERGO by UL.Listen to this episode as Jon and René discuss expectations, criteria, and obligations for importers under EU MDR and how this role should be managed for post-market surveillance, tracking, labeling, translations, and complaints.Some highlights of this episode include:Only two economic operators can be held responsible for placing a device on the market - a legal manufacturer that resides in the European Union or an importer.EU MDR does not clearly define who is who in the supply chain when it comes to economic operators. Articles 11, 13, and 14 overlap activities, obligations, and responsibilities for authorized representatives, importers, and distributors.According to René, there are three kinds of distributors: 1. Takes on the role of importer, as well; 2. Capable of taking on the importer role; and 3. Refuses to take on extra liability as the importer.Conduct proper due diligence when selecting an importer. First, map out who is who within your supply chain. Are there multiple distributors with quality agreements in place? Are obligations properly addressed to be met?Importers and/or distributors should have a quality management system (QMS) that complies with ISO 13485 and MDR to fulfill obligations.Person Responsible for Regulatory Compliance (PRRC) and importers are definitely different. PRRC is within an organization, and importers are outside representatives hired to provide services.Memorable Quotes from René Van De Zande:“It’s here, and it’s here to stay. There are no delays - at least not for the MDR. Since May 26, it’s alive and kicking.”“The role of the importer is a critical one because there are only two of the economic operators that can be held responsible for placing a device on the market.”“The MDR has not clearly defined who is who in the supply chain when it comes to economic operators.”“You need to do proper due diligence. First, you need to map out as a company, who is who within your supply chain.”Links:René Van De Zande on LinkedInMedEnvoy GlobalEmergoUnderwriters Laboratories (UL)European Union - Medical Device Regulation (EU MDR)Economic Operators Guidance DocumentMedical Devices Directive (MDD)EU In-Vitro Diagnostics Regulation (IVDR)ISO 13485Mutual Recognition Agreement (MRA) for Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru