Global Medical Device Podcast powered by Greenlight Guru

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. In this special 200th episode of the Global Medical Device Podcast, host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterfall and agile methodologies for medical device product development, how they were first introduced and how they are interpreted and used today, while also dispelling common myths about the two approaches.Listen as the battle between the methodologies is finally laid to rest by Jon and Devon, with one key theme emerging: the name of your chosen methodology is not nearly as important as the defined processes you follow during product development and throughout the course of your medical device project.Some highlights of this episode include:The FDA’s Design Control Guidance for Medical Device Manufacturers is outdated and includes the waterfall design process. However, medical device manufacturers do not have to follow the waterfall approach. Industry norm? Read the entire guidance before making an incorrect assumption. The waterfall approach is one way, but the guidance offers other approaches and best practices to consider or follow. The waterfall approach was not revolutionary, but it did serve a lot of good for a lot of people. It helped companies establish infrastructure and understand how to develop medical devices in a safe and efficacious manner to meet patient needs.The term, ‘agile,’ as far as a product development methodology, didn’t exist until 2001 with the Agile Manifesto. There were huge gains in efficiency, productivity, and customer satisfaction for software companies using this shiny new approach.What does a good prototype look like? It might be a misconception that one approach is slower or faster than the other. Embrace and acknowledge the idea of continuous change and iteration. Document early, revise often.However, a certain order of operation needs to be followed for verification, validation, traceability, and flow of requirements, regulations, and other factors.Memorable quotes from this episode:“The big confusion about medical device product development is exacerbated by the infamous waterfall diagram that’s published in the FDA guidance.” Jon Speer“Incorrect impression: Well, the FDA says we have to do this, and therefore, we shall do this. They’ve given us a model. This is the way we have to do it. It doesn’t say that.”  Devon Campbell“People, they just see this waterfall approach and use it. Kind of blindly, almost.” Devon Campbell“You start seeing huge gains in efficiency and productivity and customer satisfaction for software companies where they are using this approach.” Devon CampbellLinks:FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)FDA - Quality System Regulation, Part 820 Agile ManifestoScaled Agile Framework (SAFe)Large-Scale Scrum (LeSS)Software as a Medical Device (SaMD)ISO 13485 - Medical DevicesProdct LLCDevon Campbell’s EmailDevon Campbell on LinkedInDevon Campbell on TwitterProject Medtech Podcast with Duane ManciniEasy Medical Device Podcast with Monir El AzzouziGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement.  In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru.Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits as well as learnings from leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits throughout her career in the medical device industry.Some of the highlights of the show include:Internal audits shouldn’t be about checking a box. If you know about problems, fix them first. Internal auditing offers opportunities for improvement. From a risk perspective, where are the trends and weak areas? Find them before someone else does and causes complaints or extra work. It is valuable to be able to look into those problem areas that need to be fixed. More medical device companies need to change their mindset by embracing quality as part of their culture, not as an obstacle or barrier. Collaborate with other departments because everyone has to own their process and procedure.Quality auditors may say there’s no choice, this has to be done. If the company has a CAPA or other options to be compliant, management will offer its buy-in. Misconceptions about internal audits include conducting internal audits on every process and procedure at least once a year, and if there’s any audit finding, you must create a CAPA. Key Tips: Make a plan/schedule, document and follow internal audit process, and realize that CAPA’s are only meant for major, risk-based, systemic issues. Memorable quotes from this episode:“We can always get better. Internal auditing is one method that, done properly, can help us improve our processes and our operations as medical device companies.” Jon Speer“I like rules. I like boundaries. I like guidelines.” Sara Adams“You can fix it and not give someone else an opportunity to find that.” Sara Adams“Your internal audits should be the toughest audits that you ever have.” Jon Speer“Being able to present options that still will take you into compliance, I think, is huge for getting management’s buy-in.” Sara AdamsLinks:Sara AdamsISO 13485:2016FDA - Medical Device Single Audit Program (MDSAP)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?  In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS).Jon and Milton discuss practical pointers for determining and describing the similarities and differences between the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to consider when it comes to regulatory compliance and their quality system.Some highlights of this episode include:An IVD consists of the agents, instruments, and systems used for the diagnosis of disease or other health conditions, such as HIV, hepatitis, diabetes, and flu.From a patient perspective, the IVD is not invasive. A sample of something, such as saliva, urine, or blood from the patient is taken. Then, the sample is prepared and put through an IVD for analysis to determine the results of a specific test. An IVD is the equipment that analyzes the patient’s sample, not the actual patient. The IVD focuses on the fidelity and accuracy of the tested sample. There’s risk for the patient. Who’s performing the test (lab or licensed clinician), what’s being tested for (non-life threatening disease or not), and if results are inaccurate.Information has to be crystal clear because the user population could be a child, elderly person, or otherwise who takes the wrong action or misinterprets actions that could lead to death. If you have been tested for the coronavirus (COVID), how was the sample collected? How long was the swab that went up your nose? How long was it in?An IVD is a medical device and is subject to the same pre- and post-market controls. It needs a quality system and similar risk-based classification.Treat people and their data in your clinical study well. A lab developed test (LDT) and investigative device should not be perceived as a regulatory path.Memorable quotes from this episode:“That’s the key difference. There’s no patient. There is a sample.” Milton Yarberry“It clearly gives you a target population, a way they’re going to use it, a way they can misinterpret it, and all of those should become mitigations in your design.” Milton Yarberry“You can tell if you hit the right spot if the person wants to punch you.” Milton Yarberry“It’s hard to translate some of that science, that research, that clinical, that laboratory side of things into something that’s commercialized and into something that’s regulated.” Jon Speer“It’s a mindset of the manufacturer that I think is the main difference.” Milton YarberryLinks:Integrated Computer Solutions (ICS)ICS & Greenlight Guru PartnershipCenters for Disease Control and Prevention (CDC) - Waived TestsClinical Laboratory Improvement Amendments (CLIA)FDA - CLIA Waiver by Application510(k) Premarket Notification IEC Standard 6236621 CFR Part 820ISO 13485Laboratory Developed Tests (LDT)EU MDR and IVDREmergency Use Authorization (EUA)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seize all] opportunities.In this episode of the Global Medical Device Podcast, Jon Speer talks to John Kapitan, CEO at Kapstone Medical, about the difference between knowing and doing as medical device professionals and how to do what’s right for the success of your medical device.Some highlights of this episode include:People view quality differently and need to overcome pessimistic and negative perceptions. Quality is a mindset and helps companies solve business problems.Quality is knowing the right thing to do versus doing it. Some people are ignorant because quality is not their role and do not necessarily know best practices. Other people are outwardly antagonistic who know the right thing to do, but choose not to do it for a variety of reasons.  Apathetic people have an idea of what to do or have been told what to do and want to do the right thing by the patients, regulatory bodies, and investors. Quality is common sense that focuses on best practices, documentation, and performance. Rather than caring about traditional technical quality related areas, a quality system is one of the last things some companies/investors consider.Pre-revenue and pre-commercialization companies don’t need to build a quality system that has all the bells and whistles. Start with the core and add-on as needs arise.There is a right and wrong way to implement quality in any organization. Take an efficient, effective, and pragmatic approach to understand compliance and the must-haves, not the nice-to-haves. Make sure to have someone on your team to discuss and champion quality, and implement a quality system that runs the company, not the company running it. Memorable quotes from John Kapitan:“I want to do the right thing. I know I can learn because I don’t know everything and there’s probably better ways to do this. More efficient ways, more effective ways to do this.”“If quality is not your role, you’re not necessarily going to be on top of what good practice is, what best practice is for quality, and what quality requirements are from FDA or overseas. You may be ignorant of just what to do and how to do it. ”“Quality is common sense. It’s not procedures, it’s common sense. It’s how would you do this if you were going to have this device put in your own body or your family members?”“There is a right way and a wrong way to implement quality in any organization.”“It’s always about prioritizing what we spend time thinking about, what we talk about, and what we invest in.”Links:John Kapitan on LinkedInKapstone MedicalFDA - Design ControlsISO 13485 - Medical Devices Premarket Notification 510(k)Premarket Approval (PMA)Investigational Device Exemption (IDE)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them?    In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and provide personal protection during the coronavirus pandemic.Some of highlights of this episode include:Breathe99’s mask filters 97 and 99 percent of airborne particles. It is not N95 certified, yet, but was designed based on those requirements.The prototype of the B1 mask offered protection with complete sealing around the mouth and nose, but allowed adequate breathing through a high-quality filter.The kickstarter for the B1 mask didn’t reach its goal, but then came an obviously serious and urgent need for high-quality respiratory protection. So, the kickstarter campaign for the B2 mask started. A total of more than $750,000 was raised.Positive Feedback—Doctors, teachers, volunteers, and other people feel safer wearing Breathe99’s B2 mask. It’s allowed them to continue doing their job.The FDA regulatory product approval process and NIOSH certification is not straightforward. Documenting users’ needs and testing requirements is a long-term path that requires proper and realistic planning.Alison discusses how Greenlight has been a resource for bringing the B2 mask to market. It offers peace of mind by going step by step at an appropriate pace to navigate the design and development process.The bureaucratic and complicated regulatory process takes much longer than expected. It presents common challenges, such as checks and balances of medical devices, change orders, and regulatory approval. Medical Device Journey: Learn while you’re learning it. Be deliberate and perform due diligence to be part of the solution. Understand your scope, users’ needs, and why it’s important to design appropriate, safe, and effective products. Memorable quotes from Alison Lee:“We’re a startup company based in Minneapolis that makes a high-quality face mask that filters 97 and 99 percent of airborne particles. Can’t say we’re N95-certified yet, but those are the requirements that we’ve designed our mask around.”“We love hearing about how people feel safer wearing our mask. It’s allowed them to continue doing their job.” “That stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product.” “Be aware of your scope, and you can really only do that by talking to people as soon as possible before you, I guess, make an assumption. We definitely thought the regulatory process would be a lot faster.”

Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it.In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy discusses the pros and cons of being a physician, entrepreneur, and inventor of reusable, physiologic medical products to eliminate unnecessary pain.Some highlights of this episode include:The medical world works on 2-D pharmaceutical schematics, but doctors’ minds work on three dimensions. Physician inventors see the whole body, person, and need to develop effective medical products.Physician inventors think they know everything, so it’s difficult for them to follow ISO 13485 and painstaking medical device development and not get frustrated. The time duration for Amy’s innovation and invention journey took years to get patents, meet regulatory requirements, and address the opioid crisis. Pain management is esoteric and subjective. Amy encourages physician inventors to fall in love with their problem, not their solution. Pain, chronic or not, is a real problem. Amy shares life lessons for physician colleagues with innovative ideas. Find a group like Greenlight Guru or GCMI to understand navigation early on. Branding matters, so choose wisely.Also, Amy advises physician investors to not get hung up on non-disclosure agreements (NDAs). Nobody steals an idea, they steal a medical product.Amy expects the future of pain management to include multiple specific energy devices in people’s medicine cabinets to use before and after surgery. Mechanical stimulation will be the primary one because it’s easy and safe to use.Buzzy® is a palm-sized device that combines cold and mechanical stimulation to block pain and improve muscle soreness, blood flow, and recovery. The VibraCool® Cryo-vibration product, VibraCool’s M-Stim, is 2-3.4 times superior to electrical stimulation (TENS) for physical therapy. It has demonstrated 35% fewer opioid tablets. Also, a lower back pain device is in clinical trials and expected to be released this year.Memorable quotes by Amy Baxter:“We see the whole body, we see the whole person, and we see the need.”“The downside of being a physician inventor is that we both feel like we know everything.” “Wanting to be able to do something is really the push that puts a lot of physicians into the entrepreneurial space.”“Fall in love with your problem, don’t fall in love with your solution.”“Try your idea out on someone who does not love you.”Links:Pain Care LabsISO 13485 - Medical DevicesISO 14971 - Application of Risk ManagementFDA - Part 11EU MDRNIH Small Business Innovation Research (SBIR))/Small Business Technology Transfer (STTR) Mayday FoundationGlobal Center for Medical Innovation (GCMI)Dr. Richard MelkerMedical Device Podcast, Ep 186: Building a Startup in the MedTech Industry Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them.Some highlights of this episode include:Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.The FDA’s classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rules that are philosophically different. The significant vs. nonsignificant risk system focuses on clinical trials for medical devices. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption (IDE).The software level of concern is important because it determines the level of documentation required for software development. The default classification for any new medical device is Class III. If it’s a new device, it’s not well-established and the benefits and risks are relatively unknown.When it comes to labeling, say anything as long as you can prove and support it. When technology stays the same but the labeling claim changes, risk changes.  The determination of significant or nonsignificant risk is not made by the FDA or Institutional Review Board (IRB), but the medical device company.The software level of concern consists of Class a, b, and c. Does the software have no possibility of causing injury or damage to health? Is non-serious injury possible? Or, is serious injury or death possible?Memorable quotes by Mike Drues:“Theoretically, the classification of your medical device depends on risk. In other words, the higher the class, the higher the risk. The lower the class, the lower the risk.”“The default classification for any new medical device is Class III, which basically means we set the bar at the highest possible level.”“Oftentimes in regulation, we do things not because they make sense, but because that’s the way we’ve done them in the past.”  “The determination of significant or nonsignificant risk is not up to the FDA. It’s not even up to your IRB, or Institutional Review Board, it’s up to the company.”Links:FDA - Classify Your Medical DeviceFDA - Significant Risk and Nonsignificant RiskFDA - Software Level of ConcernFDA - Product Code Classification DatabaseInvestigational Device Exemption (IDE)De Novo Classification ProcessCenter for Devices and Radiological Health (CDRH)Requests for Feedback and Meetings for Medical Device SubmissionsMike Drues on LinkedInGreenlight Guru Webinar - Advanced Strategies and Tactics for Using the De Novo PathwayGreenlight Guru Webinar - Understanding the Medical Device Classification SystemGreenlight Guru Podcast EP 37: Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences?In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems consulting, regulatory consulting, and implementation training.Joanne offers valuable insights on the topic of managing quality for in vitro diagnostic devices and the unique relationship these devices have to medical devices in terms of industry best practices and tools that manufacturers can use to produce high quality devices that are safe and effective for end users.Some highlights of this episode include:IVDs are different from medical devices and therefore treated differently. The difference between IVDs and medical devices is the way performance is proven.Read the FDA and EU regulations for medical devices and IVDs because changes are immense for the classification of devices. The amount of growth for IVD startups is driven by the up cropping of contract manufacturers. There’s a lot more bringing it to market with less resources.The pandemic has been good for the medical device industry and for bringing products from concept to fruition and through regulatory approvals quickly.Don’t reinvent the wheel. Focus on your technology and seek advice from quality professionals to achieve efficiency and effectiveness.Or, make space for the FDA to move in for months for an inspection and audit. Do the right thing and know what the right thing is. Keep your audit manageable.Perform quarterly quality fire drills with a robust internal quality audit program to prepare ahead of time. Review inventory, complaints, deviations, and more to be current on compliance. Big Mistakes and Common Challenges: Starting design control and risk management too late. It doesn’t take that much effort to document work. Memorable quotes by Joanne LeBrun:“The difference between IVDs and medical devices is the way that you can prove performance.”“The quality systems are similar, but if you’re a medical device person and you’re headed into an IVD situation, do keep in mind that it is quite different and the rules for IVDs are just a little bit more forgiving than in a medical device arena.”“There’s a lot more bringing it to market with less resources to be able to use some of those contractors.”“The pandemic, while it’s been very hard on a lot of people and I don’t certainly belittle that, it has been very, very good for our industry and has been very good for bringing products from concept to fruition and through regulatory approvals so fast, maybe too fast.” Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEuropean Union Medical Device Regulation (EU MDR)EU IVDRISO 13485 Quality Management for Medical DevicesAbbott LaboratoriesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process.In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and how to navigate this process in an efficient and compliant manner.Some highlights of this episode include:FDA has a few programs to consider when it comes to safety and significant risk or not for products. High-risk devices could fall into a non-significant risk study.Exempt or not? Make sure to provide sufficient information to identify significant or not risks based on objective evidence. COVID-19 issues prompted FDA to post guidance on statistical considerations, confounding factors, and remote monitoring for IDE and clinical studies.When does FDA require an IDE? If it’s a new device category or significant departure from the existing technology, FDA will probably need clinical data.All PMA devices do not require an IDE. Also, a device that follows the 510(k) path does not require clinical data, but an IDE may be requested with a clinical study for marketing submissions and reimbursement. The contents of an IDE application must include 12 items, such as the name and address of the sponsor; a complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan; and a description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device.Within 30 days, the FDA is expected to give a decision on the submission. The study will be approved, approved with conditions, or disapproved.Memorable quotes by David Pudwill:“Everybody wants to be breakthrough, but not everybody is breakthrough.” “There are a lot of clinical studies that are just exempt from IDE regulations.”“Even high-risk devices could fall into a not significant risk kind of a study.”“There’s always a chance that the FDA is going to disagree with you, if you think it’s non-significant risk. FDA is going to lean, in general, towards a slightly more conservative judgement on gray area issues.” “Specifically, if it’s a new sort of category of device or a significant departure from the existing technology, you’re probably going to need clinical information.”Links:David Pudwill (Mr. Regulatory) on LinkedInMr. Regulatory WebsiteMr. Regulatory on YouTubeFDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramInvestigational Device Exemption (IDE)FDA - IDE  BasicsPodcast - An Introduction to FDA’s Regulation of Medical DevicesPremarket Approval (PMA)Premarket Notification 510(k)De Novo ClassificationHumanitarian Device Exemption (HDE)Breakthrough Devices Program (BDP)Early Feasibility Studies (EFS) ProgramEFS Breakthrough Device Designation Safer Technologies Program (STeP)Center for Devices and Radiological Health (CDRH) LearnInstitutional Review Boards (IRB)Significant Risk vs. Non-Significant Risk for Medical Devices21 CFR Part 812Greenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier.In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD.Bassil discusses QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufacturers find compliant solutions to fulfill obligations and achieve continuity that puts medical devices on the market.Some highlights of this episode include:QE is a one-stop shop, like Amazon is for consumer products and Google is to ask questions about everything. However, QE specifically searches for healthcare, medical devices, pharma, and IVD products and service providers. QE is a platform invented but not influenced by QUINIQUE. Every notified body and registered consultants are listed. With QE, you can find, identify, select, and contact global suppliers.To join and register for QE, book a membership package, choose a service provider type, and search by selecting relevant criteria. QE includes testing labs, distributors, suppliers, and requests. Otherwise, if you’re searching for results, you have to connect with multiple places and people.Evaluating, monitoring, and selecting suppliers can be frustrating and time consuming. QE simplifies supplier management. Transparency is necessary to have fair competition and a clear supplier selection. Then, you no longer need to be dependent on a single supplier.Memorable quotes from Bassil Akra:“We are helping manufacturers and we are finding solutions toward getting them really compliant, but getting them also in a lean way fulfilling their obligation and being able to achieve the target of market continuity and getting their device on the market.” “Every one of us is nowadays struggling to find things.”“It is not the end list, this is the beginning. We’re going to extend this platform to get more transparency on the market.” “We have a large number of service providers who are unknown and they are available when we need them but we don’t know about them.” “Transparency is all what we need in life to have fair competition and a clear supplier selection.”Links:Watch this episode on YouTubeBassil Akra on LinkedIn‎Quality EngineQUNIQUE GroupEuropean CommissionEuropean Union Medical Device Regulation (EU MDR)European Union In-Vitro Diagnostics Regulation (EU IVDR) Notified BodiesTÜV SÜDMedTech EuropeAdvaMedGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals.In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers bringing a Class III medical device to market in the United States.

Why is design, manufacturing, quality, and culture so important in the medical device industry? These key elements must exist and function in synchrony so that a medical device can save and improve patient lives.In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufacturing firm that takes medical devices through an entire lifecycle.Dan gives listeners an update on Project V, an initiative involving the mass production of ventilators comprising five separate devices aimed at saving lives and meeting worldwide demand in response to COVID-19.Some highlights of this episode include:Velentium partnered with Ventec Life Systems, General Motors (GM), and the U.S. Government to build 30,000 ventilators and 141 manufacturing test stands in a 6-8 week period for Project V.Managing Manufacturing: The challenge with COVID is that so much is unknown. CDC provides guidelines for who can/cannot be in your facility, but not for who should/should not be allowed in your facility.Humans are hurting because of COVID. The gain or loss of productivity focuses on these key areas: Messiness of COVID, quality manufacturing, and culture of safety. How can a company maintain a culture of empathy, and at the same time, get a job done to pay the bills?Top Tips and Best Practices: Data Repositories: Move, store, and transition source code files, data, and other information as soon as possible to the Cloud.Design and Development: Foster a culture of understanding, efficiency, and flexibility.Four Variants of Design:Design for Manufacturability: Device passes design controls and receives approval, but it is extremely expensive and/or impossible to make.Design for Test: Testing throughout as you go, including product characterization testing and design verification testing.Design for Longevity: Manufacturable but think about design materials around longevity-oriented parts.  Design for Quality: Analyze for number of times used, shelf-life, patient safety, and cybersecurity.Memorable quotes from Dan Purvis:“That project was extremely successful. Thirty-thousand ventilators were built in Kokomo, Indiana, in an automotive factory that had not ever built a ventilator before.” “When you send these devices out into the marketplace, one hospital at a time, you can be assured that they’re going to do good just like they were intended to.” “Remind people that this is the real deal. Most of us, if not all Americans at this point, know someone who has passed away. Or, they know someone who knows someone who has passed away.” “The science is clear that when we are masked up and distanced, we have a much better chance of not spreading the disease.”

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible?In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answers to these questions and educate listeners on this new, voluntary program, helping manufacturers with eligible devices leverage STeP for easier, faster entrance into the US marketplace.

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise.In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru. Sara shares how her professional journey began as a biomedical engineer in the post-manufacturing industry. Listen as Sara offers valuable advice to listeners about her work as a quality engineer leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits.

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan.In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon and Duane talk about building a startup in the MedTech industry and why it’s so important for MedTech startups to be strategic in their approach to bringing a device to market, like taking advantage of reimbursement opportunities and leveraging a QMS to support all efforts along the way.

What makes Greenlight Guru unique? 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 Karen Schuyler, a Medical Device Guru at Greenlight Guru with nearly 15 years of experience working in the medical device industry.Listen as Karen offers value advice to medical device professionals on how to establish important system connections that coincide with regulations so that you can make your processes more efficient and supercharge the quality management engine for your medical device.

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedures, or its manufacturer.In this episode of the Global Medical Device Podcast, Jon Speer talks to Annie Campbell and Emily Holden from Now Medical Studios, where they create medical illustrations and animations for the healthcare industry. Listen to Annie and Emily explain how their unique artwork is transforming the way we see and understand medical devices.

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance?In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firsthand experience working for FDA.Listen to Mr. Regulatory and Jon discuss all things related to SaMD from the perspective of FDA and how the agency is regulating these emerging medical device technologies.

How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready.In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectively, within the FDA and Life Sciences division of their law firm, King & Spalding LLC.Listen to this episode where Steven and Eric share their keen insights and knowledge from working in the global regulatory sector of the medical device industry and offer best practices and tips that will help you prepare for FDA inspections and other audit events.

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device.In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance. Together, Monir and Jon discuss the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements.Some highlights from this episode include:Medical device manufacturers have several QMS standards, regulations, and frameworks to follow, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820. Rumor has it that the FDA is harmonizing its Quality System Regulation (QSR) with ISO 13485:2016. Why? FDA’s QSR and ISO 13485:2016 offer significant similarities toward harmonization depending on where medical device companies, manufacturers, and products are located (in the United States or European Union). EU MDR implementation involves a complex transition process, it’s not about simply updating a technical file.What are the differences between ISO 13485:2016 and EU MDR? Refer to Article 10.9 for process requirements and Easy Medical Device courses. Research notified bodies to determine and verify authenticity, authorization, and accreditation. QMS changes related to EU MDR place greater emphasis on clinical and post-market surveillance as well as risk/benefit management. Be proactive!When everything goes well, nobody rechecks what you are doing. As soon as there is an issue on the market or there is a competitor that may want to raise some concerns, then the authorities can come and visit your site.EU MDR: Will it be delayed or postponed again due to COVID, remote audits, or because it’s too difficult to implement? MDR is a chance to level up and raise the bar in the medical device world. Memorable quotes from Monir El Azzouzi:“A quality management system is not just a bunch of documents.” “When you are, for example, manufacturing some medical devices, you have to respect some rules, some regulations.” “Don’t pay something twice (choose certification vs. notified bodies wisely).” “EU MDR is a regulation that is...raising the bar in terms of requirements and things that you need.” “When everything goes well, nobody will recheck what you are doing. But as soon as there is an issue on the market, as soon as there is a competitor that maybe wants to raise some concerns, then the authorities can come and visit your site.”

What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible.In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years worth of knowledge and experience in the regulatory environment of healthcare and life sciences. Colleen provides listeners with guidance and support for engaging in virtual auditing and navigating the post-COVID digital world of compliance.

Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one of the most important things a medical device company can do to be successful. In this episode of the Global Medical Device Podcast, Jon Speer talks to Ed Bills, risk management consultant and technical committee member of the working group for ISO 14971:2019 and ISO TR 24971:2020, who shares key insights from his work developing the latest version of the international risk standard and offers recommendations for companies that will help strengthen their product risk management practices.

Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled to, is left on the table. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the importance of medical device reimbursement and offers tips listeners can use to build a competitive reimbursement strategy that puts dollars back in the company’s pocket once a device is on the market.

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-19 testing technologies that shorten viral detection cycles and increase access to reliable, accurate testing on a widespread scale. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell, founder of Prodct, who has been a major contributor in supporting the efforts being made by RADx teams. Listen as Jon and Devon share five actionable lessons learned from Devon’s involvement with RADx, each of which can be applied by medical device companies across the board.

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about CDRH’s previous, current, and future strategic priorities, including those impacted by the COVID-19 pandemic.

What’s the relationship between product feedback, complaints, and adverse events? In this episode of the Global Medical Device Podcast, Jon Speer talks to guest Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research (CRO). Jon and Isabella discuss some important processes and methods medical device companies should consider for soliciting, receiving, and handling feedback.

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device industry thus far? Have the emergence of these new technologies created new, unanticipated regulatory and quality challenges for industry professionals? In this episode of the Global Medical Device Podcast, host Jon Speer and guest Mike Drues from Vascular Sciences revisit the topic of AI/ML to identify notable changes and technological advancements that have emerged as a result of these technologies and how industry professionals are responding.

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that’s expected to take shape from 2021 onward. Steven, a former FDA deputy associate commissioner and COO for the agency’s Office of Regulatory Affairs currently serves alongside Eric as the Quality Systems and Compliance lead consultants in the FDA and Life Sciences practice of their law firm. With more than 50 years of combined industry experience between Steven and Eric, the insights and knowledge of this episode’s guests, specifically as it relates to this topic is a MUST listen for any medical device professional. Some of the highlights of the show include: Steven and Eric discuss how COVID is pushing the FDA toward a voluntary pilot program for agency investigators to conduct virtual facility inspections. Steven describes the current state of FDA inspections as challenging to work remotely and conduct follow-ups when appropriate. The FDA has established a paradigm to continue on-site mission critical inspections. Eric expands on the logistical challenge for inspections by explaining that since the FDA has put a hiatus on its inspection scheme, many organizations are following the Medical Device Single Audit Program (MDSAP). The Medical Device Coordination Group’s (MDCG) 2020-4 Guidance lists four circumstances where organizations under MDSAP or EU notified bodies have remote audits—surveillance, re-certification, change notification, and termination. Impact of the Emergency Use Authorization (EUA) program and the influx of requests on FDA. Some EUA submissions require pre-approval inspections. Before EUAs are revoked, build a remediated QMS, prepare for inspection, and decide whether to continue manufacturing a product after the pandemic. King & Spalding’s FDA and Life Sciences team offers a full-service approach, including cardiologists to help with health assessment risks, premarket and postmarket mergers and acquisitions, and warning letters. Pre-submission is an initial but formal way to build communication, collaboration with the FDA. A pre-submission can be an effective means for understanding regulatory requirements.

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition? In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of ‎QUNIQUE Group, a quality and regulatory consultancy. Bassil offers expert advice on how device companies need to prepare for these regulatory deadlines and transition to meeting the requirements of EU MDR/IVDR sooner rather than later. Some of the highlights of the show include: COVID-19 is an additional burden by impacting implementation, increasing requirements, and not being transparent about limited notified body capacity. EU MDR/IVDR Readiness: Under the new legislation, every device needs to receive re-certification by notified bodies to keep market access. EU MDR/IVDR Challenges: Additional guidance needed during transition to apply these regulations. Regulations put expectations that are not ready, such as EUDAMED. Increased requirements on clinical evidence via higher clinical and performance evaluation requirements. Continuous reporting increases expectations on resources for new and existing medical devices. EU MDR/IVDR Timeline: Number of notified bodies isn’t the most important part. How much capacity do those notified bodies have to address market needs? Tips for Medical Device and In-vitro Diagnostic Companies: Read the regulation(s). Understand implication(s) of regulation(s) on system(s). Identify/re-evaluate notified bodies that can address needs. Manage timeline/deadline for submission, implementation, certification.

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.” Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic.

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device industry. How are regulators keeping pace with its growth? FDA has a set of specific requirements unique to SaMD that companies are expected to meet in order to market these devices in the United States. In this episode of the Global Medical Device Podcast, Jon Speer talks to Andrew Frink, regulatory affairs manager at Proxima Clinical Research (CRO) about the ways in which SaMD companies can improve final submission outcomes of these devices by leveraging Pre-submissions to FDA, which involves meeting the agency's applicable regulatory guidelines and pre-sub expectations.

There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings. In this episode of the Global Medical Device Podcast Jon Speer and his cohost, colleague and medical device guru Wade Schroeder, talk to guests Monti Leija and Robert Futch from the Delta Development Team, manufacturers of ruggedized thermal systems who specialize in military applications. Listen to this episode to learn about the Delta Development Team’s journey designing their latest product the Autonomous Portable Refrigeration Unit (APRU) that provides a cooling and heating systems for extreme environments. Some of the highlights of the show include: APRU is medical refrigeration for medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications. APRU applications include military operations, disaster relief response, and emergency medical systems (EMS) because the device meets AABB guidelines and FDA regulations. The military provided end-user feedback on how it wants the APRU to function and perform. Therefore, the APRU is unique because it’s small and runs on a battery that can be charged. Power of Innovation: The biggest power consumers are refrigerators and air conditioners—both require refrigeration. Obstacles and Challenges: Every time somebody goes through the medical device journey it involves learning and becoming aware of regulatory guidelines. Recommendations: Find the right consultants, team members, and standards management tools. Wade Schroeder, Greenlight Medical Device Guru, has been a major asset to the Delta Development Team by providing regulatory guidance. Testing Methodologies: Motivation is to meet extreme environment requirements and standards. Some manufacturers choose to not meet some standards to make mobile medical devices that don’t work as well. APRU is the new standard. Root Cause and Right Configuration: Make minor adjustments to prototypes to reduce complexity, cost, and failure points via due diligence rather than rebuild.

Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s being developed, especially a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devin Mack, mechanical engineer and owner of Enqual, about the importance of spending enough time defining and managing requirements for medical devices. Some of the highlights of the show include: Story Behind Business Name: Enqual is a combination of Devin’s background in engineering plus quality to provide a balance between both. A picture (or graph and diagram) is worth a 1,000 words to describe product development and design controls for medical devices. A challenge that medical device companies tend to miss is the establishment of well-defined requirements during the product development process. Best Practices: Open communication between internal and external customers and the product development team as well as cross-functional involvement to define good requirements early in the process. Potential Pitfalls: What if stakeholders, engineers, and end users are not adequately considered in the development process? Everyone needs to voice their opinion to meet end user satisfaction and create a competitive edge to achieve goals. Stop Light, Agile, or Six Sigma Methodology? Track team’s progress versus focusing on customer specifications. Constantly evaluate where you are with respect to your requirements. Mantra: Invest time and money in useability/engineering models to get it right the first time to prove indications and meet proper requirements.

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly utilized regulatory pathway to market in the United States. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Jon and Erica discuss the positive and negative impacts of the EUA program on the medical device industry as well as the need for increased responsiveness to streamline distribution of in-demand products and services, such as tests, masks, and ventilators. Some of the highlights of the show include: EUA and PPE: Erica comes from a regulatory background and describes how the huge influx of EUA applications for ventilators and masks to in-vitro diagnostic device (IVD) and lab developed tests affect FDA tiers that reach consumers and companies. The FDA is government-funded and has a limited amount of resources. As a result, it’s scrambling to allocate people to review EUA submissions and 510(k)s for COVID-19 related tests to be legally marketed. Due Diligence: FDA’s review periods on other products have slowed down, but timelines still need to be met. Also, the quality of reviews has declined, not only with the EUAs but 510(k)s because of limited resources. FDA Statistics: A 510(k) review is supposed to take up to 90 days from the point of submission to an official response from the agency. However, EUA applications are being reviewed quickly to address a global public health crisis. Maybe too quick for regulatory quality and risks to be properly evaluated. Compare and Contrast: Erica describes the pros and cons of false-negative and false-positive results for COVID-19 and/or IVD tests. What risks do those results pose to the public? Research Use Only (RUO) to IVD: Companies that are not or have never been a medical device company need to have a quality management system (QMS), appropriate resources, and manufacturing transfers that can scale. This process takes time. FDA EUA Guidance: Proper development and design control provisions should not be viewed as optional. Companies should not cut corners but be expected to follow best practices and post-market challenges for quality events. EUA Impact Everywhere: Non-EUA products, procedures, and supplies were delayed, costs increased, and biocompatibility testing was affected due to the push for COVID-related products and services and eventual lift of those EUAs?

Should your medical device company address biocompatibility? The short answer is, yes. Every single medical device should conduct some level of biocompatibility testing. What’s important is that you understand to what extent. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about biocompatibility of devices, the applicable FDA and ISO guidelines companies need to follow, and the possible ramifications if you don’t. Some of the highlights of the show include: Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: FDA Draft Guidance is new, but doesn’t cover any new content. FDA’s intent is to clarify the types of biocompatibility information in submissions for certain devices made from common polymers and fabrics that come in contact with intact skin. What is biocompatibility testing? If you don’t know, that’s why regulation and guidance is necessary. Nobody knows everything, recognize what you don’t. ISO 10993 Evaluation and Testing: Review guidance, educate yourself, and engage experts because objective evidence is needed to corroborate the case for biocompatibility. FDA’s Recommendations for Biocompatibility: List device materials with direct/indirect skin contact and statement comparing/confirming safe use of those materials. Provide history and clinical study reports of adverse effects/events of skin contact materials, such as redness, swelling, irritation, allergic responses. Documenting sponsorship determining where biocompatibility risk and testing is not necessary, such as purchasing controls. Using labeling to mitigate risk of possible skin reactions. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: FDA Final Guidance raises special considerations for thermomechanical behavior and processing sensitivity of nitinol when compared to conventional metals.

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Erica shares her unique career journey working in the healthcare sector, which ultimately led her to enter the medical device and in-vitro diagnostic device space where she now provides world-class quality and regulatory support to device companies. Prior to joining Greenlight Guru, Erica worked in both the pharmaceutical and the biotech industry, serving as senior manager of quality and regulatory where she was responsible for implementing eQMS platforms for global enterprise companies. Some highlights of this episode include: As a medical device guru, Erica enjoys working with a wide range of companies, learns about various products, and helps those companies reach their goals by using a robust QMS. Erica’s superpowers, specialities, and strengths as a medical device guru revolve around all things regulatory and quality management to help companies function better and offer a sense of security. Conventional Wisdom: Are regulatory affairs and quality assurance the same or two different disciplines? Know it all and provide cross-functionality from product development to regulatory where quality doesn’t get in the way of productivity. Thought Process: Manufacturers, engineers, and others don’t have the mindset or systemic way to document inputs, outputs, and design development activities. Gentle hand or strict hindrance? Quality can enable or be an obstacle, but it’s the right thing to do. Check documentation, make changes, and meet demand. DiSC: If you have a hard time staying still, breathe and meditate for business development and personal growth. Strut industry knowledge to help companies. How can medical device companies be successful in today’s market? Time: Don’t rush or overlook anything. Plan for extra time and failures. People: Invest in the right and enough people, equipment, and space. Quality: Research and investigate suppliers. Make sure to have backups.

What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.

What could go wrong as more medical device products are used at home and in similar non-traditional environments outside of hospitals and healthcare facilities by non-medical professionals? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences. Jon and Mike discuss challenges related to safety, risk, and usability when medical devices intended for "at home" environments interface with untrained end-users.

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Special, and Abbreviated Premarket Notification 510(k) programs? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the Safety and Performance Based Pathway that's designated for certain types of medical devices only and what eligible companies should consider when using this pathway for submitting a 510(k) to receive FDA clearance.

Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences. Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of medical device professionals with more than seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Wade Schroeder, a medical device Guru at Greenlight Guru. As an electrical engineer and risk management enthusiast, Wade shares his unique approach to medical device product development and complying with regulations. He also shares a few of his favorite customer stories and offers his key recommendations to listeners on how to find success in the medical device industry.

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself accountable and stay audit-ready, so you can remove any pre existing concerns from the equation altogether. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru at Greenlight Guru and certified Lead Auditor for ISO 13485. Taylor offers valuable tips on one of her favorite topics—audit etiquette. She explains her beliefs around how practicing a high level of conduct during audits alongside a right-sized quality system results in True Quality medical devices with high marks from your auditor.

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge. In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device Guru at Greenlight Guru. Tom brings a breadth of knowledge to the Guru team with a biomedical engineering background and experience developing implant and instrument systems for one of the world’s leading orthopedic companies. Tom expresses his unbridled commitment to helping medical device companies, for customers by leveraging our MDQMS software to bring safe, true quality products to market faster, and for listeners by offering practical advice on industry regulations, standards, and frameworks. Some of the highlights of the show include: Tom’s favorite aspect of being a Guru is trying new medical devices in the tech industry and learning the business side of sales, clients, and personalities. Tom shares his beliefs on the best way to approach regulations, standards, and frameworks by taking a step back and looking at the big picture — they’re not overly complicated, but fairly simple efficiencies. One-man Teams: Tom admires surgeons, sales reps, and others that strike out on their own to start something important to them. They knew what it took to commercialize a product, but not enough about medical device regulations. Right-size your QMS: Look at the regulations. Focus on areas important to you. What makes sense now and worry about operations and other quality items later. Procedure Overload: People like to define the most efficient way to get things done. Write and test procedures while doing them. Keys to Customer Success: Keep it simple, focus on what you need to now, and stick to your business plan. Non-stop Paperwork: You need documentation for your submission, audit, design controls, and risk matrix. Don’t wait, do it as you go through the process to add value and communicate with others.

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst medical device companies worldwide. Are there creative ways to stay on track while ensuring the safety of those involved? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Regulatory Affairs Consultant, and Stephanie Mull, Director of Clinical Project Management, from Proxima Clinical Research (CRO). Together, they discuss the challenges and concerns for medical device companies conducting clinical trials during the COVID-19 pandemic and offers new perspectives for listeners to consider in terms of potential efficiencies and cost savings to gain. Some of the highlights of the show include: - Challenges related to COVID-19 include sites suspending operations of clinical trials, and restricting CROs and subjects from traveling or coming to sites. - Some medical device spaces, products, and technologies have been impacted more than others. It’s more difficult than normal, but not impossible, to perform elective procedures, especially in hospitals. - Widespread, Worldwide: Clinical trials continue to be conducted in the United States, but in a different atmosphere with changes compared to other areas that have completely suspended trials temporarily, such as Europe and China. - Subject safety is the primary issue to be considered and evaluated related to risks, reasons, and causes to suspend clinical trials. - Staff Availability: Sites must have adequate and properly qualified and trained staff to conduct and provide oversight to continue clinical trials safely. - Electronic data capture (EDC) versus paper management of sites and studies for clinical trials is a more controllable way to document and collect data from patient monitoring and different types of visits. - Protocol deviations and amendments should be approved by the FDA before proceeding with a clinical trial. Subject safety, again, is always the first priority. - Human Factors: Changes should make medical device and clinical trial design more usable, such as patient monitoring from a safe distance due to COVID-19.

Are you considering patent protection for your software as a medical device? Should you keep your secret sauce via the trade secret route? Perform due diligence to stay ahead of the competition. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Buckley and Neil Thompson from Torrey Pines Law Group. Their biotech-focused legal firm specializes in artificial intelligence (AI) applied to medical devices. Together, they discuss intellectual property (IP) with software as a medical device (SaMD) and AI and machine learning (ML) powered technologies. Some highlights of this episode include: • Patent or not? From a patent perspective, it’s easier to understand protecting software from an IP perspective by considering the problem to be solved. • Perform a patent search using third-party vendors to determine if competitors have claimed inventions and infringement information. • Due diligence of competitive intelligence should address licensing, acquisition, investments, and freedom to operate that enhances research and development. • Interest in adapting AI, machine learning (ML), and SaMD is increasing as clients develop technologies from scratch (De Novo) for better ways to help people. • When deciding whether to seek patent protection on technology, consider international patent laws and follow the Alice: Two-step Rule for patent eligibility. • The pros and cons of choosing the patent protection over trade secret route include whether clients need limited or unlimited duration to enforce patent rights. • AI-enabled inventions, such as X-ray imaging, is software that utilizes and combines new/existing devices as systems using ML, algorithms, and datasets. • Regulatory pathways for medical devices include 510(k) and De Novo. Predicate devices may be required and potential improvements may be patentable.

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with over seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Jesseca Lyons, a senior medical device guru at Greenlight Guru, a self-proclaimed design control junkie with a mechanical engineer background. Listen as Jesseca shares her insights on the importance of design controls and how a deep understanding of the different pieces and parts can lead to improved outcomes for both the device and patients who use it. Some highlights of this episode include: • Customer Success Team: Jesseca is passionate about the medical device industry and connecting with customers to make a difference in their lives. • Jesseca’s favorite aspect of being a guru is the opportunity to work on different types of devices and ideas from beginning to end of the development process. • Customer Success Stories: Audits can be intimidating, but terrified customers are put at ease due to Jesseca’s extensive preparation tips and best practices. • Opportunities to help medical device companies worldwide improve quality of life is a rewarding experience for patients, providers, engineers, and everyone else. • The Greenlight Guru True Quality Virtual Summit and other content/conferences are opportunities to share knowledge and experience that makes an impact. • Jesseca is a Type A personality that enjoys being in control and telling people what to do based on the best options available and to get things done. • Design controls are necessary, exist, and may change. Most people either like or dislike design controls, but they have a much greater impact than realized. • Probable or Improbable? Jesseca once hated risk management until figuring out that nobody wants to cause harm. Now, risk management is important and fun.

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures. In this episode of the Global Medical Device Podcast, Jon Speer talks to quality and regulatory expert Mike Drues, president of Vascular Sciences. Together they discuss why a QMS is so important to a company as it sets up its business and processes. Laying a proper foundation for a QMS to operate at its full capacity is just as critical, which involves a shared mindset and philosophy across the organization that reinforces a culture of True Quality. Some highlights of this episode include: • A QMS is not a system of compliance. It should describe how business is conducted through policies, procedures, processes, and philosophies. • If a QMS consists of devices not manufactured by the company, it’s an example of the copy-and-past approach to be compliant, but not customized. • A QMS is important to describe, document, and demonstrate roles, responsibilities, and rules to make decisions about products for patients. • A QMS focuses on four key areas: Accountability, traceability, consistency, and continuity. • Preamble/Introduction: One company’s QMS should not be a carbon copy of another company’s QMS. It should focus on its own mindset and philosophy. • Every QMS should include complaints, change management, and customer feedback to trigger notifications that affect safety, efficacy, and performance. • Product Lifecycle: During research and development, conduct post-market surveillance, beta test change management, and review risk management plan. • Document Management Control: All complaints and conflicts are not created equal. Get it right to make sure it’s effective and efficient.

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over eight decades of combined industry experience. Greenlight Guru’s mission is to improve quality of life, and those of customers, through True Quality products managed through its medical device quality management system (MDQMS) software. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru for Greenlight Guru’s Customer Success team with 7+ years of industry experience. Taylor shares her valuable insights and learnings from auditing quality management systems as a certified Lead Auditor for ISO 13485. Some highlights of this episode include: • Taylor equates auditing to what needs to be done, just follow the rules, perform everything correctly, and understand how processes/people meet regulations. • Ins and Outs of ISO 13485: Understand the importance of following rules and regulations to be in compliance and not dread an audit. • Greenlight Guru: Taylor lives for meaningful lightbulb moments, such as when procedures, training, and guidelines make sense to bring devices to market. • Equalizer Experience: There’s no delay or stalker culture at Greenlight Guru to be efficient and get what you need completed. • Love/Hate Relationship: Audits with customers that implement Greenlight leads to losing fewer documents, a smoother process, and getting done sooner. • Celebrate successful customer stories, such as collaboration, continuous growth, and improvement. You don’t need to accomplish/implement everything on Day 1. • Every good idea starts with a plan. A phased approach sets clear expectations. If you don’t document something, you didn’t do it, according to the FDA. • Sometimes, it’s just not that deep. Due to the nature of the industry and pressure to comply quickly, people tend to over-complicate things and strive for perfection.

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory strategies and pathways? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about the importance of and reasons for regulatory due diligence that all medical device professionals should understand. Some of the highlights of the show include: • Regulatory due diligence involves looking at what’s been done so far when a company is developing a medical device similar to one on the market already. • Due diligence is important for business, regulatory, and engineering/product development perspectives to know before investing time, effort, and resources. • Differences and Similarities: Regulatory due diligence, regulatory strategy, and regulatory pathway to market are not synonymous and may depend on another. • Regulatory due diligence can be applicable to new or existing medical devices. Due diligence from an existing device provides essential background information. • Reminders/Requirements: Update regulatory due diligence in quality management system (QMS) and risk management plan through product lifecycle. • Past, Present, Future Challenges: Evolve and emphasize changes/corrections for prevention, design, risk, manufacturing, and regulatory perspectives. • Decouple and Rebuild: FDA is inherently concerned about entirely new and/or novel medical devices and technologies. • Take a cross-functional team approach to understand different perspectives, roles, and tasks to produce improved quality and regulatory due diligence.

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focus to a story centered on positivity and innovation that will reignite hope for a better, safer road ahead. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO and co-founder of Velentium. Dan shares some much needed positivity through the uplifting stories and experiences of Project V, a collaborative venture backed by Velentium, Ventec Life Systems, and General Motors (GM). Project V is making a lasting difference by mass producing ventilators comprised of five separate devices to save lives and meet worldwide demand in response to COVID-19. Some of the highlights of the show include: • One-Stop Shop: Velentium is an end-to-end design, development, and manufacturing firm that transforms intellectual property into fully submitted and approved commercial medical devices. • The nine key areas of a medical device are human factors, cyber security, test systems, electrical, firmware, mobile, Cloud, mechanical, systems engineering. • Ask ‘why’ before ‘what’ when it comes to Velentium. Cash is necessary in a business, but it’s not the reason ‘why,’ which is to change lives for a better world. • Project V: Ventec could build more ventilators, if more resources and help were available. Velentium and GM answered the call for action. Right thing to do! • Pieces, Parts, and Production: Ventec’s 5-in-1 ventilator, oxygen concentrator, cough assist, suction, and nebulizer (VOCSN) device was scaled to a simple ventilator line called, V+Pro. • Politics, Businesses, and Pace: What’s more important and necessary? Dan describes obstacles and how Project V device developers overcame them. From a quality perspective, ventilators must help, not hurt people. • Human Moments: Ask for help and take business, physical, interpersonal, and emotional risks by reaching out during isolation. You won’t regret it.