Global Medical Device Podcast powered by Greenlight Guru

What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests with UDI experience. You’ll learn a lot about UDI and learn where to find some fantastic resources that can increase your knowledge.Laura Maher and Brittani Smith are both Medical Device Gurus and Greenlight Gurus. Their jobs involve guiding companies through regulations and quality requirements and challenges unique to MedTech companies and medical device professionals, and UDI is among those challenges. Both Brittani and Laura bring a wealth of experience and knowledge to the topic.Listen to the episode to learn the difference between device identifiers and product identifiers, the process of getting a UDI and applying it, then going on with the registration process, and how to think about the UDI requirements that are coming into effect. Some of the highlights of this episode include:What UDI is and the difference between the device identifier and the product identifierPhysical applications of UDIThe leading zeros and what they mean for packagingThe process flow of getting the UDI, applying the UDI, and registering the deviceChallenges with bar code verificationTips for manufacturers going through UDI implementationUploading to GUDIDWhy the UDI requirement is in placeThe different acronyms involved in UDIThe importance of finding and using the resources available to youMemorable quotes from this episode:FDA doesn’t set a specification for what your bar code quality should be, but depending on who you’re using, your GS1 specifically, they have standards for what the quality of their bar code should be.” –Laura Maher“Just like Laura, I became a little bit of a UDI expert at the company, just because I got to learn the ins and the outs of it.” –Brittani Smith“You’ve got to be careful about contrast and the color that you’re using for your bar code.” –Laura Maher“For your surgeons and your patients, the end users, the biggest thing is safety.” -Brittani SmithLinks:Brittani Smith LinkedInLaura Maher LinkedInGS1UDI with Gary SanerGreenlight Guru Ultimate Guide to UDIEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in his book and will be talking more about them in today’s interview.Kevin Becker has a bachelor’s degree in Mechanical Engineering from the University of Minnesota and a Master's degree in Reliability Engineering from the University of Maryland. Kevin is an ASQ Certified Quality Engineer, Reliability Engineer, and Six Sigma Black Belt with experience as a Quality/Reliability Engineer, Quality Manager, Director of Engineering, and Director of Quality in the medical device field. Kevin has authored and co-authored published papers in the areas of reliability, probabilistic risk assessment, and measurement correlation and has written a book titled Quality Myths and Lessons Learned.Listen to the episode to hear what Kevin has to say about ethical considerations in Quality, Quality’s PR problem, and why having a principle-based decision-making process matters. Some of the highlights of this episode include:What prompted Kevin to start a consulting businessExamples of things few engineers realizeHow you grow the muscle of realizing what you’re incentivizingWhat a quality engineer might specifically be interested in with regard to ethicsGray areas in ethicsHow to use flow chartsHaving a principle-based decision-making processHow a competitive culture can lead to pushing the rulesOvercoming peer pressure in the industryThe most important part of a quality management systemMemorable quotes from Kevin Becker:“Communication is another issue that is really difficult for engineers. They should be good at it, but they’re not.”“The worst possible answer is wrong but believable.”“I’ve seen some flow charts that have a lot of circular loops, and I don’t think they help make things clearer.”“The goal of any company should be: recognize (ethical deterioration) long before it gets to an ethical or, even worse, legal consideration, and then take action to correct it in a timely fashion.Links:Kevin Beckers LinkedInQuality Myths & Lessons Learned BookEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’ll hear about in today’s episode.Jesseca Lyons joins the podcast today to share more information about user needs. Jesseca is a Mechanical Engineer who’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. During today’s conversation, you’ll learn more about how Jessica is thinking about challenges in getting to user needs, using Root Cause Analysis to get to true user needs, and determining who will be interacting with the medical device and which ones are users. Some of the highlights of this episode include:Themes that trip people up regarding user needs and how Jesseca helps themFears about problems during FDA inspections and 510k submissionsWhat Jesseca thinks of when she thinks of user needsGuiding a customer through figuring out a user needWhat makes it difficult to get to user needsAn example of a standalone design inputWhen to stop divergent thinkingMore user needs pitfallsWhich people are usersMemorable quotes from Jesseca Lyons:“Most of the time, our user needs aren’t really doing a good job of telling us what the user is actually looking for; what problem we’re trying to solve.”“I always found it interesting that we were so willing to solve a problem before we really understood what the requirements were.”“Anyone who comes in contact with your medical device could be a user.”“Every fear is a legitimate fear.”“Your design inputs shouldn’t be so restrictive that there’s only one right answer.”Links:Jesseca Lyons LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What does the False Claims Act do, and when does it involve medical devices? In today’s episode, you’ll hear from Jonathon Tycko, an attorney who represents whistleblowers. Jonathan is a founding Partner with Tycko & Zavareei LLP, a law firm with offices in Washington, D.C., and California. His practice represents whistleblowers under the False Claims Act, along with similar statutes. Jonathon created and hosts his own podcast, The Garrulous Gavel.In today’s conversation, we cover the history of the False Claims Act and the lifecycle of the medical device. Listen to the episode to hear what Jonathon has to say about the process of the whistleblower’s claim, best practices for companies in relation to whistleblowers, and what kinds of penalties might result from a finding of fraud.Some of the highlights of this episode include:History of the False Claims ActThe process of filing a whistleblower claimWhat happens if the whistleblower’s claim isn’t investigatedThe flow of money in whistleblower casesHow many whistleblower cases are successful each yearBest practices for companies in relation to whistleblowersWhether whistleblowers can be reintegrated into the company when they don’t have a caseWhistleblower cases in the medical device fieldBoundaries and understanding when you’re on the hook for what you do within your companyWhat the penalty for potential fraud could look likeDefinitions of profiteering and price differentiations between the government or another entityAdvice for medical and medical device companiesMemorable quotes from Jonathon Tycko:“The vast, vast, vast majority of the cases that the government brings is because of whistleblowers, because of that 1986 amendment.”“This is where most companies get in trouble in the device field. It’s in the marketing of the product.”“You don’t want to do this and get caught by the Department of Justice. It will not be worth it to you.”“If your goal is to have a sustainable company that’s going to be around for a while, you have to accept the fact that you’re in a highly, highly, highly regulated business, and you can’t just put the blinders on when it comes to compliance.”Links:Jonathan Tycko LinkedInTycko & Zavareei LLPThe Garrulous Gavel podcastEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that.Sara Adams is a Medical Device Guru at Greenlight Guru. Medical Device Gurus are part of Greenlight Guru’s “Guru Edge.” Medical Device Guru’s help customers onboard to their new software and guide them through the various regulatory requirements and challenges unique to MedTech companies and Medical Device Professionals.Listen to the episode to hear Sara share some of her wisdom about audits. She talks about what happens when you don’t accept the finding of an audit, the different types of rules and approaches to different kinds of audits, and the kinds of problems she consistently sees from people when they’re learning to do audits. She also shares details about her own first audit!Some of the highlights of this episode include:Sara’s background and experience with auditsHow Sara trained other people to auditHow to build a culture of collaborationSara’s first audit experienceWhat the process of negotiating an audit finding looks likeWhat’s unique about each auditThe partnership in a supplier auditConsistent problems people face during audits and how to overcome themWhat’s important to know about getting ISO certificationMemorable quotes from Sara Adams:“In an internal audit, you need to avoid a conflict of interest. Like I don’t need to be auditing my own work.”“Quality is everyone’s responsibility and not just the quality department’s.”“We all have a first day. Everybody has a first day.”“Never look at something as just a checkbox.”Links:Sara Adams LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Why is the state of MedTech culture and tools the way it is? How should the industry be thinking about moving away from generic compliance and toward MedTech Lifecycle Excellence?Jon Bergsteinsson, co-founder of SMART-TRIAL by Greenlight Guru, is a MedTech professional and clinical affairs expert. Jon is also involved in educating and helping the MedTech industry get safe and effective devices to market faster and more efficiently.Listen to the episode to learn more about how MedTech is different from pharmaceuticals and other similar fields in the industry, why it’s important to look at the entire lifecycle of a medical device, and where the MedTech industry is going. Some of the highlights of this episode include:The gap that medical device technology companies experienceHow regulations are changing and how it could help the industryWhat could be accomplished by pursuing MedTech Lifecycle ExcellenceHow people in the industry feel about sharing informationWhere the MedTech industry should be goingKeeping talent in the MedTech industry and drawing more talent into the fieldMemorable quotes from Jon Ingi Bergsteinsson:“When you start working in MedTech, and you have experience from other parts of the life science industry, you start to realize how different it is from pharmaceuticals and other similar product developments like biotech, for example.“It’s easier to innovate medical device technology.”“Ease of use has a lot to do with the fact that you haven’t involved your end users well enough, or you haven’t involved the right end users.”“When it really comes down to it, you can’t really help or facilitate growth and development in the industry without experiences and insights from other industries.”Links:Jon Ingi BergsteinssonSMART-TRIALEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st.In honor of many podcast episodes featuring Jon and Mike Drues, this episode is a tribute to some of the best episode topics that the two of them have tackled. They review some of their favorite episodes and throughlines of their discussions throughout the time they’ve been podcasting together. Listen to Jon and Mike discuss how they met, which episodes stuck out for them, and what thoughts they want to leave the audience with. Some of the highlights of this episode include:How Mike and Jon metInterpreting regulationsCommunicating with the FDAFDA plans to modernize 510KDeveloping a regulatory strategyThe most important thing to rememberUnderstanding all your pathways to marketUsability testing and how it applies in the real worldThe Emergency Use Authorization for medical devicesMemorable quotes from Mike Drues:“When the rules make sense, follow them, but when they don’t make sense should we follow them?” “Regulation is about two things: it’s about the interpretation of words and our ability to defend our interpretation.”“You need to know what all of your options are.”“Tell don’t ask, lead don’t follow.” Links: Jon Speer LinkedInMike Drues LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today’s episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general.Today’s conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. In this episode, you’ll hear what Mike has to say about what’s on the FDA’s A-list and B-list for the fiscal year 2023, what isn’t on the list but perhaps should be, and what differences exist between draft guidelines and final guidelines. Some of the highlights of this episode include:What the CDRH proposed guidelines for fiscal year 2023 are about and why it’s important to think about themThings that stick out on the FDA’s A-list of guidelinesItems that are surprising or exciting on the A-listWhat is on the FDA’s B-list of guidelinesWhat’s missing from the A-list or the B-listHow collective wisdom is shared across various organizationsWhether the FDA should be giving guidance to help companies get products to marketThe difference between draft guidance and final guidanceIdentifying changes between versions of guidelinesWhether you have to do something if it’s in the guidelinesMemorable quotes from Mike Drues:“Not to be too arrogant here, but I’m very proud of the fact many of the things that I’ve done in submissions over the years, whether it’s with AI or BioComp or other kinds of testing has actually gone into guidance for the future.”“That’s why there’s a guidance document database, so you and I don’t have to memorize such esoteric trivia.”“It’s really not FDA’s job to help a company bring a product on the market.”“All guidance, indeed all regulation, is very evolutionary. It’s a work in progress.”Links:Mike Drues LinkedInFDA Website: CDRH Proposed Guidance’s for Fiscal Year 2023RAPS Article: FDA device center guidance priority lists targets COVID, digital health (RAPS, 18 October 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today’s discussion with guest, Mike Drues.Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn what Mike has to say about what EUAs are, what COVID has taught the market about EUAs, and what path FDA reviews are on now. Some of the highlights of this episode include:What an EUA is, and when it’s usedAn EUA as a pathway to marketWhat the COVID experience has taught us about EUAWhether FDA reviews are back to normalThe poor quality of some EUA submissionsQuality requirements for EUA vs. non-EUA devicesWhat’s new in EUAs beyond COVIDMonkeypox EUA developmentsImprovements in EUA qualities as submissions continueTop takeaways from today’s discussionMemorable quotes from Mike Drues:“One of the things I’ve learned in playing this game now for about 30 years is most problems that companies get into, not only are they preventable, they’re predictable.”“As a matter of fact, FDA estimates that 80% of submissions, 80% of EUA submissions, needed revisions, needed additional information.” “If you have experience doing these things, you’re going to be more successful. If you don’t have experience doing these things, that’s not a problem; you can’t be an expert at everything, but get somebody to help you.” “Don’t treat FDA as our elementary school teacher.” Links:Mike Drues LinkedInArticle: FDA wants COVID test developers to shift from EUAs to traditional premarket pathways (RAPS, Sept 27, 2022)Article: FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing (HHS, Office of Inspector General, Sept 2022) ReportCDRH Website: Monkeypox Emergency Use Authorizations for Medical DevicesArticle: FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicFDA Guidance: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyFDA Guidance: Transition 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? Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 1 hereMike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 2 hereEmergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know (GreenLight.Guru, April, 2020)Podcast: Tips For Being Prepared Post-EUA (January, 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient experience in collaboration with each other? These are some of the ideas you’ll hear about in today’s conversation with Daniel Kraft about the future of healthcare. Daniel Kraft is a Stanford and Harvard-trained Physician-Scientist innovator and investor with over 25 years of clinical, research, biotechnology, and entrepreneurial experience. He’s the Chair of Medicine at Singularity University and the founder and chair of Exponential Medicine. Daniel is Board Certified in Internal Medicine & Pediatrics and completed fellowships in hematology/oncology & bone marrow transplantation at Stanford. He’s also Faculty Chair of Medicine at Singularity University and Founder, and Chair of Exponential Medicine, a unique cross-disciplinary program that explores how rapidly advancing, convergent technologies can shape the future of healthcare. Advisor to several leading biomedical & digital health startups. He’s given six TEDx & TEDMED talks.Listen to the episode to learn more about how Daniel sees the need to start integrating across platforms to give doctors a more holistic view of the patient, the transition from “sick care” to healthcare, and what actions he thinks will help shape the future of healthcare. Some of the highlights of this episode include:Advice for developers on creating devices with a symbiotic relationship with other devices in the fieldWhat the future looks like for physicians when patients can do their own self-assessmentsWhether physicians are too hands-off and removing physical touch because of digital devicesHow to achieve cross-pollination among specialists in different medical fieldsPositive outcomes in digital health due to COVIDHow Daniel keeps tabs on a variety of different fieldsFinding unmet needs in the marketNew ways to engage with patientsActions to take for the futureMemorable quotes from Daniel Kraft:“Most every medical device can have some sort of digital layer to it.”“The future’s already here, just not evenly distributed.”“Lateral thinking means also just… trying new things and staying curious, but also sharing that with others.”“You don’t want a separate device or app for every medical condition, you kind of want one ring to rule them all and to make holistic sense out of this.”Links:Daniel Kraft's WebsiteDaniel Kraft LinkedInDaniel Kraft TwitterNextMed.Health EventData DonorMedTech DevicesDaniel Kraft's Venture FundDigital.Healthhttps://www.xprize.org/homeEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed?This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exemptions, how classifications do and don’t intersect with exemptions, and why some items are exempt.Some of the highlights of this episode include:The meaning of 510(k) exemptWhy “exempt” may not be the best wordWhat unregulated medical devices are calledClassifications don’t necessarily mean that a device is exemptComparing and contrasting Class I and Class IIThe difference between general controls and special controlsExamples of exemptions and why they’re exemptThe shades of gray in regulationThe regulatory logicMemorable quotes from Mike Drues:“An exempt device, whether it’s a Class I exempt or a Class II exempt device, it doesn’t matter, is still a regulated medical device.”“Instead of calling these special controls, we should call them specific controls.”“One of my frustrations with a lot of folks in this business is they just follow the regulations like a recipe, like a computer executing lines of code one by one without asking does this make sense?”“What is much much more important than the answer is the logic you use to get the answer.”Links:Mike Drues LinkedInCDRH Website: Class I and Class II Device ExemptionsList of Exempt Devices by regulation number (CDRH Website): Medical Device Exemptions 510(k) and GMP RequirementsWebinar: When do we need FDA’s permission to market our device and when do we not? (Nov 2020)Webinar: Special Controls: What are they, and how can we use them to our advantage? (May 2022)Webinar: Understanding the Medical Device Classification System (July 2020)Webinar: General Wellness Devices and Wearables (May, 2018)Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.Some of the highlights of this episode include:What regulatory strategy is and what it isn’tWhy a good regulatory strategy is so importantWhat competitive regulatory strategy isThe mistake of focusing on only one companyHow the EU MDR is affecting regulatory strategyWhat causes delays in complying with regulationsThe industry record on post-market surveillanceReimbursement and regulatory strategyMemorable quotes from Mike Drues:“Let’s not forget my old friend, competitive regulatory strategy.”“It’s never too soon, in my opinion, to start thinking about regulatory strategy.”“As a general rule, we have done an abysmal job on post-market surveillance across the board.”“I consider this whole thing to be a poker game, in every sense of the word.”Links:Mike Drues LinkedInHow to Construct an Effective Regulatory Strategy Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode.Mark Alpert is the Director of Quality at Greenlight Guru and has a background working for a Notified Body, and was most recently the Vice President of Business Assurance Division for TUV SUD America.Listen to the episode to hear what Mark has to say about how he uses a quality system as a competitive advantage, what companies should be doing after they achieve certification, and how a quality system connects to the business strategy of the company.Some of the highlights of this episode include:What ISO 9001 and ISO 27001 are and what they’re needed forThe challenges of going through the ISO processesWhat happens when a company achieves certificationThe disconnect between business strategy and quality managementHow to overlap systems or create strategic alignmentWhat to include or not include in an auditHow having a quality management system drives continuous improvementPitfalls that companies get to once they get the certificationAdvice for other companies going through this processMemorable quotes from Mark Alpert:“What drew me to Greenlight was the fact that we weren’t certified.”“Achieving (ISO) certification is not the destination. It’s the beginning.”“It’s quality management, but it’s business management.”“If you’re looking at your processes and you think everything’s under control, create the gap.”Links:Mark Alpert LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with Scott Carson on the future of buying and selling used medical devices.Scott has been in healthcare marketing, business development, sales, and management experience for more than 30 years. He was on the team that built the eBay Healthcare Marketplace structure and founded US Medical, Inc., the first Internet distributor of new and pre-owned capital medical equipment to the healthcare industry. Although he started US Medical in his basement, it became a member of the Inc. 500 five years later. Listen to the episode to learn about what’s accelerating the market for used medical devices, what the future of reprocessing used devices will look like, and what facilities already working towards reprocessing devices should be thinking about. Some of the highlights of this episode include:Why the medical devices may now be keeping up with online communitiesThe impact online medical devices sales has on regulatorsThe scope of medical healthcare devices on eBay vs. AlibabaThe path forward for early-stage manufacturing companiesHow manufacturers should think about the entire life cycle of devices, including resaleHow to think about the used market from a global standpointWhat practical regulation to curb the bad actors in the market would look likeMemorable quotes from Scott Carson:“Probably the single biggest accelerant was actually the pandemic.”“The entire worldwide community is completely flatfooted and stuck and not even aware what’s occurring – in my view doesn’t even understand what’s occurring and how they’re going to start to regulate this.”“eBay is mostly what we call – and you may know this phrase – spray and pray. Spray with Windex and pray that it works. And that is not a regulated process.”“I think manufacturers need to change their position and think about the profitability of maintaining and supporting that through the (online) channel and the life of the product in the (online) channel.”Links:Scott Carson LinkedInPowered by MRPEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Today’s episode features Chris Beddard, VP of US Marketing at BD. She joins the podcast today to discuss a product she and her team have been working on to improve the lives of women. Chris is passionate about bringing awareness about health options to women around the world. Listen to the episode to hear what Chris has to say about why the test she’s been working on is special, what kinds of challenges a team faces when developing these tests, and why cervical cancer screening is so important. Some of the highlights of today’s episode include:What BD is doing and how Chris is working with itHow to go about choosing specific treatments to targetWhat makes the current test specialCervical screening focus on women in AfricaChallenges in developing testsWhy cervical cancer screening matters so muchThe ongoing impact of the pandemic on testingAdvice for medical health professionals in the process of long-term developmentMemorable quotes from Chris Beddard:“Extended genotyping provides different information, information that’s critical to a clinician to basically manage a woman’s risk for developing cervical cancer or precancer.”“In order to get all three testing paradigms approved through the FDA, there was an extensive clinical trials that did take place, again spanning many years.”“HPV is the most common sexually transmitted infection in the United States.”“We’re seeing women returning to testing; we’re seeing –again –our view of healthcare changing based on the pandemic.”Links:Chris BeddardBDEtienne Nichols [email protected] Excellence CommunityGreenlight Guru AcademyGreenlight Guru

What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies.Kari Haab has been working in the medical device world for over 10 years. She’s a part-time mentor in residence at Western Michigan University and a Partner with Cantilever Business Partners, and an independent consultant for start-up organizations. Prior to this role, she was Vice President of Product Strategy, at Aquaro Histology. Kari has implemented quality management systems and led the launch of products through development, clinical trials, FDA and CFDA approval, and marketing campaigns during her years in the field. Listen to the episode to hear what Kari has to say about discovering the market fit for a device, overcoming the “bias of technology,” learning how to apply critical feedback to improve your product, and filling out the customer ecosystem.Some of the highlights of today’s show include:The process for customer discoveryThe most successful team or approach for customer discoveryWhat customer discovery for a client looks likeHow to handle technology looking for a problemBiases that Kari sees most prevalentlyRecommendations for looking at market fitThe process to establish user needsHow to start filling out the ecosystem to consider all the people involvedLinks:Kari HaabCantilever Business PartnersEtienne Nichols [email protected] Excellence CommunityGreenlight Guru AcademyGreenlight Guru

There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. Kyle Rose joins the podcast today to talk more about it. Kyle is the President of RookQS and works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Listen to the episode to hear what Kyle has to say about the EUA transition deadline, the potential uses for the EUA going forward, and what companies should focus on if they only started selling medical devices during the EUA.Some of the highlights of today’s show include:Whether there’s an EUA transition deadline yetWhat EUA companies need to be doing right now on the quality side of thingsWhat the EUA transition will look likeHow adverse events need to be documentedThe potential for the EUA as the norm in certain situationsWhat to focus on for companies that started with a non-med device then got into the EUAWhat happens if you go past the 180 daysMemorable quotes from Kyle Rose:"This is going to end, and companies have to figure out what to do to go back to their traditional regulatory path for their device or their expansion of labeling and use to maintain compliance.""You need to start working on this before phase three.""From phase one to phase two is 90, from phase two to phase three is 90, and then phase three it says 180 days after implementation.""If you’re going to build your quality system, I would definitely say you can apply with both FDA and ISO."“If you have submitted, and it goes past the 180 deadline into phase three, you’re still able to sell as long as you’re under review."LinksRook Quality SystemKyle RoseFDA Guidance DocumentFDA Webinar SlidesEtienne Nichols [email protected] NationGG AcademyGreenlight Guru

What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Today’s guest, Karandeep Singh Badwal, is a Regulatory Affairs Quality Consultant who is well-versed in EU MDR, and regularly works with medical companies producing Class I, II, and III medical devices.Listen as we talk about what a quality management system is and what the goal of a QMS is, the importance of validating software, and the differences between AI and machine learning, among other things. Some of the highlights of this episode include:A quality management system is a structured system of procedures and processes covering all aspects of design, manufacturing, supply, risk management, management responsibilities, customer-related processes, corrective actions, and preventative actions.Quality management systems come in several forms.There are differences for QMSs at SaMD companiesValidating software means making sure it can do what needs to be done and produces consistent resultsIssues or shortcomings that SaMD companies have with validatingFor SaMD, intellectual data that you’re storing on your servers could be considered customer property and needs to be addressed in your QMSIt’s important to define specific roles and responsibilities for when the person ordinarily responsible for that role isn’t available.The differences between AI and machine learning: AI basically mimics human behavior. Machine learning is more like a neural network.Memorable quotes from Karandeep Singh Badwal:“That’s one mistake that a lot of these software as a medical device companies are making. They just validate their own software.”“Basically, what I’m looking for is evidence to prove you’ve done what you said, basically.”“Customer property is one that I see a lot of Software as a Medical Device companies not addressing effectively.”“Software as a Medical Device companies don’t realize that the software platforms they use are suppliers, and those need to be controlled.”“The whole point of an internal audit is you want someone who’s independent.”Links:Karandeep Singh Badwal's LinkedInKarandeep’s YouTubeMedTech PodcastEtienne Nichols [email protected] Guru AcademyMedTech Excellence CommunityGreenlight Guru

What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but it’s an important part of the process and impacts product development more than you may think at first.Orla Connaughton joins the podcast today to discuss design assurance with Etienne Nichols. Orla began as a mechanical engineer and has a Master’s degree in Project Management. She has 18 years of experience, mostly working in the medical device sector, and has worked at a Senior Management level for both multi-national and start-up organizations. She’s been running her own company, Aztek Medical, for over 8 years. And she has a lot to say about design assurance.Listen to the episode to hear the conversation as they discuss what’s involved in design assurance and why it’s so important. Orla shares how her thoughts on the scope of the design assurance process are related to The Lion King and how design assurance “packs the parachute” for the overall product design process.Some of the highlights of this episode include:Orla explains what’s involved in design assurance and why it’s required. Global regulations require that a product is developed in a specific way and that there’s evidence that the project is developed that way. A working prototype is a great thing to have, but it’s only a starting point.Design assurance personnel have to be able to touch all the different processes and regulations. Orla explains that design assurance involves understanding the basic quality system standards and regulations, to product-specific standards, clinical investigations, and more.There are no college programs that lead to a career as a design assurance professional. These positions want a technical background with a high level of understanding of many different types of products and roughly 5-10 years of relevant work experience in the area. The position also requires a level of creativity.Although there’s no degree program leading to quality assurance, it’s often done as a module of a regulatory-type qualification, so it can be taught to people who are interested in learning the concepts.Design assurance packs the parachute for the product design process by putting the pieces together in order to tell a cohesive story to the regulators that allow the device to get approved. People may not see design assurance up front, but they’re serving a vital function in the process.Design assurance is a valuable process and skillset in its own right. It’s part of the big picture. Memorable quotes from Orla Connaughton:“Having a working, functioning prototype is great, and of course, it’s required, and it’s a great starting point, but really that is what it is – it’s a starting point.”“Once you have a good technical solution, at that point, you should implement your design controls and start creating your documents and start releasing your procedures through this control process.“What I really think makes a good design assurance specialist is the mindset element.”“I think quite often creativity is not a trait that’s recognized with quality type professions, but really it’s very valuable in these situations.”“The design assurance person is your quality engineer of the R&D process.”Links:Orla ConnaughtonAztek MedicalEtienne Nichols [email protected] Guru AcademyMedTech Excellence CommunityGreenlight Guru

What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you know what it is if you encounter it? In today’s episode of the Global Medical Device Podcast, we have a wide-ranging conversation with Mike Baca about the lessons we can learn from him as an industry leader and about the long game involved in a MedTech career. Mike is currently the president of White Rook Consulting, and he has more than 38 years of experience as a quality professional working with medical devices, including classes I, II, and III. He worked in a variety of quality roles for Johnson & Johnson, Medtronic, and Stryker before starting his own independent consulting firm. Today’s conversation covers a lot of ground, including the three phases of Mike’s career, how understanding VULCA can help you handle a black swan event, and how adopting a set of principles and values will guide you through challenging times. We also discussed “badge on the table” situations, speaking the language of other departments, and working through and getting rid of imposter syndrome. Some of the highlights of this episode include:The tough moments that medical device professionals are going to face: There’s the unique issue that the work they do will impact someone in the most personal way possible. The languages of other businesses and how Mike learned to navigate thatMike’s definition of a mentor: not an advocate, not a sponsorThe three segments of Mike’s career: Learning, Contributing, Returning How Mike might hold the record for most 483sHow to process the black swan moments without breaking down emotionally: accepting that you acted in accordance with your principles and valuesWhat VUCA means and how to approach it: Volatility, Uncertainty, Complexity, and AmbiguityThe differences between ego and self-confidenceMemorable quotes from Mike Baca:“It’s my responsibility to do everything I can to make sure that everything I’m responsible for is done the best that it can be so that outcome is going to be favorable to that ultimate patient who is going to have the device used on them.”“If you see something that needs to be fixed, something that can be improved, seek that out.”“As a leader, you should consider adopting a set of absolute principles that define how you will lead and how you will be.”“If you’re going to delegate something, you need to be willing to stand behind, but when you delegate, you need to delegate at a level that failure will not be fatal to the business or that individual. Because guess what? Sometimes they’re going to fail.”Links:Mike BacaEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and rejections. It only takes common sense and simple solutions to overcome these issues.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about common 510(k) mistakes and how to avoid them. They also cover what has changed (if anything) in the past five years since Jon wrote the article, 7 Common Mistakes That Sink FDA 510(k) Clearance.Some of the highlights of this episode include:Mistake #1 - Inconsistency with Documentation: The intended use statement often is inconsistently put into other sections of the 510(k). It’s important to understand the difference between indications for and intended use.Mistake #2 - Not Using Checklist: The FDA’s 510(k) submission guidance provides a Refuse to Accept (RTA) checklist. Help yourself and reviewers out. The FDA states what it is going to do and what it wants, so there should be no surprises.Mistake #3 - Not Providing All Expected Testing: The FDA rarely accepts promissory commitments to do sterilization, validation, or biocompatibility testing later. Also, you should include protocols, results, and reports to verify rigorousness of testing.Mistake #4 - Not Doing Real-time Shelf-life Studies: FDA wants evidence to back up claims of stated shelf life and wants a correlation between real-time and accelerated aging data. Shelf life is what happens to your product in the future.Mistake #5 - Underestimating Risk Management Requirements: Show list of requirements and provide the paper trail for your traceability. The FDA needs to conclude that your product is safe and substantially equivalent to a predicate.Mistake #6 - Not Demonstrating Equivalence with Predicates: You need to depict your device as novel and unique, but not so different that the FDA thinks your predicate is not a good example.Mistake #7 - Formatting Submission Incorrectly: Include page numbers and an eCopy. Also, the size of the file matters and needs to be named according to conventions.Memorable quotes from this episode:“The intended use statement is a pretty important premise for any 510(k) submission because for all intents and purposes, that statement helps regulators and helps you determine how your product is ultimately going to be classified.” Jon Speer“One of the most common reasons why they are rejected is because the high-level labeling when it is repeated is not repeated exactly the same way.” Mike Drues“Intended use focuses on the device. Whereas, indications for use focuses on the patient.” Mike Drues“The RTA checklist was intended to be a tool for the FDA reviewer, when submission received, for them to go through and make sure all the constituent parts and components and what is expected to be in that submission is included.” Jon Speer“FDA reviewers see probably dozens, maybe hundreds of submissions in a finite period of time. Some are better than others. Well, make yours standout. Make yours easier to read.” Jon SpeerLinks:7 Common Mistakes That Sink FDA 510(k) ClearanceFDA - 510(k) Submission Process7 FDA Pathways to Bring Your Medical Device to MarketCenter for Devices and Radiological Health (CDRH)ISO 14971Mike Drues on LinkedInVascular SciencesGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process, especially when researching clinical evidence? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Keith and Kevin Kallmes of Nested Knowledge. Following in the footsteps of their father who was a medical device inventor, the two brothers designed and developed a balloon catheter that was acquired by a major strategic. Some of the highlights of this episode include:Keith and Kevin focus on clinical, regulatory, and publication consulting in the data management/data analysis services industry.Like other entrepreneurs, Keith and Kevin understand the importance of central clinical outcomes data in every stage of the medical device development process for a product rooted in an unmet clinical need.Engineers tend to focus on the immediate task at hand. Entrepreneurs have to consider why startups succeed or fail. Rather than fixating on money, the biggest reason devices fail is a lack of product market fit.Companies should look at the science before the development. Examine clinical evidence, decision-making, prototyping, and design controls.Customer Discovery: Read literature and talk to clinicians about needs. They are on the frontlines of patient care and research-capable.To find scientific evidence and outcomes, search for different articles and filter/screen the articles to know when you have enough relevant information.Calculate risk, know timelines, perform tests, and document design history accurately or start the design process over and learn an expensive lesson.Which evidence is leading to which decisions? Share and manage evidence to make sure it is usable and effective. Memorable quotes from this episode:“You really realize how central clinical outcomes data are to every stage of the medical device development process.” Keith Kallmes“It’s looking at clinical evidence and convincing end users and purchasers that your device is worth the cost.” Keith Kallmes“You should be making good decisions and good decisions should pre-exist everything in the development landscape. Design controls should come only after you’ve basically validated your need and you’ve prototyped enough that you know that you should continue.” Kevin Kallmes“Lack of product market fit - that’s why devices fail. They’re not addressing an unmet need in the marketplace.” Keith Kallmes“Start your design controls at concept.” Kevin KallmesLinks:Keith Kallmes on LinkedInKevin Kallmes on LinkedInEtienne Nichols on LinkedInNested KnowledgePubMedFDA - Medical Device OverviewISO - Medical Device TestingGG AcademyMedTech NationGreenlight Guru

What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech. Duane has experience in go-to-market strategy, including regulatory and reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design and execution. He has developed a comprehensive understanding of what early-stage startups need to do to be successful.With all of the complexities of running a medtech company and taking a product to the market, Duane has seen a huge variation in how startups develop strategies and milestones. In this episode, we discuss how early decisions impact other aspects in the future and how companies can create a blueprint to build and grow long-term.Some of the highlights of this episode include:Fundraising: Figure out who you want to raise capital from, what should be in your pitch deck, and what questions will investors ask about problems/solutions.When trying to raise money, startups need to know that there are three types of investors—good, neutral, and bad. Sometimes, bad investors are hard to spot.When considering acquiring a company, some of the top things strategics look at is how you capture more clients, build your team, incorporate a quality management system (QMS), and handle regulatory challenges.If you are selling products to a hospital system, you will need to check three things—physician/clinician (especially nurses) ownership, patient improvement, and economic benefit.Build, develop, and invest in your team by finding people who complement your weaknesses. Don’t be afraid to fractionalize. One of the most important thing you can do for your company is to find advisors, partners, and mentors with large professional networks.When people are raising money, unless you are raising from a high net worth individual or angel group, be strategic with who you want to raise money. Venture Capitalists have a responsibility to spend (invest) their money just like you have a responsibility to raise it.Clients need to understand that regulatory fits into their business, clinical, reimbursement, and commercialization strategies—all those things work together and overlap, so make sure to ask the right questions to the right expert.Memorable quotes from Duane Mancini:“The #1 thing we try to tell all of our startups when they’re going out to raise money is there’s three types of investors. There’s good, neutral, and bad. You really want to avoid bad.”“For those first few investors, you want to find a good investor. Someone who’s going to bring something else to the table. Fill a knowledge or network gap that you don’t have. Understand what your mission is for the company and how they are going to support it.”“We talk to a lot of investors and a lot of entrepreneurs, and the one thing we’ve learned is that there is more than one way to raise money. However, there are patterns.” “Regulatory fits into your business strategy, fits into your clinical strategy, fits into your commercialization strategy—all those things work together and overlap.”Links:Duane Mancini on LinkedInProject MedtechProject Medtech PodcastEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - 510(k) ClearancesFDA - Premarket Approval (PMA)Build by Tony FadellGG AcademyMedTech NationGreenlight Guru

The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practices.Jeff has 25 years of experience in the medical device industry, specializes in getting new devices to market, and scaling your commercialization. He has extensive knowledge and understanding of ISO 11607-1 & -2, Packaging for Terminally Sterilized Medical Devices.Some of the highlights of this episode include:Sterilization validations/revalidations take a lot of money ($40,000-80,000) and a long time (16-20 weeks) to complete.Don’t underestimate labeling - 40% of FDA recalls are due to labeling. Make sure your CM has good labeling controls.Over a third of all package validations fail the lab test for transit. The biggest reason why companies fail packaging validation is not understanding the various shipping modes and their related testing.ISO’s 11607 standard has two parts: Part 1 is about designing the package; Part 2 is validating the package. Also, there is a guidance document due to the complexity of the packaging process.The criteria for filing a 510(k) and steps related to packaging include validating that the seals are good from a sterile barrier standpoint and the product is good and has not changed over time because of transit testing or aging.From a design standpoint, document how the package has been designed and meets customers’ needs. Recently, the FDA added user testing to the standard for sterile transfer.Feasibility testing of prototypes and samples of vibration, drops, and humidity should be conducted to prevent potential problems. Ask engineers about product changes and the risks for redesign of packaging to know if the package will fail or pass.Memorable quotes from Jeff Barrett:“The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There’s two parts to it, Part 1 and Part 2. Part 1 is all about designing the package and Part 2 is about validating the package.” “Over a third of all package validations failed at the lab for transit. It’s staggering.” “Less so do we see damage to the product itself. So, I’d say, 8 out of 10 times on these failures, it’s the product and the seal failing, not the product breaking.” “One of the biggest problems we see is, (the FDA) they don’t do any validation. They say, ‘We’re going to do it later.’ That’s obviously a problem. You can’t market the product if the package hasn’t been validated. That’s why the FDA gives you a break on that.”“The bottom line is you’re trying to maintain the product without getting damaged and without the sterile barriers getting damaged. That is the end goal.”Links:Jeff Barrett on LinkedInJ-Pac MedicalEtienne Nichols on LinkedInISO 11607-1ISO 11607-2ISO 13485ASTM InternationalFDA - 510(k) ClearancesGG AcademyMedTech NationGreenlight Guru

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.Some of the highlights of this episode include:When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.Competition: When most medical devices are being developed, there is intent. Either it’s a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations. Memorable quotes from Chris Parker:“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It’s otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”“A lot of devices, when they are being developed, you’re doing it with intent in mind. Either it’s a completely novel, new idea or you saw a product and you said there’s a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”“Let’s try to keep out anything of potential concern that we can at any concentration.”Links:Chris Parker on LinkedInLabcorpEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact SkinISO 10993-1:2018 - Biological evaluation of medical devicesProposition 65European Union Medical Device Regulation (EU MDR)Medical Design and Manufacturing Event (MD&M West)GG AcademyMedTech NationGreenlight Guru

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year after year.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about whether your medical device company’s CAPA process needs a CAPA. Why are medical devices companies continuing to struggle with CAPAs?Some of the highlights of this episode include:Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or FDA. People tend to report every little event as a CAPA or report nothing at all. The five most common reasons why the FDA issued 483 observations and warning letters over the last 5 years were CAPAs, customer complaints, purchasing controls, medical device reporting, and process validation.If CAPA is the #1 reason why companies are getting 483 observations and warning letters, it may be due to an ineffective quality management system (QMS).Things happen every day during the course of running a business. Processes and routines may not go routinely. When something happens unexpectedly, will it happen again? What are you changing to ensure it does not happen again?CAPAs continue be the #1 reason because people do not have a common sense understanding of the quality system regulation. They focus on the words, but do not try to understand the meaning.CAPAs often generate negative connotations—the process requires extra work and more resources, not in the budget, and time pressure. However, people should view CAPA’s as an opportunity to improve a product and prevent problems in the future. People do not follow procedures because sometimes they don’t even know that procedures exist, or those procedures are not updated/revised after events.Memorable quotes from this episode:“A CAPA is an opportunity to really do a deep dive investigation to determine, is there a systemic issue that is influencing that process that you are following?” Jon Speer “People don’t focus on the common sensical understanding.” Mike Drues “Unless regulation makes sense, I don’t care what the regulation is, unless it makes sense, it is not good regulation.” Mike Drues “Part of going through the CAPA procedure is to identify the root cause of the problem.” Mike Drues “Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or to the FDA.” Mike DruesLinks:FDA - Corrective and Preventive Actions (CAPA)FDA - Form 483 Observations and Warning LettersFDA - Medical Device OverviewInternational Medical Device Regulators Forum (IMDRF)ISO 13485 CAPA21 CFR Part 820Mike Drues on LinkedInGreenlight Guru AcademyGreenlight Guru CommunityMedTech NationGreenlight Guru MedTech Lifecycle Excellence

What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and differences, as well as the four quadrants of UDI that companies need to be aware of? Don’t underestimate your time to comply because it always takes longer than expected.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Gary Saner, Senior Manager of Information Solutions for Life Sciences at Reed Tech, about UDI and the current state of global implementation.Gary has been helping companies achieve UDI compliance on a global scale for years.  He is considered to be a thought leader and recognized authority on medical device UDI compliance.Some of the highlights of this episode include:As the U.S. FDA Class I UDI deadline approaches, companies should refer to the FDA’s final guidance, which describes the compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.Delays seem to be a part of the history of UDI. Manufacturers face challenges and pitfalls from UDI being rolled out easily. There are a number of issues with the brand new requirement in the United States.The four quadrants of UDI are identifying a product, reprocessed/reused products, reporting attributes, and documenting standard operating procedures (SOPs) in a quality management system (QMS).The EU has a complicated UDI implementation schedule, as well. Delays have been announced, but the impact was due to the European Commission completely revamping the regulatory platform. In Europe, UDI becomes one of the many things that a manufacturer has to learn, be educated on, and respond to. There’s no grandfathering of products, notified bodies, and patients. Portfolios are re-evaluated to meet new regulations.With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some health authorities around the world base their policies on one or the other. However, good global harmonization is not in place.Memorable quotes from Gary Saner:“This is a challenge in that this particular dataset has never really been assembled before. So, there’s no precedent for this.”“The other issue is sometimes you find the data and it’s not accurate or it hasn’t been touched for a while. It’s not current. It’s obsolete. There’s issues with formatting. Sometimes, the formatting of that data that’s held for internal processes is not the format that actually gets submitted to the FDA.”“There’s a little bit of a nuance about making sure the acknowledgements that come back from CDRH, there’s three acknowledgements, and making sure that they’re all complete for every single record.”“UDI becomes one of the many things that a manufacturer has to learn and be educated on and then respond to and there was no grandfathering of products.”“With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some of the other health authorities around the world will kind of base their policies on one or the other - US or EU.” Links:Information Solutions - Life Sciences at Reed TechGary Saner on LinkedInThe Ultimate Guide to UDIFDA - Unique Device Identification (UDI) SystemFDA - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain DevicesCenter for Devices and Radiological Health (CDRH)European Union Medical Device Regulation (EU MDR)EU In Vitro Diagnostics Regulation (IVDR)EUDAMEDGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru MedTech Lifecycle ExcellenceGreenlight Guru YouTube ChannelEtienne Nichols on LinkedIn

How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access?   In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Joe Mullings, chairman and CEO of the Mullings Group companies, about finding true quality talent and celebrating excellence and hyper-competency to make lives better. Joe’s search firm is responsible for more than 8,000 successful searches in the medtech/healthtech/life sciences industry. DragonFly Stories produces attention and awareness campaigns for companies globally through TrueFuture. TMG360 Media utilizes the power of media and outreach in medtech/healthtech to move businesses and health forward.Some of the highlights of this episode include:Quality of Outcome vs. Opportunity: Organizations are realizing that it’s much more expensive to lose and replace a good player rather than retain a good player. The quality and output of an employee’s work matters.Networking should occur when you don’t need it. Be clever, bring value, give and not take, and create a brand around yourself.The workforce and global economy has changed because of the worldwide pandemic. Things are starting to settle down, and it’s time to reset, re-define, and re-evaluate employees’ responses to work and fulfillment.WFX: Where are employees willing and wanting to work—from home, anywhere, or in the office—and how does that affect organizations’ willingness when it comes to compensation, flexibility, and the networking process to retain talent?Two-way communication between workers and employers needs to be created to find balance and reduce friction for healthy relationships. The catalyst for people switching or leaving their jobs is to make more money. However, top performers want to move forward in their career from their own developmental perspective and grow their skills.The non-negotiables of working in the office or not depends on your degree and years of experience. If you’re new, it’s best to work in the office to learn and mimic others. Then, it depends on your job function.The best way to represent yourself in the marketplace is based on your behaviors and how you package yourself when appearing in front of others.Memorable quotes from Joe Mullings:“We are the #1 search firm in the world, first of all, in the medical device/healthtech industry with more than 8,000 successful placements over three decades.”“Compensation, right now, is also being driven by supply and demand.”“You’ve got better career choices now, and you’ve also got the ability to live, potentially, a better life.”“Let’s keep a better balance of power in the workforce instead of it being futile in nature where the companies call all the shots.”“The digital scales your idiocy as well as your competency equally.”Links:Joe Mullings on LinkedInThe Mullings Group - TMG SearchTMG360 MediaDragonFly StoriesTrueFutureOut of the CrisisEtienne Nichols on LinkedInGreenlight Guru AcademyGreenlight Guru CommunityMedTech NationGreenlight Guru

What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Rahul Kallampunathil, Vice President of Arbour Group’s Digital Compliance practice, about digitizing your SaMD testing.Rahul builds teams that help companies proactively manage compliance risks toward a true digital enterprise. He is an innovative thinker with more than 18 years of experience in risk management, compliance, and internal controls focused on information technology and data. Some of the highlights of this episode include:Rahul defines SaMD as software used to perform a medical purpose without being part of a hardware medical device. SaMD is capable of running on any general purpose platform, such as your Android or iOS mobile phone.SaMD is different from software in a medical device (SiMD). SaMD is independent from hardware; SiMD is embedded in a physical medical device.Also, there’s differences between SaMD and medical device data systems (MDDS). MDDS only transfers, stores, or displays medical device data, but it does not have an algorithm or business rule to help make medical decisions.IEC 62304 impacts SaMD organizations and how they approach the risk of their solution. All SaMDs are not equal, and it’s important to understand the level of risk in every SaMD.Companies should prepare for SaMD testing with a clinical evaluation to demonstrate a valid clinical association between SaMD’s output and targeted clinical condition.Before thinking about designing and developing a product, a quality management system (QMS) should be established. Software companies need to adopt and modify their QMS to serve their product and its users, while fulfilling FDA requirements.Rahul discusses the pros and cons of manual versus automated/electronic  documentation and testing, including risk management for patient safety.Best practices for SaMD testing are using agile and devops methodologies. Potential pitfalls are not testing continuously, even after the product is on the market. Memorable quotes from Rahul Kallampunathil:“Software as a medical device - it is software that is intended to be used for a medical purpose, and it performs that purpose without being part of a hardware medical device.”“There is no physical device, in this case, that you can touch and feel. It’s purely software.”“The nature of software - it’s something that you cannot touch or see. It’s all code. From a testing perspective, especially, there’s a lot of things that you need to pay attention to.” “The quality management system or quality management process, that has to be established even before you think about the product, even before you design the product.”Links:Rahul Kallampunathil on LinkedInEtienne Nichols on LinkedInArbour Group LLCFDA - SaMDFDA - Medical Device Data Systems (MDDS)FDA - CybersecurityIEC 62304International Medical Device Regulators Forum (IMDRF)Greenlight Guru YouTube ChannelGreenlight Guru CommunityGreenlight Guru AcademyMedTech NationGreenlight Guru

After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA’s Refusal to Accept (RTA) policy and guidance. Some of the highlights of this episode include:After the FDA receives a 510(k), De Novo, Pre-Market Approval (PMA), or any other submission, the 2-step process is to conduct an administrative and then a substantive/scientific review.If a submission is rejected on the administrative review, it is completely the company’s fault, not the FDA’s. If the substantive review is rejected, however, there’s room for negotiation with the FDA.Most of the FDA’s acceptance checklists have been available for more than a decade, but companies submissions are still commonly rejected on administrative review.Electronic tools and software platforms, such as eSTAR, are supposed to help and facilitate the preparation process of submissions. The problem is, this is contingent on what information is entered.Potential hangups for companies using tools like eSTAR for the submission process are that they do not evaluate the quality of the content entered. That said, they do require a Table of Contents and the use of most current forms.Never leave any sections of your submission blank. At the very least, enter Not Applicable (N/A) and explain why - or risk the FDA rejecting the submission. It’s a company’s responsibility to make sure the FDA understands their device.The draft guidance documents have been published for a reason - don’t ignore them and risk a rejection for what could easily have been avoided. Memorable quotes from this episode:“If a submission gets rejected on an administrative review, that is 100% the company’s fault, it is not FDA’s fault.” Mike Drues“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer“I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues“One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike DruesLinks:How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)Guidance: Refuse to Accept (RTA) Policy for 510(k)sGuidance: Acceptance Review for De Novo Classification RequestsGuidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)Acceptance Checklists for 510(k)sMedical Device User Fee Amendments (MDUFA)FDA - Voluntary eSTAR ProgramWhat is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required - especially when there is the potential for personnel to resist change? In this episode of the Global Medical Device Podcast, Etienne Nichols discusses lean QMS implementation with Steve Gompertz, a leader in quality systems management with more than 30 years of experience in the medical device/technology industry. Some of the highlights of this episode include:Guerilla tactics for quality leadership that involve thinking outside of the box and trying to get things done without asking for permission from authorities. Sometimes the FDA unintentionally creates fear and creates imaginary boundaries in people’s minds that stifle their creativity.People will struggle and become frustrated when working with a burdened QMS and restrictive standard operating procedures (SOPs).The regulations and standards are intentionally vague and open to interpretation because it’s not possible to have a one-size-fits-all. Meet the intent of the requirements and be ready to defend them.Lean documentation is the best approach. Weed out the things you don’t need. In a regulated or unregulated space, it’s better to have clear, precise, and intentional documentation rather than a pile of papers.Sometimes regulations and standards create negative opinions because it’s human nature to not want to be told what to do. However, what is their purpose? To produce safe and effective medical devices while also turning a profit.Approaches to implementing guerilla tactics include burying or sneaking something in without calling it what it is and getting people to do the right thing without them always knowing they are doing it.Make sure your metrics don’t incentivize the wrong thing. Some companies measure document control in QMS based on time—how fast it takes to make changes? But does that actually make the process more effective and cost less? More likely, it incentivizes cutting corners.Steve recommends shifting your mindset about document control or value-added changes by first defining the problem correctly. Don’t make assumptions.Memorable quotes from Steve Gompertz:“The regs and the standards aren’t actually that specific too often. They are intentionally vague. Sometimes, that is a point of frustration with people. But when you think about it, they have to be.”“Step back, stop just reading what the words say, and start thinking about why are they there?”“When you create a quality system, you have to think about the architecture.”“If it isn’t documented, right, it didn’t happen. If it’s not documented right, things are going to go bad.”Links:Quality & Regulatory Consulting - QRx PartnersAsk Me Anything Session with Steve GompertzISO 13485FDA - Guidance Documents (Medical Devices)21 CFR Part 820 - Quality System RegulationThe 7 Habits of Highly Effective People by Stephen R. CoveyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and increased costs are leading to diminished returns. What are specific tactics that MedTech companies can take to develop their sales process?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Omar Khateeb about preventing the death of medical sales with new data that shows where you can find prospective buyers for your medical device products.Omar is the founder of Khateeb and Co., which helps MedTech companies grow sales and drive product adoption through social media and content.Some of the highlights of this episode include:Omar describes the death of medical sales as the death of an old way. The world has changed and buyers in every industry have become more sophisticated. Social media content now influences buying decisions.Rather than unscheduled clinic and hospital visits with physicians, Omar describes the new way of medical sales as liking, commenting, and resharing their content.LinkedIn and other social media channels are powerful for communication and influence. The real value is building thought leadership and creating attention-getting content to persuade someone to meet with salespeople.Companies need new categories or different ways of doing something. A marketing campaign should include: What problem do you solve? Who do you solve that for? How are you solving it in a unique way?Be as specific as possible because your message needs to resonate with specific people. If you can’t satisfy one specific person, how can you satisfy an entire market? The riches are in the niches.There are pitfalls that some people and companies get into when utilizing a social media approach on their own. Spend more money to buy time. You can always make your money back, but you cannot get your time back. Memorable quotes from Omar Khateeb:“How the buyer’s journey for everybody, not just doctors, has become more sophisticated.”“We should be selling and marketing to physicians and hospitals using social media.”“You shouldn’t be posting stuff about your product as a salesperson.”“The riches are in the niches.”“I help medtech startups drive technology adoption and gross sales using social media.”Links:Omar Khateeb on LinkedInThe Death of Medical Sales: Igniting a New FutureUpending the Medtech Sales ModelAlex Hormozi on LinkedInGeoffrey MooreGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, director of product security at Velentium, about the shifting sands of medical device cybersecurity regulations for SaMD. Some of the highlights of this episode include:Chris views the FDA’s recent activity around cybersecurity requirements, regulations, and laws for SaMD as a necessity because manufacturers cannot seem to self-regulate. The Protecting and Transforming Cyber Health Care Act (PATCH) will give the FDA a direct mandate to manage the cybersecurity of medical devices.However, a clause in the PATCH Act allows for cybersecurity to extend to all existing legacy medical devices—not just new devices entering the market.As medical device manufacturers (MDMs) become aware of the clause, it’ll have a huge impact. MDMs will likely end support for device lines due to high costs. The biggest issue with the new guidance consensus vs. regulatory standards is alignment with software bill of materials (SBOM) tools.The most effort-intensive part of the new draft guidance is ongoing testing of anomalies to determine if they can be turned into vulnerabilities. The industry will be unable to keep up with additional testing because of resources and demand.All this added burden will be placed on MDMs at the cost of marginal improvements in cybersecurity. So, there’s no real benefit to the manufacturer.Structure a standard by not creating something brand new that is ill/undefined but align best practices to create secure medical devices.Memorable quotes from Chris Gates:“Legally-backed cybersecurity requirements by a regulatory agency are necessary to ensure secure devices are entering the marketplace and hopefully replacing the insecure legacy devices.”“This clause is going to have a huge impact on medical device manufacturers (MDMs) and I find it amazing how many MDMs are completely unaware of this.”“An SBOM is a software bill of materials. It’s an ingredients list for your application.”“This isn’t just one-and-done testing in your life cycle.”“You’re going to have a lot of extra work coming your way.”Links:Medical Device Cybersecurity for Engineers and ManufacturersRegulations (Submit comments to the FDA)Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsPATCH ActInternational Electrotechnical Commission (IEC)ISO (International Organization for Standardization)International Medical Device Regulators Forum (IMDRF)Chris Gates on LinkedInChris Gates EmailGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling medical devices in today's market...and there's a new revenue intelligence tool to help you bridge the gap.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Skylar Talley and Mark Mescher from MedScout, a territory prioritization and sales enablement platform.Skylar and Mark discuss early stage territory planning to get more medical device sales, different aspects of go-to-market strategies, and building and demonstrating meaningful value by understanding pain points. Some of the highlights of this episode include:Tools have evolved and MedScout’s platform is a huge step forward. Basically, it brings an Excel spreadsheet to life, maximizes territory data, and is very intuitive and useful for sales reps to understand.Skylar has observed an evolution from frameworks/methodologies on the market based on geographic coverage to put numbers, early sales, and clinical proof-points out as fast as possible and leverage an early budgeted staff.Companies should start thinking about territory planning early on during the fundraising phase to benefit the commercialization and purchase processes.Skylar describes the 3-stage early commercialization roadmap strategy as getting the product into market, developing case studies and understanding where to take them, and knowing the distribution or rep model to execute.Relationships are vital early on with the development and commercialization of a medical device company. Physicians educate and innovate, just like engineers.Skylar and Mark agree that it’s worth being thoughtful when evaluating available solutions to make sure they are not adding time to your managers and reps.Marketers find and generate leads through interesting means, so there’s much better coexistence and co-creation between sales and marketing teams today.Memorable quotes from this episode:“Sales reps aren’t always the best at Excel spreadsheets. Most of them don’t have any idea what a pivot table is.” Mark Mescher“I don’t hear from a lot of reps out there in the field that they’re just over the moon with how they have to use Salesforce on a day-to-day basis and if they use it on a day-to-day basis.” Mark Mescher“No two health systems are created equal when it comes to product approval.” Mark Mescher“Marketing teams are really at the forefront of being very creative in finding and generating leads through really interesting means that weren’t necessarily accessible previously.” Mark Mescher“Anytime you’re in an early stage environment, or doing something entrepreneurial, go talk to 20 to 30 people that you’re going to be trying to create an impact for.” Skylar TalleyLinks:MedScoutMedScout on LinkedInThe Rise of the Next Generation of Medtech “Milkmen”Omnichannel engagement in medtech: The time is nowThe rise of digital marketing in medtechEuropean Union Medical Device Regulation (EU MDR)SalesforceReptraxGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru Community

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