Global Medical Device Podcast powered by Greenlight Guru

Jesseca Lyons, a Mechanical Engineer, discusses challenges in determining user needs for medical devices. She highlights using Root Cause Analysis, guiding customers through defining user needs, and the importance of understanding the problem before solving it. Lyons emphasizes the significance of identifying core user needs early in the design process to avoid pitfalls and ensure successful outcomes.

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