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 LinkedInetienne.nichols@greenlight.guruMedTech 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 LinkedInetienne.nichols@greenlight.guruMedtech Excellence CommunityGreenlight Guru AcademyGreenlight Guru