Global Medical Device Podcast powered by Greenlight Guru

What tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be talking about in today’s conversation.Laura Maher previously appeared on the podcast to talk about UDI, and now she’s here to talk more about sterilization. Laura is a Medical Device Guru at Greenlight Guru and is a self-proclaimed sterilization enthusiast. Listen to the episode to learn what Laura has to say about Gamma vs. EO, new modalities recognized by the FDA, and the sterility pitfalls Laura has experienced or heard of.Some of the highlights of this episode include:Different types of sterilizationDifferent sterilization modalitiesChoosing gas vs. radiationTools of the sterilization tradeWhat to do when you have dose audit failureWhat “too numerous to count” meansSterility pitfallsMemorable quotes from Laura Maher:“Biology is my main passion with chemistry kind of like behind it.”“People will talk your ear off about sterility all day, which is super fun.”“Packaging is a huge component of sterility because it IS your sterile barrier.”“If you have a chance to see a Gamma source, take it. It is really cool.”Links:Laura Maher’s LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight 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

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