Global Medical Device Podcast powered by Greenlight Guru

With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming more so due to increased risk measures, and it’s important to understand what’s happening in the industry. To that end, today’s guest, Tyler Foxworthy, will share his expertise on the subject. Tyler Foxworthy was the Chief Data Scientist at Resultant, then the Chief Scientist at Demand Jump. Before founding his own company, he applied statistics and machine learning to help the medical device industry make informed decisions about changes to their devices. The company that he founded, Vertex was acquired by Greenlight Guru, where Tyler is now the Chief Scientist.Listen to the episode to hear Tyler explain more about data quality, the future of risk assessment, and how Bayesian statistics and analysis come into play.Some of the highlights of this episode include:When can we reach a point where we know the data is accurateThe future of risk assessment for MedTechWhy use a model for predicting riskHow this model impacts a companyThe change in trajectory for the medical device industryMemorable quotes from Tyler Foxworthy:“There is no such thing as absolutely perfect data, there’s only degrees of quality.”“I would like to see it as more rigor, in general, brought to the industry.”“This whole field of probabilistic risk assessment is firmly rooted in Bayesian analysis.”“This idea of using, bringing out tools and techniques and knowledge from other domains and fork lifting it into our industry, and making it valuable, to me there’s just something really intellectually appealing about that.”Links:Tyler Foxworthy LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs professionals and regulatory affairs attorneys? Those are just a few of the items covered in today’s live discussion with Mark DuVal.Mark is the founder and president of Duval & Associates. He’s been in healthcare marketing and advertising for over 20 years and is a leading expert in medical device promotion. In today’s episode, you’ll learn his tips for creating “appropriately aggressive, yet compliant” ad campaigns. Learn from Mark’s expertise as he discusses the four buckets of knowledge for information sharing, the different perspectives between regulatory and legal, and how to think about the information provided with a medical device.Some of the highlights of this episode include:The difference in perspectives between a regulatory affairs professional and a regulatory affairs attorneyBest recommendations for regulatory affairs professionals when approaching off-labelExamples of when the dissemination or communication of on and off-label information comes into playGeneral and specific use, and being specific with your indication for useWhether a case study could be built around a physician’s off-label useHow compliance monitors sales for off-label promotionAd promo enforcement actionMemorable quotes from Mark DuVal:“The regulatory affairs professionals are, a lot of times, they’re biomedical engineers and scientists, and they are much more steeped in the medicine and the science as we would be as lawyers.”“It’s kind of a mantra I make everyone repeat when I do a training exercise – I make them repeat after me, truthful, not misleading, fairly balanced.”“You have every right to participate in social media. But again, you’re still regulated.”“We don’t feel people should unnecessarily leave money on the table, nor should they foolishly aggravate FDA and receive a warning letter and get told to cease and desist.”“When you’re in the trenches day-to-day, trying to convince them to use something that’s real-world data is work. It can be done, though!”Links:Mark DuValDuVal & AssociatesCardiac Arrest: 5 Years as a CEO on the Feds Hit List (book)Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended PracticesMedical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and AnswersWashington legal foundation caseGeneral/Specific Intended Use - Guidance for IndustryEtienne Nichols LinkedInGreenlight Guru

What makes a clinical investigation run smoothly? In today’s conversation, you’ll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical investigations. Jon has a master’s degree in biomedical engineering and is the founder of SMART-TRIAL by Greenlight Guru, which helps MedTech companies close the gap between their devices and clinical data. He was the CTO of SMART-TRIAL from 2013 to 2017, and since then has been leading SMART-TRIAL’s clinical operations. His valuable insights come from 10 years of experience in the MedTech clinical space plus a strong technical background.Listen to today’s episode to hear what Jon has to say about using Electronic Data Capture (EDC) systems in clinical investigations, the importance of data quality and what that really means, the tools available for clinical investigations, and educating leadership about clinical investigations.Some of the highlights of this episode include:The biggest challenges companies face during clinical investigationsWhat kinds of tools are available for clinical InvestigationsThe relationship between data quality and formattingThe impact a purpose-built tool has on a companyThe costs associated with clinical investigationsEducating leadership about clinical operationsWhat makes the best stand outMemorable quotes from Jón I. Bergsteinsson:“Data quality has everything to do with how you format your data.”“The leadership just doesn’t have that much of an understanding of what clinical operations do, so they need to be educated.”“When you have a person who’s very efficient, you can get 100 attributes in a couple of minutes.”“Digital first is what sets the best from the rest.”Links:Jón BergsteinssonSMART-TRIAL by Greenlight GuruEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide companies through the various quality and regulatory requirements and challenges that are unique to MedTech companies and Medical Device Professionals - like QMS implementation. Brittney has a bachelor’s degree in Biological Science, a master’s degree in Bioengineering from Clemson University, and is an ISO 13485 Lead Auditor.Listen to the episode to learn about Brittney’s experience shadowing doctors and watching surgery, the part of her job that involves handling complaints, and how complaints are related to post-market surveillance.Some of the highlights of this episode include:What effect does shadowing doctors and seeing surgeries haveThe difficulties of a complaint handling role and how Brittney would structure the role in the companyRegulations around the complaint-handling processDifferent streams that come into play as far as complaints goManufacturer employee complaints on social mediaHow complaints are related to post-market surveillanceAdvice and recommendations for companies about complaintsMemorable quotes from Brittney McIver:“One of the things I wasn’t prepared for was the sheer volume of complaints sometimes.”“You always look at a complaint and try to determine whether it is a complaint or not.”“Any decision you’re making, you want to make sure that it’s informed and you have a rationale behind it.”“One of the things that you don’t want to happen is your customer not report the complaint to you, but they report it to the FDA.”Links:Brittney McIverEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today’s conversation to learn how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate. Some of the highlights of this episode include:What happens when the predicate that you’d like to use for your 510(k) has undergone a Class 1 recallThe risk management element of using a predicate that’s undergone a Class 1 recallThe statistics about recall predicates used in 510(k)sHow the way the 510(k) is used has changed since it was first createdWhy the descendants of a predicate with a Class 1 recall are so much more likely to also undergo a recallSolving the problem of a predicate that’s been through multiple recallsConsidering competitor’s products or other products similar to the one yours is based onWhat post-market surveillance should entailThe direct and indirect economic impact of a Class 1 recallChanges that may happen with the FDA in the futureMemorable quotes from Mike Drues:“I can tell you that of the total number of devices that come onto the market, less than 5% are Class 3s.”“When the 510(k) was created half a century ago, it was intended to be an exception, not the rule.”“I do not advocate these simple-minded solutions like no 510(k) should allow to use a predicate that’s undergone a recall.”“Unfortunately, good news does not sell. Bad news sells.”Links:Mike DruesVascular Sciences510(k) GuidanceJAMA Study 1JAMA Study 2FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare YoursUltimate Guide to Postmarket Surveillance of Medical DevicesEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What’s it like to become a Medical Device Guru? In today’s episode, you’ll meet one of our newer Gurus, Brittani Smith, and find out more about her role and journey working through UDI implementation, EU MDR preparation, and finding her place in a MedTech company.Brittani is a Medical Device Guru at Greenlight Guru. Our Medical Device Gurus are part of what we call the Guru Edge here at Greenlight Guru. As a Medical Device Guru, Brittney helps guide companies through the various Quality and regulatory requirements and challenges that are unique to MedTech companies and Medical Device Professionals. Listen to this episode to hear Brittani talk about the challenges of working through UDI & EU MDR implementation, the resources that helped her learn more about regulatory and quality, and what a day in the life of a Guru entails. Some of the highlights of this episode include:Resources that Brittani uses everyday in regulatory and qualityHow to identify a company's power centers and knowledge in a company and building social capitalCommon pitfalls Brittani sees during implementationExamples of things people don’t think to documentHaving knowledge dismissed due to youthConsistent questions MedTech professionals seeMemorable quotes from Brittani Smith:“I was in every audit that we were a part of from when I started to when I left the company, so audits are my jam.”“Everyone in regulatory is learning it on the job.”“I wasn’t afraid to be wrong, but I didn’t want to be wrong because I didn’t have the right resources.”“I think the simplest answer is I’d love to manage people.”Links:Brittani SmithEtienne Nichols LinkedInThe Essential Guide to Preparing your QMS for EU MDRUltimate Guide to UDI for Medical Devices Greenlight Guru AcademyGreenlight Guru

How do human relationships impact supplier management in the medical device field? Today you’ll hear from Taylor Brown, a Medical Device Guru and Manager of Onboarding and Implementation for Greenlight Guru, and Maxime Rochon, the Director of Quality Assurance and Clinical Affairs for Puzzle Medical.In this episode you’ll hear about why building supplier relationships is so important and some of the best practices for those relationships. Listen to the episode to hear how Taylor and Maxime are thinking about whether and how human relationships make things easier, tips for new companies establishing beginning relationships, and social capital in relation to suppliers. Some of the highlights of this episode include:Recommendations for employing the human side of supply and managementWhether not knowing the people involved make transactions easierTips and tricks for establishing human relationships in businessBest practices tips for companies beginning relationships at the beginningIf it’s helpful to know the relationship between a company you have a relationship with and another department who also has a relationship with themSuppliers and social capitalMemorable quotes from this episode:“I saw on Instagram or Buzzfeed or something that you can hire a Karen to be your customer service representative.” – Taylor Brown“In general, I would say you need people who can be both friendly and stuff like that, but keep their professionalism at the same time.” – Maxime Rochon“If I’m looking for a supplier, what is that supplier going to do for me specifically?” – Taylor Brown“We were taking the product the final mile for this manufacturing company who spent hundreds and hundreds of thousands of dollars – that person in the van better be the right person in the van. You just can’t pick any distribution company off the street. –Taylor Brown.Links:Maxime’s LinkedInPuzzle MedicalTaylor’s LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps?  In today’s episode, you’ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting.In today’s conversation, we covered topics like where information for the literature review comes from, the types of tools used to make evaluations, and more. Listen to the episode to hear what Ethan has to say about the process of performing a CER, the mistakes and pitfalls he sees people make in the process, and what kinds of actionable steps companies can take.Some of the highlights of this episode include:What clinical evaluation reporting isThe big change in EUMDRThe process of performing a CERWhere people go to get the data for a CERHow to tell if a search is comprehensive enoughWhat mistakes Ethan has seen people makingThe process once the deliverable is submittedHow much time it takes for evaluations to go throughAdvice for companies going through the processMemorable quotes from Ethan Drower:“In comparison to the FDA, the big change, the big difference that’s happened with EUMDR is kind of a renewed scrutiny and focus on your actual data.”“It’s a compilation game, which is why nobody likes doing it. Because you have to bring in so many different pieces of data and different plans and that’s why it’s a difficult document to write.”“Once you’ve gone through the nightmare of pulling all this information together, now somebody has to read it.”“Don’t expect that what you searched and your process in the past, don’t expect it to just work and be glossed right over. It needs to be exceptionally thorough, and it needs to be iron tight.”Links:Ethan Drowers LinkedinCitemedEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of Design Controls. Tom is the Director of Guru Services at Greenlight Guru and a Product Development Engineer in Orthopedics.Listen as we talk about the differences between user needs and design inputs and the pitfalls companies get into when building design controls. Tom also shares what he thinks people should understand about cross-functionality, why it sometimes makes sense to start from scratch, and using the design control process strategically.Some of the highlights of this episode include:Thinking in terms of manufacturingThings everyone ought to know about working cross-functionallyWhy starting from scratch may be betterWho needs to be looking at design controls and when they should be lookingThe difference between a design review and a stage reviewWhat Tom got to see that helped him understand how things workedWhat to look for on the manufacturing floorUsing the design control process strategicallyMemorable quotes from Tom Rish:“If you can get a tool in a certain spot you can do it, but if you can’t, you can’t.”“We like to say at Greenlight Guru: the outputs are the recipe.”“I think that a lot of times people use design reviews and stage reviews interchangeably.”“I can’t even put into words how valuable it was to go down to the manufacturing floor as an engineer.”Links:Tom Rish LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Mike is a medical device professional possessing regulatory expertise who understands the ins and outs of the regulation systems in the medical device industry and is passionate about helping others better understand it as well.Listen to the episode to learn more about the most common mistakes companies make that result in Form 483s, what companies can do to avoid these mistakes, and how you should be thinking about root cause analysis.Some of the highlights of this episode include:Common reasons why companies get in trouble during FDA inspectionsWhy CAPA is specifically at the top of reasons for 483s and how to prevent thatExamples of design control problems and how to avoid themThe root causes of these issues and root cause analysisWhat complaint handling problems look likeWhat causes people not to handle complaints correctlyWhether anything about these problems is new or trendingWhat the FDA does when they find these problemsMemorable quotes from Mike Drues:“The emphasis should be on prevention, not correction.”“I consider myself to be a medical device professional, and I do not use the word “professional” lightly. Along with it comes the responsibility, including knowing what the heck you’re doing.”  “What is the point of getting complaints or post-market surveillance or anything else if you’re not going to act on it?”“I hate to say it, but we are the poster children for Einstein’s definition of insanity.”Links:Mike Drues LinkedInVascular SciencesEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru