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

What’s the difference between design verification and validation, and why are these activities so important?Today’s guest is Niki Price. Niki is a Medical Device Guru with 15 years of experience in medical devices who worked in production, quality, product development, and project manager. Today she discusses questions like what is being tested by design verification and what is being tested by design validation.Listen to the episode to hear Niki discuss what’s involved in being a verification engineer, tests used for verification, and the biggest challenges she experiences in her role. Some of the highlights of this episode include:Niki’s background and experienceThe process involved in being a verification engineerThe Greenlight Guru differenceThe steps that a verification engineer has to go throughTests used for verificationDifficulties with the steps for verificationThe career path to design assurance professionalThe biggest challenges about this rolePitfalls of design verificationMemorable quotes from Niki Price:“I wanted to be drawing body parts in an OR somewhere. Or illustrations in books.”“The best time I ever had was sitting at my desk running through thousands of lines of data and trying to make charts out of it. I loved it.”“Requirements are a lot of times going to be your acceptance criteria for your testing.”“You have to think about verification is for design inputs, validation is for user needs.”Links:Niki Price LinkedInEtienne Nichols LinkedInBeginner's Guide to Design Verification & Design Validation for Medical DevicesGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest.In today’s episode, we spoke with Maryann Mitchell on the topic of Compliance Management. Maryann Mitchell is a Solutions Engineer at Greenlight Guru and is part of what we call our Guru Edge. She has more than 15 years of experience in Medical Devices and has worked in a variety of quality and regulatory roles.Listen to the episode to learn what Maryann has to share about the cultural barriers between engineering and quality management, the challenges she experienced as a compliance manager, and what aspects of implementing an eQMS stand out for Maryann. Some of the highlights of this episode include:What the compliance manager role was like for Maryann and what it meant to herThe relationship with compliance across departmentsAuditing across sitesPains companies go through when looking for quality management systemsCultural barriers between engineering and quality controlCompliance manager challengesHow the quality management system is like a design projectThe contrast in quality manager vs. compliance matterImplementing an eQMS and the difference between that and a paper systemThe relationship between compliance and quality departmentsAdvice for people filling multiple rolesAdvice for companies working toward compliance and developing a quality mindset. Memorable quotes from Maryann Mitchell:“Engineers love to iterate, they love to tinker, but you need to be able to document something, and that’s the importance of it so you can go back to it if you need to.”“We built better processes going forward so we wouldn’t recreate this problem.’“I love that you get to defend your quality system.”“A quality system doesn’t work in a silo, and what I was seeing was departments working in silos.”Links:Maryann Mitchell LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the differences between them as well as how they interact with each other.Medical Device Guru Laura Court joins the podcast today to discuss these three documents – what you need to know about them, what to do with them, and why it matters. Listen to the episode to learn how Laura thinks about best practices, what companies get wrong, and how to improve when dealing with these three different kinds of documentation.Some of the highlights of this episode include:DHF vs. DMR vs. DHRWhat’s involved with the design history fileRecommendations for retaining the design history fileThe difficulties of paper filesWhat device master records areMaking sense out of device history recordsWhat goes into the DHR per the FDAHow engineers can do a better job of the feedback processThe change control process to update the DMRLaura’s additional advice about documenting earlyMemorable quotes from Laura Court:“I am on the onboarding and implementation side of our team for the gurus here, so I help get our customers started in the software.”“Your design history file is truly the history of how your product was developed.” “Don’t assume that you know everything. Even if you’ve been reading your DHF, you’re not going to know everything.”“Everything should go through document control.”Links:Laura Court LinkedInDesign History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?Etienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast.Joining the show this episode is Lesley Worthington. Lesley has 20 years of quality and regulatory experience in medical devices, and she uses that experience to work with individuals and teams to fine-tune their quality conversations, initiatives, and internal communications with the goal of creating more and better understanding of the role and concepts of quality assurance in organizations.Listen to the episode to hear Lesley’s take on how communication affects the outcome of audits, impacts the lives of quality professionals, and the common communication pitfalls Lesley sees in organizations. Some of the highlights of this episode include:Why writing to be understood is difficult for quality professionalsWhether it’s possible to get completely away from jargonCommon pitfalls that Lesley has seenThe length of attention spans and how reading and writing have changedThe importance of reading, including fictionWhat audits mean for communication and writingFear of writing differently from the way it’s always been doneLesley’s LinkedIn game and how she keeps up with all the writingOther important points that Lesley covers when teachingEmbracing the hatersMaking sure that everyone has the same visionLetting down your guardMemorable quotes from Lesley Worthington:“It’s not just about sounding different; it’s about the science of how we sound and how we read.”“The clearer your writing is, the more likely the reader will be to think that you know what you’re doing.”“Sometimes when things get really technical and really complex and really high-level, people lose the thread.”“The purpose of regulations are completely different from the purpose of procedures in your organization.”Links:Lesley Worthington's LinkedInLesley Worthington ConsultingEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru