Global Medical Device Podcast Powered By Greenlight.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

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 read

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today’s episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they’re ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in ant

What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today’s episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes

What’s involved in switching from a paper-based QMS to an eQMS? What kinds of difficulties do companies experience when making that change? Today’s guest will explain her experiences with making that switch.In today’s episode, you’ll hear a conversation with Kendyl Williams on the topic of Implementing an eQMS. Kendyl is a Medical Device Guru at Greenlight Guru. When it comes to implementing an eQMS - Kendyl has experienced the sales process and has also implemented it for her company, and now she works with companies to help them implement the new software as well.Listen to the episode to hear what Kendyl has to say about the pain points of a paper QMS that can prompt making a switch to eQMS, challenges at the beginning of the switch, and a realistic timeline for implementing the new system. Some of the highlights of this episode include:The pain points of a paper-based QMSThe effectiveness of document-signing partiesWhat the implementation of the eQMS was likeWhat isn’t validated out of the boxComplain

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 s

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 differenc

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 ma

What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’ll hear about in today’s episode.Jesseca Lyons joins the podcast today to share more information about user needs. Jesseca is a Mechanical Engineer who’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. During today’s conversation, you’ll learn more about how Jessica is thinking about challenges in getting to user needs, using Root Cause Analysis to get to true user needs, and determining who will be interacting with the medical device and which ones are users. Some of the highlights of this episode include:Themes that trip people up regarding user needs and how Jesseca helps themFears about problems during FDA inspections and 510k submissionsWhat Jesseca thinks of when she thinks of user needsGuiding a customer through figuring out

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

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 collaborationSar

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 goingKeepin

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

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 surprisin

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 quot

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

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

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 fr

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 continuou

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 wi