Global Medical Device Podcast powered by Greenlight 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

There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. Kyle Rose joins the podcast today to talk more about it. Kyle is the President of RookQS and works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Listen to the episode to hear what Kyle has to say about the EUA transition deadline, the potential uses for the EUA going forward, and what companies should focus on if they only started selling medical devices during the EUA.Some of the highlights of today’s show include:Whether there’s an EUA transition deadline yetWhat EUA companies need to be doing right now on the quality side of thingsWhat the EUA transition will look likeHow adverse events need to be documentedThe potential for the EUA as the norm in certain situationsWhat to focus on for companies that started with a non-med device then got into the EUAWhat happens if you go past the 180 daysMemorable quotes from Kyle Rose:"This is going to end, and companies have to figure out what to do to go back to their traditional regulatory path for their device or their expansion of labeling and use to maintain compliance.""You need to start working on this before phase three.""From phase one to phase two is 90, from phase two to phase three is 90, and then phase three it says 180 days after implementation.""If you’re going to build your quality system, I would definitely say you can apply with both FDA and ISO."“If you have submitted, and it goes past the 180 deadline into phase three, you’re still able to sell as long as you’re under review."LinksRook Quality SystemKyle RoseFDA Guidance DocumentFDA Webinar SlidesEtienne Nichols LinkedInetienne.nichols@greenlight.guruMedTech NationGG AcademyGreenlight Guru

What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Today’s guest, Karandeep Singh Badwal, is a Regulatory Affairs Quality Consultant who is well-versed in EU MDR, and regularly works with medical companies producing Class I, II, and III medical devices.Listen as we talk about what a quality management system is and what the goal of a QMS is, the importance of validating software, and the differences between AI and machine learning, among other things. Some of the highlights of this episode include:A quality management system is a structured system of procedures and processes covering all aspects of design, manufacturing, supply, risk management, management responsibilities, customer-related processes, corrective actions, and preventative actions.Quality management systems come in several forms.There are differences for QMSs at SaMD companiesValidating software means making sure it can do what needs to be done and produces consistent resultsIssues or shortcomings that SaMD companies have with validatingFor SaMD, intellectual data that you’re storing on your servers could be considered customer property and needs to be addressed in your QMSIt’s important to define specific roles and responsibilities for when the person ordinarily responsible for that role isn’t available.The differences between AI and machine learning: AI basically mimics human behavior. Machine learning is more like a neural network.Memorable quotes from Karandeep Singh Badwal:“That’s one mistake that a lot of these software as a medical device companies are making. They just validate their own software.”“Basically, what I’m looking for is evidence to prove you’ve done what you said, basically.”“Customer property is one that I see a lot of Software as a Medical Device companies not addressing effectively.”“Software as a Medical Device companies don’t realize that the software platforms they use are suppliers, and those need to be controlled.”“The whole point of an internal audit is you want someone who’s independent.”Links:Karandeep Singh Badwal's LinkedInKarandeep’s YouTubeMedTech PodcastEtienne Nichols LinkedInetienne.nichols@greenlight.guruGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but it’s an important part of the process and impacts product development more than you may think at first.Orla Connaughton joins the podcast today to discuss design assurance with Etienne Nichols. Orla began as a mechanical engineer and has a Master’s degree in Project Management. She has 18 years of experience, mostly working in the medical device sector, and has worked at a Senior Management level for both multi-national and start-up organizations. She’s been running her own company, Aztek Medical, for over 8 years. And she has a lot to say about design assurance.Listen to the episode to hear the conversation as they discuss what’s involved in design assurance and why it’s so important. Orla shares how her thoughts on the scope of the design assurance process are related to The Lion King and how design assurance “packs the parachute” for the overall product design process.Some of the highlights of this episode include:Orla explains what’s involved in design assurance and why it’s required. Global regulations require that a product is developed in a specific way and that there’s evidence that the project is developed that way. A working prototype is a great thing to have, but it’s only a starting point.Design assurance personnel have to be able to touch all the different processes and regulations. Orla explains that design assurance involves understanding the basic quality system standards and regulations, to product-specific standards, clinical investigations, and more.There are no college programs that lead to a career as a design assurance professional. These positions want a technical background with a high level of understanding of many different types of products and roughly 5-10 years of relevant work experience in the area. The position also requires a level of creativity.Although there’s no degree program leading to quality assurance, it’s often done as a module of a regulatory-type qualification, so it can be taught to people who are interested in learning the concepts.Design assurance packs the parachute for the product design process by putting the pieces together in order to tell a cohesive story to the regulators that allow the device to get approved. People may not see design assurance up front, but they’re serving a vital function in the process.Design assurance is a valuable process and skillset in its own right. It’s part of the big picture. Memorable quotes from Orla Connaughton:“Having a working, functioning prototype is great, and of course, it’s required, and it’s a great starting point, but really that is what it is – it’s a starting point.”“Once you have a good technical solution, at that point, you should implement your design controls and start creating your documents and start releasing your procedures through this control process.“What I really think makes a good design assurance specialist is the mindset element.”“I think quite often creativity is not a trait that’s recognized with quality type professions, but really it’s very valuable in these situations.”“The design assurance person is your quality engineer of the R&D process.”Links:Orla ConnaughtonAztek MedicalEtienne Nichols LinkedInetienne.nichols@greenlight.guruGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you know what it is if you encounter it? In today’s episode of the Global Medical Device Podcast, we have a wide-ranging conversation with Mike Baca about the lessons we can learn from him as an industry leader and about the long game involved in a MedTech career. Mike is currently the president of White Rook Consulting, and he has more than 38 years of experience as a quality professional working with medical devices, including classes I, II, and III. He worked in a variety of quality roles for Johnson & Johnson, Medtronic, and Stryker before starting his own independent consulting firm. Today’s conversation covers a lot of ground, including the three phases of Mike’s career, how understanding VULCA can help you handle a black swan event, and how adopting a set of principles and values will guide you through challenging times. We also discussed “badge on the table” situations, speaking the language of other departments, and working through and getting rid of imposter syndrome. Some of the highlights of this episode include:The tough moments that medical device professionals are going to face: There’s the unique issue that the work they do will impact someone in the most personal way possible. The languages of other businesses and how Mike learned to navigate thatMike’s definition of a mentor: not an advocate, not a sponsorThe three segments of Mike’s career: Learning, Contributing, Returning How Mike might hold the record for most 483sHow to process the black swan moments without breaking down emotionally: accepting that you acted in accordance with your principles and valuesWhat VUCA means and how to approach it: Volatility, Uncertainty, Complexity, and AmbiguityThe differences between ego and self-confidenceMemorable quotes from Mike Baca:“It’s my responsibility to do everything I can to make sure that everything I’m responsible for is done the best that it can be so that outcome is going to be favorable to that ultimate patient who is going to have the device used on them.”“If you see something that needs to be fixed, something that can be improved, seek that out.”“As a leader, you should consider adopting a set of absolute principles that define how you will lead and how you will be.”“If you’re going to delegate something, you need to be willing to stand behind, but when you delegate, you need to delegate at a level that failure will not be fatal to the business or that individual. Because guess what? Sometimes they’re going to fail.”Links:Mike BacaEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and rejections. It only takes common sense and simple solutions to overcome these issues.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about common 510(k) mistakes and how to avoid them. They also cover what has changed (if anything) in the past five years since Jon wrote the article, 7 Common Mistakes That Sink FDA 510(k) Clearance.Some of the highlights of this episode include:Mistake #1 - Inconsistency with Documentation: The intended use statement often is inconsistently put into other sections of the 510(k). It’s important to understand the difference between indications for and intended use.Mistake #2 - Not Using Checklist: The FDA’s 510(k) submission guidance provides a Refuse to Accept (RTA) checklist. Help yourself and reviewers out. The FDA states what it is going to do and what it wants, so there should be no surprises.Mistake #3 - Not Providing All Expected Testing: The FDA rarely accepts promissory commitments to do sterilization, validation, or biocompatibility testing later. Also, you should include protocols, results, and reports to verify rigorousness of testing.Mistake #4 - Not Doing Real-time Shelf-life Studies: FDA wants evidence to back up claims of stated shelf life and wants a correlation between real-time and accelerated aging data. Shelf life is what happens to your product in the future.Mistake #5 - Underestimating Risk Management Requirements: Show list of requirements and provide the paper trail for your traceability. The FDA needs to conclude that your product is safe and substantially equivalent to a predicate.Mistake #6 - Not Demonstrating Equivalence with Predicates: You need to depict your device as novel and unique, but not so different that the FDA thinks your predicate is not a good example.Mistake #7 - Formatting Submission Incorrectly: Include page numbers and an eCopy. Also, the size of the file matters and needs to be named according to conventions.Memorable quotes from this episode:“The intended use statement is a pretty important premise for any 510(k) submission because for all intents and purposes, that statement helps regulators and helps you determine how your product is ultimately going to be classified.” Jon Speer“One of the most common reasons why they are rejected is because the high-level labeling when it is repeated is not repeated exactly the same way.” Mike Drues“Intended use focuses on the device. Whereas, indications for use focuses on the patient.” Mike Drues“The RTA checklist was intended to be a tool for the FDA reviewer, when submission received, for them to go through and make sure all the constituent parts and components and what is expected to be in that submission is included.” Jon Speer“FDA reviewers see probably dozens, maybe hundreds of submissions in a finite period of time. Some are better than others. Well, make yours standout. Make yours easier to read.” Jon SpeerLinks:7 Common Mistakes That Sink FDA 510(k) ClearanceFDA - 510(k) Submission Process7 FDA Pathways to Bring Your Medical Device to MarketCenter for Devices and Radiological Health (CDRH)ISO 14971Mike Drues on LinkedInVascular SciencesGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process, especially when researching clinical evidence? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Keith and Kevin Kallmes of Nested Knowledge. Following in the footsteps of their father who was a medical device inventor, the two brothers designed and developed a balloon catheter that was acquired by a major strategic. Some of the highlights of this episode include:Keith and Kevin focus on clinical, regulatory, and publication consulting in the data management/data analysis services industry.Like other entrepreneurs, Keith and Kevin understand the importance of central clinical outcomes data in every stage of the medical device development process for a product rooted in an unmet clinical need.Engineers tend to focus on the immediate task at hand. Entrepreneurs have to consider why startups succeed or fail. Rather than fixating on money, the biggest reason devices fail is a lack of product market fit.Companies should look at the science before the development. Examine clinical evidence, decision-making, prototyping, and design controls.Customer Discovery: Read literature and talk to clinicians about needs. They are on the frontlines of patient care and research-capable.To find scientific evidence and outcomes, search for different articles and filter/screen the articles to know when you have enough relevant information.Calculate risk, know timelines, perform tests, and document design history accurately or start the design process over and learn an expensive lesson.Which evidence is leading to which decisions? Share and manage evidence to make sure it is usable and effective. Memorable quotes from this episode:“You really realize how central clinical outcomes data are to every stage of the medical device development process.” Keith Kallmes“It’s looking at clinical evidence and convincing end users and purchasers that your device is worth the cost.” Keith Kallmes“You should be making good decisions and good decisions should pre-exist everything in the development landscape. Design controls should come only after you’ve basically validated your need and you’ve prototyped enough that you know that you should continue.” Kevin Kallmes“Lack of product market fit - that’s why devices fail. They’re not addressing an unmet need in the marketplace.” Keith Kallmes“Start your design controls at concept.” Kevin KallmesLinks:Keith Kallmes on LinkedInKevin Kallmes on LinkedInEtienne Nichols on LinkedInNested KnowledgePubMedFDA - Medical Device OverviewISO - Medical Device TestingGG AcademyMedTech NationGreenlight Guru