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

What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech. Duane has experience in go-to-market strategy, including regulatory and reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design and execution. He has developed a comprehensive understanding of what early-stage startups need to do to be successful.With all of the complexities of running a medtech company and taking a product to the market, Duane has seen a huge variation in how startups develop strategies and milestones. In this episode, we discuss how early decisions impact other aspects in the future and how companies can create a blueprint to build and grow long-term.Some of the highlights of this episode include:Fundraising: Figure out who you want to raise capital from, what should be in your pitch deck, and what questions will investors ask about problems/solutions.When trying to raise money, startups need to know that there are three types of investors—good, neutral, and bad. Sometimes, bad investors are hard to spot.When considering acquiring a company, some of the top things strategics look at is how you capture more clients, build your team, incorporate a quality management system (QMS), and handle regulatory challenges.If you are selling products to a hospital system, you will need to check three things—physician/clinician (especially nurses) ownership, patient improvement, and economic benefit.Build, develop, and invest in your team by finding people who complement your weaknesses. Don’t be afraid to fractionalize. One of the most important thing you can do for your company is to find advisors, partners, and mentors with large professional networks.When people are raising money, unless you are raising from a high net worth individual or angel group, be strategic with who you want to raise money. Venture Capitalists have a responsibility to spend (invest) their money just like you have a responsibility to raise it.Clients need to understand that regulatory fits into their business, clinical, reimbursement, and commercialization strategies—all those things work together and overlap, so make sure to ask the right questions to the right expert.Memorable quotes from Duane Mancini:“The #1 thing we try to tell all of our startups when they’re going out to raise money is there’s three types of investors. There’s good, neutral, and bad. You really want to avoid bad.”“For those first few investors, you want to find a good investor. Someone who’s going to bring something else to the table. Fill a knowledge or network gap that you don’t have. Understand what your mission is for the company and how they are going to support it.”“We talk to a lot of investors and a lot of entrepreneurs, and the one thing we’ve learned is that there is more than one way to raise money. However, there are patterns.” “Regulatory fits into your business strategy, fits into your clinical strategy, fits into your commercialization strategy—all those things work together and overlap.”Links:Duane Mancini on LinkedInProject MedtechProject Medtech PodcastEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - 510(k) ClearancesFDA - Premarket Approval (PMA)Build by Tony FadellGG AcademyMedTech NationGreenlight Guru

The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practices.Jeff has 25 years of experience in the medical device industry, specializes in getting new devices to market, and scaling your commercialization. He has extensive knowledge and understanding of ISO 11607-1 & -2, Packaging for Terminally Sterilized Medical Devices.Some of the highlights of this episode include:Sterilization validations/revalidations take a lot of money ($40,000-80,000) and a long time (16-20 weeks) to complete.Don’t underestimate labeling - 40% of FDA recalls are due to labeling. Make sure your CM has good labeling controls.Over a third of all package validations fail the lab test for transit. The biggest reason why companies fail packaging validation is not understanding the various shipping modes and their related testing.ISO’s 11607 standard has two parts: Part 1 is about designing the package; Part 2 is validating the package. Also, there is a guidance document due to the complexity of the packaging process.The criteria for filing a 510(k) and steps related to packaging include validating that the seals are good from a sterile barrier standpoint and the product is good and has not changed over time because of transit testing or aging.From a design standpoint, document how the package has been designed and meets customers’ needs. Recently, the FDA added user testing to the standard for sterile transfer.Feasibility testing of prototypes and samples of vibration, drops, and humidity should be conducted to prevent potential problems. Ask engineers about product changes and the risks for redesign of packaging to know if the package will fail or pass.Memorable quotes from Jeff Barrett:“The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There’s two parts to it, Part 1 and Part 2. Part 1 is all about designing the package and Part 2 is about validating the package.” “Over a third of all package validations failed at the lab for transit. It’s staggering.” “Less so do we see damage to the product itself. So, I’d say, 8 out of 10 times on these failures, it’s the product and the seal failing, not the product breaking.” “One of the biggest problems we see is, (the FDA) they don’t do any validation. They say, ‘We’re going to do it later.’ That’s obviously a problem. You can’t market the product if the package hasn’t been validated. That’s why the FDA gives you a break on that.”“The bottom line is you’re trying to maintain the product without getting damaged and without the sterile barriers getting damaged. That is the end goal.”Links:Jeff Barrett on LinkedInJ-Pac MedicalEtienne Nichols on LinkedInISO 11607-1ISO 11607-2ISO 13485ASTM InternationalFDA - 510(k) ClearancesGG AcademyMedTech NationGreenlight Guru

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.Some of the highlights of this episode include:When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.Competition: When most medical devices are being developed, there is intent. Either it’s a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations. Memorable quotes from Chris Parker:“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It’s otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”“A lot of devices, when they are being developed, you’re doing it with intent in mind. Either it’s a completely novel, new idea or you saw a product and you said there’s a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”“Let’s try to keep out anything of potential concern that we can at any concentration.”Links:Chris Parker on LinkedInLabcorpEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact SkinISO 10993-1:2018 - Biological evaluation of medical devicesProposition 65European Union Medical Device Regulation (EU MDR)Medical Design and Manufacturing Event (MD&M West)GG AcademyMedTech NationGreenlight Guru

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year after year.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about whether your medical device company’s CAPA process needs a CAPA. Why are medical devices companies continuing to struggle with CAPAs?Some of the highlights of this episode include:Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or FDA. People tend to report every little event as a CAPA or report nothing at all. The five most common reasons why the FDA issued 483 observations and warning letters over the last 5 years were CAPAs, customer complaints, purchasing controls, medical device reporting, and process validation.If CAPA is the #1 reason why companies are getting 483 observations and warning letters, it may be due to an ineffective quality management system (QMS).Things happen every day during the course of running a business. Processes and routines may not go routinely. When something happens unexpectedly, will it happen again? What are you changing to ensure it does not happen again?CAPAs continue be the #1 reason because people do not have a common sense understanding of the quality system regulation. They focus on the words, but do not try to understand the meaning.CAPAs often generate negative connotations—the process requires extra work and more resources, not in the budget, and time pressure. However, people should view CAPA’s as an opportunity to improve a product and prevent problems in the future. People do not follow procedures because sometimes they don’t even know that procedures exist, or those procedures are not updated/revised after events.Memorable quotes from this episode:“A CAPA is an opportunity to really do a deep dive investigation to determine, is there a systemic issue that is influencing that process that you are following?” Jon Speer “People don’t focus on the common sensical understanding.” Mike Drues “Unless regulation makes sense, I don’t care what the regulation is, unless it makes sense, it is not good regulation.” Mike Drues “Part of going through the CAPA procedure is to identify the root cause of the problem.” Mike Drues “Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or to the FDA.” Mike DruesLinks:FDA - Corrective and Preventive Actions (CAPA)FDA - Form 483 Observations and Warning LettersFDA - Medical Device OverviewInternational Medical Device Regulators Forum (IMDRF)ISO 13485 CAPA21 CFR Part 820Mike Drues on LinkedInGreenlight Guru AcademyGreenlight Guru CommunityMedTech NationGreenlight Guru MedTech Lifecycle Excellence