282 episodes

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Global Medical Device Podcast powered by Greenlight Guru Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory

    • Health & Fitness
    • 4.7 • 48 Ratings

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

    7 Common 510(k) Mistakes and How to Avoid Them

    7 Common 510(k) Mistakes and How to Avoid Them

    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 Speer
    Links:7 Common Mistakes That Sink FDA 510(k) Clearance
    FDA - 510(k) Submission Process
    7 FDA Pathways to Bring Your Medical Device to Market
    Center for Devices and Radiological Health (CDRH)
    ISO 14971
    Mike Drues on LinkedIn
    Vascular Sciences
    Greenlight Guru Academy
    MedTech Excellence Community
    Greenlight Guru

    • 55 min
    Best Practices for Clinical Evidence Management

    Best Practices for Clinical Evidence Management

    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 Kallmes
    Links:Keith Kallmes on LinkedIn
    Kevin Kallmes on LinkedIn
    Etienne Nichols on LinkedIn
    Nested Knowledge
    FDA - Medical Device Overview
    ISO - Medical Device Testing
    GG Academy
    MedTech Nation
    Greenlight Guru

    • 46 min
    Building Your Regulatory Strategy for Commercialization

    Building Your Regulatory Strategy for Commercialization

    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 LinkedIn
    Project Medtech
    Project Medtech Podcast
    Etienne Nichols on LinkedIn
    FDA - Overview of Device Regulation
    FDA - 510(k) Clearances
    FDA - Premarket Approval (PMA)
    Build by Tony Fadell
    GG Academy
    MedTech Nation
    Greenlight Guru

    • 43 min
    Packaging Validation Best Practices

    Packaging Validation Best Practices

    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 LinkedIn
    J-Pac Medical
    Etienne Nichols on LinkedIn
    ISO 11607-1
    ISO 11607-2
    ISO 13485
    ASTM International
    FDA - 510(k) Clearances
    GG Academy
    MedTech Nation
    Greenlight Guru

    • 37 min
    Overcoming Submission Deficiencies due to Biocompatibility

    Overcoming Submission Deficiencies due to Biocompatibility

    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 LinkedIn
    Etienne Nichols on LinkedIn
    FDA - Overview of Device Regulation
    FDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
    ISO 10993-1:2018 - Biological evaluation of medical devices
    Proposition 65
    European Union Medical Device Regulation (EU MDR)
    Medical Design and Manufacturing Event (MD&M West)
    GG Academy
    MedTech Nation
    Greenlight Guru

    • 29 min
    Does Your CAPA Process Need a CAPA?

    Does Your CAPA Process Need a CAPA?

    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 Drues
    Links:FDA - Corrective and Preventive Actions (CAPA)
    FDA - Form 483 Observations and Warning Letters
    FDA - Medical Device Overview
    International Medical Device Regulators Forum (IMDRF)
    ISO 13485 CAPA
    21 CFR Part 820
    Mike Drues on LinkedIn
    Greenlight Guru Academy
    Greenlight Guru Community
    MedTech Nation
    Greenlight Guru MedTech Lifecycle Excellence

    • 51 min

Customer Reviews

4.7 out of 5
48 Ratings

48 Ratings

JoshCrist ,

Energizing, Illuminating and Insightful! 🙌

Regardless of your role in the industry - this is a must listen for you! Etienne and Jon do an incredible job of covering all the insights, innovations and organizations you need to stay connected within this ecosystem - with inspiring guests that actually have firsthand experience. Highly recommend listening and subscribing!

MacJ2300 ,

A must listen for medical device professional!

If a medical device professional, there are a must. The pod casts appeal to everyone within your organization, from CEO to Engineer to Quality to Regulatory. Very informative.

Esmath ,

Effective Regulatory Strategy

I appreciate your comment on being hopeful when bringing in regulatory early and bringing regulatory late as if it were a dreaded requirement.

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