243 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

    • Business
    • 4.7 • 45 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.

    Tips for Being Prepared Post-EUA (Emergency Use Authorization)

    Tips for Being Prepared Post-EUA (Emergency Use Authorization)

    Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare?
    In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA.
    Some of the highlights of this episode include:EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo, or Premarket Approval (PMA) cleared.Quality versus Quantity: What is worse - not having enough ventilators, diagnostics or more ventilators, diagnostics that don’t work? Both the regulatory and quality burden is higher for companies in the medical device industry.Certain shortcuts are justified in the short-term but not in the long-term. What companies did before for COVID/EUA medical devices is not enough now. Don’t waste the FDA’s time. The EUA needs to be a part of a company’s overall regulatory strategy to determine how it fits into the bigger picture.Memorable quotes from this episode:“For those of you that have products that went through the EUA pathway to get to market, if you want to keep those products in the market post-EUA, there’s things that you should be doing and frankly you should have already been doing them.” Jon Speer
     “The emergency use authorization or the EUA is one of many pathways to market that medical device companies can use to bring devices onto the market here in the U.S.” Mike Drues
     “Basically, it’s a very, very special kind of pathway. It is not an approval. It is not a clearance. It’s an authorization.” Mike Drues
     “If you’re not building a plan, a strategy, and starting to execute that strategy, you’re going to be leaving the market with your products.” Jon Speer
    Links:FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic
    Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
    Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
    Webinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?
    The End of EUA Is Coming Soon
    FDA - Medical Device Overview
    Mike Drues on LinkedIn
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 41 min
    Understanding the UDI System for Medical Devices

    Understanding the UDI System for Medical Devices

    Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.
    TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.
    Some of the highlights of this episode include:The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.The UDI is stored in a worldwide central database. Different countries have different requirements. In the United States, medical device manufacturers can use three different types of identifiers (GS1, HIBC, and blood banking). For Bills of Materials (BOMs), it’s important to understand the rules of interchangeability to set medical device products apart and determine whether to assign different codes.A data matrix and quick resource (QR) code are intermixed and both are two-dimensional. Mark explains how to visually tell the difference between the two and the three components required.Integrating UDIs and codes into databases represents levels of complexity that are added to medical devices.The UDI is intended for the hospital user. So, a sellable product needs to have a UDI that can be scanned and validated. When parts are too tiny, the UDI will be placed elsewhere on the product packaging.Memorable quotes from Mark Rutkiewicz:“Every part that you use in the hospital room has a barcode on it.”
    “If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.” 
    “Nobody's really standardized." 
    “You can scan it to make sure that you are using the right product with the right other products and with the right patient.” 
    Links:Mark Rutkiewicz on LinkedIn
    Mark Rutkiewicz on Twitter
    Innovize
    Consiliso LLC
    Medical Device Company In A Box: The Case For Consiliso
    FDA - Unique Device Identification System (UDI System)
    European Union Medical Device Regulation (EU MDR)
    Medical Device Innovation Consortium (MDIC)
    ISO 13485 - Medical Devices
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 34 min
    Shaking Things Up: What's Next for the Global Medical Device Podcast

    Shaking Things Up: What's Next for the Global Medical Device Podcast

    Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about amazing products and technology improving the quality of life. Now, there’s an opportunity to take the most listened to podcast in the medical device industry in a new direction by introducing a second voice to the show to share a variety of contexts and perspectives around the why behind what we do that matters.
    In this episode Jon is joined by Etienne Nichols, a medical device guru at Greenlight Guru and Jon’s new co-host of the Global Medical Device Podcast. This is a must-listen-to episode, offering details into this exciting news and other key thoughts and observations Jon and Etienne share about the medical device industry.
    Some of the highlights of this episode include:Etienne is passionate about the medical device industry and decided to join Greenlight Guru to help make things better, such as documentation. Guru Edge: Greenlight Guru is the only medical device system platform for the medical device industry built by actual medical device professionals.Greenlight Guru runs the gamut and covers everything from electrical and mechanical to packaging and production. There’s more medical device experience at Greenlight Guru than at most medical device companies.  In the future, Etienne predicts that data-driven decision making involving patients will be one of the biggest trends or themes in the medical device industry.Jon is anticipating the convergence or blending of technology with everyday devices (i.e., wellness wearables). The lines between what is and is not a medical device are blurry. The COVID pandemic has created opportunities for innovation in healthcare. Wellness, telehealth, and home-use products have become more common and make patients more comfortable.Etienne has experienced highs and lows with the FDA in the past. Now, he appreciates and is thankful for FDA regulations as guardrails, not limitations, that are flexible and open to interpretation. The FDA’s job is to protect and promote the health of U.S. citizens. It not only covers medical devices, but many other areas. It’s an awesome responsibility that encourages collaboration and communication.Memorable quotes from this episode:“When I came to Greenlight Guru, part of what kind of led me here, was the desire for things to be better.” Etienne Nichols
    “No one guru has all the answers on our team, self included." Jon Speer
    “I’m excited about all the different ways the medical device industry is going to be improving our lives in the future.” Etienne Nichols
    “The more data that can be behind a decision, I love that.” Etienne Nichols
    Links:Meet a Guru: Etienne Nichols
    Etienne Nichols on LinkedIn
    21 CFR Part 820
    FDA - Medical Devices
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 34 min
    How Augmented Reality (AR) is Revolutionizing Healthcare

    How Augmented Reality (AR) is Revolutionizing Healthcare

    Technology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and there’s greater potential for it to be revolutionary, not just evolutionary.
    In this episode of the Global Medical Device Podcast Jon Speer talks to Jennifer Esposito, Vice President and Managing Director of Magic Leap's Health business unit, about AR in healthcare, explaining what it is and is not, as well as how it compares and contrasts to virtual reality (VR), machine learning (ML), and artificial intelligence (AI).
    Some of the highlights of this episode include:AR is a relatively new technology that some people don’t quite understand how it is or can be used in healthcare today and in the future. It’s important for people to try Magic Leap’s AR device and platform to expand their thinking of use cases.AR is not the same as VR and other technologies. VR is completely immersive and involves wearing a headset. You can’t see the real world. All you’re seeing is digital content. VR has advantages and limitations.Magic Leap’s AR headset device allows users to not only see the real world, but digital content can be overlayed on top of the real world while maintaining spatial awareness and sensibility.Magic Leap isn’t just about AR, but the convergence of other elements and capabilities, such as AI, 5G, and Internet of Things (IoT). AR is going to be the catalyst that generates additional new sources of data not currently captured.AR is not replacing healthcare providers, doctors, nurses, and others. It augments the clinical workforce to present/provide insights that advance and enhance the practice and expertise of medicine when delivering care.Memorable quotes from Jennifer Esposito:
    “There are places where the differences between those technologies is actually really important in terms of deciding which one you would use for a certain use case.”

    “What we’re doing isn’t really just about AR. It is this convergence of these other capabilities.”

    “Augmented reality is also going to be the catalyst to generate additional new sources of data that we don’t currently have.”

    Links:Jennifer Esposito on LinkedIn
    Magic Leap: Augmented reality platform for Enterprise
    Medical Device Innovation Consortium (MDIC)
    FDA - Medical Devices
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 25 min
    Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

    Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

    At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?
    In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software.
    The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. 
    Some of the highlights of this episode include:According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.There are a few reasons why the FDA is making CDS software important and its #1 priority. More companies and customers are or want to work and produce products in this space.For now, CDS software is not regulated by the FDA due to limited resources. However, that will change when companies’ products provide wrong or inaccurate information. Nobody or not too many people have been harmed, yet.According to Mike, CDS software provides clinicians as well as patients with information to enhance health and health care. Examples of CDS software include telehealth and AI platforms that ask patients questions about their health.FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person - not by a device or software.Make sure that CDS software properly provides accurate information because there can be major product liability implications if not regulatory ones.Regulated or not, usability testing is a must. What if your software tells patients they don’t have a problem, but actually do, and wait to take care of it? Memorable quotes from Mike Drues:“I’ve got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.”
    “Right now, much of this is not being regulated by the FDA. The FDA - they’re using their enforcement discretion to not regulate.”
    “FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.”
     “As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.”
    Links:Clinical decision support guidance tops FDA’s agenda for 2022 (Med City News) (Oct. 29, 2021)
    FDA's 2022 A-list guidance plan hits on software, post-pandemic future
    CDRH Guidance: Clinical Decision Support Software (September 2019)
    FDA - Medical Devices
    Software as a Medical Device (SaMD)
    Combination Products Webinar
    https://www.greenlight.guru/webinar/combination-products
    General Wellness Device and Wearable Exemption Webinar
    WebMD
    Mike Drues on LinkedIn
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 31 min
    Why Usability Matters

    Why Usability Matters

    Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.
    In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices.
    Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user.
    Some of the highlights of this episode include:Medical device professionals may develop something that they view as perfect, but what matters is what the person or patient using the product thinks of it. Medical devices/software should support people with health issues/problems.Those in the medical device industry and at Custom Medical have a major impact on the quality of life for many people. They can save and improve lives as well as prevent damage by doing their work correctly.Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. They should not have to overcome barriers and adapt to the device. It should be easy to use, safe, and supportive.Determine if you are on track when developing a product by conducting formative evaluations of tasks that need to be done and how they should be done.When done with development, a summative evaluation shows the use of a medical device does not come with any unacceptable risks. It offers proof of use.Opportunities for Improvement: Some mistakes that Michaela has observed include not meeting or listening to users, starting too late, and not conducting formative before summative evaluations for feedback. Memorable quotes from Michaela Kauer-Franz:“It’s not about me being excited about it, but about the user being excited about it. Being able to understand it. I think this is a very valuable insight.”
    “You have so much impact on the quality of life of so many people. You can save life, you can improve life, you can prevent damage if you do your work right.”
    “Usability is the translation from the capacity that an expert or user has into a device that is being easily used and intuitive, understood, and safe.”
    “See usability as something that you have to do constantly. It’s not a one-time activity that you do.”
    Links:Michaela Kauer-Franz
    Custom Medical
    Greenlight Guru Academy
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 25 min

Customer Reviews

4.7 out of 5
45 Ratings

45 Ratings

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.

med device industry insights ,

tips and pointers

This podcast is geared towards medical device professionals and current hot topics in the industry. Plenty of tips and tidbits provided from industry veterans.

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