170 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 Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers

    • Business
    • 4.6 • 38 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.

    What Goes into Designing Devices for Military and Emergency Applications?

    What Goes into Designing Devices for Military and Emergency Applications?

    There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings.
    In this episode of the Global Medical Device Podcast Jon Speer and his cohost, colleague and medical device guru Wade Schroeder, talk to guests Monti Leija and Robert Futch from the Delta Development Team, manufacturers of ruggedized thermal systems who specialize in military applications.
    Listen to this episode to learn about the Delta Development Team’s journey designing their latest product the Autonomous Portable Refrigeration Unit (APRU) that provides a cooling and heating systems for extreme environments.
    Some of the highlights of the show include:
    APRU is medical refrigeration for medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications.
    APRU applications include military operations, disaster relief response, and emergency medical systems (EMS) because the device meets AABB guidelines and FDA regulations.
    The military provided end-user feedback on how it wants the APRU to function and perform. Therefore, the APRU is unique because it’s small and runs on a battery that can be charged.
    Power of Innovation: The biggest power consumers are refrigerators and air conditioners—both require refrigeration.
    Obstacles and Challenges: Every time somebody goes through the medical device journey it involves learning and becoming aware of regulatory guidelines.
    Recommendations: Find the right consultants, team members, and standards management tools. Wade Schroeder, Greenlight Medical Device Guru, has been a major asset to the Delta Development Team by providing regulatory guidance.
    Testing Methodologies: Motivation is to meet extreme environment requirements and standards. Some manufacturers choose to not meet some standards to make mobile medical devices that don’t work as well. APRU is the new standard.
    Root Cause and Right Configuration: Make minor adjustments to prototypes to reduce complexity, cost, and failure points via due diligence rather than rebuild.

    • 38 min
    Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

    Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

    Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s being developed, especially a medical device.
    In this episode of the Global Medical Device Podcast, Jon Speer talks to Devin Mack, mechanical engineer and owner of Enqual, about the importance of spending enough time defining and managing requirements for medical devices.
    Some of the highlights of the show include:
    Story Behind Business Name: Enqual is a combination of Devin’s background in engineering plus quality to provide a balance between both.
    A picture (or graph and diagram) is worth a 1,000 words to describe product development and design controls for medical devices.
    A challenge that medical device companies tend to miss is the establishment of well-defined requirements during the product development process.
    Best Practices: Open communication between internal and external customers and the product development team as well as cross-functional involvement to define good requirements early in the process.
    Potential Pitfalls: What if stakeholders, engineers, and end users are not adequately considered in the development process? Everyone needs to voice their opinion to meet end user satisfaction and create a competitive edge to achieve goals.
    Stop Light, Agile, or Six Sigma Methodology? Track team’s progress versus focusing on customer specifications. Constantly evaluate where you are with respect to your requirements.
    Mantra: Invest time and money in useability/engineering models to get it right the first time to prove indications and meet proper requirements.

    • 35 min
    Positive and Negative Impacts of EUA on the Medical Device Industry

    Positive and Negative Impacts of EUA on the Medical Device Industry

    As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly utilized regulatory pathway to market in the United States.
    In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru.
    Jon and Erica discuss the positive and negative impacts of the EUA program on the medical device industry as well as the need for increased responsiveness to streamline distribution of in-demand products and services, such as tests, masks, and ventilators.
    Some of the highlights of the show include:
    EUA and PPE: Erica comes from a regulatory background and describes how the huge influx of EUA applications for ventilators and masks to in-vitro diagnostic device (IVD) and lab developed tests affect FDA tiers that reach consumers and companies.
    The FDA is government-funded and has a limited amount of resources. As a result, it’s scrambling to allocate people to review EUA submissions and 510(k)s for COVID-19 related tests to be legally marketed.
    Due Diligence: FDA’s review periods on other products have slowed down, but timelines still need to be met. Also, the quality of reviews has declined, not only with the EUAs but 510(k)s because of limited resources.
    FDA Statistics: A 510(k) review is supposed to take up to 90 days from the point of submission to an official response from the agency. However, EUA applications are being reviewed quickly to address a global public health crisis. Maybe too quick for regulatory quality and risks to be properly evaluated.
    Compare and Contrast: Erica describes the pros and cons of false-negative and false-positive results for COVID-19 and/or IVD tests. What risks do those results pose to the public?
    Research Use Only (RUO) to IVD: Companies that are not or have never been a medical device company need to have a quality management system (QMS), appropriate resources, and manufacturing transfers that can scale. This process takes time.
    FDA EUA Guidance: Proper development and design control provisions should not be viewed as optional. Companies should not cut corners but be expected to follow best practices and post-market challenges for quality events.
    EUA Impact Everywhere: Non-EUA products, procedures, and supplies were delayed, costs increased, and biocompatibility testing was affected due to the push for COVID-related products and services and eventual lift of those EUAs?

    • 37 min
    Why Biocompatibility Should be Addressed by Every Medical Device Company

    Why Biocompatibility Should be Addressed by Every Medical Device Company

    Should your medical device company address biocompatibility? The short answer is, yes. Every single medical device should conduct some level of biocompatibility testing. What’s important is that you understand to what extent.
    In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about biocompatibility of devices, the applicable FDA and ISO guidelines companies need to follow, and the possible ramifications if you don’t.
    Some of the highlights of the show include:
    Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: FDA Draft Guidance is new, but doesn’t cover any new content. FDA’s intent is to clarify the types of biocompatibility information in submissions for certain devices made from common polymers and fabrics that come in contact with intact skin.
    What is biocompatibility testing? If you don’t know, that’s why regulation and guidance is necessary. Nobody knows everything, recognize what you don’t.
    ISO 10993 Evaluation and Testing: Review guidance, educate yourself, and engage experts because objective evidence is needed to corroborate the case for biocompatibility.
    FDA’s Recommendations for Biocompatibility:
    List device materials with direct/indirect skin contact and statement comparing/confirming safe use of those materials.
    Provide history and clinical study reports of adverse effects/events of skin contact materials, such as redness, swelling, irritation, allergic responses.
    Documenting sponsorship determining where biocompatibility risk and testing is not necessary, such as purchasing controls.
    Using labeling to mitigate risk of possible skin reactions.
    Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: FDA Final Guidance raises special considerations for thermomechanical behavior and processing sensitivity of nitinol when compared to conventional metals.

    • 48 min
    Meet a Guru: Erica Loring

    Meet a Guru: Erica Loring

    What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success.
    In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Erica shares her unique career journey working in the healthcare sector, which ultimately led her to enter the medical device and in-vitro diagnostic device space where she now provides world-class quality and regulatory support to device companies.
    Prior to joining Greenlight Guru, Erica worked in both the pharmaceutical and the biotech industry, serving as senior manager of quality and regulatory where she was responsible for implementing eQMS platforms for global enterprise companies.
    Some highlights of this episode include:
    As a medical device guru, Erica enjoys working with a wide range of companies, learns about various products, and helps those companies reach their goals by using a robust QMS.
    Erica’s superpowers, specialities, and strengths as a medical device guru revolve around all things regulatory and quality management to help companies function better and offer a sense of security.
    Conventional Wisdom: Are regulatory affairs and quality assurance the same or two different disciplines? Know it all and provide cross-functionality from product development to regulatory where quality doesn’t get in the way of productivity.
    Thought Process: Manufacturers, engineers, and others don’t have the mindset or systemic way to document inputs, outputs, and design development activities.
    Gentle hand or strict hindrance? Quality can enable or be an obstacle, but it’s the right thing to do. Check documentation, make changes, and meet demand.
    DiSC: If you have a hard time staying still, breathe and meditate for business development and personal growth. Strut industry knowledge to help companies.
    How can medical device companies be successful in today’s market?
    Time: Don’t rush or overlook anything. Plan for extra time and failures.
    People: Invest in the right and enough people, equipment, and space.
    Quality: Research and investigate suppliers. Make sure to have backups.

    • 38 min
    What is a Multiple Function Device?

    What is a Multiple Function Device?

    What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.

    • 41 min

Customer Reviews

4.6 out of 5
38 Ratings

38 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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