Rephonic
Artwork for Medtech Matters
FDA
Regulatory Affairs
Medical Devices
QMSR
E&L Testing
MPO
Biocompatibility Testing
Government Shutdown
Quality Management System
ISO 10993
Quality Management
MPO Summit
Artificial Intelligence

A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.

PublishesMonthlyEpisodes160Founded7 years ago
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Artwork for Medtech Matters

Latest Episodes

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing the list of top health technology hazards identified by ECRI. ECRI is an independent, nonprofit organization that improves the... more

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about how to best determine the efficacy of regulatory and quality team members. A variety of real-world examples are provided ... more

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s third-party review program. This option is available for certain 510k reviews. It is performed through an independe... more

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorpo... more

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Recent Guests

Mike Drues
President of Vascular Sciences
Vascular Sciences
Episode: FDA's Third-Party Review Program
Audrey Turley
Representative at Nelson Labs
Nelson Labs
Episode: A Deep Dive into E&L and Biocomp Testing
Kristin Treece
Representative at Nelson Labs
Nelson Labs
Episode: A Deep Dive into E&L and Biocomp Testing

Host

Sean Fenske
Host of the show, Editor-in-Chief of MPO, MPO Magazine

Reviews

4.6 out of 5 stars from 8 ratings
  • Highly Recommend

    Great show. I thought your latest episode on the Molli Surgical’s Breast Tumor Market was very informative. Nice work.

    If you are interested, I host a CNC Machining podcast called, “The Right Direction Podcast” from Compass Precision. Check it out if you have time!

    Apple Podcasts
    5
    dmholcomb
    United States5 years ago
  • Great show!

    The hosts of the Medtech matters podcast, highlight all aspects of med tech and more in this can’t miss podcast! The hosts and expert guests offer insightful advice and information that is helpful to anyone that listens!

    Apple Podcasts
    5
    stinkbug01
    United States5 years ago
  • CEO

    A lot of useful information for medtech professionals!!

    Apple Podcasts
    5
    medtech professional
    United States7 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

Great show for medtech pros seeking actionable guidance.
Positive feedback on expert guests and candid industry stories.
Listeners praise practical insights on regulatory strategy and risk management.
Listeners appreciate the clarity and depth of discussion for complex topics.
Audiences value the mix of regulatory detail and real-world application.

Talking Points

Recent interactions between the hosts and their guests.

Planning for FDA Shutdowns Now and in the Future
Q: Are presubmissions still possible during a shutdown, and what about fee payments?
Presubmissions do not require user fees, so they can technically be submitted; however, submissions requiring fees cannot be processed until funding is restored, creating a strategic workaround for some cases.
Planning for FDA Shutdowns Now and in the Future
Q: What should a company do if they already have a submission in progress as of October 1st?
Reach out to the lead reviewer with brief questions about delays and timelines, perform an independent pre-submission review, and consider submitting presubmissions during the shutdown if allowed by fee rules.
Planning for FDA Shutdowns Now and in the Future
Q: First, what does FDA intend to do during a shutdown and how does that affect ongoing submissions?
FDA will continue to handle vital public health activities, but the exact scope is subject to interpretation; practitioners should prepare for potential delays and maintain proactive communication with reviewers.
Triaging Your QMS: Considerations Based on the New QMSR
Q: What should manufacturers do to ensure their QMS isn't just ticking boxes but actually functioning well?
Regularly test the system by injecting hypothetical problems to observe whether it is detected and properly managed, maintain a unique, evolving QMS tailored to the company, and ensure documentation reflects both the current state and planned improvements to show regulators the system isn't static.
Triaging Your QMS: Considerations Based on the New QMSR
Q: If a company never intends to market its device, do they still need a QMSR?
Most companies intend to market or distribute devices, making QMSR applicable; exceptions exist for startups or license-outs where another entity will handle the quality system, or for investments where a predicate device may be used. Even in exceptions, keeping some core sections in draft form can facilitate future compliance.

Audience Metrics

Listeners, social reach, demographics and more for this podcast.

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Gender Skew
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Frequently Asked Questions About Medtech Matters

What is Medtech Matters about and what kind of topics does it cover?

The show consistently centers on regulatory, quality, and market-access topics within the medical device space, with a strong emphasis on practical decision-making, risk management, and navigating FDA processes. Episodes frequently feature expert guests and offer concrete hiring questions, implementation tips for QMS/QMSR, guidance on third-party review, E&L and biocompatibility testing, and strategies for handling regulatory challenges amid industry disruptions. A notable hook is the blend of real-world stories, cautionary tales, and actionable takeaways designed for manufacturers, consultants, and regulatory professionals alike, often grounded in non-fiction case studies and current regulatory debates. The format tends to attract listener... more

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Which podcasts are similar to Medtech Matters?

These podcasts share a similar audience with Medtech Matters:

1. Global Medical Device Podcast powered by Greenlight Guru
2. Medical Device made Easy Podcast
3. HBR On Leadership
4. A Bit of Optimism

How many episodes of Medtech Matters are there?

Medtech Matters launched 7 years ago and published 160 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

How do I contact Medtech Matters?

Our systems regularly scour the web to find email addresses and social media links for this podcast. We scanned the web and collated all of the contact information that we could find in our podcast database. But in the unlikely event that you can't find what you're looking for, our concierge service lets you request our research team to source better contacts for you.

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What guests have appeared on Medtech Matters?

Recent guests on Medtech Matters include:

1. Mike Drues
2. Audrey Turley
3. Kristin Treece

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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