Podcasts
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Surgical
Mike on Medtech: The Bleeding Edge, Part 2
The discussion over the controversial Netflix documentary continues between Sean Fenske and Mike Drues in this episode.Sean Fenske, Editor-in-Chief 09.07.18
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Surgical
Mike on Medtech: The Bleeding Edge, Part 1
Sean Fenske and Mike Drues begin a multi-part series on the controversial Netflix documentary on the medtech industry.Sean Fenske, Editor-in-Chief 09.05.18
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Mike on Medtech: Breakthrough Designation Program
Sean Fenske and Mike Drues discuss the FDA's Breakthrough Designation Program and address common questions.Sean Fenske, Editor-in-Chief 08.10.18
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Mike on Medtech: 15 Tips for Getting New Products Through FDA
Mike Drues provides insight to Sean Fenske on what he's learned about getting devices through the FDA over the last 15 years.Sean Fenske, Editor-in-Chief 07.03.18
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Digital Health | Electronics
Mike on Medtech: Voice-Enabled Medtech
Sean Fenske and Mike Drues discuss voice-enabled medtech and its potential in healthcare.Sean Fenske, Editor-in-Chief 05.17.18
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Mike on Medtech: Changing Pathway to Market?
Sean Fenske and Mike Drues discuss the changing MDR for CE mark and its impact on the “first to market” route companies take.Sean Fenske, Editor-in-Chief 04.25.18
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3D/Additive Manufacturing
Mike on Medtech: 3D Printing Healthcare at the Point of Care
Sean Fenske and Mike Drues discuss the regulatory implications with 3D printing devices at a healthcare facility.Sean Fenske, Editor 03.23.18
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Mike on Medtech: Quality vs. Regulatory
Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.Sean Fenske, Editor-in-Chief 03.02.18
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Mike on Medtech: The 'New' Alternative 510k
Mike Drues and Sean Fenske discuss a recently announced 510(k) pathway that actually resembles an already existing option.Sean Fenske, Editor 01.29.18
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Materials
Mike on Medtech: Regulatory Approval Pathway for Biomaterials
Mike Drues and Sean Fenske discuss the potential advantages of implementing an approval pathway for biomaterials.Sean Fenske, Editor 01.02.18
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R&D & Design | Testing
Mike on Medtech: Pre-Sub with the FDA
Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.Sean Fenske, Editor 11.06.17
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R&D & Design | Testing
Mike on Medtech: Human Factors
Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.Sean Fenske, Editor 10.09.17
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Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
Mike on Medtech: MDUFA IV and Its Impact on Medtech Innovation
Mike Drues and Sean Fenske discuss the harmful effect the latest version of MDUFA could have on medtech development.Sean Fenske, Editor 09.07.17
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Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
Mike on Medtech: Off-Label Use
Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use.Sean Fenske, Editor 08.25.17
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Materials
Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable
Mike Drues speaks with Sean Fenske to discuss biomaterials, biofriendly, biocompatible, bioabsorbable, and more.Sean Fenske, Editor 07.24.17
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3D/Additive Manufacturing
Mike on Medtech: 3D Printing in Healthcare
Mike Drues joins Sean Fenske to chat about the role of 3D printing in medtech and healthcare today and challenges that exist.Sean Fenske, Editor 06.05.17
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R&D & Design
Mike on Medtech: Reimbursement for Engineers
A look at the relationship between medical device reimbursement and medtech product design and development.Sean Fenske, Editor 05.05.17
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Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
Mike on Medtech: Device Incident Reporting
Sean and Mike discuss the topic of hospitals reporting medical device incidents and what needs to change with the process.Sean Fenske, Editor 03.30.17
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Mike on Medtech: Real World Evidence
Mike Drues of Vascular Sciences offers insights into the use of real world evidence in medtech regulatory approval processes.Sean Fenske, Editor 02.24.17
