Supply Chain
Podcasts
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Packaging & Sterilization
Mike on Medtech: EtO Sterilization Concerns
Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.Sean Fenske, Editor-in-Chief 03.30.20
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Testing
Mike on Medtech: Human Factors/Usability, Part 2
Mike Drues and Sean Fenske discuss the implications of not meeting with the FDA’s requirements for human factors testing.Sean Fenske, Editor-in-Chief 02.03.20
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Testing
Mike on Medtech: Human Factors/Usability, Part 1
Mike Drues and Sean Fenske discuss the importance of human factors within the regulatory landscape and how it came to matter to FDA.Sean Fenske, Editor-in-Chief 02.03.20
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Materials
Mike on Medtech: FDA's Material Evaluation
Sean Fenske and Mike Drues discuss the FDA's announcement that the agency will review materials used in the manufacture of medical devices.Sean Fenske, Editor-in-Chief 04.02.19
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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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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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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-in-Chief 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-in-Chief 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-in-Chief 10.09.17
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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-in-Chief 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-in-Chief 06.05.17
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R&D & Design
Mike on Medtech: Reimbursement for Engineers
Sean Fenske and Mike Drues take a look at the relationship between medical device reimbursement and medtech product design and development.Sean Fenske, Editor-in-Chief 05.05.17
