Podcasts
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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
