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Sean Fenske
Medical Product Outsourcing - PodcastsEpisodes
Sean Fenske
Medical Product Outsourcing - Podcasts
A Business podcast
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Episodes of Medical Product Outsourcing
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The discussion over the controversial Netflix documentary continues between Sean Fenske and Mike Drues in this episode.
Sean Fenske and Mike Drues begin a multi-part series on the controversial Netflix documentary on the medtech industry.
Sean Fenske and Mike Drues discuss the FDA's Breakthrough Designation Program and address common questions.
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 and Mike Drues discuss voice-enabled medtech and its potential in healthcare.
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 and Mike Drues discuss the regulatory implications with 3D printing devices at a healthcare facility.
Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.
Mike Drues and Sean Fenske discuss a recently announced 510(k) pathway that actually resembles an already existing option.
Mike Drues and Sean Fenske discuss the potential advantages of implementing an approval pathway for biomaterials.
Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.
Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.
Mike Drues and Sean Fenske discuss the harmful effect the latest version of MDUFA could have on medtech development.
Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use.
Mike Drues speaks with Sean Fenske to discuss biomaterials, biofriendly, biocompatible, bioabsorbable, and more.
Mike Drues joins Sean Fenske to chat about the role of 3D printing in medtech and healthcare today and challenges that exist.
A look at the relationship between medical device reimbursement and medtech product design and development.
Sean and Mike discuss the topic of hospitals reporting medical device incidents and what needs to change with the process.
Mike Drues of Vascular Sciences offers insights into the use of real world evidence in medtech regulatory approval processes.
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