Medtech Matters
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
- Update frequency
- every 8 days
- Average duration
- 31 minutes
- Episodes
- 154
- Years Active
- 2017 - 2025
Economical Orthopedic Implants
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Itai Nemovicher, CEO and founder of The Orthopaedic Impl…
Vital Signs Monitoring Via Telehealth Interface
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Maman, CEO and co-founder of Binah. Maman shares i…
Multiple Function Device Products
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidance on Multiple Function Device Products. While the terminology c…
Breakthrough Designation Program Update
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss how the breakthrough designation program has changed since its inception. While …
50th Episode: A Look Back
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look back at a variety of the topics that have been covered in the past 49 episodes. We …
Combination Products Update
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of a new compliance program with regard to inspections for combinatio…
Binding vs. Nonbinding FDA Feedback
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the term “nonbinding feedback” and what it means for medical device manufacturer…
Real World Evidence Revisited
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use (or lack of use) of real world evidence. This discussion is a sort of up…
FDA Pre-Sub Best Practices
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pre-sub program and best practices for companies to consider prior to …
Scott Whitaker of AdvaMed on Medtech's Response to COVID-19
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Scott Whitaker, CEO and president of AdvaMed, the world’…
COVID-19, Part 2
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss recent coverage of a two-minute COVID-19 test that had miscommunicated obtaining…
COVID-19, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss questions raised by news of medical technology being rolled out to help battle t…
EtO Sterilization Concerns
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the concern surrounding the use of EtO for medical device sterilization. Questio…
FDA's eSTAR Program
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pilot of an interactive 510(k) template called eSTAR (electronic Submi…
Human Factors/Usability, Part 2
In the second part of this Medtech Matters podcast series of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usabilit…
Human Factors/Usability, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. Medica…
Change Management, Part 2
In the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it w…
Change Management, Part 1
In this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The ty…
Safety and Performance Based 510k
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Safety and Performance Based 510k pathway, which offers a pathway for …
The Special 510k Program
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manu…