S2E33 Custom Medical Device Manufacturing, Durability, & the Future of Med Device Tech | Mark A. Farber, MD

Being an Engineer · 30 Jul 2021 · 45m · Episode 33

What this episode covers

Dr. Mark Farber, a vascular surgeon at the University of North Carolina and medical device consultant, discusses the challenges of developing custom medical devices for aneurysm treatment. He highlights the difficulty of predicting long-term durability in the harsh mechanical environment of the human body, noting that off-the-shelf devices only fit 25% of patients, necessitating custom manufacturing that can take months. Dr. Farber emphasizes the critical need for engineers to observe clinical procedures to understand the complex, dynamic variables of in vivo testing that lab simulations often miss.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 30m

    Challenges related to Home Use Devices

    Mike Drues, founder of Vascular Sciences, discusses the unique safety, risk, and usability challenges of medical devices used in non-traditional, home-like environments by laypeople rather than trained professionals. He highlights the difficulty of defining user subgroups for human factors testing, noting that engineers often fail to represent patients with physical or cognitive limitations. Drues argues that risk mitigation should rely on intelligent design rather than labeling, as users rarely read manuals, and emphasizes the need to decouple regulated and consumer functions when assessing combined system risks.

  • Manufacturing Happy Hour · 31m

    A Look Inside Medical Device Manufacturing with Philips’ Natalia Mendez

    Natalia Mendez, VP Head of Manufacturing Medical Devices at Philips, discusses the unique regulatory and operational challenges of medical device manufacturing, comparing it to aerospace and pharma. She emphasizes the critical importance of early involvement of manufacturing, quality, and sourcing experts in the product design phase to ensure supply chain resilience and meet customer needs, such as a 48-hour delivery requirement. Mendez also highlights how regional regulations, cultural preferences, and geopolitical factors influence global manufacturing footprints and product design.

  • Global Medical Device Podcast · 47m

    #461: Why Manufacturing is Part of Product Development with Mike Dolphin

    Mike Dolphin, CEO of GuideStar Medical Devices, explains why manufacturing process development must be integrated into product design rather than treated as a post-development step. He details the engineering of a closed-loop epidural safety device, emphasizing early decisions on injection molding and radiation sterilization to ensure scalability. Dolphin highlights the financial and timeline risks of using contract manufacturers for iterative development, advocating for in-house manufacturing to reduce costs and accelerate FDA 510(k) clearance.

  • Global Medical Device Podcast · 39m

    #470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova

    Lisa Voronkova, co-founder of OVA Solutions, draws on data from over 200 medical devices to outline the real costs and timelines of MedTech innovation. She details four engineering phases—Discovery, Proof of Concept, Design, and Development—and provides specific hour estimates for projects ranging from simple electronics to complex continuous glucose monitors (CGMs). Voronkova emphasizes the critical importance of validating devices in real clinical environments and explains why Design for Manufacturability (DFM) requires significant additional engineering investment to avoid costly late-stage redesigns.

  • Let's Combinate · 58m

    005 - “Compassionate Product Development” with Cameron Jones

    Cameron Jones, Co-Founder and CEO of Avasys Medical, discusses his journey from academic research at Vanderbilt, the University of Kentucky, and Johns Hopkins to founding a medical device company. He details the process of identifying unmet clinical needs through direct observation of clinicians, highlighting a specific case where a tourniquet design required 14 prototypes to meet size and safety constraints. Jones also explains his work on catheter interfaces to reduce infection risks and his philosophy on managing conflicts of interest while moonlighting between startups and large manufacturers.

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Being an Engineer. The episode itself belongs to its publisher.