# Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-06-22
- Length: 45m
- Episode: 268
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry
- Listen: https://podcast.greenlight.guru/episode/regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry

## Summary

Mike Drues of Vascular Sciences, joined by hosts Jon Speer and Etienne Nichols, explains the regulatory and quality distinctions between 3D printing and additive manufacturing, noting that over 100 3D-printed medical devices have received FDA clearance. Drues argues that for personalized, point-of-care devices like patient-specific stents or anatomical models, validation must focus on the manufacturing process rather than the individual product, as clinical trials for single-patient devices are infeasible. The discussion highlights the challenges of regulating point-of-care printing in settings ranging from cath labs to home garages, and the need for software certification and process validation to ensure safety without stifling innovation.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry#t=0) Introduction: Green Light Guru Academy and Episode Overview
- [2:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry#t=133) Defining 3D Printing vs. Additive Manufactured with Mike Drues
- [5:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry#t=333) FDA Guidance and the Challenge of Personalized Medicine Validation
- [10:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry#t=636) Point-of-Care Printing: Cath Labs, Pharmacies, and Home Use
- [16:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry#t=967) Regulatory Gray Areas: Practice of Medicine vs. Industry Regulation
- [26:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry#t=1573) Regulatory Strategy for 3D Printed Knees: 510(k) and Process Validation
- [34:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry#t=2057) Responsibility, Liability, and the Future of Medical Device Business Models

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

early-stage companies

## Mentioned

- Green Light Guru (company)
- Vascular Sciences (company)
- FDA (other)
- Green Light Guru Academy (other)

## Related episodes from other shows

- [Unlocking the Potential: 3D Printing’s Impact on Medical Innovation and Beyond with Laura Gilmour](https://hardwarepodcasts.com/podcast/additive-snack/2023-09-12-unlocking-the-potential-3d-printings-impact-on-medical-innovation-and-beyond-wit) (Additive Snack)
- [Evolving the Orthopedic Frontier: A Deep Dive into the History of Medical AM with Charles Hansford](https://hardwarepodcasts.com/podcast/additive-snack/2023-09-26-evolving-the-orthopedic-frontier-a-deep-dive-into-the-history-of-medical-am-with) (Additive Snack)
- [3D Printing and Additive Manufacturing with Steve Szymeczek of Penumbra Engineering](https://hardwarepodcasts.com/podcast/predictable-designs-podcast/2020-04-02-3d-printing-and-additive-manufacturing-with-steve-szymeczek-of-penumbra-engineer) (Predictable Designs Podcast)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)
- [When Production Overtakes Prototyping: Materialise’s Next Phase of AM](https://hardwarepodcasts.com/podcast/additive-snack/2026-10-13-when-production-overtakes-prototyping-materialises-next-phase-of-am) (Additive Snack)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-22-regulatory-quality-perspectives-of-3d-printing-in-the-medical-device-industry. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.