# Cybersecurity and the Future of MedTech

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-06-02
- Length: 1h 12m
- Episode: 321
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-02-cybersecurity-and-the-future-of-medtech
- Listen: https://podcast.greenlight.guru/episode/cybersecurity-and-the-future-of-medtech

## Summary

Chris Gates of Velentium, Chris Reed of Medtronic, and Ken Hoyme of Dark Star Consulting discuss the impact of the Consolidated Appropriations Act of 2023 on medical device cybersecurity regulation. They explain how the FDA now has explicit legal authority to enforce cybersecurity hygiene, moving beyond just safety and efficacy, and detail the requirements for pre-market submissions under the April 2022 draft guidance. The panelists emphasize the critical importance of Software Bill of Materials (SBOMs), threat modeling, and security architecture analysis, while clarifying misconceptions about legacy devices and the role of VEX documents.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-02-cybersecurity-and-the-future-of-medtech#t=0) Introduction and Regulatory Context
- [12:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-02-cybersecurity-and-the-future-of-medtech#t=728) The Omnibus Act and FDA Authority
- [25:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-02-cybersecurity-and-the-future-of-medtech#t=1548) Pre-market Submission Requirements and eSTAR
- [47:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-02-cybersecurity-and-the-future-of-medtech#t=2828) SBOMs, VEX, and Transitive Dependencies
- [56:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-02-cybersecurity-and-the-future-of-medtech#t=3414) Post-market Maintenance and Cloud Security

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

large enterprises

## Mentioned

- Velentium (company)
- Medtronic (company)
- Dark Star Consulting (company)
- Boston Scientific (company)
- Greenlight Guru (company)
- eSTAR (tool)
- CycloneDX (tool)
- SPDX (tool)
- Log4j (other)

## Related episodes from other shows

- [#000: How New IoT Security Regulations Will Shape the Industry's Future](https://hardwarepodcasts.com/podcast/coredump-sessions/2024-09-17-000-how-new-iot-security-regulations-will-shape-the-industrys-future) (Coredump Sessions)
- [140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-12-140-medical-device-diagnostics-cybersecurity-3rd-party-software-sboms-evaluating) (Let's Combinate)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [515: Script Boomers](https://hardwarepodcasts.com/podcast/embedded-fm/2025-11-27-515-script-boomers) (Embedded.fm)

## 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/2023-06-02-cybersecurity-and-the-future-of-medtech. 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.