# #426: Software as a Medical Device: Securing Your Digital Future

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-09-29
- Length: 44m
- Episode: 426
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future
- Listen: https://podcast.greenlight.guru/episode/software-as-a-medical-device-securing-your-digital-future

## Summary

Jose Bohorquez and Mohamad Foustok from CyberMed explain that Software as a Medical Device (SaMD) must be treated as a medical device from inception, integrating security into the architecture rather than treating it as an afterthought. They highlight the 2023 FDA guidance shift, which raised the regulatory bar for all devices with software functions, regardless of connectivity, and discuss the 'zero trust' principle and 'reasonable assurance of cybersecurity.' The guests warn that skipping architectural planning leads to costly redesigns and legal risks, citing the recent $9.8 million DOJ settlement with Illumina as a cautionary tale for legacy devices.

## Chapters

- [0:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=31) Introduction: Jose Bohorquez and Mohamad Foustok from CyberMed
- [2:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=179) Common SaMD Pitfalls: Ignoring IEC 62304 and FDA Guidance
- [5:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=334) Cybersecurity Scope: Patients, Supply Chains, and Non-Connected Devices
- [9:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=570) Zero Trust and Hospital Network Vulnerabilities
- [15:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=955) The Security-First Development Lifecycle and Architecture
- [25:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=1532) FDA Guidance History: The 2023 Regulatory Shift
- [33:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=2027) Legacy Devices, No Grandfathering, and the Illumina Settlement
- [40:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future#t=2429) Final Advice: Seeking Expertise and CyberMed Resources

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- CyberMed (company)
- Bold Type (company)
- FDA (other)
- IEC 62304 (other)
- Illumina (company)
- CISA (other)
- NIST (other)
- FIPS (other)

## Related episodes from other shows

- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [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)
- [#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)
- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (Let's Combinate)
- [128: Creating an App for Your Hardware Device](https://hardwarepodcasts.com/podcast/product-startup/2022-06-08-128-creating-an-app-for-your-hardware-device) (Product Startup)

## 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/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future. 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.