# 021 - "Options" with Karandeep Singh Badwal

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-02-23
- Length: 1h 03m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/021---Options-with-Karandeep-Singh-Badwal-e1eadl6

## Summary

Karandeep Singh Badwal, a QA/RA consultant and host of The MedTech Podcast, explains how defining 'intended use' determines whether a product is a regulated medical device or unregulated software, a critical distinction for startups. He details the specific regulatory challenges of Software as a Medical Device (SaMD), including cybersecurity, GDPR compliance, and the impact of the EU MDR on software classification. Badwal also discusses the strategic advantages for UK software companies post-Brexit, where they can still self-certify as Class 1 devices while EU counterparts face stricter notified body audits.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=0) Introduction: Karandeep Singh Badwal and The MedTech Podcast
- [3:17](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=197) Badwal's Career Path: From Pharmaceutical Science to Medical Devices
- [8:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=507) The Value of QA/RA: Information Density and Strategic Decision Making
- [17:01](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=1021) Defining Intended Use: Statements, Claims, and Product Options
- [26:28](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=1588) Software as a Medical Device (SaMD): Risk, Security, and GDPR
- [39:54](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=2394) UK NHS Infrastructure Challenges and Software Deployment
- [42:57](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=2577) AI in Medical Devices: Assistance Tools vs. Autonomous Systems
- [48:41](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=2921) Brexit Impact: UK Self-Certification vs. EU MDR Class 2A Requirements
- [52:33](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal#t=3153) Consulting vs. In-House: Diversity, Robert Green, and The MedTech Podcast

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)
- [Direct-to-consumer & e-commerce](https://hardwarepodcasts.com/topic/direct-to-consumer)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- The MedTech Podcast (other)
- Eudamed (other)
- MHRA (other)
- FDA (other)
- MDR (other)
- MDD (other)
- ISO 13485 (other)
- GDPR (other)
- Robert Green (other)
- 48 Laws of Power (other)
- The 50th Law (other)
- Daily Laws (other)
- Proximie (product)

## Related episodes from other shows

- [Everything you Need to Know about SaMD from an FDA Perspective](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective) (Global Medical Device Podcast)
- [Digitizing your SaMD Testing](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing) (Global Medical Device Podcast)
- [Understanding the Value of a Medical Device Guru](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru) (Global Medical Device Podcast)
- [The Future of Cybersecurity](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-30-the-future-of-cybersecurity) (Global Medical Device Podcast)
- [#426: Software as a Medical Device: Securing Your Digital Future](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-29-426-software-as-a-medical-device-securing-your-digital-future) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal. 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 Let's Combinate.