# 104: Medical Device Certification vs Wellness Device

- Show: [Product Startup](https://hardwarepodcasts.com/podcast/product-startup)
- Published: 2021-12-01
- Length: 23m
- Page: https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device
- Listen: https://productstartup.com/

## Summary

Bryon Bhagwandin, a medical device entrepreneur with a PhD from the University of Washington, explains the critical differences between wellness and medical devices, emphasizing that medical clearance allows sales into clinical settings. He details the three pillars of medical certification: safety, efficacy (verification and validation), and manufacturing consistency, noting that hand-built prototypes cannot be certified without statistical proof of uniform production. Bhagwandin advises that while wellness devices are cheaper to launch, starting with a medical device strategy is often superior because it opens higher-margin B2B channels and allows for easier transition to consumer markets. He also suggests that founders can leverage user data from existing wellness products to support the regulatory submission of a redesigned medical version, provided they maintain rigorous quality and avoid feature creep.

## Chapters

- [0:46](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=46) Introduction: Bryon Bhagwandin and Medical Device Background
- [2:23](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=143) Defining Medical Devices vs. Wellness Devices
- [5:22](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=322) The Manufacturing Pillar: Consistency and Statistical Significance
- [7:55](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=475) The Efficacy Pillar: Verification, Validation, and Specs
- [12:20](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=740) The Safety Pillar: Biocompatibility and Physical Safety
- [13:38](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=818) Market Strategy: B2B Clinical Sales vs. Consumer Wellness
- [16:52](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=1012) Leveraging Wellness Data for Medical Certification
- [19:08](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device#t=1148) Quality Focus and Avoiding Feature Creep

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Prototyping & iteration](https://hardwarepodcasts.com/topic/prototyping)

## Most relevant to

early-stage companies

## Mentioned

- Eli Lilly (company)
- FDA (other)
- Mako Design + Invent (company)
- R&D Magazine (other)

## Related episodes from other shows

- [#451: Building a MedTech Powerhouse: The 5 Stages of Founder Success](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-16-451-building-a-medtech-powerhouse-the-5-stages-of-founder-success) (Global Medical Device Podcast)
- [#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-22-392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell) (Global Medical Device Podcast)
- [Best Practices for Clinical Evidence Management](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management) (Global Medical Device Podcast)
- [#369: Advice to Medical Device Inventors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-23-369-advice-to-medical-device-inventors) (Global Medical Device Podcast)
- [#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-29-393-engineering-medtech-success-simplifying-prototypes-pivoting-strategy-and-cre) (Global Medical Device Podcast)

## Citing this page

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