# #392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-11-22
- Length: 58m
- Episode: 392
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-22-392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell
- Listen: https://podcast.greenlight.guru/episode/392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell

## Summary

Devon Campbell, a medical device consultant, explains the critical distinctions between verification (did we build the product right?) and validation (did we build the right product?) for early-stage medtech companies. He emphasizes that strong, testable user needs and design inputs are prerequisites for successful V&V, warning that weak requirements lead to validation failures. Campbell advocates for pre-verification testing to refine protocols and manage sample sizes, ensuring that design reviews and traceability are robust before formal regulatory submission.

## Outline

1. Introduction: Devon Campbell and the V&V Misconception
2. Defining User Needs: Specifying the User and Scope
3. Design Inputs: Sources Beyond User Needs and Risk Management
4. Design Reviews and Requirements Management: Granularity and Control
5. Verification Strategies: Pre-verification and Component Testing
6. Common Challenges: Sample Size Justification and Protocol Writing
7. Feedback Loops and Final Takeaways for V&V Success

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- ISO 14971 (other)
- IEC 62304 (other)

## Related episodes from other shows

- [Dakota Welker | User Needs, Design Inputs, Verification & Validation](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation) (Being an Engineer)
- [Requirements Engineering, part 2:  A Practical Process for Safety-Critical Development](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm) (The Pragmatic Embedded Podcast)
- [157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific) (Let's Combinate)
- [104: Medical Device Certification vs Wellness Device](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device) (Product Startup)
- [074: Medical Device Product Development Best Practices](https://hardwarepodcasts.com/podcast/product-startup/2021-05-05-074-medical-device-product-development-best-practices) (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/2024-11-22-392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell. 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.