In this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development.
Whether you’re a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares practical advice on defining user needs, writing strong design inputs, conducting pre-verification testing, and ensuring that verification protocols provide meaningful evidence.
The discussion explores how to avoid common pitfalls, optimize your design reviews, and strategically approach V&V for complex devices, offering listeners a wealth of actionable takeaways for navigating regulatory challenges and accelerating market access.
Key Timestamps:
- 00:01 – Introduction to Greenlight Guru’s QMS capabilities
- 03:15 – Setting the stage: Why verification and validation matter
- 08:30 – Differences between verification and validation explained
- 12:50 – Importance of strong user needs and design inputs
- 23:45 – Writing effective user needs and identifying users
- 33:00 – Creating robust design inputs and their sources beyond user needs
- 40:10 – From design inputs to design outputs: Key considerations
- 48:20 – Best practices for conducting design reviews and managing revisions
- 57:15 – Verification strategies: The importance of pre-verification
- 01:05:40 – Common challenges in V&V, including sample sizes and justifying tests
- 01:15:10 – Using feedback during testing and leveraging observations
- 01:23:00 – Final takeaways and practical advice for V&V success
Standout Quotes:
- "Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell
- "You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell
3 Key Takeaways:
- Verification and Validation Are Not the Same: Understand that verification ensures your device meets specified design inputs, while validation confirms it meets user needs and functions as intended.
- Pre-Verification Testing Minimizes Risk: Conducting a "pre-verification" run allows you to refine testing protocols and identify potential design issues before formal verification begins.
- Define Users Clearly in User Needs: Avoid generic statements; specify which user (e.g., clinician, technician, patient) has which needs to ensure robust validation testing.
References:
MedTech 101:
Verification vs. Validation – Verification checks if a product meets specified requirements, while validation ensures it fulfills the needs and expectations of its intended users. Both are critical steps in medical device development, and their successful execution depends on precise, testable requirements.
Audience Engagement:
Poll Question: "What’s been your biggest challenge in navigating verification and validation for your medical device? Share your experiences below!"
Feedback:
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