Managing Risk in Clinical Investigations

April 23, 2024

GMDP_362 (1)

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations.

They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.

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Key Timestamps

  • 00:00:45 - Introduction to Helene Quie and the topic of risk management in clinical investigations.
  • 00:05:22 - Discussing the first leg of risk management: managing residual risks in product safety.
  • 00:17:50 - Exploring the second leg: the procedural risks in clinical protocols.
  • 00:28:30 - Challenges of enrollment and protocol design.
  • 00:35:45 - The impact of regulatory changes on clinical investigations.
  • 00:49:10 - Addressing the integration of artificial intelligence in medical devices.
  • 01:03:15 - Closing thoughts and call to action from Helene Quie.

Key Takeaways

1. Insights on MedTech Trends:

  • The increasing importance of data in justifying product safety and efficacy.
  • The shift from intuition-based to evidence-based risk assessment.
  • Regulatory bodies are placing greater emphasis on comprehensive clinical evaluations.

2. Practical Tips for MedTech Professionals:

  • Ensure that risk assessments are detailed and backed by solid data.
  • Consider the practical aspects of clinical trial protocols from multiple perspectives.
  • Stay updated on regulatory changes to adapt protocols and product development effectively.

3. Future Predictions in MedTech:

  • Enhanced scrutiny and requirements for clinical investigations.
  • Greater integration of AI and digital tools in medical devices.
  • Potential regulatory adaptations to accommodate innovations.


Memorable quotes:

  • "It's not just about managing risks; it's about ensuring that the benefits are powerful enough to justify those risks." - Helene Quie
  • "Every clinical investigation introduces its own set of risks, not just from the product but from the study protocol itself." - Helene Quie
  • "We must not only wear different glasses to see through the regulatory and practical aspects but also validate our views with the actual stakeholders involved." - Helene Quie


Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at


This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru.

About the Global Medical Device Podcast:

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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