Summary

“You need to base your summary and conclusions based on facts, not assumptions. Work smarter, not harder.”

In this Let’s Talk Risk! conversation, Dr. Queenita Fernandes shares her extensive experience in the healthcare industry, particularly in risk management and clinical evaluation. She emphasizes the importance of collaboration, leveraging technology, and the role of AI in enhancing clinical literature reviews and signal detection in adverse events. The discussion also highlights the need for effective communication through storyboarding and the proactive approach required in the medical device industry. Dr. Fernandes concludes with key takeaways that inspire risk practitioners to embrace change and work towards better patient outcomes.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:13 Introducing Dr. Queenita Fernandes

02:02 Personal Journey and Influences

03:44 Literature Review from a Clinician's Perspective

07:56 Integrate Clinical Perspective with Engineering to Design for Safety

10:04 Working Smart with AI Tools for Reviewing Clinical Literature

16:58 Using Storyboards for Effective Communication

20:50 Embracing AI Tools to Facilitate Collaboration

23:19 Imagining a Validated Real-Time AI System for Clinical Review

25:43 Announcements, Key Takeaways and Closing Comments

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Databases and automation tools for clinical evaluation.

LTR: Understanding the notified body perspective on clinical evaluation.

ACHIEVE: FMEA Workshop.

Key Takeaways

* Think proactive and partner cross-functionally.

* Embrace technology and work smart.

* AI should be viewed as a tool, not a replacement.

* People generally intend to do good things.

* Literature review can be intimidating but manageable.

* Engage healthcare professionals in decision-making.

* Use storyboarding for effective communication.

* Signal detection is crucial in adverse event reporting.

* Collaboration is key in the medical device industry.

* Always put the patient at the center of evaluations.

Keywords

Risk management, healthcare, clinical evaluation, AI in healthcare, adverse events, medical devices, literature review, signal detection, technology in healthcare, collaboration

About Queenita Fernandes

Queenita Fernandes is a physician executive and certified patient safety expert with over 20 years of experience in medical safety, post-market surveillance, and regulatory writing. Her background spans clinical medicine, nutrition, and leadership roles across the MedTech ecosystem.

Queenita is known for her work in proactive PMS, systematic literature reviews, and benefit-risk analysis under EU MDR and FDA frameworks. She brings a unique ability to translate clinical insight into regulatory strategy, improving safety signal detection and patient outcomes.

A frequent speaker at international conferences and webinars, she is a trusted voice on how to strengthen post-market processes through rigor, ethics, and cross-functional collaboration.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe