Summary

“Wireless coexistence is not a checkbox. It’s a risk management approach”.

In this Let’s Talk Risk! conversation, Dr. Naveen Agarwal sits down with Omar Al Kalaa, PhD, Founder of Inovectrum and former FDA wireless scientist, to explore the challenges and opportunities of integrating wireless technology into medical devices. Omar shares his journey from academic research on wireless coexistence to leading FDA initiatives on 5G-enabled medical devices, offering a unique perspective at the intersection of MedTech, telecom, and regulatory science.

The conversation covers key issues manufacturers face when adopting wireless connectivity, such as defining quality of service, assessing risk categories, and ensuring coexistence in crowded spectrum environments. Omar explains why medical devices must be viewed as connected systems rather than standalone products, highlighting risks from Bluetooth- and Wi-Fi-enabled devices, lessons from real-world recalls, and the growing need to integrate safety, cybersecurity, and interoperability into design. His takeaways emphasize a holistic, systems-based approach to innovation and evaluation in connected healthcare.

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

Chapters

01:00 Omar’s Journey - From Academia to FDA to Entrepreneurship

03:35 Understanding First Principles of Wireless in MedTech

06:14 Risk Categories for Wireless Functions

08:16 Understanding Wireless Coexistence

13:00 Thinking in Systems, Not a Stand Alone Device

15:35 Real-World Recall Example

19:17 Wireless Immunity and 5G

24:42 Announcements, Key Takeaways and Closing Thoughts

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Suggested links:

LTR: A new paradigm for building connected medical devices.

LTR: FDA guidance on interoperable devices.

ACHIEVE: PMS Workshop.

Key Takeaways

* The FDA wireless guidance is crucial for incorporating wireless technology.

* Understanding the risk category for wireless functions is essential.

* Wireless coexistence is a risk management approach, not just a checkbox.

* Medical devices should be viewed as interconnected systems.

* Cybersecurity must be considered alongside other technical aspects.

* Evaluating the end-to-end system is vital for safety and performance.

* Device manufacturers should consult relevant technical documents for guidance.

* The introduction of new technologies requires updated evaluation standards.

* Communication between devices can impact performance and safety.

* A holistic approach is necessary for effective risk management.

Keywords

Medical devices, wireless technology, risk management, FDA guidelines, wireless coexistence, medical systems, cybersecurity, connectivity, healthcare innovation, regulatory compliance

About Omar Al Kalaa

Omar Al Kalaa is the Founder and Principal of Inovectrum, a technology practice bridging MedTech and telecom through wireless innovation. He helps companies design and deploy high-performance connectivity solutions for medical devices, clinical environments, and digital health systems.

Before founding Inovectrum, Omar spent over eight years at the FDA, where he led regulatory science initiatives on 5G-enabled medical devices, developed wireless coexistence standards, and guided industry on complex compliance challenges. With a PhD in Electrical and Computer Engineering from the University of Oklahoma, he combines deep technical expertise with regulatory insight to advance future-ready connected health technologies.

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.

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