Summary

“We talk about risk all the time, but we forget to talk about the benefit. FDA’s job is to protect and promote public health, and benefit–risk is how those two missions meet.”

In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal sits down with Dr. Allison Komiyama, neuroscientist, former FDA reviewer, regulatory strategist, and founder of Bluestocking Health. Known for her ability to make complex FDA topics understandable and fun, Allison brings fresh clarity to one of the most misunderstood areas in risk management: benefit–risk evaluation.

Together, they explore why benefit–risk thinking goes far beyond premarket submissions, how companies can use it to guide post-market decisions, and why QA/RA professionals have a massive leadership opportunity as technology accelerates faster than regulations can keep up. Allison also shares the inspiration behind her new venture, Bluestocking Health, and her mission to spark more accessible, joyful conversations about medical technologies.

Chapters

01:20 Introducing Allison Komiyama

03:40 How FDA thinks about benefit and risk

08:10 Why benefits must be evidence-based, not marketing claims

10:45 The missing benefit–risk conversation in 510(k) submissions

13:45 Reverse-engineering FDA’s benefit–risk guidance for real devices

14:30 How AI/ML challenges traditional benefit–risk evaluation

17:00 Why intended use and indications are the foundation

18:40 Bringing marketing, clinical, and reimbursement into early conversations

20:05 QA/RA as strategic leaders, not gatekeepers

24:30 How the patient voice reframes quality and purpose

26:00 The mission behind Bluestocking Health

30:15 Final message for QA/RA professionals: “Keep talking to each other.”

Suggested links:

* FDA: Benefit-Risk Case Study for an AI/ML Device.

* LTR: An Ideal Medical Device.

* FDA: Benefit-Risk Guidance for 510(k) Submissions.

Key Takeaways

* Benefit–risk is fundamental to safety and effectiveness but there is no cookie-cutter formula.

* FDA reviewers weigh benefit just as heavily as risk, but industry often forgets the benefit side.

* Many devices enter the market via 510(k), where benefit–risk is rarely discussed, despite being essential.

* FDA does provide benefit–risk guidance for substantial equivalence, a tool few companies actually use.

* Post-market benefit–risk evaluation is critical; clearance is the starting line, not the finish line.

* For AI/ML devices, understanding good machine-learning practices and PCCPs helps establish safe guardrails.

* Intended use and indications are the anchor for any meaningful benefit–risk assessment.

* QA/RA professionals can play a strategic leadership role by connecting benefit–risk to business, clinical, and patient perspectives.

* Cross-functional conversations among engineering, marketing, reimbursement, clinical must start early, not at the end.

* The patient voice remains the most powerful unifying force in developing safe, beneficial technology.

Keywords

Benefit–risk evaluation, FDA submissions, 510(k)/De Novo/PMA, post-market safety, AI/ML devices, regulatory strategy, quality leadership, Bluestocking Health, patient-centric design, MedTech innovation.

About Allison Komiyama

Allison Komiyama is the Founder & CEO of Bluestocking Health, a new platform dedicated to elevating conversations around medical technologies and helping patients, caregivers, and innovators better understand the devices that shape healthcare. A former FDA reviewer at CDRH, Allison has spent more than a decade supporting hundreds of submissions across the full product lifecycle, spanning startups to global enterprises.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. 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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