{"podcast":{"title":"Let's Talk Risk! Podcast","slug":"let-s-talk-risk-podcast-6693844","podcast_index_feed_id":6693844,"rss_url":"https://api.substack.com/feed/podcast/1477050.rss","website_url":"https://naveenagarwalphd.substack.com/podcast","image_url":"https://substackcdn.com/feed/podcast/1477050/ee2039dcd34796f25b1263b7e1659bef.jpg","author":"Where MedTech professionals gain clarity and confidence to navigate complex decisions.","episode_count":166,"summary":"Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.","last_synced_at":null,"page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844"},"episode":{"title":"LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech","slug":"ltr-135-allison-komiyama-on-rethinking-benefit-risk-in-medtech","published_at":"2025-12-05T13:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-135-allison-komiyama-on-rethinking-benefit-risk-in-medtech","show_page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844","url":"https://naveenagarwalphd.substack.com/p/ltr-135-allison-komiyama-on-rethinking-benefit-risk","audio_url":"https://api.substack.com/feed/podcast/179141714/2818000978d4d2482445f7a7a2466ccd.mp3","summary":"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 De…","meta_description":"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…","key_points":[],"chapters":[],"topics":[],"duration_seconds":1925,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-talk-risk-podcast-6693844/episodes/ltr-135-allison-komiyama-on-rethinking-benefit-risk-in-medtech/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-135-allison-komiyama-on-rethinking-benefit-risk-in-medtech.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}