Bluestock Talk

Allison Komiyama
  • 5.0 (3)
  • Technology
  • Updated Weekly

Hosted by Allison Komiyama, PhD, RAC, founder of Bluestocking Health, Bluestock Talk is a podcast dedicated to authentic conversations and unique takes about the incredible impact of MedTech on our guests' lives. Each episode focuses on innovative medical devices, stories that spark joy, and how all of our lives benefit from advances in healthcare. Allison graduated from UC Berkeley with a degree in Molecular and Cell Biology, earned her doctorate in Neuroscience at Stanford, and was an FDA reviewer in the Center for Devices and Radiological Health.

  1. Oct 13

    Born from Innovation & Ready to Lead: A Conversation with Jenny Hoffmann

    What happens when your own life is the result of healthcare innovation? For Jenny Hoffmann, that question is deeply personal. Jenny is one of the first IVF babies in the United States. Years later, she survived a severe postpartum hemorrhage that changed the direction of her career. Today, as President of the New England Medical Innovation Center (NEMIC), she helps founders and innovators turn promising healthcare ideas into solutions that can actually reach patients. In this episode of Bluestock Talk, Allison and Jenny get into the parts of MedTech innovation that rarely fit neatly into a pitch deck: commercial viability, regulatory and reimbursement strategy, collaboration, vulnerability, leadership, and what keeps teams moving through the messy middle. Jenny puts it simply: “Innovation happens through collisions.” Sometimes that collision is a founder meeting the right clinician, investor, regulatory expert, hospital partner, or another entrepreneur who has already been through the problem keeping you awake at night. And sometimes it’s Allison meeting Jenny at a conference and immediately thinking, “I need to know EVERYTHING about what this person does.” 😂 They also talk about: • Why NEMIC starts with commercial viability, not just cool technology • Finding the right experts at the right time • Why cohorts can make entrepreneurship a lot less lonely • Collaboration vs. competition in MedTech • How challenging moments can accelerate innovation • Leading with curiosity, empathy, connection, and vulnerability • Why you don’t need a fancy title to be a leader • The medical technologies that have changed Jenny’s life and her family’s lives Jenny also shares the story behind her book, Open Up: Step Into the Leader You Are Meant to Be, and why she believes leadership is about shaping a vision and helping bring it to life.  One of the most powerful moments comes near the end, when Jenny talks about the “messy middle” of MedTech development. Timelines stretch. Teams get tired. Quitting can start to sound pretty reasonable. Her reminder? Remember the patient. That’s why we keep going. CHAPTERS 00:00 Meet Jenny Hoffmann 00:38 Jenny’s IVF origin story 04:37 Surviving postpartum hemorrhage 08:28 Commercial viability first 12:19 Finding the right experts 15:51 Community & “innovation therapy” 19:03 Collaboration over competition 22:55 Why challenge can accelerate innovation 28:40 Leading with vulnerability 32:23 Leadership from anywhere 35:12 The MedTech that changed Jenny’s life 41:40 Finding joy and impact in your work Learn more about NEMIC: https://nemic.org/ Jenny’s book: Open Up: Step Into the Leader You Are Meant to Be 💙 Want more conversations about MedTech, innovation, and the people behind it? Learn more: https://www.bluestocking.health/

  2. Oct 1

    There’s No Such Thing as Zero Risk: A Conversation with Naveen Agarwal

    Is there such a thing as a “good” risk? According to Naveen Agarwal, absolutely. And if the phrase makes your Regulatory or Quality brain twitch a little... well, that’s probably a good reason to listen. 😄 In this episode of Bluestock Talk, Allison sits down with Naveen, founder of Let’s Talk Risk, to talk about something we deal with constantly in MedTech but still manage to make really, really complicated: risk. Naveen started Let’s Talk Risk because he noticed that people weren’t struggling from a lack of standards, webinars, or training. There’s plenty of that. What’s harder is figuring out how to actually use what we know when we have to make a real decision. His answer has been to get people talking, sharing experiences, and getting more comfortable with the judgment that risk management requires. Because, as Naveen puts it: “A good risk is never zero risk.” That launches Allison and Naveen into a conversation about good risk, bad risk, benefit-risk decisions, and why getting everything into the green box on a risk matrix doesn’t necessarily mean you’ve done your job. They also get into one of Allison’s “red-flag” claims: “Our device has zero risk!” 😬 Rather than immediately reaching for a standard and explaining why that’s wrong, Naveen suggests something much more human: get curious. Ask why someone believes so strongly in the device. Understand the excitement first. Then help translate it into language that FDA will understand. A few things to take away: Zero risk isn’t the goal. Good judgment is.Risk management belongs to all of us, not just QA/RA folks.Benefit-risk changes as products, evidence, and alternatives evolve.CHAPTERS 00:00 Meet Naveen 01:26 Why Let’s Talk Risk exists 05:09 Community, conversation & content 13:59 Why risk isn’t one-size-fits-all 20:03 “Our device has zero risk!” 24:17 Why Naveen isn’t writing a book 30:58 Write for one person 34:53 Unsubscribers, criticism & staying focused 47:35 AI hallucinations, bias & critical thinking 50:11 The MedTech that changed Naveen’s life 53:35 A future benefit-risk episode? Naveen’s “Let’s Talk Risk!” podcast brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. Check it out on his YouTube channel at https://www.youtube.com/@NaveenAgarwalPhD, on Substack at https://naveenagarwalphd.substack.com/podcast, on Spotify at https://open.spotify.com/show/3lmY8rpFa2snQIJSBUaW0c, or via your other favorite platforms. 💙 Bluestock Talk explores the people, ideas, and medical technologies transforming healthcare. Want more honest conversations about MedTech, innovation, and the people building it? Tune in to Bluestock Talk as Allison Komiyama, PhD, RAC, explores the people, ideas, and medical technologies transforming healthcare. Have a guest, medical device, or healthcare topic you’d like Allison to explore? Let us know in the comments.  #BluestockTalk #BluestockingHealth #MedTech #MedicalDevices #RiskManagement #RegulatoryAffairs #Quality #HealthcareInnovation

  3. Sep 11

    AI, Wearables, and the Future of Healthcare: A Conversation with Blythe Karow

    We have more health data at our fingertips than ever before.  So... now what? Wearables can track our sleep, activity, heart rate, blood pressure, and an ever-growing list of health measures. AI is getting better at finding patterns within all that information. But as Blythe Karow puts it: “We’ve hit a breaking point where there’s too much data. Now we want interpretation.” In this episode of Bluestock Talk, Allison Komiyama, PhD, FRAPS, sits down with Blythe, CEO of The Karow Advisory Group and creator of The Device Files, for a candid conversation about AI, wearables, digital health, and the increasingly blurry boundary between consumer wellness technology and regulated medical devices. The possibilities are exciting. Could AI become the interpretive layer that helps make sense of our health data, recognize potential problems sooner, and get patients to the right clinician faster? As Blythe points out: “Right now, our journey to diagnosis is years.” But there’s a flip side. What happens when clinicians become so reliant on AI-powered tools that their own diagnostic skills begin to erode? How do we use technology to augment human expertise without losing the knowledge and judgment we still need humans to have? Along the way, Allison and Blythe explore: Why the future of wearables may be less about more data and more about better interpretationHow AI could help shorten the journey to diagnosisAmbient sensing, implants, and the future of health monitoringWomen’s health, biomarkers, and why patients deserve better answersAnd because this is Bluestock Talk, there are also side quests into wood chopping, Punky Brewster, Comic-Con, Dungeons & Dragons, and a possible Bluestocking/Device Files collab. KEY TAKEAWAYS More health data only helps if we can interpret it meaningfully and reliably.AI could help patients and clinicians recognize important patterns sooner.Consumer technology, wearables, digital health, AI, and medical devices are converging, creating new opportunities and regulatory questions.Finding the right balance between technology and human judgment may be one of healthcare’s biggest challenges.CHAPTERS 00:00 Meet Blythe Karow 04:30 Authenticity, thought leadership & The Device Files 07:30 Career detours, creativity & giving yourself grace 10:45 Wearables & what comes next 12:45 Too much health data: Now what? 16:00 AI, FDA & clinical judgment 18:45 Could AI weaken diagnostic skills? 23:30 Will we even “wear” wearables in the future? 30:30 Longevity, healthy living & behavior change 34:15 Women’s health, biomarkers & better answers 45:00 The MedTech that changed Blythe’s life ABOUT BLYTHE Blythe Karow is CEO of The Karow Advisory Group, where she advises executives and boards navigating MedTech, digital health, wearables, AI, and consumer technology. She also writes The Device Files. 💙 Want more honest conversations about MedTech, innovation, and the people building it? Tune in to Bluestock Talk as Allison explores the people, ideas, and medical technologies transforming healthcare. Have a guest, medical device, or healthcare topic you'd like Allison to explore? Let us know! #BluestockTalk #MedTech #MedicalDevices #ArtificialIntelligence #Wearables #DigitalHealth #HealthcareInnovation #AIinHealthcare #BluestockingHealth

  4. Aug 10

    We Can Do Better: A Conversation with Justin McKay

    What if one of healthcare's biggest safety risks has been hiding in plain sight, right under our noses…literally! Lead aprons are used every day in hospitals, imaging suites, and dental offices to protect healthcare workers and patients from radiation exposure. But how often are they cleaned? Inspected? Repaired? In this episode of Bluestock Talk, Allison sits down with Justin McKay, co-founder of RadCare Services, to explore this often-overlooked aspect of healthcare quality. What began with Justin developing an infection after wearing a shared lead apron became the catalyst for building a company dedicated to improving patient safety, PPE compliance, and quality assurance across healthcare. His message is simple: "We can do better." Together, they discuss why quality shouldn't be viewed as a burden, why preventing problems is always better than reacting to them, and how innovation often begins by asking questions that everyone else has stopped asking. Along the way, they explore: The connection between proper maintenance, infection control, and patient safetyWhat organizations can learn from adopting a proactive, rather than a reactive, approach to riskHow perseverance helped transform an overlooked idea into a growing companyThe conversation also highlights the importance of asking difficult questions, challenging long-standing practices, and remembering that innovation doesn't always require inventing something new. It can begin by improving the systems already in place. If that’s not a metaphor for life, then what is?! Key TakeawaysPatient safety can often depend on the details that go unnoticedQuality systems exist to protect people, not create bureaucracyPreventative maintenance can reduce unnecessary risk for both patients and providersHealthcare innovation frequently starts by solving overlooked problemsChapters00:00 Intro and Justin's healthcare journey 03:30 The story that inspired RadCare Services 08:30 Lead aprons, PPE, and hidden infection risks 14:30 Why quality systems matter more than most people realize 22:30 Changing the perception of quality and regulatory compliance 28:30 Growing a company through education and persistence 35:00 Rethinking long-standing hospital practices Whether you work in healthcare, MedTech, QA, RA, infection prevention, or simply care about improving patient outcomes, this episode offers a look at how small changes can make a big difference. Justin is the co-founder of RadCare Services, a company focused on helping healthcare organizations improve the cleaning, inspection, repair, management, and compliance of lead aprons and other radiological protective equipment. His mission is rooted in a simple belief: Healthcare can, and should, do better. Read more at https://www.linkedin.com/in/justinmckay22/ and https://www.linkedin.com/company/radcare-services/. #BluestockTalk #PatientSafety #InfectionControl #MedicalDevices #Radiology #QualitySystems #RegulatoryAffairs #HealthcareInnovation #PPE 💙 Want more honest conversations about MedTech, innovation, and the people building it? Tune in to Bluestock Talk as Allison Komiyama, PhD, RAC, explores the people, ideas, and medical technologies transforming healthcare. Have a guest, medical device, or healthcare topic you’d like Allison to explore? Let us know in the comments.

  5. Jul 21

    Why Children Can't Be an Afterthought: A Conversation with Dr. Juan Espinoza

    What if we stopped asking how to adapt medical technologies for children... ...and started asking how to innovate for children first? In this episode of Bluestock Talk, Allison is joined by Juan C. Espinoza, MD, Executive Director and Principal Investigator of the Consortium for Technology & Innovation in Pediatrics (CTIP), and Chief Research Informatics Officer, Stanley Manne Children’s Research Institute at Ann & Robert Lurie Children’s Hospital of Chicago, for an inspiring conversation about the future of pediatric medical devices. Although children make up nearly one-quarter of the U.S. population, pediatric healthcare continues to receive a disproportionately small share of funding, research, and reimbursement, with less than 10% of all healthcare dollars going to pediatric care. Dr. Espinoza explains why that gap exists and what it will take to build an innovation ecosystem that truly serves children and their families. One of Dr. Espinoza's most thought-provoking questions: "How do we innovate for children first?" That question leads to a broader discussion about designing devices specifically for pediatric patients, partnering with families from the earliest stages of development, and creating incentives that encourage companies to think about children before, not after, a product reaches the market. Along the way, Allison and Juan discuss: • Why pediatric innovation has historically been underfunded • The role of the Pediatric Device Consortia Program and CTIP • Designing medical devices for children at home, not just in hospitals • Why families are eager to participate in research and product development • Balancing benefit and risk in pediatric medical devices • The importance of collaboration across industry, regulators, clinicians, researchers, and patient advocates Juan also shares why continuous glucose monitors have transformed diabetes care, and why improving access to proven technologies may be just as important as inventing new ones. KEY TAKEAWAYS• Children deserve to be part of the innovation conversation from the beginning • Families are valuable partners in research and device development • Home-use design is a critical opportunity in pediatric MedTech • Collaboration is essential to advancing pediatric innovation • Better access to medical technologies leads to better patient outcomes CHAPTERS00:00 Introduction to Dr. Juan Espinoza 02:00 The funding gap in pediatric healthcare 08:00 The Pediatric Device Consortia Program 15:00 Why we should innovate for children first 22:00 Benefit-risk in pediatric devices 28:00 Designing technologies for home use 33:00 Partnering with families early in development 36:00 Continuous glucose monitors and expanding access 40:00 The future of pediatric innovation Learn more about Dr. Juan Espinoza: https://www.linkedin.com/in/juanespinozamd/ and https://www.ctipmedtech.org/team-bios/juan-espinoza-md #BluestockTalk #Pediatrics #MedTech #MedicalDevices #HealthcareInnovation #DigitalHealth #PatientCenteredDesign #PediatricCare #MedicalDeviceInnovation 💙 Want more honest conversations about MedTech, innovation, and the people building it? Tune in to Bluestock Talk as Allison Komiyama, PhD, RAC, explores the people, ideas, and medical technologies transforming healthcare. Have a guest, medical device, or healthcare topic you’d like Allison to explore? Let us know in the comments.

  6. Jul 6

    Empathy Belongs in the Boardroom: A Conversation with Dr. Denise Bronner

    What if one of the most overlooked skills in healthcare leadership isn't strategy, fundraising, or operations? What if it's empathy? In this episode of Bluestock Talk, Allison is joined by Denise Bronner, PhD, founder of Empactful Ventures, board advisor, consultant, and former academic researcher, for a thoughtful conversation about leadership, collaboration, and the human side of innovation. Denise shares her journey from academia to entrepreneurship and explains why she believes empathy is one of the most powerful, and underutilized, tools in healthcare and business. As Denise points out, many organizations unintentionally create silos between departments, vendors, leaders, and teams. Yet some of the biggest breakthroughs happen when people take the time to listen, understand different perspectives, and work toward shared goals. One of Denise's most powerful takeaways: "You can have passion and profits together." That idea becomes the foundation for a broader discussion about mission-driven leadership, building high-performing teams, and helping founders communicate the value of their work without losing sight of why they started in the first place. Along the way, Allison and Denise discuss: • Why empathy is often missing from leadership conversations • How to break down silos across organizations and teams • The importance of listening before leading • Academic skills that translate surprisingly well into industry • Vendor and sponsor relationships built on partnership rather than transactions • Why communication can make or break collaboration • How mission-driven companies can balance impact and profitability Denise also shares why some of the best leaders create space for their teams to grow rather than standing in their way, and why listening to what people actually want is often more important than deciding for them. The conversation concludes with a powerful discussion about medical innovations that improve quality of life, including advances in cancer therapies, women's health, and technologies that help patients maintain dignity, comfort, and control throughout their healthcare journey. KEY TAKEAWAYS• Empathy is a powerful leadership tool, not a weakness • Passion and profitability can coexist • Strong teams are built through listening and trust • Cross-functional collaboration drives innovation • Relationships matter as much as expertise in healthcare CHAPTERS00:00 Introduction to Denise Bronner 02:00 From academia to entrepreneurship 06:00 Empathy as a leadership strategy 11:00 Why people resonate with Denise's LinkedIn content 18:00 Listening, leadership, and team development 25:00 Vendor relationships and breaking down silos 31:00 Building partnerships instead of transactions 34:00 Medical innovations that improve quality of life 37:00 Final thoughts on impact and leadership Read more about Dr. Bronner: https://www.linkedin.com/in/dnbronner/. #BluestockTalk #Leadership #HealthcareInnovation #MedTech #WomenInLeadership #HealthTech #EmpathyInLeadership #StartupLeadership #HealthcareLeadership #DeniseBronner 💙 Want more honest conversations about MedTech, innovation, and the people building it? Tune in to Bluestock Talk as Allison Komiyama, PhD, RAC, explores the people, ideas, and medical technologies transforming healthcare. Have a guest, medical device, or healthcare topic you’d like Allison to explore? Let us know in the comments.

  7. Jun 11

    FDA Doesn't Write Checks: A Conversation with Mark Domyahn

    What happens when a MedTech company successfully gets through FDA? That is often when the real work begins. In this episode of Bluestock Talk, Allison is joined by reimbursement expert Mark Domyahn, Partner at JD Lymon Group (and Bluestocking Health Advisory Board member), to explore one of the most important (and frequently misunderstood) aspects of MedTech commercialization: getting paid. As Mark explains, regulatory approval is only one piece of the puzzle. Hospitals, physicians, payers, and investors all evaluate new technologies differently, and increasingly, investors want to understand not just whether a product can reach the market, but whether there is a realistic path to reimbursement and adoption. One of Mark's most memorable observations: "FDA doesn't write checks." That simple statement becomes the foundation for a fascinating discussion about why reimbursement strategy should be considered alongside regulatory strategy from the earliest stages of development. Together, Allison and Mark explore how coding, coverage, payment, clinical evidence, and market access all influence whether innovative technologies ultimately reach patients. Along the way, they discuss: • Why reimbursement is often one of the most overlooked aspects of MedTech strategy • How investors are changing the questions they ask startups • The difference between FDA approval and payer adoption • Medicare, Medicare Advantage, and healthcare payment dynamics • Why clinical unmet need drives both reimbursement and innovation • Why understanding the healthcare system is just as important as building great technology The episode also features one of the most entertaining Bluestock Talk segments yet, as Allison challenges Mark to a game of "Is It a Regulated Medical Device?" featuring implantable microchips, smell tests, and other surprisingly real technologies. KEY TAKEAWAYS• Regulatory and reimbursement strategies should be developed together • FDA approval does not automatically lead to payment or adoption • Investors increasingly want to understand long-term reimbursement pathways • Clinical evidence requirements may differ between regulators and payers • Mobility technologies and brain-computer interfaces may transform patient independence and quality of life CHAPTERS00:00 Introduction to Mark Domyahn 02:00 Understanding reimbursement in MedTech 08:00 Why investors are asking different questions 13:00 Let’s play “Is It a Regulated Medical Device?” 24:00 Who pays for healthcare innovation? 33:00 Medical technologies that changed Mark's life 37:00 Exoskeletons, mobility, and brain-computer interfaces 41:00 Why reimbursement and regulatory strategy must align Read more about Mark Domyahn at https://jdlymon.com/ and  https://www.linkedin.com/in/mark-domyahn/. #BluestockTalk #MedTech #HealthcareInnovation #Reimbursement #MarketAccess #MedicalDevices #HealthcareEconomics #DigitalHealth #BrainComputerInterface #Exoskeletons #MarkDomyahn 💙 Want more honest conversations about MedTech, innovation, and the people building it? Tune in to Bluestock Talk as Allison Komiyama, PhD, RAC, explores the people, ideas, and medical technologies transforming healthcare. Have a guest, medical device, or healthcare topic you’d like Allison to explore? Let us know in the comments.

  8. May 22

    The FemTech Revolution: A Conversation with Bethany Corbin

    What happens when women’s healthcare is finally treated not as a niche category… but as one of the biggest opportunities in healthcare innovation? In this episode of Bluestock Talk, Allison is joined by Bethany Corbin, healthcare attorney, FemTech advocate, author of The FemTech Revolution, and founder of FemInnovation, to explore the rapidly evolving world of women’s health technology. Bethany shares her deeply personal journey into FemTech, from watching her mother struggle for years to receive a diagnosis for a rare illness to navigating her own painful experiences within the healthcare system. But as Bethany reflects, one of the hardest parts was not always being dismissed by others. It was learning how often women are conditioned to dismiss their own symptoms, pain, and experiences for years before seeking care. That experience ultimately reshaped her career and fueled her mission to help build a future where women’s healthcare is taken more seriously, better funded, more privacy conscious, and designed with real patient experiences in mind. One of Bethany’s most powerful takeaways: “We are not charity cases. We are 50+% percent of the population. We make 80% of healthcare decisions.” Along the way, Allison and Bethany explore: • The evolution of the term “FemTech” since 2016 • Why women’s healthcare is still frequently dismissed • The importance of diverse representation in venture capital • Why storytelling and openness are helping reduce stigma around women’s health Bethany also explains why healthcare data may be one of the most valuable forms of personal information people unknowingly give away, especially through health and wellness apps. The conversation highlights several emerging technologies reshaping women’s healthcare, including AI-enabled breast exams, cervical cancer screening innovations, at-home testing tools, and period tracking platforms that help women advocate more effectively for their own care. KEY TAKEAWAYS • Women’s healthcare represents a major innovation and investment opportunity • Healthcare data privacy deserves far more attention from consumers and companies • Diverse representation improves healthcare innovation and investment decisions • FemTech innovation has the potential to improve outcomes for millions of women CHAPTERS 00:00 Introduction to Bethany Corbin 02:00 Bethany’s journey into FemTech and healthcare law 08:00 Why women’s healthcare is still often dismissed 11:00 Building FemInnovation and supporting founders 16:00 Investment challenges in women’s healthcare 21:00 Privacy, healthcare data, and digital health apps 30:00 How consumers can evaluate privacy protections 35:00 Emerging FemTech innovations 43:00 The future of women’s healthcare innovation 44:00 Medical technologies that impacted Bethany’s life Read more about Bethany Corbin at https://www.linkedin.com/in/bethanycorbin/, and more about The FemTech Revolution at  https://www.amazon.com/FemTech-Revolution-Bethany-Corbin/dp/B0D7Q7M7YQ #BluestockTalk #FemTech #WomensHealth #MedTech #HealthcareInnovation #DigitalHealth #DataPrivacy #MedicalDevices #HealthcareLeadership #HealthTech #BethanyCorbin #FemInnovation

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Ratings & Reviews

5
out of 5
3 Ratings

About

Hosted by Allison Komiyama, PhD, RAC, founder of Bluestocking Health, Bluestock Talk is a podcast dedicated to authentic conversations and unique takes about the incredible impact of MedTech on our guests' lives. Each episode focuses on innovative medical devices, stories that spark joy, and how all of our lives benefit from advances in healthcare. Allison graduated from UC Berkeley with a degree in Molecular and Cell Biology, earned her doctorate in Neuroscience at Stanford, and was an FDA reviewer in the Center for Devices and Radiological Health.

Information

  • Creator
    Allison Komiyama
  • Years Active
    2026
  • Episodes
    15
  • Rating
    Explicit
  • Copyright
    © 2026 Allison Komiyama
  • Show Website
    Bluestock Talk

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