Bluestock Talk

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

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 interpretation
• How AI could help shorten the journey to diagnosis
• Ambient sensing, implants, and the future of health monitoring
• Women’s health, biomarkers, and why patients deserve better answers

And 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
39:00 Comic-Con, Dungeons & Dragons & other side quests
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

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 safety
• What organizations can learn from adopting a proactive, rather than a reactive, approach to risk
• How perseverance helped transform an overlooked idea into a growing company

The 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?!

• Patient safety can often depend on the details that go unnoticed
• Quality systems exist to protect people, not create bureaucracy
• Preventative maintenance can reduce unnecessary risk for both patients and providers
• Healthcare innovation frequently starts by solving overlooked problems

00:00 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.

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.

• 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

00:00 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.

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.

• 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

00:00 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.

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.

• 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

00:00 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.

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

What if one of the biggest challenges in healthcare is not treating disease… but preventing it before symptoms ever begin?

In this episode of Bluestock Talk, Allison is joined by Dr. Pradeep Natarajan, preventive cardiologist, physician scientist, and leader in cardiovascular genetics at Massachusetts General Hospital and Harvard Medical School, to explore how genomics, wearable technologies, and systems thinking are reshaping the future of preventive medicine.

As Pradeep points out, medicine is still largely designed to react once people become sick, not necessarily to stop disease before it starts. Yet advances in genetics, biomarker research, imaging, and wearable technologies are beginning to shift healthcare toward earlier prediction, personalized prevention, and more proactive care.

The conversation explores how human genetics helps researchers move beyond correlation toward a deeper understanding of what actually causes disease, and why those discoveries are increasingly shaping the development of new therapies and risk prediction tools.

One of Pradeep’s most powerful takeaways:

“Longevity is just rebranded prevention.”

That idea becomes a jumping off point for a much larger conversation about why prevention has historically been underfunded, difficult to scale, and surprisingly hard to integrate into modern healthcare systems, even though almost everyone agrees it matters.

Allison and Pradeep also unpack why “longevity” has suddenly become one of healthcare’s biggest conversations and why, underneath the branding, it is really a conversation about prevention, systems, access, and behavior.

Along the way Allison and Pradeep discuss:

• Why prevention is still not a major focus in medicine
• How genetics improves disease prediction and therapeutic development
• How wearable technologies may improve public health
• Why evidence matters in preventive medicine
• How AI may improve workflows without replacing physicians

KEY TAKEAWAYS

• Prevention requires long-term thinking
• Genetics can improve prediction and treatment development
• Personalized medicine depends on both technology and communication
• AI may improve healthcare workflows when thoughtfully implemented

CHAPTERS

00:00 Introduction to Dr. Pradeep Natarajan
03:00 From UC Berkeley to cardiovascular genetics
07:00 Combining medicine, research, and patient care
12:00 Why prevention remains difficult in healthcare
17:00 Longevity, prevention, and healthcare systems
20:00 Human genetics and causal inference in disease
27:00 Communicating prevention to patients
29:00 AI, clinician workflows, and healthcare technology
33:00 Wearables, fitness tracking, and digital health
39:00 Blood pressure monitoring and future consumer health tools
43:00 The future of preventive cardiovascular medicine

Read more about Dr. Pradeep Natarajan: https://www.massgeneral.org/doctors/19689/pradeep-natarajan

#BluestockTalk #PreventiveMedicine #Cardiology #PrecisionMedicine #Genetics #DigitalHealth #Wearables #HealthcareInnovation #MedTech #CardiovascularHealth #AIinHealthcare #Longevity #PradeepNatarajan

💙 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.

What if one of the most powerful tools in pediatric healthcare is not a device at all, but something much more fundamental?

Play.

In this episode of Bluestock Talk, Allison is joined by Mary Jenner, RN, BSNS, CTSS, former pediatric oncology nurse and founder of The Butterfly Pig, to explore how play is transforming the healthcare experience for children and families.

Mary shares the moment that started everything: a frightened young patient, a teddy bear, and a simple idea to treat the toy first. What followed was a shift in trust, cooperation, and care.

That moment revealed something deeper. When children understand what is happening to them, they feel safer. And when they feel safer, everything changes.

Today, Mary designs imaginative, medically inclusive toys that help children process complex medical experiences, from IV lines and feeding tubes to imaging procedures. They are intended as tools for preparation, communication, and emotional safety.

One of Mary’s most powerful takeaways:
“Kids’ language is play. They deserve the right to play with things that represent their world.”

Allison and Mary explore how small moments in healthcare can shape lifelong perceptions of care, and how unaddressed medical trauma can lead to fear, avoidance, and worse outcomes later in life.

They also discuss the reality clinicians face, including “transient empathic blindness,” where providers must prioritize tasks over emotional connection in high pressure moments, and how that can unintentionally contribute to trauma.

Mary also shares a personal story about a life-saving medical technology that helped her daughter recover from a traumatic birth, a powerful reminder of how innovation and care intersect in real life.

Along the way Allison and Mary discuss:

• How play builds trust and reduces fear
• Why children need preparation, not surprise
• The role of child life specialists
• How small clinical moments can have lasting impact
• Why medical trauma can lead to healthcare avoidance
• How toys give children a sense of control
• The importance of collaboration across care teams

KEY TAKEAWAYS

• Play is a powerful tool for communication and emotional safety
• Preparing children improves care experiences
• Medical trauma has long term consequences
• Emotional safety should be part of standard care
• Innovation does not always have to be complex

CHAPTERS

00:00 Introduction to Mary Jenner
02:00 The moment that sparked Butterfly Pig
06:00 Building trust through play
12:00 Understanding medical trauma
18:00 The role of child life specialists
24:00 Designing medical toys
30:00 Preparing children for procedures
36:00 Long term impact of care experiences
42:00 A life-saving medical technology story

#BluestockTalk #PediatricCare #MedTech #HealthcareInnovation #MedicalDevices #PatientExperience #ChildLife #TraumaInformedCare #DigitalHealth #MaryJenner

💙 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.

Brilliant medical technologies are invented every year though many never reach patients.

Why?

In this episode of Bluestock Talk, Allison sits down with Dr. Adam Brown, physician, healthcare strategist, and founder of ABIG Health, to unpack one of the most misunderstood challenges in MedTech innovation: the long and complicated journey from idea to real-world adoption.

Dr. Brown explains how he is helping MedTech founders navigate the journey from ideation to commercialization, translating the value of new technologies for the many stakeholders involved in healthcare systems.

As he discusses, inventors often build brilliant technology but struggle to communicate its value to hospital leaders, regulators, payers, and investors. Each group evaluates innovation through a completely different lens.

The conversation explores why early strategic planning is critical to avoid what many in healthcare call the “Valley of Death,” the stage where technologies receive regulatory clearance but fail to reach real clinical adoption.

Understanding the entire ecosystem of healthcare innovation from regulation to reimbursement to hospital adoption can dramatically increase the chances that a technology actually reaches patients.

Along the way Allison and Adam discuss:

• Why many MedTech innovations fail after regulatory approval
• How ABIG Health helps innovators translate technology value across stakeholders
• Why founders should start commercialization planning at the ideation stage
• The global impact of geopolitical decisions on drug and device availability
• How artificial intelligence tools may improve clinical workflows
• Why user centered design is critical for clinician adoption

• Healthcare commercialization requires understanding multiple stakeholders
• Early planning can prevent costly delays and product failure
• Even simple medical technologies can dramatically change lives

00:00 Introduction to Dr. Adam Brown
02:25 The mission behind ABIG Health
06:10 Understanding the Healthcare “Valley of Death”
10:30 Stakeholder health and the global healthcare ecosystem
17:30 COVID trauma and healthcare workforce challenges
26:45 AI and clinical workflow improvements
33:40 Medical devices that transform care
37:20 Personal story of vision restoration through medical technology

#BluestockTalk #MedTech #HealthcareInnovation #MedicalDevices #DigitalHealth #HealthPolicy #HealthcareLeadership #StartupInnovation #HealthcarePodcast #AdamBrown

💙 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.

🎥 YouTube: https://www.youtube.com/@Bluestocking.Health/podcasts 

🎧 Apple Podcasts: https://podcasts.apple.com/us/podcast/bluestock-talk/id1874148438 

🎧 Spotify: https://open.spotify.com/show/0T2mEj0NfMNnMznqtKHKmZ?si=e37e0b2c88904172 

Have a guest, medical device, or healthcare topic you’d like Allison to explore? Let us know in the comments.