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/

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
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