Inside MedTech Innovation

Dr. Bob Gabbay has spent decades at the intersection of diabetes research, clinical care, and technology innovation. From leading the Joslin Diabetes Center to serving as Chief Scientific and Medical Officer at the American Diabetes Association, he witnessed the field transform from sharpening needles on stones to closed-loop insulin systems. Yet despite incredible technological advances, a critical problem persists: the tools that could help people with diabetes simply aren't reaching them or being used effectively.

In this conversation, Dr. Bob shares how the DIY diabetes community's "We Are Not Waiting" movement pushed both industry and regulators forward, why A1C and time in range tell complementary stories about glucose management, and how his year of "semi-retirement" turned into mentoring startups and crystallizing decades of knowledge. He discusses the holy grail features still missing from automated insulin delivery, from exercise mode to meal-snap AI, and makes the case for why patient-reported outcomes deserve equal billing with clinical measures. Dr. Bob also reflects on moonshot thinking, the tension between individualizing treatment and population-level safety, and why the last mile problem matters more than the next breakthrough.

[00:00:00] Introduction and Dr. Bob's journey from chemistry sets to diabetes care

[00:06:00] Creating opportunities through cold calling and community building

[00:10:00] Med school without planning to see patients

[00:12:00] Leading the American Diabetes Association

[00:15:00] Seven turns in diabetes management

[00:17:00] A1C versus time in range as outcome measures

[00:21:00] Semi-retirement as a digital nomad

[00:23:00] Fluid knowledge versus crystallized knowledge

[00:26:00] The "We Are Not Waiting" movement's impact

[00:30:00] What's still not solved in automated insulin delivery

[00:34:00] The mascara metaphor and spoon theory

[00:39:00] Sotagliflozin and weighing DKA risk versus benefits

[00:46:00] Making emotional outcomes measurable

[00:51:00] Moonshots and the Startup Health approach

[00:55:00] Non-invasive glucose monitoring lessons

[00:58:00] Rapid fire questions

Follow Shannon and Dr Bob:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Dr Bob: 

LinkedIn: https://www.linkedin.com/in/drbobgabbay/

One medical device company cut their software recall response time from 180 days to under 30 by automating compliance evidence collection.

In regulated industries like MedTech, shipping software takes weeks not because the code isn't ready, but because proving compliance requires manual evidence gathering. Automated governance captures proof continuously as developers work. When it's time to ship, compliance happens automatically or developers get blocked. The result: 85% faster time to market and developers who become collaborators instead of adversaries.

In this episode, Shannon Lantzy talks with Michael Edenzon, CEO of Fianu, about turning cyclical compliance work into continuous automation, why transparency changes developer behavior, and why objective, reproducible evidence should be the new regulatory standard.

Timestamps:

00:00 – Why automated governance is the missing piece in DevOps

04:00 – How Michael went from constitutional law student to software governance innovator

06:00 – What automated governance is (and why it's not just another tool)

09:00 – The screenshot problem: When developers game manual compliance systems

12:00 – Do developers hate automated governance or does it free them?

15:00 – What happens when requirements are incomplete or wrong

18:00 – The flywheel effect: How continuous feedback improves control effectiveness

20:00 – Creating a shared language: Pass, fail, in progress, or not found

24:00 – Case study: How a CGM company cut recall response from 180 to 30 days

30:00 – Why you should never automate to a higher standard than you're currently at

33:00 – Simulating the impact of policy changes before enforcing them

37:00 – The power of annotations: Accepting risk while maintaining auditability

40:00 – Why transparency turns developers into your best collaborators

42:00 – Who should (and shouldn't) adopt automated governance

48:00 – What Michael would change about FDA regulation if he could wave a wand

52:00 – Tracking software from Jira story to production runtime and back to adverse events

54:00 – What's next for Fianu: Statistics, reporting, and compliance incentive structures

Follow Shannon and Michael:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy/

Website: https://www.shannonlantzy.com/

Connect with Michael: 

LinkedIn: https://www.linkedin.com/in/michaeledenzon/

Website: https://www.fianu.io/

Only 2% of sickle cell patients who could benefit from blood therapy actually receive it, despite it being first-line treatment.

Marketing in medical devices isn't about jingles or promotions. It's about looking at data, drawing hypotheses, testing them, and ensuring every claim you make is scientifically relevant. It's closer to research than advertising, requiring the ability to translate between what physicians know, what devices do, and what patients need.

In this episode, Shannon Lantzy talks with Joy Duemke, Director of Marketing at Terumo Blood and Cell Technologies, about her 15-year journey across six different roles at one company. They discuss why learning agility matters more than subject matter expertise, how to navigate the overlap between clinical knowledge and product understanding, and what it takes to launch the Bet on Blood program, a partnership addressing systemic gaps in sickle cell care.

Timestamps:

00:00 – Why marketing in medical devices is closer to science

03:00 – Joy's path from software to MedTech and the art of cat herding

06:00 – Learning agility: Getting B-pluses in everything from jazz to business law

08:00 – What Terumo does: Unlocking the potential of blood

11:00 – Blood supply chain resilience and the Blood Emergency Readiness Corps

14:00 – The Bet on Blood campaign for sickle cell patients

17:00 – Strategic vs. clinical vs. tactical marketing

20:00 – Getting humble pie from physicians and learning not to guess

23:00 – Creating business cases for new device applications

26:00 – Why marketing is a translator for science

28:00 – Managing claims with precision across legal, regulatory, and clinical teams

32:00 – The art of translation: Making apheresis "an oil change"

35:00 – When you want to make claims but can't support them yet

37:00 – Patient stories and the importance of peripheral vascular access

40:00 – Navigating tariffs and AI in MedTech today

44:00 – Rapid fire: Bet on Blood, heroes, and listening to patients

Follow Shannon and Joy:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Joy: 

LinkedIn: https://www.linkedin.com/in/joy-duemke-339a922/

Website: https://www.terumobct.com

What if you could see inside a patient's body instantly, without moving them from their bed in the emergency department?

Dr. Resa Lewiss spent 25 years in emergency medicine, pioneering the integration of point-of-care ultrasound into clinical practice. As the founding head of ultrasound at Mount Sinai St. Luke's Roosevelt, she built education curricula, established quality improvement processes, and trained the next generation of emergency physicians to use this life-saving technology at the bedside.

Her work helped transform ultrasound from a specialty radiologist's tool into a standard part of emergency medicine training—so much so that no emergency medicine resident can now graduate without being deemed competent in bedside ultrasound.

In this conversation, Resa reveals how ultrasound changed emergency procedures from blind needle sticks to guided visualization, why she thinks emergency doctors are like assembly line cooks, and how she's democratizing medical education through free, open-access platforms. Plus, she shares a decades-later validation of a life-saving diagnosis that she thought no one had witnessed.

TIME STAMPS: 

00:00 Introduction to Emergency Medicine and Guest Speaker

00:40 Meet Dr. Risa Lewiss: Career Highlights and Achievements

02:05 Dr. Lewiss' Journey into Medicine

05:16 Choosing Emergency Medicine

08:10 The Reality of Emergency Medicine

10:41 Founding an Ultrasound Program

13:33 The Importance of Point of Care Ultrasound

17:06 Challenges and Future of Ultrasound in Emergency Medicine

22:39 Balancing Administrative and Clinical Roles

23:43 The Role of Ultrasound in Trauma Care

27:14 Challenges and Misuses of Ultrasound

30:07 Med Tech Innovations and Middleware

36:10 The Future of Medical Education

39:44 Rapid Fire Questions and Personal Insights

42:09 Concluding Thoughts and Reflections

Follow Shannon and Resa:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Resa: 

LinkedIn: linkedin.com/in/resa-Lewisss-md

Website: https://www.resaLewiss.com/

Sasha Keck was the only girl in her high school engineering class of 26 students. By her senior year of college, she and her team had patented a surgical device that could cut spinal surgery exposure time in half.

As a Technical Development Program Engineer at Edwards Lifesciences, Sasha bridges the gap between R&D innovation and manufacturing reality. She's part of a generation that grew up during a pandemic, learned to code with ChatGPT, and shares their location with friends as naturally as older generations exchange phone numbers.

In this conversation, Sasha shares her journey from building mobility devices for paralyzed dogs named Harold and Fred in high school, to developing VacuTrac—a combined retractor and suction device for spinal surgery at Rice University. She reveals what it's like to be a young woman in mechanical engineering, how she and her team iterated through hundreds of 3D-printed prototypes, and why this generation's adaptability might be exactly what MedTech needs.

Timestamps:

00:00 Introduction and Guest Welcome

01:03 Choosing an Undergraduate Program During COVID-19

03:36 High School Engineering Projects

05:56 Freshman Year at Rice University

09:48 Senior Design Project: VacuTrac

20:58 Current Work and Future Aspirations

25:36 Ensuring Accurate Testing and Identifying Failure Points

26:17 Utilizing AI and Automated Tools in Engineering

28:24 Challenges and Opportunities in Medical Device Development

31:09 The Importance of Pediatric and Rare Disease Research

33:47 Navigating Career Paths and Future Aspirations

43:36 Addressing Gender Disparities in Engineering

49:09 Reflections and Advice for Young Professionals

52:45 Conclusion and Final Thoughts

Follow Shannon and Sasha:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy/

Website: https://www.shannonlantzy.com/

Connect with Sasha: 

LinkedIn: https://www.linkedin.com/in/sasha-keck/

In this episode of Inside MedTech Innovation, Haley King, co-founder and CEO of Paxos Health, joins host Shannon Lantzy to explore how technology can level the playing field when patients face insurance denials.

Haley shares her journey from designing cardiovascular implants at Medtronic to founding a company that helps patients overturn insurance denials with a 90% success rate. The conversation examines why reimbursement strategy matters as much as FDA approval, how AI can help patients navigate complex coverage systems, and what happens when innovation meets the reality of payment barriers.

For med tech founders, innovators, and anyone who has faced an insurance denial, this discussion offers insight into the gap between regulatory approval and patient access, and how one startup is working to close it.

Timestamps:

00:00 Welcome to Inside Med Tech Innovation

00:04 The Invisible Barrier: Insurance Denials

01:01 Personal Story: Navigating Insurance Denials

02:50 Introducing Haley King and Paxos Health

04:19 Haley King's Journey: From Engineering to Entrepreneurship

14:23 The Birth of Paxos Health

20:30 From Service to Product: Building AI Tools

25:43 Navigating the Healthcare Ecosystem

34:28 Challenges in Pediatric Drug Testing

35:35 Software as a Medical Device

36:37 Navigating CMS and Private Insurers

37:53 The Importance of Reimbursement Strategy

44:31 Balancing Speed and Accuracy in Startups

48:51 Marketing and Sales Strategies

56:24 AI in Healthcare Access

01:01:04 Patient Success Stories

01:03:15 Rapid Fire Questions and Closing Remarks

Follow Shannon and Haley:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy/ 

Website: https://www.shannonlantzy.com/ 

Connect with Haley: 

LinkedIn: linkedin.com/in/haleymking/

Website: paxoshealth.com/about

What happens when a digital health pioneer becomes a cancer patient and discovers his own doctors missed a life-threatening diagnosis? Steve Brown, founder and CEO of CureWise, shares his remarkable journey from building one of the first remote patient monitoring companies to nearly losing his life to a rare blood cancer that went undetected until the Palisades Fire displaced him to new doctors with fresh eyes.

In this episode of Inside MedTech Innovation, Steve joins Shannon Lantzy to discuss how he built AI agents that diagnosed his own cancer using the same data his original doctors had reviewed, then used those same tools to advocate for off-label precision treatments that saved his life. Now, he's building CureWise to give every patient access to the same level of personalized treatment insights.

Steve and Shannon explore:

• Why the standard of care often represents what we knew years ago, not what's possible today

• How AI can synthesize all of medical knowledge to enable truly personalized medicine

• The critical difference between building healthcare solutions for others versus being patient zero

• Why precision oncology requires new regulatory paradigms beyond randomized controlled trials

• How patient advocacy powered by AI can level the playing field in cancer treatment

• The role of FDA innovation in accelerating life-saving treatments without compromising safety

Timestamps

00:00 The Promise and Perils of AI in Healthcare

00:08 Introducing Steve Brown: A Digital Health Pioneer

01:30 Steve's Journey from Video Games to Healthcare Innovation

03:52 The Impact of Remote Patient Monitoring

06:15 A Personal Health Crisis: Steve's Cancer Diagnosis

14:10 The Role of AI in Steve's Diagnosis and Treatment

23:00 The Vision for Cure Wise: Precision Medicine for All

25:04 The Future of Personalized Medicine

27:21 Navigating Medical Scenarios and Doctor Conversations

28:54 The Role of AI in Personalized Medicine

29:20 Business Model and Future Vision

30:36 Challenges and Opportunities in AI and Healthcare

32:20 Focus on Cancer and Personalized Medicine

35:22 Patient Education and Advocacy

37:54 Regulatory Innovation and AI

47:02 The Paradigm Shift in Medical Knowledge

49:30 Rapid Fire Questions and Final Thoughts

Follow Shannon and Steve:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy/

Website: https://www.shannonlantzy.com/

Connect with Steve: 

LinkedIn: https://www.linkedin.com/in/brown2020/

Website: curewise.com

When your insulin pump connects to your phone or your glucose monitor shares data with the cloud, is it secure? And what does "secure" even mean?

In this episode of Inside MedTech Innovation, Shannon Lantzy sits down with Jacob Combs, Chief Information Security Officer and VP of Cybersecurity at Tandem Diabetes Care. Jacob brings deep expertise from across telecom, defense, financial services, and healthcare—and now protects connected devices that deliver life-sustaining insulin therapy to people with diabetes.

This conversation explores the unique challenges of medical device cybersecurity: the tension between usability and security, the reality of legacy systems and security debt, how to scale security by design across engineering teams, and why regulatory requirements can actually be a competitive advantage.

Jacob and Shannon discuss:

• Why medical device security is fundamentally different from enterprise IT security

• The critical balance between safety risk and security risk in insulin delivery systems

• How threat modeling becomes a verb that transforms engineering culture

• The challenge of maintaining security across interoperable diabetes management ecosystems

• Why "secure enough" requires sophisticated risk management, not just risk assessment

• How compensating controls and lifecycle management address security debt in fielded devices

• The role of FDA guidance in driving security programs forward

• What it takes to push software updates quickly while maintaining quality and regulatory compliance

Timestamps

• 00:00 Introduction to Medical Device Cybersecurity

• 01:03 Meet Jacob Combs: Expert in Medical Device Cybersecurity

• 02:12 The Mission-Driven Approach to Cybersecurity

• 03:16 Balancing Safety and Security in Medical Devices

• 05:18 Challenges in Medical Device Cybersecurity

• 09:57 The Role of a CISO in Medical Device Companies

• 13:55 Risk Management and Cybersecurity in Medical Devices

• 17:17 Interoperability and Complexity in Medical Devices

• 26:55 Future of Cybersecurity in Medical Devices

• 36:08 Cybersecurity in Med Tech: A Non-Competitive Necessity

• 36:30 The Ethical Dilemma of Charging for Security

• 37:25 Product Security as a Growth Engine

• 38:50 Marketing Security: A Competitive Edge

• 39:32 Quality and Security: A Symbiotic Relationship

• 41:08 Regulatory Challenges and Operational Efficiency

• 42:36 Measuring Cybersecurity Quality

• 43:57 Navigating Regulatory Requirements

• 51:23 Innovating with AI in Security Documentation

• 55:25 Threat Modeling: A Cultural Shift

• 59:23 Legacy Devices and Security Debt

• 01:06:03 Balancing Security and Innovation

• 01:09:08 Rapid Fire Questions and Closing Thoughts

Follow Shannon and Jacob:

Connect with Shannon : 

LinkedIn: https://www.linkedin.com/in/shannonlantzy/

Website: https://www.shannonlantzy.com/

Connect with Jacob: 

LinkedIn: https://www.linkedin.com/in/jacobcombs/

Website: Left to Our Own Devices Podcast

When Justin Eastzer was misdiagnosed with type 2 diabetes at 30, he turned to TikTok to share his experience with a new glucose meter. The community's response changed everything: he actually had type 1 diabetes, and his doctor had missed it. That moment launched Diabetic Tech, now one of the most trusted patient education platforms in the diabetes space with over a million downloads. 

In this conversation with Shannon Lantzy, Justin breaks down the disconnect between what medtech companies think users want and what actually matters. He shares why the DIY diabetes community has been building their own automated insulin delivery systems since 2016, how AI meal-snap features could transform daily management, and why companies announcing problems matters more than the problems themselves. Justin also discusses the regulatory tension between innovating for advanced users versus protecting the broader population, and offers a compelling vision for how continuous software updates could bring diabetes tech to the speed of consumer technology.

Timestamps:

[00:00:00] Introduction and Justin's misdiagnosis journey

[00:04:15] What makes Diabetech's approach unique

[00:08:25] Balancing entertainment, education, and technical accuracy

[00:12:10] Language matters: "diabetic" vs "person living with diabetes"

[00:14:30] Creative bursts during low blood sugars

[00:18:35] Interviewing executives and asking hard questions

[00:21:50] The Dexcom G7 sensor issues and transparency problems

[00:25:10] Real-time discussion of Tandem pump safety alert

[00:29:30] Why transparency matters more than the problem itself

[00:33:20] Justin's business model and team structure

[00:37:45] The innovation speed problem in diabetes tech

[00:40:30] AI meal-snap features: the holy grail that's already here in DIY

[00:46:35] What it's like to calculate carbs for every meal

[00:49:05] Exercise management and the temp basal feature gap

[00:51:25] A1C vs time in range vs lived experience

[00:56:00] CGMs for wellness: opportunity or distraction?

[01:02:20] Balancing innovation for advanced users vs general safety

[01:05:10] Shannon's moonshot proposal for trustworthy software updates

[01:13:25] Cybersecurity, safety testing, and the path to faster features

[01:14:50] Rapid fire questions

Follow Shannon and Justin:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Justin: 

LinkedIn: https://www.linkedin.com/in/justin-eastzer-70402034

Website: https://www.tiktok.com/@diabe_tech

Most medical device companies think quality systems slow them down. Kyle Rose proves the opposite is true.

Kyle Rose is the founder and president of Rook Quality Systems, a consulting firm that helps early-stage medical device companies build efficient, compliant quality management systems. With 13 years of experience and nearly 40 employees, Rook has guided companies through FDA submissions, acquisitions, and their first audits by focusing on lean processes over bureaucracy.

In this conversation, Kyle shares stories from the trenches: the software company that accidentally logged thousands of "complaints" in Zendesk, the smart pill dispenser that failed to block light properly, and the COVID diagnostics work that helped get critical products to market fast. He explains why quality systems actually help companies catch problems before they become catastrophic, how AI is changing regulatory submissions, and why more over-the-counter medical devices could transform healthcare access.

Timestamps:

• [00:01:30] Introduction to Rook Quality Systems

• [00:02:10] Kyle's journey from industry to consulting

• [00:05:20] Professional lessons and standout moments

• [00:08:05] When software companies realize they're medical devices

• [00:09:15] The Zendesk complaint story

• [00:13:05] Success story: acquisition and first FDA audit

• [00:15:20] When companies don't buy into quality systems

• [00:16:40] The FDA warning letter discussion

• [00:19:00] How quality systems catch device failures

• [00:19:50] The smart pill dispenser light-blocking failure

• [00:24:30] How tech is changing consulting and compliance

• [00:28:45] MDSAP and international standards

• [00:31:15] FDA's Medical Device Development Tools program

• [00:34:00] Regulatory pathways that need improvement

• [00:37:10] What would help FDA reviewers most

• [00:42:05] Verifying hyperscalers like AWS and Google

• [00:44:35] Rapid-fire questions

  
  

Follow Shannon and Kyle:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Kyle: 

LinkedIn: https://www.linkedin.com/in/kyle-rose-rook

Website: https://rookqs.com/