Software problems cause 20 medical device recalls a month. 82% of those are classified as software design failures. Dr. Robert Charette has spent five decades documenting why large-scale technology systems fail and why organizations keep repeating the same mistakes.

In this conversation with Shannon Lantzy, Bob brings a perspective rarely heard in medtech: one shaped not by the device industry, but by NASA, the Department of Defense, Fortune 100 companies, and the national rollout of electronic health records. He introduces the distinction between software failures and software blunders, explains why testing is impossible to perfect but impossible to skip, and walks through the risk ecology framework that looks at technical, financial, political, and organizational forces together. He also addresses the Change Healthcare ransomware attack as a case study in systemic interface risk, the red-yellow-green project management inversion, and what AI-generated code means for regulated software.

Timestamps:

[00:00:00] Introduction and the 20 recalls a month statistic

[00:02:44] Why Bob's outsider perspective is the point

[00:03:16] NASA Challenger and the software review panel

[00:08:44] Why you can never test everything but can never stop testing

[00:11:56] Failures vs. blunders: a critical distinction

[00:13:12] What is a risk ecologist?

[00:15:16] When FDA regulation is the only incentive that works

[00:16:08] The case for market-driven standards and tort law

[00:22:24] Bob's role in the EHR meaningful use panel

[00:25:44] Why the national EHR rollout was not well thought through

[00:29:00] Change Healthcare as a systemic interface failure

[00:30:16] How to map interfaces and assume failure

[00:33:36] Efficiency vs. single point of failure

[00:34:44] International regulatory reliance and the turtles all the way down problem

[00:39:24] Designing software to be verified and validated from the start

[00:43:00] Applying V&V to automated insulin delivery systems

[00:48:00] Flipping the risk dashboard: start at red, prove your way to green

[00:51:20] Why no one wants to be the naysayer

[00:53:08] How executives actually tolerate risk

[00:55:04] The Hubble Effect and knowing when to kill a project

[00:56:28] AI and regulated software: the gray beard's take

[01:01:04] AI is perfect for experts and dangerous for everyone else

[01:03:16] Cardinal rule: your system will be evaluated outside the criteria you set

[01:04:12] Rapid fire questions

Follow Shannon and Robert:

Connect with Shannon: 

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

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

Connect with Robert: 

LinkedIn: https://www.linkedin.com/in/robert-charette-500309/

Website: https://www.ieee.org/

Randy Horton is Chief Solutions Officer at Orthogonal, a firm that specializes in accelerating software as a medical device, digital therapeutics, and connected device ecosystems. He has spent his career at the intersection of product management, digital transformation, and regulatory compliance, and co-chairs the cloud computing standards committee at AAMI with Pat Baird from Philips.

In this conversation with Shannon Lantzy, Randy breaks down why medtech companies are either too cautious about cloud or not cautious enough, and what good cloud design for medical devices actually looks like. He explains the concept of indirect control, why the medical device you had at 8am may not be the same one you have at 8pm, and how modern software practices from Netflix, Amazon, and other tech giants are more compatible with medtech's safety requirements than most people realize. He also addresses the language gap between tech and medtech, the role of the quality systems engineer, and why the FDA is no longer the biggest barrier to innovation.

Timestamps:

[00:00:00] Introduction and the cloud computing challenge in medtech

[00:02:36] Randy's origin story and the early commercial web

[00:03:28] How healthcare ran through his career before medtech

[00:05:44] Lessons from an $80 million IT transformation

[00:07:00] Why established companies struggle to separate why from how

[00:09:56] The all-nighter on Mosaic that started everything

[00:11:00] Retail tech, hardware is hard, and the limits of the physical world

[00:13:20] Sensors, foundational models, and the promise vs. reality of platforms

[00:15:08] History as systems thinking

[00:17:24] Safe, effective, and commercially successful: what that means in cloud

[00:19:52] How cloud providers change constantly and why that matters

[00:21:44] Indirect control: the crux of cloud in medtech

[00:23:36] Conservative cloud architecture as good medical device design

[00:24:00] Post-market surveillance vs. revalidation: the naming debate

[00:25:44] Two scenarios: too conservative and not conservative enough

[00:27:32] Risk matrices and why Shannon hates them

[00:29:40] Deming, total quality management, and the real conversation

[00:31:08] What medtech can learn from unregulated industries

[00:33:52] Why medtech still builds custom

[00:34:16] The language gap between tech and medtech

[00:37:20] Wrapping risk-based thinking around AI development

[00:42:44] The quality systems engineer role

[00:45:00] Evidence and traceability as the real difference

[00:46:00] Cost, documentation, and tools like GitHub and Jira

[00:48:52] Sales conversations at Orthogonal

[00:51:36] What is next: neurostimulation, home diagnostics, new business models

[00:53:48] CMS is now the bigger barrier than FDA

[00:54:24] Rapid fire questions

Follow Shannon and Randy:

Connect with Shannon: 

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

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

Connect with Randy: 

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

Website: https://orthogonal.io/

Dr. Adam Cifu is a general internist and professor at the University of Chicago, co-author of Medical Reversal, and co-founder of Sensible Medicine, one of the most widely read independent medical publications in the country. He sees patients daily, teaches the next generation of physicians, and writes about the gap between medical consensus and medical evidence.

In this conversation with Shannon Lantzy, Dr. Cifu breaks down what medical reversal actually means and why hormone replacement therapy is one of the most instructive examples of how medicine gets things wrong. He shares his nuanced take on CGMs, AFib detection, wearables, and blood pressure monitoring, and explains why the same device can be genuinely helpful for one patient and harmful for another. He also reflects on what evidence-based regulation should look like, what he hopes changes at FDA, and why primary care is still the most important relationship in medicine.

Timestamps: 

[00:00:00] Introduction and Dr. Cifu's background

[00:01:44] Deciding to become a doctor

[00:03:08] What other career he might have had

[00:04:40] Writing, publishing, and the piece that changed everything

[00:05:40] What his practice actually looks like

[00:07:32] Why Sensible Medicine is a group publication

[00:10:16] Finding Sensible Medicine through Marty Makary's book

[00:11:28] What medical reversal means

[00:12:40] Hormone replacement therapy as the defining case

[00:15:40] Shannon's personal experience and the gap in clinical practice

[00:17:00] When turning healthy people into patients goes wrong

[00:20:20] The Oura ring and what biofeedback actually teaches

[00:22:04] Should daily burden be measured? Dr. Cifu pushes back

[00:24:08] When data doesn't help

[00:26:44] N of one trials and personalized medicine

[00:32:48] Technology in primary care: entering with trepidation

[00:34:28] Stenting and the cautionary tale of extrapolation

[00:38:28] Early adopters as beta testers

[00:39:16] What a clinic day actually looks like

[00:43:12] The Whoop blood pressure controversy

[00:46:32] AFib detection: who it helps and who it harms

[00:49:40] A hypothetical 82-year-old, Apple Watch data, and a caregiver's anxiety

[00:51:32] When information helps patients and when it makes things worse

[00:53:24] Adam Cifu AI: the case for and against

[00:57:24] When a test won't change management

[01:00:44] Hopes for FDA and evidence-based regulation

[01:04:00] Medical devices and the surgical reversal risk

[01:07:04] Rapid fire questions

Follow Shannon and Adam:

Connect with Shannon: 

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

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

Connect with Adam: 

LinkedIn: https://www.linkedin.com/in/adam-cifu-bbb8ba206/

Website: https://www.sensible-med.com/

Mike Monovoukas is the co-founder and CEO of AcuityMD, a platform that helps medical device manufacturers accelerate commercial adoption. Before founding AcuityMD, Mike started his career as a management consultant, then co-founded a medical device startup with his brother, where he first experienced firsthand how much time and effort it took just to prepare for a single sales call. That experience became the foundation for AcuityMD.

In this conversation with Shannon Lantzy, Mike walks through how AcuityMD combines publicly available market data with internal commercial data to surface highly personalized opportunities for medical device sales teams. He shares the customer story that defined the company's mission, why the physics of a business model matter as much as the mission statement, and what he believes regulators can do to unlock innovation. He also reflects on building culture at scale, why he hires missionaries not mercenaries, and the spidey sense every founder needs to keep.

Timestamps:

[00:00:00] Introduction and AcuityMD overview

[00:01:00] Competitive swimming, discipline, and early mornings

[00:02:04] From athlete to founder: the origin story

[00:03:36] First medical device startup with his brother

[00:05:08] The research problem that became AcuityMD

[00:06:28] The aha moment: combining market data with internal data

[00:08:28] What customers measure AcuityMD on

[00:09:16] Paul Graham, COVID, and the things that did not scale

[00:14:28] Walking through the Synchron use case

[00:17:24] What pre-commercial use looks like in practice

[00:19:12] Switching between business language and medtech language

[00:20:04] Hiring missionaries not mercenaries

[00:21:04] Why the physics of the business model matter

[00:22:28] The problem with business models that restrict care

[00:23:52] Prior auth, AI, and creating bottlenecks

[00:25:32] Using FDA's MAUDE database for competitive intelligence

[00:27:24] How sales data can feed back into product development

[00:30:52] Most gratifying customer story: the rural hospital

[00:35:40] Open payments, over-prescription, and the hard questions

[00:38:52] AcuityMD's mission: making healthcare abundant

[00:42:32] Pre-reimbursement use cases

[00:43:44] What is hardest right now: scaling culture

[00:45:08] Culture is how people make decisions when you are not in the room

[00:46:24] Rapid fire questions

Follow Shannon and Mike:

Connect with Shannon: 

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

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

Connect with Mike: 

LinkedIn: https://www.linkedin.com/in/michael-monovoukas-0786a52b/

Website: https://www.acuitymd.com/

Dr. William Brody has had at least four careers: foundational researcher in CT and MRI, co-founder of three medical device companies, 13-year president of Johns Hopkins University, and leader of the Salk Institute. Now he's codified a lifetime of lessons in his new book, Uncommon Sense, released April 28, 2026.

In this conversation with Shannon Lantzy, Dr. Brody shares the decision-making framework that shaped his career: from a course at MIT that changed how he approached hard problems, to the three snake rules of management he still lives by. He discusses the economics of quality in healthcare, why curiosity and focus are both essential to discovery, and what AI-native companies consistently get wrong about breaking into medicine. He also reflects on kindness, risk, survivorship bias, and what it really means to succeed.

Uncommon Sense is available through Johns Hopkins Press.

Timestamps: 

[00:00:00] Introduction and Dr. Brody's four careers

[00:01:36] Welcome back and the book overview

[00:02:56] Goals of Uncommon Sense and learning to think

[00:05:08] What students give back and a note from a former student

[00:06:00] Uncertainty, suffering, and the Buddhist parallel

[00:07:24] Amar Bose and learning to tackle hard problems

[00:08:44] Rob Wallace: from ballet to Stanford's CIO

[00:10:36] Career planning is an oxymoron

[00:13:56] Bloomberg, kindness, and the mayor who shouldn't have run

[00:15:44] The economics of quality at Johns Hopkins and the Toyota system

[00:19:44] Treating patients, research, or inventing devices

[00:21:32] Turtle on a post: spotting uncommon signals

[00:23:24] Curiosity vs. confirmatory research

[00:25:16] The MRI contrarian and what it cost him

[00:29:36] Kindness as strategy: does it correlate with success?

[00:31:04] What is enough?

[00:33:08] The book's philosophical tone

[00:35:04] Does this advice apply to the common person?

[00:38:28] AI in healthcare and what founders get wrong

[00:40:30] How Epic actually started

[00:41:44] Where the most exciting healthcare innovation is happening

[00:43:00] Risk management, uncertainty, and the over-lawyered world

[00:47:48] The three snake rules of management

[00:50:04] Norman Shumway and "the bleeding always stops"

[00:52:28] Rapid fire questions

Follow Shannon and William:

Connect with Shannon: 

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

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

Connect with William: 

LinkedIn: https://www.linkedin.com/in/william-brody-138920106/

FDA commissioners come and go, but career civil servants are always there, applying the rules without financial conflicts of interest.

Dr. Robert Califf served as FDA Commissioner twice, making him one of the most experienced regulatory leaders in healthcare history. Before FDA, he built the world's largest clinical research institute at Duke and spent time in Silicon Valley with Google's Verily. Now he writes weekly on Substack, sharing opinions on controversial topics with specific evidence and nuance.

In this episode, Shannon Lantzy talks with Dr. Califf about the referee role of the FDA, why political appointees shouldn't make decisions about individual products, and what delighted him most during his terms. They discuss the history of why we regulate medical products differently than consumer goods, how AI could transform regulatory review, and why studying failures teaches more than studying successes.

Timestamps:

00:00 – Regulators as referees who apply rules made by politicians

02:00 – Why the man in the arena is also the referee

04:00 – How honest referees keep societies and sports functioning

06:00 – Commissioner vs. center directors: political vs. career civil servants

08:00 – When rules reflect cultural beliefs vs. scientific evidence

11:00 – Why middle schoolers need to understand FDA's mission

13:00 – Health is different from consumer products: we don't experiment on expendable humans

15:00 – Regulatory innovation before the boom: unsung but vital

17:00 – The hardest thing: keeping hands off individual product decisions

19:00 – Everything delightful: teams working together under imperfect information

21:00 – When ICDs showed 40% reduction in sudden death

23:00 – AI for automated detection and its impact on clinical decisions

26:00 – Why we need regulatory systems to channel activity toward benefit

27:00 – Evidence-based decision making and controversial approvals

30:00 – The iceberg: most FDA impact happens in decisions you never see

32:00 – Moving toward public knowledge of early studies and failures

34:00 – How AI can summarize decisions in minutes for good or harm

35:00 – Rapid fire: Keep your compass on being a good referee

Follow Shannon and Robert:

Connect with Shannon: 

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

Website: https://www.shannonlantzy.com

Connect with Robert: 

Substack: https://robcaliff272993.substack.com/

LinkedIn: https://www.linkedin.com/in/robert-califf-69040016/

The Stanford Mussallem Center for Biodesign has trained innovators whose inventions have touched over 18 million lives while they were still in training.

Most people think breakthrough innovation is magic or unpredictable. Dr. Josh Makower proved otherwise. As co-founder of the Stanford Mussallem Center for Biodesign, he created a systematic methodology that breaks innovation into learnable steps: identify who you're serving, understand their needs through direct observation, define the problem without embedding a solution, then invent against clear criteria. The result is a repeatable process that dramatically increases the probability of success.

In this episode, Shannon Lantzy talks with Dr. Makower about his journey from mechanical engineering and medical school to founding ExploraMed, an incubator that launched companies like NeoTract and Willow. They discuss how two men created the first wearable breast pump by studying how babies actually feed, why regulatory reform requires empathy on both sides, and what it takes to sustain the innovation ecosystem through capital returns while serving patients.

Timestamps:

00:00 – You must return capital to investors to keep the ecosystem going

03:00 – From The Bionic Man to biomedical engineering

06:00 – Learning the language of business to stay in the room

09:00 – Why sustainable businesses, not charity, solve medical problems

12:00 – ExploraMed and the biodesign process in action

14:00 – The hardest part: keeping engineers from racing to solutions

16:00 – Creating the first wearable breast pump

19:00 – How two men learned to solve a problem they don't have

23:00 – Why outsiders can see what insiders miss

26:00 – The golden era of medical devices and what changed in 2008

28:00 – Getting FDASIA passed: fighting for regulatory reform

32:00 – Breaking innovation into learnable steps

35:00 – When needs statements should (and shouldn't) change

37:00 – Disease burden as an invisible, unmeasured problem

40:00 – How to prioritize: outcome severity multiplied by people impacted

44:00 – Who biodesign serves and why the ecosystem matters

47:00 – Measuring impact: 18 million lives and counting

52:00 – Are we over-engineering healthcare?

56:00 – What FDA still needs to improve: consistency across reviewers

01:00:00 – Empathy on both sides of regulation

Follow Shannon and Josh:

Connect with Shannon: 

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

Website: https://www.shannonlantzy.com

Connect with Josh: 

LinkedIn: https://www.linkedin.com/in/josh-makower/

Website: https://biodesign.stanford.edu

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