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Inside MedTech Innovation

Shannon Lantzy
FDA
Medtech
Diabetes
Artificial Intelligence
Fianu
Medical Devices
Obesity
LED Flicker
Threat Modeling
Risk Management
Interoperability
Stanford Biodesign
Stenting
Ilant Health
Cybersecurity
Automated Governance
Curewise
Medical Device Cybersecurity
Paxos Health
Medical Reversal

Join Shannon Lantzy, as she brings you stories from inside the medtech ecosystem, featuring innovators, commercializers, regulators, and consumers. The show covers a wide array of topics, from patient-driven innovation to cybersecurity. We’ll examine the details that influence individual regulatory decisions and the broader impacts of emerging global issues, ensuring that great technology reaches ... more

PublishesTwice monthlyEpisodes49Founded2 years ago
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Technology

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Artwork for Inside MedTech Innovation

Latest Episodes

Generative AI doesn't act like a medical device. It acts like a form of intelligence, and Dr. David Blumenthal thinks it should be overseen like one. Blumenthal, the Harvard-trained physician and policy expert who ran the $25 billion federal rollout ... more

The technology to secure healthcare already exists. Getting it adopted by the people building medical devices is a different problem entirely. Andrew Carney spent a decade in classified offensive cyber operations, defended one of the world's largest ... more

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 th... more

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, dig... more

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, ... more

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 s... more

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 les... more

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 h... more

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Recent Guests

David Blumenthal
Harvard-trained physician and public policy expert who oversaw the largest federal digital health rollout in US history
Harvard School of Public Health (Center for Health Policy, Technology and Oversight)
Episode: AI Regulation in MedTech w. Dr. David Blumenthal
Andrew Carney
Executive at ARPA-H and DARPA veteran focused on healthcare cybersecurity
ARPA-H / DARPA
Episode: MedTech Cybersecurity w. Andrew Carney
Robert Charette
Risk ecologist, IEEE Spectrum contributor and software risk management author
IEEE Spectrum/IEEE ISO standards
Episode: Medtech Risk Ecology w. Robert Charette
Randy Horton
Chief Solutions Officer at Orthogonal
Orthogonal
Episode: Cloud Based MedTech with Randy Horton
Adam Cifu
General internist, professor at the University of Chicago, author of Medical Reversal
University of Chicago
Episode: Rethinking MedTech w. Adam Cifu
Mike Monvoukas
Founder and CEO of AcuityMD
AcuityMD
Episode: Mission-Driven MedTech w. Mike Monovoukas
William Brody
Former president Johns Hopkins University; former president Salk Institute; author of Uncommon Sense
Johns Hopkins University / Salk Institute
Episode: Uncommon Sense w. Dr. William Brody
Robert Califf
Former Commissioner of the FDA, physician-scientist with decades in regulatory leadership
FDA
Episode: Behind FDA’s Heroes w. Dr. Robert Califf
Josh Makower
Physician, biomedical engineer, and founder involved with Stanford Biodesign and ExploraMed
Stanford Biodesign; ExploraMed
Episode: Biodesign for MedTech w. Josh Makower

Host

Shannon Lantzy
Host of Inside MedTech Innovation

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Talking Points

Recent interactions between the hosts and their guests.

AI Regulation in MedTech w. Dr. David Blumenthal
Q: What was your role in advancing electronic health records and Meaningful Use, and how did you approach the adoption challenge?
My approach was to frame Meaningful Use as a gradual escalator: start with a modest, achievable first step, provide incentives, and then build up to more complex data collection and quality metrics as clinicians gain confidence and see the value in digital records.
Medtech Risk Ecology w. Robert Charette
Q: What is the biggest misconception about why software projects fail?
The biggest misconception is that failures stem from poorly defined initial requirements alone; in reality, success depends on managing evolving assumptions, interfaces, and the interplay of technical and organizational factors through the lifecycle.
Medtech Risk Ecology w. Robert Charette
Q: How do you think about risk when dealing with distributed healthcare IT ecosystems and regulatory reviews across borders?
Risk must be approached as an ecology, where interfaces, boundaries, and dependencies are analyzed; relying on a single standard or review is insufficient because different countries have different heritage, problem sets, and levels of trust in reviews, creating systemic risk unless we carefully manage cross-border dependencies.
Rethinking MedTech w. Adam Cifu
Q: What impact do you hope FDA regulation will have going forward?
He hopes regulation becomes more evidence-based with transparency and patient education, allowing high-risk or uncertain treatments to be studied while patients are informed about benefits and risks.
Rethinking MedTech w. Adam Cifu
Q: What are you most excited about these days?
He expresses continued enthusiasm for patient interaction and the core care relationship, valuing time spent with patients and the opportunity to help people, despite the arousal of new technologies.

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Frequently Asked Questions About Inside MedTech Innovation

What is Inside MedTech Innovation about and what kind of topics does it cover?

The show concentrates on medtech ecosystems, exploring how innovators, regulators, and clinicians collaborate to bring new devices and software to market. Episodes frequently drill into regulation, payer dynamics, patient access, cybersecurity, and practical product development challenges, often featuring founders, senior marketers, quality and regulatory leaders, and prominent industry regulators or university leaders. A standout throughline is translating complex clinical and regulatory concepts into actionable insights for product teams, executives, and investors. The format tends to balance founder stories, regulatory context, and real-world case studies, making it valuable for listeners who want a nuanced view of what drives adoption a... more

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Inside MedTech Innovation launched 2 years ago and published 49 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Inside MedTech Innovation?

Recent guests on Inside MedTech Innovation include:

1. David Blumenthal
2. Andrew Carney
3. Robert Charette
4. Randy Horton
5. Adam Cifu
6. Mike Monvoukas
7. William Brody
8. Robert Califf

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