Learn how athenahealth is building the AI-native EHR to reduce clinician burnout. Paul Brient shares insights on ambient dictation and revenue cycle management.

Episode Resources

• athenaOne: All-in-One Health Software
• Paul Brient, Chief Product Officer Profile
• athenahealth Ambient Notes

Traditional electronic health records often feel like a digital burden rather than a helpful tool. Paul Brient, Chief Product and Operations Officer at athenahealth, joins the show to discuss how they are transforming the industry by building an AI-native EHR designed specifically for the modern ambulatory setting.

Paul shares the evolution of athenahealth from an OBGYN startup to a multi-billion dollar platform supporting 170,000 providers. We explore how ambient dictation is moving beyond simple transcription to automate clinical orders and significantly reduce clinician burnout. By leveraging data-driven insights, athenahealth is helping independent practices remain competitive through streamlined revenue cycle management and integrated patient engagement tools.

If you are a healthcare leader or clinician looking to reclaim your "pajama time" and understand the future of clinical documentation, this episode is for you. Learn how to navigate the AI hype cycle and implement technology that offers real, incremental value to your daily workflow.

Is the EHR causing physician burnout? Wellsheet CEO Craig Limoli joins HealthTech Remedy to discuss reducing "pajama time," integrating UpToDate, and using AI to transform clinical documentation.

Episode Resources:

• Learn more about Wellsheet
• Follow Craig Limoli on LinkedIn
• Details on the Wellsheet & UpToDate Partnership

In this episode of HealthTech Remedy, hosts Dr. Tim Showalter, Dr. Paul Gerrard, and Dr. Trevor Royce dive into one of the most persistent frustrations in modern medicine: the burden of the Electronic Health Record (EHR). We sit down with Craig Limoli, Co-founder and CEO of Wellsheet, to discuss how his company is tackling the dreaded "pajama time" - the hours physicians spend charting late at night - not by replacing the EHR, but by fixing how clinicians interact with it. If you’ve ever felt buried under thirty open tabs while trying to find a single lab result, this conversation is for you.

Craig breaks down Wellsheet’s unique approach as an intelligent "layer" that sits on top of existing systems like Epic and Cerner. We explore how their predictive workflow technology consolidates fragmented patient data into a single, intuitive view, and discuss their game-changing partnership with UpToDate that brings clinical guidelines directly into the decision-making process. The discussion also covers their latest AI advancements, including an agent that allows doctors to "chat" with a patient's chart to retrieve data instantly and features that automate inpatient documentation to save hours of manual work.

Finally, we look ahead to the "healthcare utopia of 2030." We discuss why smarter collaboration tools are essential for solving the looming clinical workforce shortage and how responsible AI can reduce burnout while improving patient safety. Whether you are a healthcare executive, a practicing clinician, or a tech enthusiast, this episode offers a pragmatic look at how intelligent workflows are reshaping the future of care delivery.

About Our Guest:

Craig Limoli is the Co-Founder and CEO of Wellsheet, a company on a mission to fix the usability crisis in healthcare technology. His journey began as a strategy consultant at IBM's Watson Health, where he witnessed firsthand the immense frustration clinicians faced with antiquated and inefficient EHR systems. Motivated by a nursing leader who broke down in tears over her inability to access the data needed to treat her patients, Craig left to build the solution himself. Wellsheet was born from this experience, with the goal of creating a single, intelligent "sheet" that synthesizes all relevant data for clinical decision-making.

Timestamps:

(00:00) Introduction: The Problem with Medical Charting

(02:56) Defining the Crisis: EHRs, "Pajama Time," and Clinician Burnout

(04:51) Wellsheet's Strategy: An Intelligent Layer, Not a New EHR

(08:28) Improving Care Team Collaboration and ROI for Health Systems

(13:25) Meet the Founder: Craig Limoli's Journey from IBM to Wellsheet

(17:58) The Strategic Advantage of Integrating With, Not Replacing, the EHR

(20:55) Product Deep Dive: How AI Summarizes Data and Automates Documentation

(25:21) Enhancing Workflows with Clinical Decision Support (UpToDate Integration)

(32:22) The Business Model: Selling to Clinicians and Hospital Executives

(34:31) Building Guardrails for AI in Healthcare

(37:24) The Future Vision for a Productive and Efficient Healthcare System

What were the biggest health tech trends in 2025? After a year of conversations with dozens of founders, clinicians, and investors, we're cutting through the noise to reveal what actually changed, where the hype fell flat, and where real momentum is building. We unpack the surprising gap between private equity investment and medical AI, debating whether AI is truly making healthcare faster and cheaper or if the money is flowing elsewhere.

In this special 2025 year-in-review, the HealthTech Remedy hosts - Dr. Tim Showalter, Dr. Paul Gerrard, and Dr. Trevor Royce - step back to connect the dots from a transformative year. We explore the massive theme of AI in healthcare, moving beyond buzzwords to distinguish between generative AI and classification models and how they are practically applied in the clinic today. We challenge the narrative of AI replacing doctors, arguing instead that technology is empowering clinicians with new "superpowers" and cementing the importance of the human element in patient care.

This episode synthesizes a year of insights into the most important health tech trends of 2025. We dive deep into the rise of physician entrepreneurs in health tech, highlighting how clinical leaders are the key to building successful companies that solve real-world workflow problems. We also tackle the foundational, less glamorous, but critical challenges of healthcare data integration and EHR interoperability, discussing how solving these "1980s engineering problems" is finally unlocking modern innovation. From automating healthcare administration nightmares with companies like Infinitus Systems to creating entirely new categories of patient care with Viz.ai, we cover the companies and ideas that challenged our thinking. We discuss the last-mile delivery solutions of Sprinter Health and Hims & Hers, the drug repurposing mission of Every Cure, the paradigm-shifting vision of the Enhanced Games, and key takeaways from the HLTH 2025 conference. Join us as we reflect on the lessons learned and what they mean for the future of healthcare.

Timestamps

(00:00) Holiday Banter & Intro

(00:55) Reflecting on 2025's Key Health Tech Learnings

(02:37) The Big Picture: AI Investment vs. Private Equity in Healthcare

(05:31) Defining the Role of AI: Generative vs. Classification and Augmenting Humans

(07:05) The Rise of Physician Entrepreneurs in Health Tech

(09:58) The Foundational Challenge: Healthcare Data Integration and EHR Interoperability

(12:47) Standout Companies and Surprising Insights from 2025 (Every Cure, Infinitus Systems, Hims & Hers)

(16:36) Tackling an Endless Pain Point: Automating Healthcare Administration

(18:09) Beyond Efficiency: How AI Is Creating Net-New Healthcare Products (Viz.ai)

(20:17) Unlocking Untapped Data: From Endoscopy Footage to Clinical Guidelines

(21:59) Key Company Takeaways from the HLTH 2025 Conference (Rimidi, Weight Watchers, GE Healthcare)

(24:40) Rethinking Human Performance: The Provocative Case of the Enhanced Games

(27:07) Final Reflections on the Podcast Journey & Top Episodes of the Year

Episode Resources

Companies Discussed in This Episode:

• Every Cure
• Infinitus Systems
• Sprinter Health
• Hims & Hers
• Viz.ai
• Artisight
• Virgo
• Cohere Health
• Turquoise Health
• SmarterDX
• ASCO (American Society of Clinical Oncology)
• GE Healthcare
• WeightWatchers
• Rimidi
• Enhanced Games

How does a pharmacist become a venture capitalist? Hear Meg Powell's story on the transition from big pharma to startup and her advice for women in healthcare leadership.

Episode resources:

• Learn about 501 Ventures
• Follow Meg Powell on LinkedIn

Have you ever wondered if your clinical training could lead to a career in high-stakes investing? This episode charts the incredible journey of Meg Powell, who forged a unique path from pharmacist to venture capitalist. Meg shares the invaluable lessons, pivotal moments, and scrappy determination that took her from a small town in North Carolina to the executive suites of Big Pharma, the trenches of a successful startup, and finally to the helm of her own venture capital firm. We explore the core question: How do you build a multifaceted career in healthcare, and what does it truly take to transition from clinician to entrepreneur to investor?

In this deep-dive conversation, Meg Powell, co-founder and CEO of 501 Ventures, reveals the playbook for navigating a dynamic career in the life sciences. She details her foundational years at Eli Lilly and GSK, explaining why a transition from big pharma to startup life provided her with indispensable training and an unparalleled network. Meg walks us through the origin story of Target RWE, a pioneering real world evidence company she co-founded with Dr. Mike Freed. She shares the challenges of building a profitable company from the ground up with minimal funding, the importance of finding the right co-founder, and the strategy behind their successful exit. We also learn about her experience with imposter syndrome and how being a "scrappy entrepreneur" became her greatest asset.

Now, Meg is focused on the next frontier of medicine through healthcare venture capital. She discusses the formation of 501 Ventures with her partner Enrique Conterno (former President of Lilly Diabetes) and their investment thesis in the booming metabolic health and obesity market, fueled by innovations like Tirzepatide (Zepbound). A significant part of our discussion is dedicated to women in healthcare leadership. Meg speaks candidly about the "aha moments" that ignited her passion for mentorship, the challenges she faced, and how she is paying it forward with "The Fierce Collaborative," a network dedicated to supporting women and mothers in the life sciences. This episode is packed with authentic career advice, insights into the future of healthcare investing, and the inspiring story of a leader who has consistently broken new ground.

About our guest:

Meg Powell is the Co-founder and CEO of 501 Ventures, a venture capital firm focused on metabolic health. A PharmD by training, Meg began her career in Big Pharma at Eli Lilly and GlaxoSmithKline before transitioning to the startup world. She was the co-founder and CEO of Target RWE, a leading real-world evidence company that she grew from an idea to a highly successful exit. Meg is a passionate advocate for women in leadership and a mentor to the next generation of healthcare entrepreneurs.

Most doctors have brilliant ideas, but why do 98% of them fail before they ever reach a patient? The brutal truth is that a clinical mindset is not an entrepreneurial mindset, and the skills that make a great doctor are not the same ones that build a successful company. In this episode, we sit down with the ultimate physician entrepreneur, Dr. Arlen Meyers, to uncover the harsh realities of medical innovation and why your great idea is probably destined to fail without a fundamental shift in thinking.

Dr. Meyers, an academic surgeon turned serial entrepreneur, shares his own frustrating journey as an "accidental med-tech entrepreneur" trying to commercialize a cancer-detecting gadget. This experience revealed a massive gap in medical education: the complete lack of training in the business of medicine. This gap inspired him to create the Society of Physician Entrepreneurs (SoPE), a global network dedicated to helping clinicians navigate the treacherous path from idea to impact. We explore the critical need for doctors to develop an entrepreneurial mindset, whether they are launching a startup, pioneering medical innovation within a hospital (as an "intrapreneur"), or considering a physician career change. Dr. Meyers provides a clear definition of what it truly means to be a physician entrepreneur, arguing that it's a mindset that can be developed, not just an innate trait. He introduces the concept of the "innerpreneur"—the hidden innovator DNA that many clinicians possess but don't know how to activate. We also discuss why he believes most MD-MBA programs are a "bad idea" and why teaching the business of medicine must be integrated directly into medical school. Finally, Dr. Meyers explains the mission of the Society of Physician Entrepreneurs and offers his most important piece of advice for any doctor pursuing an entrepreneurial role: "make it personal, but don't take it personally."

About Our Guest:

Dr. Arlen Meyers is an academic surgeon, professor, MD, and MBA who became frustrated by the lack of entrepreneurial support for clinicians. He is the founder of the Society of Physician Entrepreneurs (SoPE), a global non-profit organization that provides education, resources, and networking to help physician innovators get their ideas to patients. After a long career in academic medicine, he now dedicates his time to teaching, writing, and consulting to bridge the gap between medicine and entrepreneurship.

Chapters:

(00:00) Why Most Medical Ideas from Doctors Are Doomed to Fail

(01:37) Dr. Meyers' Journey: From Accidental Med-Tech Entrepreneur to Innovator

(06:09) Defining the Physician Entrepreneur and the "Innerpreneur" Mindset

(12:06) The Critical Gap in Medical Education: The Business of Medicine

(18:24) The Creation of the Society of Physician Entrepreneurs (SoPE)

(21:37) The Forgotten Skill: Why Physician Entrepreneurs Must Learn to Sell

(25:23) The Future of the Physician Entrepreneur Ecosystem

(29:01) Final Advice: Making It Personal, But Not Taking It Personally

Episode Resources:

• Learn more about the Society of Physician Entrepreneurs (SoPE)
• Read Dr. Meyers' articles on Substack
• Connect with Dr. Meyers on LinkedIn

Is the traditional academic path failing doctors who want to innovate? For many physicians, the dream of impacting patient care on a massive scale feels out of reach within the slow-moving world of grants and publications. This episode explores the alternative: the dynamic and rapidly evolving physician career paths in health tech. We're joined by Dr. Shrujal Baxi, a physician executive and former Chief Medical Officer at Iterative Health, who shares her incredible journey from being a top medical oncologist at Memorial Sloan Kettering to becoming a leader at pioneering tech companies like Flatiron Health, Verana Health, and Iterative Health.

Dr. Baxi reveals the critical moment she realized academic research, despite its rigor, couldn't deliver solutions at the speed technology could. This conversation is a masterclass for any doctor questioning their career trajectory, offering a candid look at the challenges and rewards of transitioning from the clinic to the tech industry. We dive deep into how her skills as a clinician became her greatest asset in corporate settings, the pivotal role of real-world evidence in shaping modern medicine, and the future of AI in medicine. If you've ever wondered how to commercialize a great idea to truly help patients or what the role of clinicians in tech companies truly entails, this discussion provides the roadmap. Dr. Baxi breaks down her experience working on everything from large-scale data sets in oncology to using computer vision for endoscopy in gastroenterology, demonstrating the vast opportunities available for physicians outside of traditional practice. This episode isn't just a story; it's a guide to forging impactful physician career paths in health tech, exploring the academia vs industry for physicians debate, and understanding how to build a scalable solution that changes patient lives.

ABOUT OUR GUEST:

Dr. Shrujal Baxi is a physician executive who has built a remarkable career at the intersection of medicine and technology. After training as a medical oncologist and conducting health services research at the world-renowned Memorial Sloan Kettering Cancer Center, she made the leap to industry. She has held leadership roles at some of the most influential companies in health tech, including Flatiron Health, Verana Health, and most recently as Chief Medical Officer of Iterative Health. Dr. Baxi shares her unique perspective on leveraging real-world evidence and AI in medicine to drive innovation and improve patient outcomes.

TIMESTAMPS / CHAPTERS:

(00:00) The Rise of Physician Innovators in Health Tech

(01:40) Dr. Baxi's Origin: From Oncology to Health Services Research

(05:51) The Turning Point: Why Academic Research Moves Too Slowly

(08:49) Making the Leap to Flatiron Health & a New Career Path

(12:46) The Untapped Value of Clinicians in Tech Companies

(17:43) Scaling Real-World Evidence Beyond Oncology at Verana Health

(21:31) Pioneering AI in Medicine with Computer Vision at Iterative Health

(25:32) The Future of Health Tech & Early-Stage Innovation

(28:48) Dr. Baxi's Advice for Aspiring Physician Innovators

Episode Resources:

• Connect with Dr. Shrujal Baxi
• Learn more about Flatiron Health
• Learn more about Verana Health
• Learn more about Iterative Health

Is a "normal" mammogram result enough to truly protect your health? What if your standard scan is missing crucial information that could predict your risk for both breast cancer and heart disease years in advance? This episode challenges the one-size-fits-all approach to medical imaging and explores the future of AI in radiology for personalized patient care. We uncover how machine learning is moving healthcare from a reactive model to a proactive one, where diseases are caught earlier and treatments are tailored to the individual, not the average.

In this installment of our Physician Innovators series, host Dr. Trevor Royce sits down with Dr. Sean Raj, a practicing radiologist and the Chief Innovation Officer and Chief Medical Officer at SimonMed Imaging. Dr. Raj breaks down how his team is pioneering this shift at one of the largest outpatient imaging practices in the nation. We dive deep into SimonMed's groundbreaking programs, which are redefining what patients can learn from a single imaging session. Dr. Raj explains the revolutionary "Mammogram Plus" program, which provides a highly personalized breast cancer screening by analyzing not just the image, but a patient's individual risk factors like breast density to provide actionable insights. We also explore the incredible innovation of detecting heart disease from mammograms—a capability that leverages the same scan to identify early signs of breast arterial calcifications, giving women a powerful two-for-one look at their health. The conversation also turns to the rising trend of proactive health screening with the whole body MRI for early detection. Dr. Raj details SimonMed's "simonONE" program, which utilizes advanced 3-Tesla MRI machines and AI to conduct comprehensive scans in as little as 30 minutes, finding silent diseases years before symptoms might appear. Throughout the discussion, Dr. Raj emphasizes the benefits of AI in medical imaging, from enhancing radiologist performance to making advanced diagnostics more affordable and accessible. This episode is a must-watch for anyone interested in the future of medicine, technology, and for aspiring physician innovators in health tech looking to make a scalable impact on patient outcomes.

About Our Guest:

Dr. Sean Raj is the Chief Innovation Officer at SimonMed Imaging. A practicing radiologist who completed his breast imaging fellowship at Harvard Medical School's Beth Israel Deaconess Medical Center, Dr. Raj is dedicated to integrating cutting-edge technology into clinical practice. He leads SimonMed's initiatives in evaluating and implementing new technologies like artificial intelligence, developing patient-centered research programs, and making proactive healthcare accessible and affordable on a national scale.

Timestamps:

(00:00) Introduction to Physician Innovators & Dr. Sean Raj

(02:20) Dr. Raj's Journey: From Medicine to Health Tech Innovation

(06:12) Mammogram Plus: Using AI for Personalized Breast and Heart Health

(11:02) Measuring Success: Patient Outcomes, Experience, and Scalability

(12:01) The Radiologist's Experience: Integrating AI into the Clinical Workflow

(15:52) Proactive Health Screening with the simonONE Whole Body MRI

(19:19) Balancing Innovation, Affordability, and Patient Access

(21:10) Enhancing Patient Understanding with Digital, Digestible Reports

(25:32) The Future of Radiology: Towards Proactive and Hyper-Personalized Care

(27:22) Advice for Aspiring Physician Innovators

Learn More From Our Guest / Episode Resources:

• Learn more about SimonMed Imaging
• Explore the simonONE Whole Body MRI
• Discover Mammogram Plus and Mammogram Plus Heart
• Check out Cascaid Health's digital reports

How does a successful academic cardiologist leave a prestigious career to build a pioneering virtual mental health company from the ground up? This episode unpacks the incredible physician transition to health tech with Dr. Reena Pande, a cardiologist turned innovator who scaled a startup to a major acquisition and is now shaping the future of clinician executive leadership. If you've ever wondered how to leverage your clinical expertise beyond the bedside and make an impact at scale, this conversation is for you.

In this deep dive, Dr. Reena Pande shares the untold story of her journey from a grant-funded researcher and faculty member at Harvard Medical School to becoming the first Chief Medical Officer at AbleTo. She details the "ferocious curiosity" that led her to explore the world of health tech and venture capital, driven by a desire to address patient needs more holistically, particularly in the intersection of physical and mental health. Dr. Pande explains the challenges and triumphs of scaling a virtual mental health company, detailing how AbleTo grew from a 10-person team with a $1.5M Series A to a thousand-person organization acquired by Optum. She provides a candid look at the Chief Medical Officer role in tech, emphasizing the need to blend clinical and business acumen, roll up your sleeves, and grow as a leader as the company evolves.

This discussion offers invaluable advice for physicians in health tech, covering the pitfalls to avoid—such as acting like the sole expert—and the mindset required to succeed, including humility and a willingness to learn the language of business (from EBITDA to COGS). Dr. Pande also recounts the dramatic impact of the pandemic, which she describes as "pouring gasoline" on the simmering need for virtual care, and how AbleTo's rigorous, quality-first approach enabled them to meet the explosive demand. Now a Partner at Oxeon leading their clinician executive search practice, she shares insights on what the industry needs most from physician leaders today and her vision for training the next generation of clinicians in the age of AI. This episode is a masterclass in clinician executive leadership and a must-listen for any doctor considering a physician transition to health tech.

About Our Guest:

Dr. Reena Pande is a Partner at Oxeon, where she leads the clinician executive search practice. Before joining Oxeon, she spent nearly a decade as the Chief Medical Officer of AbleTo (now Optum Behavioral Care), a pioneer in virtual mental healthcare. At AbleTo, she led the company’s product, data, and research efforts, scaling the organization through its acquisition by Optum. Dr. Pande was previously an academic cardiologist at Brigham and Women's Hospital and a faculty member at Harvard Medical School. She is a passionate advocate for integrating technology with empathetic, human-centered care to transform health outcomes.

Timestamps / Chapters:

(00:00) Introduction to Dr. Reena Pande

(01:23) Dr. Pande's Origin Story: The Path to Medicine and Cardiology

(05:16) The Leap: Pivoting from Academic Medicine to Health Tech Innovation

(09:43) Building AbleTo: A Pioneer in Virtual Mental Healthcare

(12:04) The Chief Medical Officer Role: Scaling a Health Tech Company

(13:57) How the Pandemic Became a Catalyst for Virtual Mental Health

(19:13) From CMO to Matchmaker: A New Chapter at Oxeon

(23:16) Common Pitfalls for Physicians Transitioning to Tech Roles

(28:43) "Know Thyself": Key Advice for Aspiring Physician Innovators

(30:39) Forecasting the Future: AI and the Next Generation of Clinicians

Learn More From Our Guest / Episode Resources:

• Read Dr. Pande's writing on her Substack, "Open Mic"
• Listen to Dr. Pande's podcast, "Leadership Rounds"
• Learn more about Oxeon

What if the millions of hours of video captured during medical procedures weren't thrown away? A revolution in AI in endoscopy is underway, turning this once-wasted data into a powerful tool to predict disease and accelerate cures. In this episode, we talk to Matt Schwartz, CEO and co-founder of Virgo Surgical Video Solutions, a company at the forefront of this transformation.

Every year, over 20 million GI endoscopies are performed in the U.S., generating a massive amount of high-definition video that, until now, was simply deleted. We dive deep with Matt on how Virgo developed a seamless system for endoscopy video capture, using a small hardware device and a HIPAA-compliant cloud platform to automatically record, de-identify, and store this valuable data without changing the clinical workflow. This enormous dataset, comprising billions of video frames, is the fuel for Virgo’s groundbreaking endoscopy foundation model, EndoDINO. Matt explains how this model, pre-trained on an unprecedented scale of real-world video, can achieve state-of-the-art results in tasks like identifying anatomical landmarks and scoring ulcerative colitis severity. The most exciting application? Using AI for clinical trial endpoints. Matt reveals how EndoDINO was able to predict with remarkable accuracy (an AUROC of 0.78) whether a patient with ulcerative colitis would respond to a placebo, a breakthrough that could revolutionize how pharmaceutical companies design and run clinical trials, making them faster and more efficient. We also discuss the future of this technology, including the potential to analyze the GI tract to find early signs of cardiovascular and neurodegenerative diseases.

About Our Guest:
Matt Schwartz is the CEO and Co-founder of Virgo Surgical Video Solutions. A biomedical engineer who previously worked as a product manager at Intuitive Surgical on the DaVinci robotic surgery platform, Matt was inspired to found Virgo after realizing the immense, untapped potential of endoscopy video data. He saw an opportunity to build the infrastructure to capture this "treasure trove" of data and use it to power a new generation of AI that could fundamentally improve patient outcomes and even eliminate the need for certain surgeries altogether.

Timestamps:
(00:00) Intro: The Problem with Wasted Endoscopy Data
(01:12) Introducing Virgo: Tapping into Underutilized Video Feeds
(06:02) What is an Endoscopy Foundation Model?
(13:12) The Spark for Virgo: A Challenging Case at the Mayo Clinic
(16:09) How the Virgo Cloud Platform Automates Endoscopy Video Capture
(23:51) Building EndoDINO: Virgo’s Foundation Model for GI Endoscopy
(30:51) Applying AI to Clinical Trial Endpoints in Ulcerative Colitis
(36:23) How AI Can Revolutionize Pharmaceutical Trials
(39:11) Why Virgo Embraced a Hardware Component
(41:41) The Future: Predicting Systemic Disease from the GI Tract

Learn More & Episode Resources:

• Learn more about Virgo Surgical Video Solutions
• Connect with Matt Schwartz

How can a brilliant oncologist, computer scientist, and former top FDA official fix the slow, broken, and expensive system of clinical trials? In this episode, we sit down with Dr. Amy Abernethy, a true physician innovator, to uncover the critical need for streamlining clinical research with real-world data. Dr. Abernethy has spent her career tackling one of healthcare’s biggest challenges: how to get effective treatments to the patients who need them, faster. From pioneering research at Duke to scaling a startup to a multi-billion dollar acquisition and modernizing the FDA’s entire data infrastructure, she reveals the playbook for building a true learning health system.

In this deep-dive conversation, Dr. Amy Abernethy shares her incredible physician innovator career path, which took her from the clinic at Duke University to executive roles at Flatiron Health, the FDA, Verily, and now as the co-founder of Highlander Health. She begins by detailing her early academic work building a "Center for Learning Healthcare," where she focused on using patient-reported outcomes and electronic data to understand what treatments truly work. However, she hit a ceiling in academia, realizing that the grant-based model couldn't scale. This led to her pivot to industry and Flatiron Health, where she shares invaluable lessons on scaling health tech companies. Dr. Abernethy discusses the importance of creating a common language ("lingua franca") between clinicians, engineers, and product teams, and establishing a North Star through shared corporate values.

This experience was crucial for her next chapter at the U.S. Food and Drug Administration, where she served as Principal Deputy Commissioner. Dr. Abernethy provides a rare insider's look at the immense challenges and surprising speed of government work, particularly her focus on FDA data modernization. She explains how the looming wave of cell and gene therapies and the EVALI vaping crisis created an urgent need for a cloud-forward, scalable agency capable of using real-world data for regulatory decisions. This work in advancing real-world evidence in regulatory science set the stage for her current mission. Now in "founder mode" at Highlander Health, she is building the infrastructure for the future of evidence generation by both funding non-profit research and investing in key companies like Target RWE, continuing her lifelong mission of streamlining clinical research with real-world data. This episode is a masterclass for anyone interested in health tech, public policy, and the future of medicine.

ABOUT OUR GUEST:
Dr. Amy Abernethy is a physician, researcher, and health tech leader who is currently the co-founder of Highlander Health. Her distinguished career includes roles as a medical oncologist and researcher at Duke University, Chief Medical Officer and Chief Scientific Officer at Flatiron Health, Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA), and a leader in product development at Verily. She is a world-renowned expert in real-world data, evidence generation, and building learning health systems.

TIMESTAMPS:
(00:00) Introduction to Dr. Amy Abernethy's Trailblazing Career
(02:19) The Origin Story: From NASA Programmer to Clinical Oncologist
(05:35) Building a "Learning Health System" at Duke University
(07:57) The Pivot from Academia to Industry: Why Scale Matters
(10:10) Lessons in Scaling a Mission-Driven Health Tech Company
(15:54) Shaping the Narrative for Real-World Evidence (RWE)
(18:43) From Industry to Government: A New Chapter at the FDA
(22:27) Modernizing FDA Data Systems for Future Health Crises
(27:39) Founder Mode: The Launch of Highlander Health
(35:41) Advice for Aspiring Physician Innovators

LEARN MORE FROM OUR GUEST / EPISODE RESOURCES:

• Learn more about Highlander Health
• Learn about Highlander Health's acquisition of Target RWE
• Read the article on CMO archetypes Dr. Abernethy co-authored