The FDA is Taking a Big Risk on AI

Send us a textWhen people talk about clinical trials, they usually think of drugs, but what about the tools that deliver, diagnose, and detect? Medical device Innovation often flies under the radar despite being essential to modern care. In this episode of the HealthBiz Podcast, Jason Monteleone, CEO of Avania, discusses how his firm helps medtech, diagnostics, and digital health companies navigate clinical trials and regulatory hurdles.🎙️⚕️JASON MONTELEONEHaving spent over 25 years in the CRO, medical device, and life sciences sectors, Jason Monteleone brings impressive experience in driving innovation, collaboration, and excellence to his role as the president and CEO of Avania. He has served as CEO and CFO at major organizations like Clinipace and Theorem Clinical Research, and he founded clinical research consultancy Pivotal Financial Consulting. Monteleone is also a board member and audit chair for the Drug Information Association (DIA). He earned a Bachelor of Science degree in business administration from Millersville University and a Master of Business Administration degree from Temple University.🎙️⚕️ABOUT HEALTH BIZ PODCASTHealthBiz is a CareTalk podcast that delivers in-depth interviews on healthcare business, technology, and policy with entrepreneurs and CEOs. Host David E. Williams — president of the healthcare strategy consulting boutique Health Business Group — is also a board member, investor in private healthcare companies, and author of the Health Business Blog. Known for his strategic insights and sharp humor, David offers a refreshing break from the usual healthcare industry BS.GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk Newsletter#healthcare #healthcarepodcast #healthcarebusiness #healthcarepolicy #healthinsurance #healthcaretechnology #caretalk #fda #clinicaltrials #clinicalresearch #medtechSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textThe U.S. pays more for prescription drugs than any other country. President Trump says it’s time to change that—with a bold plan to tie American drug prices to those paid in Europe and beyond.In this episode of CareTalk: Healthcare. Unfiltered., hosts John Driscoll and David E. Williams debate whether Trump’s so-called Most Favored Nation policy will actually cut drug prices or just cause chaos.🎙️⚕️ABOUT CARETALKCareTalk is a weekly podcast that provides an incisive, no B.S. view of the US healthcare industry. Join co-hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they debate the latest in US healthcare news, business and policy. GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk NewsletterSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textAI promises to revolutionize clinical trials and reshape regulatory oversight. But is the pharma industry ready? And can the FDA keep pace with the technology? In this episode of the HealthBiz Podcast, host David Williams is joined by Tom Doyle, Chief Technology Officer of Medidata, to discuss the promises and potential pitfalls of AI in clinical trials. 🎙️⚕️ABOUT TOM DOYLETom Doyle heads product development at Medidata, a leader in clinical research technology and a life sciences arm of Dassault Systèmes. In this role, Tom leads Medidata’s work in developing industry-leading solutions for patients, sites, sponsors, and CROs, improving and accelerating the design, execution, and oversight of clinical trials – essential in bringing new and novel treatments for patients. Tom joined Medidata in 2019, bringing 20 years of global experience in medtech and data science. Before coming to Medidata, Tom held leadership roles at Janssen and at Boehringer Ingelheim, championing technology to drive new experiences and better insights. He’s passionate about the power of innovation to transform clinical research towards better outcomes and better experiences for patients.Tom has a BMath in computer science from the University of Waterloo in Ontario, Canada.🎙️⚕️ABOUT HEALTH BIZ PODCAST HealthBiz is a CareTalk podcast that delivers in-depth interviews on healthcare business, technology, and policy with entrepreneurs and CEOs. Host David E. Williams — president of the healthcare strategy consulting boutique Health Business Group — is also a board member, investor in private healthcare companies, and author of the Health Business Blog. Known for his strategic insights and sharp humor, David offers a refreshing break from the usual healthcare industry BS.GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk Newsletter#healthcare #healthcarepodcast #healthcarebusiness #healthcarepolicy #healthinsurance #healthcaretechnology #caretalk #fda #ai #clinicaltrials #clinicalresearchSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textAs viral diseases both new and old ravage countries across the world, does the growing distrust of physicians, and the healthcare industry at large, have a more profound effect on treatment than most realize?In this episode of CareTalk, Dr. Tyler Evans (CEO & Co-Founder, Wellness and Equity Alliance) joins hosts, John Driscoll and David E. Williams, to discuss the issue of healthcare inequality facing marginalized people groups across the globe, the impact a grassroots connection to a local community can have on the distribution of life-saving medicines, and the struggle to win back trust in a sea of conflicting ideology.🎙️⚕️ABOUT DR. TYLER EVANSTyler B. Evans, MD, MS, MPH, AAHIVS, DTM&H, FIDSA is a physician, academic, humanitarian, and author whose life’s work centers on advancing health equity for the world’s most vulnerable populations. He currently serves as CEO and Co-Founder of the Wellness Equity Alliance (WEA), a national network committed to transforming public health systems through community-based, equity-driven models.Dr. Evans brings decades of clinical, executive, and global health leadership experience. He previously served as CEO/CMO of Curative Medical Associates, where he helped oversee the administration of more than 2 million COVID-19 vaccine doses across 10 states with a strong emphasis on equity. On August 5, 2025, Dr. Evans will release his debut book, Poverty, Pandemics, and Politics: A Physician’s Reckoning with Injustice in Global Health—a powerful exploration of systemic inequity, moral courage, and the future of public health from the frontlines of crisis response.🎙️⚕️ABOUT CARETALKCareTalk is a weekly podcast that provides an incisive, no B.S. view of the US healthcare industry. Join co-hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they debate the latest in US healthcare news, business and policy. GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk NewsletterSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textWhat if your medications are working against you?Jim Wallace, former CEO of DecisionRx and Author of "Precision Medicine: AI and the Science of Personalized Healthcare," joins CareTalk to expose the massive issue of medication misfires and how pharmacogenomics can help fix it.From his time at SpaceX to leading innovation in personalized medicine, Jim explains why your DNA holds the key to safer, more effective care—and why you might not want to wait for your doctor or insurer to catch up.🎙️⚕️ABOUT JIM WALLACEStrategist and executive operating at the intersection of science, technology, and health. Proven track record leading private equity–backed companies and advising investors, providers, and policymakers on the shift from volume-based to personalized care.Author of Precision Medicine: AI and the Science of Personalized Healthcare (Wiley), a roadmap for transforming medicine through wearable tech, genomics, Big Data, and AI. The book offers a practical vision for replacing one-size-fits-all medicine with scalable, individualized healthcare.Senior researcher at Harvard Business School, with an MBA from Harvard and a Doctor of Business Administration from the University of South Florida. Board member and frequent speaker at national healthcare forums, with a focus on bridging cutting-edge science and real-world implementation.🎙️⚕️ABOUT CARETALKCareTalk is a weekly podcast that provides an incisive, no B.S. view of the US healthcare industry. Join co-hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they debate the latest in US healthcare news, business and policy. GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk NewsletterSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textEmployers struggle with rising healthcare costs, and their usual approach is to work with a bevy of vendors, including insurers, provider networks, point solution providers, and HR supply chain vendors. But these vendors are awfully hard to optimize and costs seem to keep on climbing.In this episode of the HealthBiz Podcast, David Neikrug, CEO of Optimatum Solutions, joins host, David E. Williams, to explain how poor vendor management fuels rising employer healthcare costs and what to do about it. 🎙️⚕️ABOUT DAVID NEIKRUG David M. Neikrug is a leading authority in the application of vendor management to the Human Resources supply chain, which encompasses applications, programs and vendors that deliver employer-sponsored healthcare, retirement, HR systems and M&A transitional services. With over 30 years of experience, David brings an extensive expertise and comprehensive understanding of the HR challenges facing today’s employers and serves as an advocate on his clients’ behalf to ensure vendors are accountable, transparent and deliver on their guarantees.David is the Founder and Chief Executive Officer of Optimatum Solutions LLC, a vendor management firm focused exclusively on the HR Supply Chain. David founded Optimatum in 2007 to fill a gap in the vendor management marketplace. His approach centers on improving client/vendor relationships through forensic analysis, vendor relationship optimization and ongoing management. 🎙️⚕️ABOUT HEALTHBIZ PODCASTHealthBiz is a CareTalk podcast that delivers in-depth interviews on healthcare business, technology, and policy with entrepreneurs and CEOs. Host David E. Williams — president of the healthcare strategy consulting boutique Health Business Group — is also a board member, investor in private healthcare companies, and author of the Health Business Blog. Known for his strategic insights and sharp humor, David offers a refreshing break from the usual healthcare industry BS.GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk Newsletter#healthcare #healthcarepodcast #healthcarebusiness #healthcarepolicy #healthinsurance #healthcaretechnology #caretalk #humanrelations #payroll #vendormanagementSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textWhat if better care starts with more trust and understanding?In this episode of CareTalk, Violet CEO Gaurang Choksi joins John Driscoll to explore why care can’t be one-size-fits-all and what happens when providers actually understand the identities and experiences of the people they treat. Drawing from his journey as a gay immigrant and early leader at Oscar Health, Gaurang shares how culturally competent care leads to stronger relationships and better outcomes for the patients who’ve long felt unseen.🎙️⚕️ABOUT GAURANG CHOKSIGaurang is the Founder & CEO of Violet - a platform dedicated to helping the healthcare industry connect underserved communities to culturally competent care, by building a new standard for identifying cultural competencies within providers. Violet's proprietary system for benchmarking cultural competence uses a variety of disparate data about each partner provider (e.g. training history, professional experiences, identities, etc.) to identify and showcase culturally competent providers. Prior to building Violet, Gaurang spent 4 years building insurance and technical products at Oscar health, a health insurance startup build from the ground up. He is also queer and an immigrant, with a passion for making healthcare more inclusive for the medicaid population.🎙️⚕️ABOUT CARETALKCareTalk is a weekly podcast that provides an incisive, no B.S. view of the US healthcare industry. Join co-hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they debate the latest in US healthcare news, business and policy. GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk NewsletterSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textThe FDA is charging ahead with generative AI, claiming it can cut scientific review times from days to minutes. But is this innovation or recklessness? In this episode of CareTalk, David Williams and John Driscoll debate whether the FDA’s rapid deployment of AI is a smart move or a potentially dangerous shortcut.Stream our episode with FDA leader, Dr. Marty Makary, here. 🎙️⚕️ABOUT CARETALKCareTalk is a weekly podcast that provides an incisive, no B.S. view of the US healthcare industry. Join co-hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they debate the latest in US healthcare news, business and policy. GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk NewsletterSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textEntrepreneurs are addressing problems in US healthcare like access to primary care, but they need mentors and investors to scale up and make a real impact. Private equity has some bad connotations, especially in healthcare delivery. Why is that and what are investors doing to prove their worth?Ariez Dustoor, Partner at NB Group Investors, joins us to talk about what thoughtful, long-term health care investing actually looks like—from scaling prevention-first primary care to avoiding the pitfalls that have plagued bigger players.🎙️⚕️ABOUT ARIEZ DUSTOORAriez is an experienced investor, entrepreneur, and advisor. Prior to NB Group, he was a member of the investment team at Audax Group, the Corporate Development team at Yahoo!, a Co-Founder of Scout Finance (sold to a strategic acquirer in 2017), and started his career as a consultant to Fortune 500 companies at McKinsey & Company.As a Co-Founder at Scout Finance, an enterprise software company focused on the financial industry, Ariez helped lead product development, sales, and fundraising. At Audax Group, a leading middle market private equity fund, Ariez evaluated new investments and worked closely with portfolio companies, including a large business media and data company, and a physical security services provider. At Yahoo!, Ariez was heavily involved in new investments and acquisitions globally in the Mobile and Online services spaces. At McKinsey, Ariez worked with Fortune 500 CEOs in a variety of industries on growth strategy and operational imrovement in the US and abroad.Ariez is a graduate of the University of Michigan, where he was elected Phi Beta Kappa. He lives in Miami with his wife and two kids. 🎙️⚕️ABOUT HEALTHBIZ PODCASTHealthBiz is a CareTalk podcast that delivers in-depth interviews on healthcare business, technology, and policy with entrepreneurs and CEOs. Host David E. Williams — president of the healthcare strategy consulting boutique Health Business Group — is also a board member, investor in private healthcare companies, and author of the Health Business Blog. Known for his strategic insights and sharp humor, David offers a refreshing break from the usual healthcare industry BS.GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk Newsletter#healthcare #healthcarepodcast #healthcarebusiness #healthcarepolicy #healthinsurance #healthcaretechnology #healthcarefinance #caretalk #privatequitySupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.

Send us a textHealth coaching is often overlooked in healthcare, but could it be the key to improving behavior change, supporting chronic care, and filling gaps left by clinical shortages? In this episode of CareTalk: Healthcare. Unfiltered., Eugene Borukhovich, COO & Co-Founder of YourCoach, joins John Driscoll to discuss why coaching is gaining traction, how YourCoach is helping scale it, and why embracing health coaches could be critical to building a stronger, more sustainable healthcare system.🎙️⚕️ABOUT EUGENE BORUKHOVICHEugene is a serial intra and entrepreneur, executive, venture builder, speaker & board advisor with a focus in digital health. Eugene is a Co-Founder & COO at YourCoach Health and founder of Initium Impact Ventures. Prior to YourCoach, Eugene served as a Global Head of Digital Health at Bayer. He has also co-founded and sold a doctor rating startup and a consulting company. Eugene enjoys running, writing, traveling and spending time with his family.🎙️⚕️ABOUT YOURCOACH HEALTHYourCoach is the only operating system for behavior change, powered by a technology-augmented army of health and wellness coaches and a full practice management platform for the rapidly growing gig-economy.🎙️⚕️ABOUT CARETALKCareTalk is a weekly podcast that provides an incisive, no B.S. view of the US healthcare industry. Join co-hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they debate the latest in US healthcare news, business and policy. GET IN TOUCHFollow CareTalk on LinkedInBecome a CareTalk sponsorGuest appearance requestsVisit us on the webSubscribe to the CareTalk NewsletterSupport the show⚙️CareTalk: Healthcare. Unfiltered. is produced by Grippi Media Digital Marketing Consulting.