Med Tech Gurus

Tom Hickey

Med Tech Gurus is a podcast dedicated to helping medical device executives stay on the leading edge of their industry. Whether you're looking to grow your sales team, commercialize new devices, set up national accounts, or improve your clinical performances, this podcast is designed to help. Each episode features an interview with a thought leader or practitioner, discussing topics like: sales force, innovation, patient outcomes, emerging technologies, supply chain, group purchasing organizations, device launches, value analysis, biotech, and more.

  1. Sep 16

    Compliance Should Accelerate Innovation

    What if the biggest bottleneck in MedTech innovation isn't science—but compliance? In this episode of Med Tech Gurus, we sit down with Zahra Timsah, Founder and CEO of i-GENTIC AI, to explore how artificial intelligence is transforming FDA readiness, regulatory operations, and healthcare compliance. With experience spanning oncology research, drug discovery, engineering, and international regulatory systems, Zahra brings a rare perspective to one of healthcare's least glamorous—but most consequential—challenges: getting innovation through the regulatory bottleneck and into patients' hands faster. What makes her story especially compelling is that this mission is personal. After witnessing a life-saving diagnostic delayed by regulatory friction, Zahra began pursuing a different vision: using AI not to replace expertise, but to augment it. We dive into her concept of "governance by design," where compliance becomes proactive instead of reactive, embedded into every stage of development rather than treated as a last-minute hurdle. Zahra also explains how contextual AI agents can act like a "digital FDA reviewer," helping companies identify inconsistencies, reduce documentation friction, and prepare stronger submissions before they ever reach regulators. The conversation also explores why most operational bottlenecks are documentation-driven rather than scientific, why specialized AI matters more than general-purpose tools, and how AI-assisted services may become the next major evolution in healthcare compliance. If you're interested in AI in healthcare, FDA strategy, MedTech compliance, regulatory affairs, healthcare AI, or digital quality systems, this episode delivers a compelling look at how intelligent compliance may become a competitive advantage for the next generation of MedTech innovators.

  2. Sep 9

    Don't Start With AI—Start With the Bottleneck

    Everyone wants to apply AI to drug development. But what if the smartest place to start isn't the technology at all—it's the bottleneck. In this episode of Med Tech Gurus, we sit down with Anastasia Christianson, former innovation and AI leader at Pfizer and Johnson & Johnson, now Managing Principal at EPAM Systems, to explore how artificial intelligence can move beyond experimentation and begin transforming clinical development. Anastasia makes a compelling case that successful AI adoption starts not with tools, but with business problems—specifically the friction points slowing trial design, patient recruitment, protocol optimization, and execution. Rather than chasing "AI everywhere," she argues companies should focus AI where it can solve high-impact challenges and deliver measurable outcomes. We dive into digital twins, virtual trials, synthetic control arms, and AI-driven patient engagement, exploring how these technologies are already improving clinical trial design and could ultimately reshape how therapies are brought to market. Anastasia also shares practical lessons on change management, scaling innovation inside complex organizations, and why process redesign—not technology alone—is often what determines whether transformation succeeds. If you're interested in AI in pharma, clinical trial innovation, digital twins, drug development, or biotech strategy, this episode offers a compelling roadmap for where the next wave of innovation is heading.

5
out of 5
18 Ratings

About

Med Tech Gurus is a podcast dedicated to helping medical device executives stay on the leading edge of their industry. Whether you're looking to grow your sales team, commercialize new devices, set up national accounts, or improve your clinical performances, this podcast is designed to help. Each episode features an interview with a thought leader or practitioner, discussing topics like: sales force, innovation, patient outcomes, emerging technologies, supply chain, group purchasing organizations, device launches, value analysis, biotech, and more.

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