What if AI isn't software anymore?

In this episode of Med Tech Gurus, we sit down with Scott Schell, MD, PhD, MBA, Chief Medical Officer at Cognizant, to explore one of the most important questions in healthcare AI: Who is responsible when the model is wrong?

Scott argues that as AI begins reviewing charts, drafting communications, processing claims, and influencing clinical decisions, it starts behaving less like software and more like a member of the workforce. And every member of the workforce needs a job description, supervision, accountability, and clear escalation pathways.

We discuss AI governance, workflow design, shadow AI, and why the smartest health systems aren't starting with technology—they're starting with operational problems that need solving.

If you're interested in AI in healthcare, digital transformation, clinical operations, healthcare leadership, or AI governance, this episode delivers practical insights on moving AI from experimentation to real-world impact.

AI Needs a Job Description

What if the biggest risk in AI isn't the technology—it's the system behind it?

In this episode of Med Tech Gurus, we sit down with Henna Karna, Co-Founder and President of NeuroVitals, to explore why artificial intelligence doesn't fix broken organizations—it accelerates whatever already exists.

Drawing on leadership experience at Google, AXA, and AIG, Henna shares a powerful perspective on the intersection of AI, healthcare, and mental wellness. While many organizations view AI as a solution, she argues that success depends on understanding culture, workflows, and human behavior before technology is deployed.

We also explore NeuroVitals' mission to combine AI, biomarkers, and behavioral science to help individuals better manage their mental and physical well-being. From personalized wellness journeys to bridging gaps between therapy sessions, Henna explains how AI can support—not replace—human connection and clinical judgment.

If you're interested in AI in healthcare, mental health innovation, digital health, patient engagement, behavioral science, or healthcare transformation, this episode offers a fresh perspective on how to build technology that strengthens people instead of simply automating processes.

The Human Side of Artificial Intelligence

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.

Compliance Should Accelerate Innovation

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.

Don't Start With AI—Start With the Bottleneck

Everyone is racing to add AI to healthcare.

But what if the bigger problem isn't adopting AI… it's the fragmented systems underneath it?

In this episode of Med Tech Gurus, we sit down with Nader Fathi, serial entrepreneur and CEO of Enlil, to explore why the future of MedTech innovation may depend less on adding more intelligence—and more on creating integrated foundations that allow innovation to scale.

With decades of experience spanning AI, big data, IoT, and regulated product development, Nader makes a compelling case that many MedTech companies are solving the wrong problem. While others rush toward AI tools, he argues the real risk is fragmentation across compliance, engineering, quality systems, and manufacturing—creating hidden vulnerabilities that slow innovation and threaten scale.

We explore why integrated compliance is becoming a strategic advantage, how private AI models and agentic AI may reshape product development, and why "customers, customers, customers" remains timeless advice for founders building scalable companies.

From FDA readiness and change control to product-market fit and investor storytelling, this episode is a masterclass in moving from product innovation to enterprise execution.

If you're interested in AI in healthcare, MedTech quality systems, regulatory strategy, SaaS for medical devices, or startup scale-up strategy, this episode delivers a powerful blueprint for building innovation that lasts.

AI Isn't the Problem—Fragmentation Is

Clinical efficacy doesn't matter if the patient won't use the device.

In this episode of Med Tech Gurus, we sit down with Anat Shani, biomedical engineer and CEO of Synchrony Medical, to explore a critical but often overlooked truth in MedTech: adherence is everything.

Anat led the development of Liberty, a patient-centered airway clearance device designed to help individuals with chronic respiratory conditions manage mucus buildup and reduce infection risk—all from home. What makes this story unique is not just the speed to market—FDA authorization and commercialization in under five years—but the relentless focus on real-world usability.

We dive into why many clinically effective respiratory devices fail in practice, how patient feedback reshaped Liberty's design from day one, and why comfort, simplicity, and workflow integration must be engineered—not added later. From iterative prototyping with patients to refining even the language used in instructions, Anat shares how small design decisions can drive massive differences in outcomes.

We also explore the realities of launching in the U.S. market, aligning messaging across stakeholders, and building a lean, disciplined team that can move quickly without losing focus.

For MedTech founders and innovators, this episode delivers a powerful message: the best product isn't the most advanced—it's the one patients actually use.

If you're interested in respiratory care, home healthcare devices, patient adherence, MedTech design, digital health, or medical device commercialization, this episode offers a practical playbook for building products that succeed beyond the clinical trial.

If Patients Won't Use It, It Won't Help

Is the future of MedTech innovation shifting away from devices—and toward manufacturing?

In this episode of Med Tech Gurus, we sit down with Mark Freitas, Managing Director and Life Sciences Leader at Alvarez & Marsal, to explore a major shift happening in MedTech: capital is moving away from traditional device acquisitions and toward advanced manufacturing platforms and CDMOs.

As device complexity increases and technologies converge across hardware, software, and biologics, the ability to manufacture at scale is becoming a strategic differentiator—not just an operational function.

Mark breaks down why 2026 is shaping up to be a pivotal year for MedTech M&A, with a surge in deal activity driven by private equity exits, OEM carve-outs, and platform roll-ups. He explains why scarcity of specialized capabilities—not revenue—is now driving valuation, and how regulatory infrastructure has emerged as a hidden but powerful competitive moat.

We also explore how founders and operators should think about CDMO partnerships, when to own manufacturing versus outsource it, and why many companies get the timing wrong.

For MedTech leaders, investors, and innovators, this episode delivers a clear message: the winners in the next wave of MedTech won't just build great products—they'll build (or partner for) the capabilities to make them.

The New MedTech Battleground

Cybersecurity in healthcare is no longer an IT issue—it's a patient safety issue.

In this episode of Med Tech Gurus, we sit down with Skip Sorrels, Field CTO and Chief Information Security Officer at Claroty, to explore how cyber threats are evolving from data breaches into full-scale clinical and operational disruptions.

With a unique background as both an ICU nurse and healthcare cybersecurity leader, Skip brings a rare perspective on what actually happens inside a hospital when systems go down. From electronic medical records shutting off to clinicians reverting to paper processes, these events don't just slow operations—they fundamentally impact patient outcomes.

We dive into the growing risks tied to connected medical devices and hospital infrastructure, including operational technologies like HVAC systems, water filtration, and building controls—areas increasingly targeted as the "path of least resistance" for attackers.

Skip also shares why healthcare organizations must begin treating cybersecurity like disaster preparedness, focusing on operational resilience, recovery planning, and real-world readiness—not just prevention.

For MedTech innovators, this episode delivers a critical message: security is no longer a feature—it's a requirement for trust, adoption, and patient safety.

If you're interested in healthcare cybersecurity, medical device security, hospital operations, digital health risk, or MedTech commercialization, this episode offers a powerful and timely perspective on one of the most important challenges facing healthcare today.

When Cyber Attacks Become Patient Care Events

Why do breakthrough medical technologies still fail to get adopted?

In this episode of Med Tech Gurus, we sit down with David Neale, Co-Founder and CEO of Argá MedTech, to explore what it really takes to bring a differentiated cardiac technology from concept to clinical adoption.

Argá is advancing next-generation pulsed field ablation (PFA) for the treatment of atrial fibrillation, with early data showing 100% procedural success, strong safety, and high lesion durability. But as David explains, great clinical data alone isn't enough.

Drawing on decades of experience in cardiac rhythm management, David shares why so many promising technologies fail—not because of engineering, but because they ignore physician workflow, hospital operations, and real-world usability. From designing a single, multi-configurable catheter platform to simplifying complex EP lab environments, Argá's strategy is built around one principle: innovation must fit the workflow to win adoption.

We dive into lessons from first-in-human trials, the importance of disciplined execution, and why companies must design for three critical stakeholders: clinicians, operational teams, and administrators. David also shares practical insights on site selection, physician alignment, and how to move from strong data to real-world adoption.

If you're interested in cardiac electrophysiology, pulsed field ablation, MedTech commercialization, clinical trials, or healthcare innovation, this episode delivers a powerful playbook for turning technology into adoption.

Why Great MedTech Doesn't Get Adopted

What does it really mean to put the patient at the center of healthcare innovation?

In this episode of Med Tech Gurus, we sit down with Stephanie Hunter-Banks of Jazz Pharmaceuticals, a leader in medical learning, patient engagement, and rare disease advocacy. But what makes this conversation truly powerful is that Stephanie doesn't just study the patient journey—she lives it.

As a rare disease patient herself, Stephanie brings a deeply personal and professional perspective to how healthcare systems, MedTech companies, and clinicians engage with patients. Her journey—spanning more than two decades without a definitive diagnosis—offers a raw and honest look into what many patients experience but few organizations truly understand.

Stephanie shares why scientific innovation alone isn't enough—and how empathy, trust, and meaningful engagement are critical to driving better outcomes. From the challenges of the "diagnostic odyssey" to the importance of resilience, she provides a framework for how healthcare leaders can rethink patient-centricity—not as a buzzword, but as a real partnership.

We also explore the role of medical affairs in translating complex science into real-world clinical decisions, the gaps that still exist between providers and patients, and how leaders can build teams grounded in trust, connection, and growth.

If you're interested in rare disease, patient engagement, medical affairs, healthcare leadership, or MedTech innovation, this episode delivers a powerful reminder: the future of healthcare isn't just about better technology—it's about better understanding the people it serves.

The Diagnostic Odyssey: What Healthcare Gets Wrong About Patients

Tom (@pctedge) · Zencastr

Tom (@pctedge)

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.