What if the key to fixing pharma’s toughest challenges wasn’t more complexity—but more clarity?

In this episode of Med Tech Gurus, Shetal Vyas, SVP of Commercial Strategy & Development at Ardelyx, joins us to explore how digital-first strategies are reshaping how we bring therapies to patients. Shetal unpacks how to overcome the $200 billion patent cliff, reframe customer engagement, and build scalable, data-driven commercial models that don’t just add tech—but center patients.

With practical insights into digital ecosystems, commercialization frameworks, and change management, this episode is packed with takeaways for MedTech innovators navigating the intersection of healthcare, pharma, and digital transformation.

Redesigning the Patient Journey

What if we could detect Alzheimer’s disease before the first memory fades?

In this powerful episode of Med Tech Gurus, Dr. Maria-Magdalena Patru, MD, PhD—who leads the neurology medical team at Roche Diagnostics US—explains how early diagnosis is being radically transformed through CSF and blood-based biomarker innovations. With Alzheimer’s affecting over 7 million Americans, Dr. Patru outlines how new guidelines, improved reimbursement, and diagnostic advances are helping clinicians identify the disease earlier—when treatments can still preserve cognition.

She also shares how her personal connection to Alzheimer’s drives her mission and offers advice to innovators navigating regulatory and clinical pathways. If you're building diagnostics or working on access-to-care challenges, this is a must-listen.

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https://diagnostics.roche.com/us/en/products/product-category/neurology/alzheimers-disease.html

 

The Future of Alzheimer’s Diagnosis

What if the future of clinical trials wasn’t just faster—but dramatically more human-centered, efficient, and aligned with real-world outcomes? In this episode of Med Tech Gurus, Meri Beckwith, co-founder of Lindus Health, shares how a broken experience during a COVID trial sparked a revolution in trial design.

Lindus is reimagining the traditional CRO with fixed-cost models, milestone-based payments, and tech-driven platforms that cut enrollment timelines by 74%. Meri reveals how their innovative culture, AI-enhanced monitoring, and focus on patient experience is building a new infrastructure for smarter trials. If you're a medtech founder tired of bloated protocols, poor enrollment, and outdated systems, this episode will help you rethink what’s possible in clinical research.

Rethinking the CRO: Faster, Smarter, More Human Trials

What if you could cut your product development time in half—and avoid the regulatory landmines that derail most startups? In this episode of Med Tech Gurus, Marcel Botha, CEO and Founder of 10XBeta, reveals how his Brooklyn-based venture studio helps innovators turn bold ideas into compliant, fundable, and scalable medical technologies.

With deep expertise in design, engineering, and regulatory strategy, Marcel shares how 10XBeta supports founders in navigating the critical—and capital-intensive—first mile of MedTech development. From pandemic-driven ventilator designs to launching 50+ products, Marcel delivers powerful lessons on speed, structure, and investor alignment. Gurus, if you’re building in the deep end of innovation, this episode is your blueprint.

From Idea to Market

What happens when clinical strategy, bioinformatics, and market access all live under one roof? Meet Tyler O’Malley, VP at Exagen, who shares how this rare triad is driving innovation in autoimmune diagnostics.

In this episode, Tyler reveals how real-world data fuels product strategy, why storytelling is key to market access, and how diagnostic innovators can scale in a payer-driven world. We explore the evolution of evidence, the importance of physician advocacy, and how to align science with unmet clinical need—without chasing shiny objects. Gurus, if you're launching diagnostics or navigating commercialization in today’s complex environment, this episode is full of insight you can’t afford to miss.

The Power of Precision

Behavioral health is in crisis—not just from rising demand, but from the chaos of inconsistent care models, fragmented data, and outdated systems. In this episode of Med Tech Gurus, Jim Szyperski, CEO of Acuity Behavioral Health, shares how his team is bringing much-needed structure and accountability to inpatient psychiatric care.

 

Backed by a $1.5 million seed round and in collaboration with health systems, Acuity is creating data-driven standards that empower nurses, improve patient outcomes, and deliver operational clarity. Jim brings lessons from decades of entrepreneurship and dives into the real-world challenges of scaling innovation in healthcare’s slowest-moving sector. Gurus, if you care about solving systemic gaps in mental health care, this conversation is a must.

Standardizing Behavioral Health from the Inside Out

What if we could finally put real answers behind the brain fog, fatigue, and lingering symptoms so many patients still face post-COVID? In this episode, Dr. Nigel McCracken, Chief Operating Officer at Virax Biolabs, returns to Med Tech Gurus to reveal how their groundbreaking ViraxImmune platform is decoding the hidden dysfunctions of the immune system. With major NHS-led trials underway and U.S. clinical sites ramping up, Nigel shares how their proprietary FluoroSpot T-cell assay brings unprecedented accuracy to diagnosing long COVID, chronic fatigue, and post-viral syndromes.

We also dive into the operational challenges of global trials, lessons from diagnostics commercialization, and how to build innovation-ready teams that scale. Gurus, this is diagnostic disruption at its best.

 

The Immune Decoder: Cracking the Code of Long COVID

Billions are being poured into healthcare AI, yet most innovations never make it past pilot projects. Why? And more importantly—how do we fix it?

In this episode of Med Tech Gurus, we sit down with Marco Smit, serial entrepreneur, life sciences executive, and AI commercialization expert. With leadership experience at Roche, Genentech, Gassund, CareSyntax, and now Dome Labs, Marco has seen the full spectrum of healthcare AI—from hype to hard-earned success.

He shares why so many organizations fall victim to “pilotitis”, the critical role of AI governance, and how startups and health systems can build scalable, evidence-driven solutions that actually deliver ROI. From navigating the complex regulatory landscape to choosing the right investors and partners, Marco offers a pragmatic playbook for moving AI from the lab to real clinical impact.

Whether you’re a startup founder, health system innovator, or medtech investor, this episode is packed with actionable insights on avoiding hype, accelerating adoption, and building AI solutions that last.

Breaking the AI Bottleneck in Healthcare

What if we could finally crack the code on treating brain cancer by opening the door that’s blocked 98% of therapies? In this episode, Dr. Michael Canney, Chief Scientific Officer of Carthera, reveals how SonoCloud—a revolutionary ultrasound implant—temporarily opens the blood-brain barrier to deliver chemotherapy directly to tumors like glioblastoma. With over 100 patients enrolled in a Phase III trial across 40 global sites, this isn’t just a bold idea—it’s happening now.

Michael also shares real-world lessons in scaling trials, FDA navigation, and aligning science with commercial success. If you’re passionate about disruptive innovation in neuro-oncology, you’ll want to hear how Carthera is changing the game.

Breaking Barriers

What if the key to solving the provider burnout crisis wasn’t adding more hours in the day—but using technology to give them back? In this episode of Med Tech Gurus, we meet David Norris, Co-Founder and CEO of Affinion Health.

David shares how his company is building an AI-powered clinical inbox that helps clinicians manage the overwhelming flood of lab results, patient messages, and admin tasks. With measurable results like five hours of reclaimed time per week per provider, David explains how Affinion’s solution is not just about efficiency—it’s about restoring balance, improving care, and preventing burnout. From his work with the Coalition for Health AI to his lessons in entrepreneurship and team-building, David offers practical wisdom for every MedTech innovator in this episode.

AI vs Burnout: How Affinion Health Is Reclaiming Time for Clinicians

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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