In this episode, we sit down with Varun Kalaiarasan, a PhD researcher in Biomedical Engineering at the University of Cincinnati, whose interdisciplinary background combines mechanical engineering, applied machine learning, and venture capital.

Varun shares his involvement in advancing VortexPAP, an innovative medical device being developed to improve comfort and treatment adherence for individuals living with obstructive sleep apnea. Working alongside Dr. Liran Oren, Varun focuses on the venture and commercialization side, helping navigate the path toward regulatory approval and market entry.

Discover how biomedical research, entrepreneurship, and patient-centered innovation come together to address real-world healthcare challenges and shape the future of medical technology.

In this episode, we welcome Dr. Ryan Beal, Founder and CEO of Dyve Biosciences, to discuss an innovative transdermal drug delivery approach targeting tumor acidity to help the immune system better recognize and attack cancer cells.

A physician and serial entrepreneur, Ryan brings extensive experience in pharmaceutical innovation, clinical development, and healthcare entrepreneurship. Join us to explore the science behind Dyve Biosciences and the future of cancer treatment.

In this episode of the MedTech Podcast, we welcome Sandi Schaible, Founder of Bonded in Science and ISO TC 194 WG14/WG1 Expert. With over 25 years of experience, Sandi brings valuable insights into chemical characterization, regulatory strategy, and scientific leadership in the medical device industry.

In this episode, we speak with Gennaro Maida, a healthcare technology executive working at the intersection of wearable technology, clinical research, and artificial intelligence.

Gennaro is CEO/CMIO of Denovo Innovations Group, Director of Clinical Products at Tactical Rehabilitation, and recently served as CMIO of The Cena Group. He also serves on the American Heart Association's Health Tech Advisory Group.

Our conversation explores how sensor data can be transformed into meaningful clinical evidence, including PPG and HRV signal processing, HIPAA-compliant remote data capture for multi-site studies, and AI architectures designed to support clinical and regulatory evidence.

Gennaro also discusses the challenges surrounding digital biomarkers, the importance of establishing "ground truth," and why AI-generated inferences must remain distinct from validated clinical facts.

He holds a BME from Duke University and an MS in Medicine from Hahnemann University, with a focus on cardiac surgery outcomes.

Dr. Ben Holmes: 3D Printing, MedTech, and the Future of Joint Repair

In this episode, we speak with Dr. Ben Holmes, CEO and Co-Founder of Nanochon, a medical technology company developing Chondrograft™, a 3D-printed synthetic implant designed to repair damaged cartilage and restore joint function for patients who are not yet candidates for knee replacement.

Dr. Holmes holds a Ph.D. in Biomedical Engineering from The George Washington University and a B.S. in Mechanical and Aerospace Engineering from the University of Virginia. His research has focused on biomaterials and 3D printing for orthopedic tissue repair.

Since co-founding Nanochon in 2016, Dr. Holmes has helped secure nearly $12 million in funding through NSF grants, venture capital, and other awards. He has also guided the company to its first-in-human clinical trial.

As a published researcher, patent holder, entrepreneur, and healthcare innovator, Dr. Holmes offers a unique perspective on the journey from biomedical research and engineering to the development and clinical evaluation of medical devices.

In this conversation, we discuss the science behind 3D-printed orthopedic implants, the challenges of developing innovative medical devices, the realities of funding a medtech startup, and the potential of advanced manufacturing and biomaterials to transform patient care.

In this episode, we are joined by Allison Komiyama, Founder of Bluestocking Health, for a conversation about medical devices, regulatory strategy, clinical evidence, and the journey of bringing innovative medical technologies to market.

Allison has spent most of her career helping medical device companies navigate the regulatory process and successfully bring their technologies to market. Over the past seventeen years, she has been involved in hundreds of FDA pre-submissions and premarket submissions covering a wide range of medical device technologies.

Her career includes serving as an FDA reviewer in the Center for Devices and Radiological Health (CDRH), as well as founding AcKnowledge Regulatory Strategies, LLC in 2014. Following its acquisition in 2021, Allison continued working with medical device companies of all sizes and across different device types throughout the product life cycle.

In 2025, she founded Bluestocking Health with the goal of creating more conversations around medical devices, science, clinical evidence, and healthcare, while helping innovative technologies communicate their value and ultimately improve people's lives.

Allison holds a degree in Molecular & Cell Biology from the University of California, Berkeley, and a doctorate in Neuroscience from Stanford University. She also earned her Regulatory Affairs Certification (US) in 2014 and became a RAPS Fellow in 2024.

In this conversation, Allison shares her experience and insights into the medical device industry, FDA regulatory pathways, clinical evidence, and the importance of communicating the value of MedTech innovation.

🎧 Listen to the full episode to learn more about the intersection of science, regulation, and medical technology.

In this episode, we speak with Daniel Zequeto, founder of ODC Life Sciences, about the challenges and opportunities of conducting clinical development across Brazil and Latin America.

With more than 20 years of experience as a commercial and clinical leader at Abbott, Hospira, Shire, and Alexion, Daniel has worked on both sides of the equation and witnessed firsthand the challenges sponsors face when entering LATAM without the right local infrastructure.

Daniel shares his perspective on clinical development, early access, and patient recruitment, with a particular focus on rare diseases, hematology, oncology, nephrology, and neurology. We also explore what biotech companies and pharmaceutical sponsors need to consider when expanding clinical programs into Latin America and how the right local expertise can make a difference in execution and patient recruitment.

Daniel Zequeto is the founder of ODC Life Sciences, a specialized clinical execution partner supporting biotech and specialty pharma companies across Brazil and Latin America.

Learn more at odclifesciences.com.

In this episode, we speak with Dr. Satabhisa Mukhopadhyay, Co-Founder and Chief Scientific Officer of 4D Path and co-inventor of its QPOR™ technology.

Dr. Mukhopadhyay discusses her journey from theoretical physics and applied mathematics to cancer systems biology, bioinformatics, and AI/ML. We explore how physics-informed algorithms and computational approaches can transform complex biological data into actionable insights for personalized cancer treatment.

She also shares insights into 4D Path’s clinical trials, predictive diagnostic technologies, regulatory strategy, and the challenges of translating AI-driven innovation into real-world cancer care.