Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

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.

Episode 140: Gennaro Maida – From Wearable Sensors to Clinical Evidence
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.