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.

In this episode, we speak with Deborah Morley, an experienced leader in cardiovascular innovation, clinical research, and medical device development. Her career spans academia and industry, with extensive expertise in regulatory strategy and Class III implantable cardiovascular devices, including LVADs and cardiac contractility modulation systems. She currently serves as Director, Cardiovascular Strategy and Delivery and Co-Leader of the Cardiovascular Center of Excellence at RQM+.

In this episode, we speak with Leonara Vidal, Global Clinical Affairs Lead at Gentell, about her international career in clinical research, healthcare innovation, and medical devices.

Leonara shares her journey from nursing and academia in Brazil to leading global clinical affairs initiatives across Europe and the UK, offering insights into clinical evidence, innovation, leadership, and improving patient outcomes.

Today's guest is Gerardo Noriega, a C-level executive, serial entrepreneur, inventor, and advisor in the medical device industry.

Having founded five medical device companies and consulted for more than 50 organizations throughout Silicon Valley, Gerardo has spent his career identifying unmet clinical needs, developing innovative technologies, and guiding products from early-stage concepts to successful commercialization.

He also serves on the advisory boards of Santa Clara University's Department of Bioengineering, the UCSF Catalyst Program, the UCSF Surgical Consortium, and Simon Fraser University's Bioengineering Innovation Boulevard. In addition, he is an Adjunct Professor at Santa Clara University's Graduate School of Bioengineering.

In this episode, we explore medical innovation, entrepreneurship, intellectual property, startup growth, and the future of healthcare technology.

In this episode, we’re joined by Matt DeNardo, a biomedical engineer and product development leader with a passion for transforming complex clinical challenges into innovative medical technologies.

Matt shares how his approach combines the rigor of systems engineering with the creativity of design thinking, enabling teams to translate unmet clinical needs into clear product strategies and successful execution. From aligning user needs and regulatory considerations to leading cross-functional teams through every stage of development, he offers valuable insights into what it takes to bring meaningful healthcare innovations to market.

Holding an M.S. in Biomedical Engineering from Northwestern University and a B.S.E. in Bioengineering from the University of Pennsylvania, Matt has spent his career at the forefront of medical technology, continuously exploring emerging technologies that can improve patient outcomes and shape the future of healthcare.

In this episode of Global Trial Accelerators, we speak with Daniel S. Chen, MD, PhD, Founder and CEO of Synthetic Design Lab and former Global Head of Cancer Immunotherapy Development at Genentech/Roche.

Daniel shares insights from his pioneering work in cancer immunotherapy, the development of breakthrough therapies such as atezolizumab, and the future of oncology innovation. We also discuss the Cancer-Immunity Cycle, translational science, and what it takes to accelerate the path from discovery to patient impact.

 Shareef Mahdavi joins the podcast to discuss how patient experience directly impacts practice growth, referrals, and retention. He shares the strategies that helped transform Laser Eye Center of Silicon Valley by improving how patients felt throughout their journey — leading to stronger reviews, increased leads, and long-term growth. 

In this episode, we sit down with Dr. Joseph Geraci — mathematical physicist, medical scientist, and AI innovator — to explore how artificial intelligence is transforming the future of medicine and clinical research.

Dr. Geraci began his career in quantum computing and mathematical physics, earning his PhD under renowned scientist Dr. Daniel Lidar with research supported by DARPA and the U.S. Army’s Disruptive Technology Office. He later expanded his work into artificial intelligence for medicine, oncology, and neuroscience, where he uncovered a critical problem in modern healthcare: traditional disease labels often fail to capture the true complexity and diversity of patients.

This realization led him to found NetraMark and develop NetraAI, a groundbreaking AI platform designed to learn from small, noisy clinical datasets. Using a novel mathematically-augmented framework and long-range memory mechanisms, NetraAI can identify hidden and explainable patient subpopulations with extraordinary precision — helping pharmaceutical companies improve clinical trial outcomes and better match treatments to the patients most likely to benefit.

In this conversation, Dr. Geraci shares insights on quantum algorithms, machine learning, the limitations of modern clinical trials, and how explainable AI could redefine our understanding of disease, health, and intelligence itself.