Ep. 3 - Building with AI

Ep. 5 - Shehan Bala

Shehan Bala is a product leader with a track record of scaling frontier tech. Currently VP of Product at Timescapes, shaping the future of construction intelligence from the ground up. Previously led product at See-Mode (AI for medical imaging) and UneeQ (digital humans), driving vision, growth, and go-to-market for category-defining platforms. With 10+ years in product across AI, healthtech, and enterprise SaaS, I thrive at the intersection of innovation, execution, and storytelling. Passionate about building teams, unlocking product-market fit, and turning complex problems into beautiful user experiences.

Ep. 4 - Georgiann Keyport

Georgiann Keyport is a cell biologist with over 40 years of experience in the regulated medical device, biotech, and pharmaceutical industries.  Her expertise is in regulatory strategy and submissions, quality system development, and compliance for drugs, biologics, medical devices, and combination products in the pre- and post-market phases of the medical product lifecycle.   She is an adjunct faculty member at the University of St. Thomas (St. Paul, MN), teaching in the Regulatory Science Master’s Program at the School of Engineering.  She has an undergraduate degree in Biology and a Master’s degree in Laboratory Medicine, with a concentration in immunology.  Georgiann is a Fellow of the Regulatory Affairs Professional Society and the founder of Canopy Regulatory Solutions Inc., advising her clients on regulatory strategy, quality systems, and clinical affairs.

Ep. 3 - Building with AI

In this conversation, Martín Ramírez and Kristina Hloptsidis discuss the use of AI in the manufacturing industry and the challenges and surprises they have encountered. They explore the need for AI to be integrated into workflows and the potential for AI to improve efficiency and compliance in regulatory processes. They also discuss the misconceptions and fears surrounding AI and the importance of understanding its capabilities. Looking to the future, they predict the evolution of AI in the next three, five, and ten years, envisioning increased regulation, widespread adoption of AI in workflows, and the emergence of fully autonomous factories.

Ep. 2 - David Hammond, MS, RAC, CCRP

David Hammond has worked in the FDA regulated field for over 25 years. He started as a clinical research coordinator first in Boise, Idaho and then in Seattle. After deciding it was time for a change, he moved to the medical device industry. While working as a clinical research associate for a Class 3 medical device trial, he found that he really enjoyed things that plug in to things that you swallow (DISCLAIMER: he does not recommend swallowing the things that are plugged in). He spent the next decade working for a series of medical device companies and through a series of job changes that he thought were well thought out, but were viewed by his parents as the sign of someone who gets bored easily, he found himself unemployed in 2008 after being laid off when his employer underwent downsizing.  This led to David deciding that his next adventure would be consulting, so with absolutely no planning, he began consulting with local biotechnology companies until, as he said, he found a real job. Thirteen years and zero real jobs later, he still consults among other activities. He is currently a regulatory and clinical research consultant in private practice and an Associate Teaching Professor and the Academic Director of the BRAMS (MS in Biomedical Regulatory Affairs) program at the University of Washington where he gets to tell bad jokes to students and they have to laugh if they want to pass. He is also an ardent collector of letters after his name currently holding a personal best of thirty-seven and a fictional lordship in Scotland.  David has a BS in Zoology from the University of Idaho and a Master’s in Biomedical Regulatory Affairs from the University of Washington.

Ep. 1 - Dr. Jay Vaishnav

Jay Vaishnav, a regulatory affairs professional with a background in physics, discusses the role of regulatory compliance and the intersection of science and creativity in the field. He explains that regulatory compliance is about following rules, but there is still room for creativity in how those rules are interpreted and applied. He shares examples of how he has used creativity in his own career, such as finding efficient ways to bring medical devices to market and optimizing compliance while still marketing the device effectively. Jay also discusses the tension between industry and regulatory agencies, the role of AI in regulatory affairs, and the evolving perception of regulatory compliance as a strategic advantage rather than just a cost center.