The Pacemaker

Dr. Arun Rai is an Assistant Professor of Urologic Surgery at Northwell Health and a co-founder of Hatchleaf, a company that aims to optimize access to healthcare by using clinical data and AI to better match patients and providers. In our conversation, Arun shares his experience with and insights into the major challenges in these respective domains, and the role that AI can play to address them.

Dr. Firat Guder is a professor in Intelligent Interfaces in the Department of Bioengineering at Imperial College London. Dr. Guder and his research group work in the intersection of material science, electronics, computing, biology and chemistry to develop intelligent interfaces to connect complex biological systems with machines. Dr. Guder's work has, in part, led to starting Unhindr, a startup focused on developing dynamically adjustable prosthetic liners for people with amputations. This episode focuses on the motivation, challenges, and promises of this important work.

Shivam Sharma is the CEO of Redbrick AI, a company which has developed a platform for rapid medical data annotation that is both assisted by automatic segmentation algorithms and optimized for medical data formats. Redbrick AI's platform is already in use by health centers and medical device companies.

Dr. Amar Sawhney is a co-founder and managing partner of Incept LLC, an investment firm holding a large and diverse rolodex of life sciences companies. Many of the companies held by Incept stem from Dr. Sawhney's own graduate work in tissue engineering, and their products span many different specialties and applications. In addition to his role as managing partner, Dr. Sawhney also runs some of these companies himself, including Instylla, Rejoni, and Pramand LLC. In total, Dr. Sawhney has himself founded ten companies, accounting for over $3 billion in revenue to date. His work is truly awe inspiring in its breadth and impact. In this episode, we discuss Dr. Sawhney's life journey, the concept behind Incept LLC, and how to create lasting impact in the medical device space.

Dr. Rob Swain is the founder of RESound Clinical Consulting, which helps medical device companies with their preclinical, clinical, and regulatory strategy. This episode taps into Rob's deep knowledge of the ins and outs of running a clinical trial. We get into many aspects of this topic including how to decide you are ready to run one, how to plan the study including selecting a facility, appropriate risk level, and study objectives, and how to run the study. This episode is on the longer side, but offers many important tips to medical device developers on a step that is crucial to get right for many devices to get to market. Whether you are in a startup or a large company, you will probably learn something beneficial from the conversation.

Dr. Dan Gray is the founder of Gray Optics (www.grayoptics.com), a design and development house specializing in optics for biomedical, life sciences, and industrial applications. Besides being an expert in biomedical optics, Dan has also used his experience at Gray Optics to develop insights into medical device product development, useful for startups and larger companies alike. As a follow up to the conversation, you can also check out Dan's blog at www.opticsdan.com.

Giovanna Forte is the CEO and founder of Forte Medical, a London-based startup focused on revolutionizing urine collection and urine-based diagnostics. Forte Medical has developed and commercialized Peezy Midstream, a urine collection method that has been clinically proven to increase the accuracy of urine testing, in part due to its improvement to the patient experience. By improving accuracy through usability, Forte demonstrates how human factors can be just as important as technology in ensuring the efficacy of medical devices.

Dr. Erik Duhaime is the CEO and co-founder of Centaur Labs, a crowdsourced medical data annotation platform allowing students and professionals from around the world to label medical data for use in AI applications, which are rapidly multiplying in the medical device space. Through a combination of gamefication, performance measurement, and consensus algorithms, Centaur Labs has harnessed the collective intelligence of a network of experts to achieve impressive results in both scale and accuracy.

Professor Dario Farina of Imperial College London is one of the world's leading scientists in human-machine interfacing, specifically for the control of movement in artificial limbs and exoskeletons. In this technology-focused conversation, Professor Farina describes the biggest challenges in the field and the work he and others are doing to bridge the gap between the biological and the manmade worlds.

Kevin Kalish is the COO of Enclear Therapies, a biotechnology company that has developed a novel platform for delivering therapeutics to hard-to-reach areas of the central nervous system by circulating the Cerebrospinal Fluid. Enclear's innovative technology holds promise as a means to treat a variety of neuro-oncological and neurodegenerative diseases. In this conversation with Kevin, we discuss the technology, its initial indications, its promises, and the challenges that must be overcome to get there.