What if we could use our consumer electronic devices, like smartphones, tablets and smartwatches, to aid in diagnosing ear infections, autism or COVID-19? Could we use our AirPods and our devices’ built-in microphones to monitor our lung health and body temperature? These scenarios, dubbed Clinical Diagnostics on Consumer Electronics (CD-CE), are quickly approaching reality.
CD-CE democratizes access to care by moving clinical diagnosis out of Points of Care and into our Points of Living. Using the smartphones in our pockets as a diagnostic tool could dramatically improve healthcare outcomes through earlier diagnosis, help close the healthcare equity gap and allow us to collectively bend the healthcare cost curve.
To realize this healthier, more equitable future, CD-CE manufacturers face safety and clinical effectiveness concerns from regulatory bodies, as well as cost and ROI concerns from insurance providers – plus a host of technical challenges when addressing the sheer range of diversity in the smartphone market.
This video is a recording of a live webinar organized by Orthogonal that took place on November 2nd, 2022. The event centered on a discussion of an emerging category of SaMD, dubbed Clinical Diagnostics on Consumer Electronics (CD-CE), with the potential to improve healthcare outcomes and health equity.
This recording includes the 50-minute roundtable discussion, followed by an additional Q&A session with the speakers.
Arna Ionescu Stoll, CEO and Founder of Wavely
Arna Ionescu Stoll, currently the CEO of Wavely Diagnostics, has spent her career at the intersection of design thinking, digital health and entrepreneurship. Throughout multiple decades, she has led the creation of dozens of high impact, innovative healthcare products that solve real human needs and integrate seamlessly into people’s lives. Arna has been a part of the digital health community since before the term “digital health” was coined, having founded and built the original Connected Health domain at IDEO, serving as Vice President of an early digital health startup that reached unicorn status and consulting with dozens of healthcare, digital health and medical devices companies.
Dr. Michael Mina, Chief Science Officer, eMed
Dr. Mina is the Chief Science Officer of eMed. Prior to eMed he was a professor of Epidemiology and of Immunology & Infectious Diseases at the Harvard T.H. Chan School of Public Health. He was also a professor in the Department of Pathology at Harvard Medical School and associate medical director of molecular virology at Brigham and Women’s Hospital. Dr. Mina’s research focused on how vaccines and infections impact how people’s immune systems respond to other infections, and how they impact the epidemiology and spread of infectious diseases, including outbreaks and pandemics. With colleagues at Princeton and the US National Institutes of Health he developed the idea of a Global Immunological Observatory that could serve as a “global weather system for viruses.”
Bernhard Kappe, CEO and Founder, Orthogonal
Bernhard is a software development leader, technologist, and pioneer who provides clients with an unequaled advantage by helping them develop Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical devices, while leveraging important trends and techniques at the leading edge of the adoption bell curve (e.g., agile software development, lean user experience, software product management, DevOps, lean startup, and open-source software). Bernhard has exclusively focused on the medical device and health-tech industry for almost a decade, working with clients to create innovative diagnostics, monitoring, and therapeutics solutions, while shortening product development life cycles, improving delivery predictability, and creating products that are financially and clinically successful.
Randy Horton, Chief Solutions Officer, Orthogonal
Randy has spent over a decade working with healthcare and life sciences organizations to tackle the Quadruple Aim: 1) optimizing health system performance by improving the individual experience of care, 2) advancing the health of populations, 3) reducing the per capita cost of care, and 4) enhancing the work-life of those who deliver care. Randy brings strong experience, expertise, and creative business thinking to his leadership role – along with nearly three decades of experience with Internet-enabled digital transformation and a passion for being a connector of people and ideas. He helps organizations break through to their “what’s next” by building new capabilities and launching innovative, digitally enabled – and highly successful – products and services.