Using our smart watches, smart speakers and smartphones to aid in diagnosing ear infections, pneumonia and COVID-19 is just the beginning of an empowering clinical revolution. Will monitoring of our vital signs be as easy as popping in our AirPods? Could mapping the human body and assessing physical injuries be done with new 3D features on our smartphones?
Clinical Diagnostics on Consumer Electronics (CD-CE) are democratizing access to healthcare by moving diagnosis from Points of Care to Points of Living. Apps on our everyday devices could improve patient outcomes through earlier diagnosis, close the healthcare equity gap and bend the cost curve.
To get there, CD-CE manufacturers must address safety and clinical effectiveness concerns from regulatory bodies, as well as cost and ROI concerns from insurance providers – plus technical challenges that arise from a bring-your-own-device approach to device computing.
MATTER Chicago and Orthogonal held a webinar overview of CD-CE with a panel of entrepreneurs at the forefront of this new class of diagnostics. The panel discussed CD-CE’s potential to create huge opportunities, the impact it will have on patients, providers and payers as well as the challenges it presents to healthcare stakeholders.
This recording includes the roughly hour and a half main program with Q&A.
Bernhard Kappe, Founder & CEO, Orthogonal
Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.
Randy Horton, Chief Solutions Officer, Orthogonal
Randy Horton is Chief Solutions Officer of Orthogonal. Orthogonal makes acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, lean startup, user-centered design and systems thinking) with the regulated focus on device safety and effectiveness that is at the heart of med tech.
Horton co-chairs AAMI’s Software Management Working Group #10 for Cloud Computing, AAMI CR510:2021 as well as the in-process TIR #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS, Xavier Health/HPC and the Human Factors and Ergonomics Society (HFES).
Arna Ionescu Stoll, currently the founder and 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.
Mike Connell is vice president for commercial at ResApp, which was acquired by Pfizer. Mike has over 30 years of commercial experience including 13 years of health leadership experience with GSK (Europe & Australia), Medibank (private health insurance) and consulting on a major global M&A project. As VP & General Manager of GlaxoSmithKlines’s (GSK) Established Product Portfolio in Europe, Mike launched this business which delivered a significant share of the £3Bn in global sales during 2014. Prior to this Mike was VP & General Manager, GSK Denmark and VP & Head of the Thrombosis Centre of Excellence (global medical/marketing strategic team). Before moving to Europe, Mike held roles as Sales Director, Marketing Manager Metabolics and Hospital & Oncology Sales & Marketing Manager at GSK Australia. Prior to his pharmaceuticals experience, Mike had a diverse commercial background with significant strategy, product, sales and marketing experience across many industries, including utilities (gas & electricity – TRU Energy), textiles, sporting footwear & apparel (Nike) and fast food (Red Rooster).