Thanks for everyone who joined our online event in August on Connected Devices. We hope you enjoy the video.
Dana Fashina, Verily Life Sciences, Software Quality
Tyrone Heggins, BD, Regional Product Security Officer, N. America
Greg Tracy, Propeller Health, CTO & Co-founder
Thomas F. Busby, Outcome Capital, LLC, Vice President (Moderator)
- Chronic disease management technology during COVID continues to advance. Technology helps patients take control of their disease, enables data driven conversation between patients and physicians, and removes doubts about medication adherence.
- While barriers in the healthcare system still put power in the hands of payers and institutions, consumers are becoming more aware, in particular through trendsetters such as Apple’s watch and Healthkit.
- The FDA is showing great interest in technology solutions. COVID has increased the pace. The FDA shows more leniency for adherence monitoring but still requires a high level of rigor for software/hardware connected devices.
- New startup founders should look for niches of unmet needs, such as a subset of a disease community. Unmet needs make it aasier to start conversations with FDA and can also be of great interest to pharma partners.
- Digital tech companies seeking FDA approval should consider existing technologies known by the FDA which does not require a 501k submission. But it’s important to set up a full QMS (Quality Management System) from the beginning. Quality processes should be part of the corporate culture from day one. Bring the clinical team in early to the development process, and align the team around the risk profile for patient harm.
- Cybersecurity in the healthcare space is a nascent concept, with the FDA starting to give guidance in 2014, and the first international best practices were released only this year. But now the FDA is at the major security conferences and a number of strong security working groups have appeared. Good security requires collaboration and cooperation since many parties are involved from network and software and devices to law enforcement and regulators.