Proportionately regulating highly adaptive AI as a medical device can be done with predetermined change control plans. The US, UK and Canada are advancing the concept, as Ropes & Gray and the US FDA explained.
Device and healthtech innovation is prone to getting ahead of regulation. The arrival of artificial intelligence as a medical device (AIaMD) is testing processing capacities to the limit, which is where pre-determined change control plans (PCCP) can serve a useful purpose.
AI/machine learning technological advances will continue to challenge regulatory systems around the world, Ropes & Gray’s Lincoln Tsang believes.
Namrata Saroj, chief business officer of Ocular Therapeutix, is highly respected in the retina community for her contributions to drug development. She talked to In Vivo about her journey in ophthalmology, leadership philosophy and the importance of authenticity in a close-knit specialty.
J&J's EMEA head of digital solutions, Julia Fishman, talks about the hurdles in scaling digital innovation and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
Emma Hodcroft, co-founder of Pathoplexus and a key Nextstrain contributor, stresses the importance of career flexibility for young scientists. She urges early-stage researchers to embrace curiosity, using her unconventional path as an example of how curiosity can lead to impactful success.
