Software as a medical device (SaMD) follows a classification system based on risk and clinical function, moving through regulatory classes as the product matures. RCube Health exemplifies this progression: they started at Class 1 and aim to reach Class 2A within 18 months, which denotes a treatment application requiring higher evidence standards [#252].
Regulators now treat software and hardware equally as medical devices [#117]. The key regulatory hurdle isn't just getting approval but proving clinicians will actually change their practice based on the software's output. Prospective studies showing efficacy mean little if practitioners don't adopt the recommendation in real clinical work [#111]. Beyond compliance, the regulatory vision is evolving: authorities want medical software companies to deploy algorithm updates as rapidly as other tech firms, compressing the approval cycle so clinicians and patients access innovation faster [#308].
For founders, decoupling software from hardware has become standard strategy to accelerate regulatory clearance [#184].
Search 450+ episodes and 42,000 chunks of healthtech conversation.