How do you bring digital therapeutics to the market?
I discussed it with the Chief Medical Officer of
@hyfeapp, Dr. Peter Small. The full interview is available on our exclusive Patreon channel:
patreon.com/posts/exclusive-โฆ
๐.โ ๐๐จ๐ฐ ๐๐จ ๐ฒ๐จ๐ฎ ๐๐๐ก๐ข๐๐ฏ๐ ๐ฉ๐ซ๐๐ฌ๐๐ซ๐ข๐ฉ๐ญ๐ข๐จ๐ง ๐ฌ๐ญ๐๐ญ๐ฎ๐ฌ ๐๐จ๐ซ ๐ ๐๐ข๐ ๐ข๐ญ๐๐ฅ ๐ญ๐ก๐๐ซ๐๐ฉ๐๐ฎ๐ญ๐ข๐?
-โ Assessing DTx/SaMD requirements from regulators based on past experience -โ Clinical trials to demonstrate safety, efficacy, and cost-effectiveness
- Compliance with relevant software-as-a-medical-device (SaMD) regulations, and data privacy and security requirements, which are evaluated as part of the SaMD review
-ย Regulatory clearance or approval from bodies like the FDA in the US, EMA in EU, PMDA in Japan
-ย Peer-reviewed dissemination / real world evidence to reinforce clinical credibility and facilitate reimbursement pathways
-ย Working with KOLs to establish new clinical standards
- Educating and training clinicians working with chronic cough patients, so they can properly prescribe the DTx