Challenges in the B2B Approach
- Gap between regulatory approval and reimbursement
- Need to demonstrate cost-effectiveness to healthcare systems
- Different assessment processes in various markets (e.g., NICE in the UK vs. fragmented process in the US)
The Importance of Clinical Evidence
- Need to demonstrate efficacy beyond placebo effects
- Importance of controlled clinical trials
- Challenges in isolating the effects of the device from other factors (e.g., accompanying app features)