Mary Lou Jepsen, Founder of Openwater.Health will be presenting a talk entitled "The Problem is $522M and 13 Years: The Average Capitalized Cost and Time to Regulatory Approval for Novel Therapeutic Medical Devices", where she will discuss the challenges and solutions in developing novel therapeutic medical devices. She will highlight the substantial average cost ($522M) and lengthy time (13 years) required for regulatory approval of these devices, pointing out that 85% of the expense is attributed to device development rather than clinical trials. In response, Mary Lou will introduce a revolutionary platform approach, enabling startups to achieve regulatory approvals in under three years with less than $10M in expenditure.