The Playbook for Building Digital Health
MDisrupt is proud to present a multi-part webinar series that explores the major steps to building digital health solutions from inception to adoption featuring some of the industry’s leading experts.
Episode 02
Regulatory as a strategy for healthtech
In episode two, we’ll cover:
- Regulatory terms 101 (LDT, 510K, analytical validation, clinical validation SAMD, intended use).
- When is it wellness versus enforcement discretion versus medical device?
- What is the process for getting a regulatory clearance? How long does it take? How much does it cost?
- What studies do I need to do and how should I start them?
Episode 01
Solve a real clinical problem
In episode one, we’ll cover:
- The top problems health systems face
- What a digital health company should do BEFORE approaching a health system
- What it takes to get a provider to adopt
- What health systems are looking for in digital health solutions