Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Eco-system Connected Medical Devices (Hardware & Software)

The Organisation for Professionals in Regulatory Affairs

5

Example: Big Health (UK) - Digital Therapeutics

Big Health digital therapeutics are safe and effective non-drug options for mental health: ● Sleepio for Treatment of Insomnia ● DayLight for Treatment of Anxiety

Takeaways

Digital is offering non-drug alternatives for treatments , as some diseases are often driven deeply by individual behaviours then metabolic imbalances. Digital Therapeutics may become first-line treatments , and even the gate to second line drug treatments. Non-drug prescription and reimbursement at scale is still a struggle compared to drugs, despite similar evidence.

●

●

●

The Organisation for Professionals in Regulatory Affairs

6

3