1. Collaborations are Deepening
A single company is rarely in possession of all the knowledge and skills to successfully develop and launch a DTx. In the last two years we have seen an explosion of partnerships between DTx companies and pharma. But there are other interesting partnerships, particularly in the commercialization and distribution space.
- Digital IBS care startup metaMe Health is launching its digital therapeutic Regulora for IBS in partnership with Indegene who will be responsible for commercializing the product, promoting it to providers, payers, and patients.
- And Akili are partnering with gaming giant Roblox to support distribution of their video game ADHD therapy.
2. Regulatory Processes are Improving
Regulatory processes are starting to become clearer and more streamlined in major markets. The FDA launched its ‘Digital Health Software Precertification (Pre-Cert) Program’ reducing regulatory burdens for DTx while maintaining quality standards. The focus is on the company versus the product, it relies on trust and transparency that the company has a robust process for verifying the continued safety, efficacy and performance of the DTx in the real world.
- Orexo was an early beneficiary of the program, rolling out digital therapeutics for depression and alcohol use disorder under the fast track process.
- Somryst, from Pear Therapeutics, a prescription digital therapeutic using cognitive behavioral therapy to treat insomnia, also benefited from the program.