How to speed up commercialization of digital therapeutics ?

"With the advent of digital therapeutics, the paradigm of treatment is shifting.
To treat depression, for example, physicians not only prescribe medications but capture the patient’s behavioral changes, analyze them by using AI, and provide customized treatment through a virtual reality (VR) game or a mobile application.
Beyond first-generation pills and second-generation antibody treatments, third-generation digital therapeutics are making a rapid expansion with growing attention all over the world.
In March last year, the Korean government announced digital therapeutics as “promising technology to prepare for the post-Covid-19 era, expanding investment and support to promote the development and use of digital therapy. In August, the Ministry of Food and Drug Safety set up guidelines for approval and review of digital therapeutics.
The pharmaceutical industry is expediting the development of digital therapeutics.
Some companies have obtained the regulatory nod for clinical trials of medical devices and are conducting the studies.
A Korean startup, Nunaps, is testing Nunap Vision, a VR technology to treat visual impairment caused by brain damage.
LifeSemantics has also developed Redpill Breath, an application helping the rehabilitation of patients with respiratory disease.
However, the companies have to go a long way to commercialize the products.
Just like conventional medicines, digital therapeutics have to go through the verification of the therapeutic effect through clinical trials and the licensing review with higher regulatory barriers..." Lire la suite