Games as Medicine | FDA Clearance Methods

Noah Falstein, @nfalstein
President, The Inspiracy
Neurogaming Consultant

Technically software and games are cleared and not approved by the FDA.

By background, Noah:

Has attended 31 GDCs
Been working in games since 1980 (started in entertainment and arcade games with Lucas Entertainment)
Gradually shifted over and consulted for 17 years on a wide variety of games
Started getting interested in medical games in 1991 (i.e. East3)
Went to Google and left due to platform perspective one had to have at Google
Game designer not a doctor, but voraciously learns about science and medical topics

Table of Content:

Why are games and health an interesting thing?

Three reasons why games for health are growing quickly and are poised to be a very important thing

It’s about helping people (i.e. Dr. Sam Rodriguez’s work Google “Rodriguez pain VR”)
It’s challenging, exciting, and more diverse than standard games (i.e. games need to be fun, but if they’re not having the desired effect, for example restoring motion after a stroke, then you encounter an interesting challenge). The people in the medical field tend to be more diverse than those in the gaming space.
It’s a huge market* FDA clearance = big market

Mis-steps along the way

Brain Training (i.e. Nintendo Gameboy had popular Japanese games claiming brain training)
Wii Fit (+U) (i.e. the balance board)
Lumosity fine (i.e. claims made that were unsubstantiated by research)

upshot: lack of research and good studies underpinning claims

Some bright spots

Remission from Hopelab (i.e. they targeted adherence: using the consequences of not having enough chemotherapy in their body)

FDA clearance is a gold standard

Because it provides a stamp of good, trustable, etc.
The burden is on the people who make products to go through a regimen of tests that are science-driven
Noah strongly recommends Game Devs to link up with a university
Working on SaMD – Software as a Med Device
Biggest single world market drives others
Necessary for a prescription and helps with insurance reimbursement
but it’s very expensive and time-consuming

FDA definition of a serious disease
[missing]

MindMaze Pro

Pear Therapeutic

Akili Interactive Labs

Treats pediatric ADHD
Late-stage trial results (Dec. 2017) were very positive with side effects of a headache and frustration, which is much better than alternatives like Ritalin
Seeking De Novo clearance
Adam Gazzaley – began as aging adult research with Neuroracer, a multi-year study published in Nature

Each successful FDA clearance helps
But they still will require big $, years to dev
you have to create a company, rigorously study it, stall production because changing your game
would make results invalid from studies, then you need to release it
Pharma is a powerful but daunting partner

Can FDA certification for games then reveal that some games are essentially street drugs?