Games as Medicine | FDA Clearance Methods

 

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:

  • Context of games for health
  • New factor of FDA clearance
  • Deeper dive
  • Adv. and Disadvan. to clearance

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
    IMG_2271

So what’s the catch?

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

IMG_2272

FDA definition of a serious disease
[missing]

MindMaze Pro

  • FDA clearance May 2017
  • Stroke Rehabilitation
  • Early in-hospital acute care while plasticity high

Pear Therapeutic

  • Positions its product as a “prescription digital therapeutic”

IMG_2273

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

The Future – Good, Bad, Ugly, Sublime

  • 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

Questions

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

 

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