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

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


FDA definition of a serious disease

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”


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


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


Snap Lens Studio

Hello World Building Augmented Reality for Snapchat

Fun fact – 30000+ lenses created by Snapchatters, leading to over a billion views of lense content
Table of Contents
Lens Studio
Hello World! Lens Studio Live Demo
High-Quality Rendering with Allegorithmic
Chester Fetch with Klei Entertainment
Cuphead and Mugman with Studio MDHR

Travis Chen

  • Worked at Bad Robot, Neversoft, and Blizzard

Lens Studio

  • Snapchat has always opened up to the camera, which has positively affected their engagement
  • Pair your phone with Lens Studio
  • A community forum on the site exists where devs q & a
  • Has been out for less than 4 months today, and the lenses have resulted in over a billion experiences
  • The tool has been used for a variety of things hamburger photogrammetry, full-screen 2d experiences,
  • Distributing your lenses is really easy

  • Within, snap you can discover a lense where you can see more lenses by the same creators or you
    can pull up on the base of a story to figure out what lense was used.

Lense Boost – All users see the Snapchat carousel, a Lens Boost to get your lense into this carousel

Find which template best fits your creative intent


  • Static object
  • Animated object
  • Interactive templates (tap, approach, look at)
  • Immersive (look around, window)
  • For 2D creators (cutout, picture frame, fullscreen, soundboard)
  • Interactive path (idle, walk, and arrival states necessary) coming soon


  • Brian Garcia, Neon Book
  • Pinot, 2D textures, cutout template, then character animator to animate
  • DFace, DDog, imported into lenstudio (from camera reflections feature)
  • Jordan & Snapchat, ‘88 static Jordan 3D model
  • Netflix & Snapchat, Stranger Things – turning on the TV, or spelling your name out,
    awakiening the demi gorgon

Hello World

Lens Studio is made up of panels:

  • Live Preview, to see what it will be like, it includes tracked content and interaction support
  • Objects panel, like the Unity scene view, it shows you what is in the preview
  • Resources panel, all your resources and where you’d import stuff


Start with the animated object template
Select an object in the resources panel and move it to the objects panel
Google blocks + mixamo + export free animations from Adobe and import your character animated from
File import monitor and astronaut
Child the imported 3D model to the fox as a child and delete the fox
Add a shadow

High-Quality Rendering

Substance Painter is an app to apply materials or paint textures for 2D or 3D.
Any material you bring in you can apply to an object, they apply uniformly, but there’s
also, smart materials which applies intelligently to geometry (rust example).

The layers tab is like the scene view the place to drag and drop

Alphas provides a cutout, you can apply materials to the cutout

Upon clicking export

Challenge: Rubber Ducky

Chester Fetch with Klei Entertainment

Games studio since 2005

Why is AR interesting for Klei?

  • AR is about bringing the virtual world out to the player.
  • Shareable
  • Limited bandwidth
  • Seems hard
  • Would require too much time from others at the Studio

Cuphead and Mugman with Studio MDHR

  • Cuphead and Mugman wanted to build and snap a boss battle
  • All of the lenses used in cuphead were from assets created directly from the game
  • Chains together 5 2D animations



  • Within the Snap app, I noticed you can rent/create a lense “as a service” how does this pertain to lens studio?
  • A question I had was, looking forward to a day when you can use targets like people for further interactable and shareable content like the examples shown in Mugman, when will person/object recognition be available to developers and users of Snap?   
  • What is the github account for Snap?

Relationships Matter: Maximizing Retention in VR


Relationships Matter: Maximizing Retention in VR
Isabel Tewes

There are many ways to measure success, but coming from the mobile world (push notification
strategy, the habit of retention mini-games, funnel analysis, making a real difference when multi-million userbases exist) Isabel talked about retention today.

Retention defined

When someone loves your app and comes back to it time and time again.

Make a great first impression

  • pinpoint your magic
  • get to that moment quickly
  • guide people through their first experience

Share your personality

  • create a tone and stay consistent
  • rethink your interactions
  • identify the pain points
  • design against them / take advantage of them

Create a lasting connection

  • make the right decisions early

First Contact – Bernie Yee

He focused on how VR can be really overwhelming and having someone acknowledge your actions can be really powerful.

The Significance Robot Waving – the way the robot waves to you at the beginning of the experience draws upon a universal sign. You know you’re supposed to wave back. The personality of your wave then comes out as well.

Wave Finding – Helped guide users through the experience the robot is helping to guide your
attention to where you should be going.

Nudge – Nudge your users patiently and with intent

Rick and Morty – Virtual Rick-ality

Establish a tone and be consistent

Against Gravity – Rec Room

Create a safe environment that people come back to
Minimizing trolling and harassment
“Whatever you are when your [organization] is small remember you’ll only be a larger version of that”

Making friends in Rec Room
Two people making friends in Rec Room is done by shaking hands with someone.

High fiving in Rec Room

Upshot: Create your values early and stick to your values ruthlessly.


UX for Created Realities

Context: I’m listening to Joshua Walton at the #CreatingRealityHackathon at USC. His talk is called UX for Created Realities. Personally found the part on Microinteractions (Dan Saffer) to be interesting.


  • A lot of this returns shit ideas –– rather than individual ideas
  • The caveat is if you have the right structure for the brainstorming session it can be more
  • key part: There’s no bad ideas but also no good ideas. People want to be heard but build
    on the ideas, go for quantities, and respect everyone and let everyone speak.

Tactics for brainstorming

  • Do your project in 1 hour
  • Work both top-down and bottom-up
  • Iterate without fear

Microinteractions (Dan Saffer) and Tips

  • Focus on dynamics that build on knowledge in the head (the Lab’s Longbow)
  • Think about sense ratios and focus (Superhot)
  • Sensing is a creative part of the design (some of the most innovative work creates a sense you
    didn’t know you needed)
  • Use sounds right away
  • Encourage people to look around
  • Consistent interactions are way more valuable than realistic interactions
  • content is king, context is scale
  • as long as there’s language we’ll have 2D
  • when you’re creating these new realities be a gracious host – learned from the hospitality industry
  • create consistent space from which to explore

Reflection: Bigscreen VR

Before I continue I’ll take a step back to define any VR application that brings together people in an environment as “social vr”. What makes Bigscreen interesting is the paradox of choice. In other social applications VR Chat, AltspaceVR, High Fidelity; there are no core activities that you can derive outside of being together, which makes the choices for what you can do very broad. With Bigscreen it’s a display extension or place to watch movies with a cinema experience. Simple.
Recently I saw that they enticed Paramount (?) studios to do a premiere of Top Gun in VR. I thought that was a nice blend of a social construct we know and love of going to the movies and social VR––though I didn’t attend the screening. I’ve used Bigscreen recently and the environments are nice with physically based shadows and lighting. Bigscreen’s reliance on virtual displays makes it well-positioned to benefit from forthcoming improvements in display clarity.
One thing worth noting is that I haven’t been able to get audio to work for all people in a living room setting. When putting your content on the Bigscreen audio seems to play only for you. This wasn’t the case in the movie theater where a host had no problem playing Rogue One off of Netflix for all to enjoy with sound.
Finally, when Oculus Home released it’s core 2.0 update everyone on Rift had the ability to see and use their desktop screen in VR. SteamVR also enables desktop viewing. Viveport? Although, today Oculus Home doesn’t offer social as Bigscreen does… this probably effects the uniqueness of their total product and must be considered for continuing fundraising.


Part of YC’s W18 Cohort, Supermedium, is a superset of webVR experiences. It features work from the likes of Inigo Quilez, Ricardo Cabello, Marpi, and others, the browser can be downloaded on Windows today.

I enjoyed Shadertoy’s audio visualizations in particular though they didn’t support touch controllers. An idiosyncrasy of the platform right now is that usually, experiences have HTC Vive controllers supported only. This means that when you use your Oculus Touch controllers the API will receive button presses and input but they will visually appear to come from an HTC Vive controller.

Check out the Supermedium website here. The founders are experienced contributors to webVR efforts, Kevin Ngo and Diego Marcos, and technical artist, Diego Goberna.