Howard Look
Founder and CEO
NIH-NIDDK Fourth Artificial Pancreas Workshop
July 7, 2016

Bethesda, Maryland
Disclosure
I own publicly traded stock

in Dexcom (DXCM)
Motivation
Katie Look
First Day of 6th Grade, 2011
Type 1 Diabetes is a really, really sucky disease.
c X
Proudly non-profit.
Open source.
Stewards of your data.
Tidepool

Uploader
Coming soon Coming soon
Production
Environment
Amazon Web ServicesPublic Internet
Staging

Environment
Production
Environment
Staging

Environment...
When you liberate data, you enable a
vibrant ecosystem

of applications and research.
earthables.com
Nutshell MySugr Engine1 Glooko
nightscout.infodexcom.com
A Vibrant Ecosystem Type 1 Diabetes Application
T1D + Fitness Data Bolus Calculator
Research Apps
and Interfaces
Remote Mo...
What does a vibrant

Artificial Pancreas Ecosystem

look like?
earthables.com
Artificial Pancreas Telemetry Dashboard
What if the Artificial Pancreas Ecosystem
were based on interoperable components?
Sensor
Algorithm
Pump
Helper Apps
Sensor
Algorithm
Pump
Helper Apps
Dexcom G4 / G5 / G6 / …
Medtronic Enlight 1 / 2 / 3 / …
Abbott CGM
NewCo CGM
…
Sensor
Algorithm
Pump
Helper Apps
Dexcom G4 / G5 / G6 / …
Medtronic Enlight 1 / 2 / 3 / …
Abbott CGM
NewCo CGM
…
Single Re...
Sensor
Algorithm
Pump
Helper Apps
Dexcom G4 / G5 / G6 / …
Medtronic Enlight 1 / 2 / 3 / …
Abbott CGM
NewCo CGM
…
Single Re...
Sensor
Algorithm
Pump
Helper Apps
Dexcom G4 / G5 / G6 / …
Medtronic Enlight 1 / 2 / 3 / …
Abbott CGM
NewCo CGM
…
Single Re...
Sensor
Algorithm
Pump
Helper Apps
Dexcom G4 / G5 / G6 / …
Medtronic Enlight 1 / 2 / 3 / …
Abbott CGM
NewCo CGM
…
Single Re...
Sensor
Algorithm
Pump
Helper Apps
Dexcom G4 / G5 / G6 / …
Medtronic Enlight 1 / 2 / 3 / …
Abbott CGM
NewCo CGM
…
Single Re...
But… how?
Authentication
Capabilities
Commands and Data
Encryption
Sensor Pump
Sensor Pump
“Hi, I’m a sensor. I’d
like to send you data.”
Sensor Pump
“Hi, I’m a sensor. I’d
like to send you data.”
“Enter your sensor code so
I know it’s really you.”
Sensor Pump
“Hi, I’m a sensor. I’d
like to send you data.”
“Enter your sensor code so
I know it’s really you.”
“Here a pub...
Sensor Pump
“Hi, I’m a sensor. I’d
like to send you data.”
“Enter your sensor code so
I know it’s really you.”
“Here a pub...
Sensor Pump
“I’m ready to
send you data.”
Sensor Pump
“I’m ready to
send you data.”
“Hold on there cowboy.
What capabilities do
you have?”
Sensor Pump
“I’m ready to
send you data.”
“Hold on there cowboy.
What capabilities do
you have?”{
“MARD” : .095
“SampleTim...
By exposing data and control protocols…

We enable interoperability.
We catalyze an ecosystem.
We foster innovation.
We ge...
Perceived challenges to an
Artificial Pancreas Ecosystem:
It’s hard.
I’m scared.
It’s extra work.
They won’t let me.
Myth:
If we expose data or control protocols, people
might do bad things.

(People might do stupid things and blame us.)
(...
Myth:
If we expose data or control protocols, people
might do bad things.

(People might do stupid things and blame us.)
(...
(If you are really worried)
Enable the “Ecosystem Switch”
Do you want to enable external
remote device control?
ONOFF
WARN...
Myth:
It’s extra work and will slow us down!
Myth:
It’s extra work and will slow us down!
Myth:
Opening protocols is a security vulnerability
and will allow hackers to remotely control
devices.
(I should wait unt...
Myth:
Opening protocols is a security vulnerability
and will allow hackers to remotely control
devices.
(I should wait unt...
Myth:
Regulators will never allow it.
We’ll never get support for it.
Myth:
Regulators will never allow it.
We’ll never get support for it.
Code of Federal Regulations (CFR)
=
Guidance Documents
This guidance represents the Food and Drug Administration's (FDA's)...
www.theodysseyonline.com
whitehouse.gov
@danalewis
gettyimages.com
Executive Order 13563
Improving Regulation and Regulatory Review
“Each agency shall also seek to identify, as
appropriate,...
Why DIY Matters.
(Hint: It’s not about the car…)
OpenAPS.org
“I woke up one morning, and I was like,
‘How do I feel today?

What’s my day going to be like?’
instead of,
‘What’s my blo...
wallpaperswide.com
Type 1 Diabetes is a really, really sucky disease.
whosthebeaver.com/?m=200807
The DIY movement
is the leading edge of the

Artificial Pancreas Ecosystem.
earthables.com
@loudnate

@jasoncalabrese
@AliMazaheri
The DIY Movement:
Empowered patients.
Driving innovation.
Taking control of their own care.
“The Innovation Wetlands”
Andrew Torrance and Eric von Hippel
www.rhodeislandpropertylaw.com
whosthebeaver.com/?m=200807
“It’s not about the car.

It’s about the drive.”
- Mark Wilson @warkmilson
shutterstock.com
1. Open data and control protocols.
2. Embrace and encourage the DIY movement.
3. Watch the ecosystem flourish and
interop...
The Horace W. Goldsmith Foundation
and Hundreds of Other Donors
Thank you!
tidepool.org
@Tidepool_org
howard@tidepool.org
@HowardLook
2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop
2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop
2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop
2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop
2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop
2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop
2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop
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2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop

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Presentation given at the NIH-NIDDK Fourth Artificial Pancreas Workshop in Bethesda, MD. Makes the case for why device makers and cloud providers should publish their data and control protocols to foster an ecosystem of innovation, applications and interoperability for people living with Type 1 Diabetes.

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2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop

  1. 1. Howard Look Founder and CEO NIH-NIDDK Fourth Artificial Pancreas Workshop July 7, 2016
 Bethesda, Maryland
  2. 2. Disclosure I own publicly traded stock
 in Dexcom (DXCM)
  3. 3. Motivation Katie Look First Day of 6th Grade, 2011
  4. 4. Type 1 Diabetes is a really, really sucky disease.
  5. 5. c X
  6. 6. Proudly non-profit. Open source. Stewards of your data.
  7. 7. Tidepool
 Uploader
  8. 8. Coming soon Coming soon
  9. 9. Production Environment Amazon Web ServicesPublic Internet Staging
 Environment Production Environment Staging
 Environment Development
 Environment MongoDB Master MongoDB Slave MongoDB Slave S3 Backup MongoDB Master Production DB Cluster Staging/Dev DB
  10. 10. When you liberate data, you enable a vibrant ecosystem
 of applications and research. earthables.com
  11. 11. Nutshell MySugr Engine1 Glooko
  12. 12. nightscout.infodexcom.com
  13. 13. A Vibrant Ecosystem Type 1 Diabetes Application T1D + Fitness Data Bolus Calculator Research Apps and Interfaces Remote Monitoring Apps for Pregnant Moms with T1D Apps for Teens Clinical Decision Support Apps for Kids Location-aware Apps Contextual Meal Memory Psycho-social Research Artificial PancreasApps for Elderly Supply
 Management T1D Triathlete
 Trainer T1D
 Telemedicine
  14. 14. What does a vibrant
 Artificial Pancreas Ecosystem
 look like? earthables.com
  15. 15. Artificial Pancreas Telemetry Dashboard
  16. 16. What if the Artificial Pancreas Ecosystem were based on interoperable components?
  17. 17. Sensor Algorithm Pump Helper Apps
  18. 18. Sensor Algorithm Pump Helper Apps Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …
  19. 19. Sensor Algorithm Pump Helper Apps Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM … Single Reservoir Dual Reservoir Patch Pump Waterproof Large Reservoir Small Reservoir Shockproof Disposable
  20. 20. Sensor Algorithm Pump Helper Apps Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM … Single Reservoir Dual Reservoir Patch Pump Waterproof T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D Large Reservoir Small Reservoir Shockproof Disposable
  21. 21. Sensor Algorithm Pump Helper Apps Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM … Single Reservoir Dual Reservoir Patch Pump Waterproof T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D Remote Monitoring Research 1 … N Athlete Training Pump Control Telemedicine … Large Reservoir Small Reservoir Shockproof Disposable
  22. 22. Sensor Algorithm Pump Helper Apps Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM … Single Reservoir Dual Reservoir Patch Pump Waterproof T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D Remote Monitoring Research 1 … N Athlete Training Pump Control Telemedicine … Large Reservoir Small Reservoir Shockproof Disposable
  23. 23. Sensor Algorithm Pump Helper Apps Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM … Single Reservoir Dual Reservoir Patch Pump Waterproof T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D Remote Monitoring Research 1 … N Athlete Training Pump Control Telemedicine … Large Reservoir Small Reservoir Shockproof Disposable
  24. 24. But… how?
  25. 25. Authentication Capabilities Commands and Data Encryption
  26. 26. Sensor Pump
  27. 27. Sensor Pump “Hi, I’m a sensor. I’d like to send you data.”
  28. 28. Sensor Pump “Hi, I’m a sensor. I’d like to send you data.” “Enter your sensor code so I know it’s really you.”
  29. 29. Sensor Pump “Hi, I’m a sensor. I’d like to send you data.” “Enter your sensor code so I know it’s really you.” “Here a public key you can use to encrypt your data.”
  30. 30. Sensor Pump “Hi, I’m a sensor. I’d like to send you data.” “Enter your sensor code so I know it’s really you.” “Here a public key you can use to encrypt your data.” “Here’s data, encrypted with that public key you gave me.”
  31. 31. Sensor Pump “I’m ready to send you data.”
  32. 32. Sensor Pump “I’m ready to send you data.” “Hold on there cowboy. What capabilities do you have?”
  33. 33. Sensor Pump “I’m ready to send you data.” “Hold on there cowboy. What capabilities do you have?”{ “MARD” : .095 “SampleTime” : 300, “TimeUnits” : “seconds”, “MaxLatency” : 750, “Value” : “egv”, “Units” : “mg/dL” }
  34. 34. By exposing data and control protocols…
 We enable interoperability. We catalyze an ecosystem. We foster innovation. We get products to market faster. We help more people, more quickly,
 safely and effectively.
  35. 35. Perceived challenges to an Artificial Pancreas Ecosystem: It’s hard. I’m scared. It’s extra work. They won’t let me.
  36. 36. Myth: If we expose data or control protocols, people might do bad things.
 (People might do stupid things and blame us.) (My competitors might misuse the data.) (I might get sued.)
  37. 37. Myth: If we expose data or control protocols, people might do bad things.
 (People might do stupid things and blame us.) (My competitors might misuse the data.) (I might get sued.)
  38. 38. (If you are really worried) Enable the “Ecosystem Switch” Do you want to enable external remote device control? ONOFF WARNING: This device is not intended for use with products that have not been FDA-approved for use with this device.
  39. 39. Myth: It’s extra work and will slow us down!
  40. 40. Myth: It’s extra work and will slow us down!
  41. 41. Myth: Opening protocols is a security vulnerability and will allow hackers to remotely control devices. (I should wait until my protocols are more secure.) (I should wait until there are standards.)
  42. 42. Myth: Opening protocols is a security vulnerability and will allow hackers to remotely control devices. (I should wait until my protocols are more secure.) (I should wait until there are standards.)
  43. 43. Myth: Regulators will never allow it. We’ll never get support for it.
  44. 44. Myth: Regulators will never allow it. We’ll never get support for it.
  45. 45. Code of Federal Regulations (CFR) = Guidance Documents This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 
 You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.
  46. 46. www.theodysseyonline.com
  47. 47. whitehouse.gov @danalewis gettyimages.com
  48. 48. Executive Order 13563 Improving Regulation and Regulatory Review “Each agency shall also seek to identify, as appropriate, means to achieve regulatory goals that are designed to promote innovation.” – President Barack Obama January 18, 2011
  49. 49. Why DIY Matters. (Hint: It’s not about the car…)
  50. 50. OpenAPS.org
  51. 51. “I woke up one morning, and I was like, ‘How do I feel today?
 What’s my day going to be like?’ instead of, ‘What’s my blood sugar and
 how can I correct that?’ “ — Sara Krugman
  52. 52. wallpaperswide.com
  53. 53. Type 1 Diabetes is a really, really sucky disease.
  54. 54. whosthebeaver.com/?m=200807
  55. 55. The DIY movement is the leading edge of the
 Artificial Pancreas Ecosystem. earthables.com
  56. 56. @loudnate
 @jasoncalabrese @AliMazaheri
  57. 57. The DIY Movement: Empowered patients. Driving innovation. Taking control of their own care.
  58. 58. “The Innovation Wetlands” Andrew Torrance and Eric von Hippel www.rhodeislandpropertylaw.com
  59. 59. whosthebeaver.com/?m=200807
  60. 60. “It’s not about the car.
 It’s about the drive.” - Mark Wilson @warkmilson shutterstock.com
  61. 61. 1. Open data and control protocols. 2. Embrace and encourage the DIY movement. 3. Watch the ecosystem flourish and interoperability happen. 4. Deliver safer and more effective products, more quickly, to more people.
  62. 62. The Horace W. Goldsmith Foundation and Hundreds of Other Donors Thank you!
  63. 63. tidepool.org @Tidepool_org howard@tidepool.org @HowardLook

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