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. Howard Look Founder and CEO NIH-NIDDK Fourth Artificial Pancreas Workshop July 7, 2016 Bethesda, Maryland
- 2. Disclosure I own publicly traded stock in Dexcom (DXCM)
- 3. Motivation Katie Look First Day of 6th Grade, 2011
- 4. Type 1 Diabetes is a really, really sucky disease.
- 6. c X
- 7. Proudly non-profit. Open source. Stewards of your data.
- 9. Coming soon Coming soon
- 10. 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
- 12. When you liberate data, you enable a vibrant ecosystem of applications and research. earthables.com
- 13. Nutshell MySugr Engine1 Glooko
- 18. 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
- 19. What does a vibrant Artificial Pancreas Ecosystem look like? earthables.com
- 20. Artificial Pancreas Telemetry Dashboard
- 21. What if the Artificial Pancreas Ecosystem were based on interoperable components?
- 23. Sensor Algorithm Pump Helper Apps Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …
- 24. 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
- 25. 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
- 26. 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
- 27. 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
- 28. 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
- 29. But… how?
- 31. Sensor Pump
- 32. Sensor Pump “Hi, I’m a sensor. I’d like to send you data.”
- 33. 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.”
- 34. 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.”
- 35. 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.”
- 36. Sensor Pump “I’m ready to send you data.”
- 37. Sensor Pump “I’m ready to send you data.” “Hold on there cowboy. What capabilities do you have?”
- 38. 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” }
- 39. 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.
- 40. Perceived challenges to an Artificial Pancreas Ecosystem: It’s hard. I’m scared. It’s extra work. They won’t let me.
- 41. 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.)
- 42. 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.)
- 43. (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.
- 44. Myth: It’s extra work and will slow us down!
- 45. Myth: It’s extra work and will slow us down!
- 46. 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.)
- 47. 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.)
- 48. Myth: Regulators will never allow it. We’ll never get support for it.
- 49. Myth: Regulators will never allow it. We’ll never get support for it.
- 50. 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.
- 53. 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
- 54. Why DIY Matters. (Hint: It’s not about the car…)
- 55. OpenAPS.org
- 57. “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
- 59. Type 1 Diabetes is a really, really sucky disease.
- 62. The DIY movement is the leading edge of the Artificial Pancreas Ecosystem. earthables.com
- 64. The DIY Movement: Empowered patients. Driving innovation. Taking control of their own care.
- 65. “The Innovation Wetlands” Andrew Torrance and Eric von Hippel www.rhodeislandpropertylaw.com
- 67. “It’s not about the car. It’s about the drive.” - Mark Wilson @warkmilson shutterstock.com
- 68. 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.
- 69. The Horace W. Goldsmith Foundation and Hundreds of Other Donors Thank you!