1. DESIGNING SMARTPHONES & TABLETS INTO MEDICAL DEVICES The Allure and the Reality Presented by Doug Halperin, SUNRISE LABS 2015 Sunrise Labs1

2. The Allure and Reality 2015 Sunrise Labs2 HEADER

3. 2015 Sunrise Labs3 THE ALLURE

4. 2015 Sunrise Labs4 SMART PHONE & TABLET ADVANTAGES Platform (essentially) for free Ubiquitous in market Not necessarily part of device cost Technology Great High Quality Hardware Powerful processor Modern User Interface High-resolution touch screen Connectivity: Wi/Fi, Bluetooth/BLE, Cellular, and NFC Peripherals – Camera, Microphone, Audio Output

5. www.motioncomputing.com/au/products/rugged-tablets/c5m www.extremetech.com 2015 Sunrise Labs5 DEVICE FLAVORS Smart Phone/Tablet & APP Smart Phone/Tablet + APP + Sensor/Peripheral/Device Tablet embedded in Medical Device www.medgadget.com/2013/05/nephosity-mobilect-ipad-radiology-viewer-receives-fda-clearance.html www.colorimetrix.com

6. 2015 Sunrise Labs6

7. 7 THE FDA VIEW OF MOBILE MEDICAL APPS APPs requiring notification to FDA Help patients self-manage Automate simple tasks for health care providers Access Electronic Health Record (EHR) systems Medical Device Data System (MDDS) APPs requiring submission & approval Active Patient Monitoring Control medical devices (e.g., delivery of insulin) With attachments (e.g., ECG electrodes) becomes like an already regulated device

8. 2015 Sunrise Labs8 WHEN IT COMES TO MEDICAL DEVICES, QUALITY PROCESS ALWAYS MATTERS www.emdt.co.uk/article/developing-medical-device-software-iso-62304

9. 2015 Sunrise Labs9 USE CASES Patient/Home Clinic/Office Hospital

10. 2015 Sunrise Labs10 TRADEOFFS The Device Requirements will tip the Scale

11. 2015 Sunrise Labs11 SAFETY & RISK

12. Liquid Ingress Protection Ratings 0No protection 1Protection against vertically falling drops of water e.g. condensation 2Protection against direct sprays of water up to 15o from the vertical 3Protected against direct sprays of water up to 60o from the vertical 4Protection against water sprayed from all directions - limited ingress permitted 5Protected against low pressure jets of water from all directions - limited ingress 6Protected against temporary flooding of water, e.g. for use on ship decks - limited ingress permitted 7Protected against the effect of immersion between 15 cm and 1 m 8Protects against long periods of immersion under pressure 2015 Sunrise Labs12 HARDWARE PERFORMANCE Computational Power Battery Life Environmental Range Form Factor/Screen Size & Resolution Ingress Protection - IPX Rating (IEC 60529 )

13. 2015 Sunrise Labs13 SOFTWARE & PLATFORM DETAILS Operating System Not Real-time Configuration Control Reduced Control Language Choices reduced User Interface Internationalization Windowing framework Compliance to OS requirements Languages Security Locking down environment Distribution Licensing Legal implications Open-source issues

14. 2015 Sunrise Labs14 PRODUCT LIFE CYCLE Smart Phones & Tablets versions < 12 months on market Medical Devices typically have far longer product life cycle Changing phone or tablet models will require significant verification and process validation on top of any engineering

15. 2015 Sunrise Labs15 PLATFORM CHOICES PlatformKey AdvantagesKey Disadvantages Apple iOS Ubiquitous Unified Platform Tightly controlled by Apple Environment closed Security is difficult More Expensive Android Ubiquitous Multiple Drivers Available Google-backed Inexpensive Hardware Multiple platforms to test Security is difficult Open-source licensing/contributions must be addressed Operating system knowledge may be necessary to build system Windows-based Well-known interfaces match PC PC developers can transition to this platform Known security vulnerabilities Less common

16. 2015 Sunrise Labs16 GETTING IT RIGHT

17. 2015 Sunrise Labs17 THANK YOU! Get a copy of our white paper at sunriselabs.com/white-papers.cfm Doug Halperin dhalperin@sunriselabs.com