Open source hardware (OSHW) and medical devices

Workshop slides presented at Thingscon '14, Berlin. Download the PDF version for clickable links.

Transcript

1. Gerrit Niezen! Postdoctoral researcher! Swansea University! Wales, United Kingdom making medical devices safer Open Source Hardware (OSHW) 
 Medical Devices Workshop @gendor
2. What is ! open source hardware?
3. "Open-source hardware creates products driven by capitalism rather than monopolies, an open environment for sharing information, and a powerful opportunity for companies and individuals to learn from each other."! Joshua M. Pearce, Open-Source Lab
4. 10 commercially successful open source hardware companies in 2013
 http://bit.ly/oshwcomp! ! • Arduino! • OpenROV! • DIY Drones! • Little Bits! • Sparkfun • Adafruit! • MakerBot! • UltiMaker! • Raspberry Pi! • beagleboard.org
5. Robohand
6. Hose clamp
7. Spectrometer
8. Raspberry Pi peristaltic pump
9. Peristaltic pump from Adafruit ($25)
10. Syringe pump (0.3ml intradermal)
11. $200 OpenFuge
12. PhoneScope
13. Arduino-based ketosis detector
14. Open source electrophysiology: FlexDrive
15. OpenBCI
16. CT scanner
18. e-Health sensor platform
19. What can be shared? • Original design files, e.g. 2D drawings, CAD files, circuit schematics and layouts! • Bill of materials! • Software and firmware! • Photos! • Instructions and other explanations! http://www.oshwa.org/sharing-best-practices/
20. Other licences include: 
 TAPR (Tucson Amateur Packet Radio) Open Hardware License, FreeBSD License, MIT License, Creative Commons Attribution (CC BY)! Licenses that do not permit commercial use are not considered to be OSHW What license should I use? CERN Open Hardware License GNU General Public License (GPL) Creative Commons Attribution Share-Alike
21. help others reproduce your work! help others use your product! explains design rationale Why document?
22. Uses oManual standard (IEEE 1874) Documentation
24. Sharing designs Why use web-based design tools?
 Easier to share design and collaborate in real-time! Sharing completed CAD models
 Thingiverse, GitHub viewer, Sketchfab
25. Free for open source: 
 https://upverter.com/pricing/alt/ Can link to GitHub Open design reviews
26. “Given enough eyeballs, all bugs are shallow” (?)
 Eric S. Raymond Safety & Security ability to fix the bug yourself! standards are necessary but not sufficient
27. Standards Medical devices - Application of usability engineering to medical devices ISO/IEC 62366:2007 Process standard ANSI/AAMI HE75:2009 Design principles standard Human Factors Engineering - Design of medical devices Other standards for electrical compliance, risk management, alarm systems, graphical symbols and labelling
28. Source: Withings Media Kit Design-led focus
29. Open Health Care UK's Open Spirometer
 https://github.com/openhealthcare/open-spirometer ! Appropedia
 http://www.appropedia.org/Portal:Health_and_safety! medevice Google Group (focus on diabetes)
 https://groups.google.com/forum/#!forum/medevice! OpenQRS.org - Open source community developing tools to assure the quality, reliability and safety of health care devices Getting involved with projects
30. Generic Infusion Pump (GIP) project making medical devices safer uses verification methods to 
 improve software safety! reference specification for PCA pump software
31. RoboHand: http://www.robohand.net/! Hose Clamp: http://www.thingiverse.com/thing:28447! Spectrometer: http://www.thingiverse.com/thing:148270! OpenBCI: http://www.openbci.com! Peristaltic pump: https://kelpforest.org/projects/peristalticpump/index.html! Syringe pump: http://www.thingiverse.com/thing:210756! OpenFuge: http://www.instructables.com/id/OpenFuge/! PhoneScope: http://www.thingiverse.com/thing:280004! Ketosis detector: http://jenslabs.com/2013/06/06/ketosense-an-arduino-based- ketosis-detector/! FlexDrive: http://open-ephys.org/#/flexdrive/! OpenBCI: http://www.openbci.com! CT scanner: http://www.tricorderproject.org/blog/towards-an-inexpensive- open-source-desktop-ct-scanner/! e-Health sensor platform: http://www.cooking-hacks.com/documentation/ tutorials/ehealth-biometric-sensor-platform-arduino-raspberry-pi-medical! Links
32. Images used under the Creative Commons license:! OpenFuge by CopabX! Question by Henry Rider from the Noun Project! Brandenburg Gate by Robert Hufton from the Noun Project! Rasperry Pi Peristaltic Pump by Amber Fechko on Flickr! Maker Faire Bay Area 2011 by James Bastow on Flickr! NHSHD_25Jan_007 by Paul Clarke on Flickr! Snap-together Robohand by MakerBot on Thingiverse! Hose Clamp - Pinch Valve by Tim_C on Thingiverse! Open Mini Spectrometer by peter_ on Thingiverse! Open Source CT Scanner by peter_ on Thingiverse! PhoneScope - customizable by tbaden on Thingiverse! Syringe pump 0.3ml intradermal by siderits on Thingiverse! Enzyme dispenser mechanism by AIR on Thingiverse! Glif + GorillaPod by m-s-y on Flickr! The Glif by Daniel Bagel on Flickr! ISO 9001 in Tsukiji by Chris 73 on Wikimedia Commons! Sparks1 by Joshua M Pearce on Appropedia (licensed under GFDL) C b n a Except where otherwise noted, this work is licensed under! http://creativecommons.org/licenses/by-nc-sa/4.0/
33. http://discuss.openpump.org