Open source hardware (OSHW) and medical devices

Open source hardware (OSHW) and medical devices

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


Gerrit Niezen

May 02, 2014


  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!

    ! • Arduino! • OpenROV! • DIY Drones! • Little Bits! • Sparkfun • Adafruit! • MakerBot! • UltiMaker! • Raspberry Pi! •
  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

  17. None
  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!
  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

  23. None
  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: 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 ! Appropedia!

    medevice Google Group (focus on diabetes)!forum/medevice! - 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:! Hose Clamp:! Spectrometer:! OpenBCI:! Peristaltic

    pump:! Syringe pump:! OpenFuge:! PhoneScope:! Ketosis detector: ketosis-detector/! FlexDrive:! OpenBCI:! CT scanner: open-source-desktop-ct-scanner/! e-Health sensor platform: 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!