Medical Device Design Standards:
Necessary But Not Sufficient
Chris Vincent & Ann Blandford
UCLIC, University College London, Gower Street, London, WC1E 6BT, UK
There are many standards, applied to support infusion pump design and manufacture:
Care outside of the hospital
Care in the hospital
“In many cases, the development landscape resembled multiple islands of individuals, maintaining they had little influence over the
“UE/HFE practitioners still reported discipline specific silos.”
“So everything that fosters communication helps. and stuff that prevents communication doesn’t.”
A guide to the design of electronic infusion devices: NPSA / NHS England.
Human factors engineering –Design of medical devices: AAMI/ANSI HE75.
Example: Number Entry Keypads: Where to put the decimal point?
For more examples, have a look at the handout, and/or get in contact: [email protected] +44(0)20 7679 0694. We want to hear about your experiences using medical device design standards.
This work forms part of the UK EPSRC funded CHI+MED project (EP/G059063).
 O'Kane, A. A., & Blandford, A. (2013). Patients’ situated affective experience with mobile medical devices. Paper presented at MediCHI, CHI Paris.
 Vincent, C.J., Li, Y, & Blandford, A. (2014). Integration of human factors and ergonomics during medical device design and development: It's all about communication. Applied Ergonomics, 45(3), 413-419.
 Vincent, C.J., & Blandford, A. (In Press) The challenges of delivering validated personas for medical equipment design. Applied Ergonomics.
 Vincent, C.J., Blandford, A., & Li, Y. (2012). QOC-E: A mediating representation to support the development of shared rationale and integration of Human Factors advice. Paper presented at the HFES 2012 Symposium on Human Factors and Ergonomics in Health Care.