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DC Field | Value | Language |
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dc.contributor.author | Borsci, S | - |
dc.contributor.author | Macredie, RD | - |
dc.contributor.author | Martin, JL | - |
dc.contributor.author | Young, T | - |
dc.date.accessioned | 2015-01-19T11:56:21Z | - |
dc.date.available | 2015-01-19T11:56:21Z | - |
dc.date.issued | 2014 | - |
dc.identifier.citation | Expert Review of Medical Devices, 11(5): 513 - 525, (01 September 2014) | en_US |
dc.identifier.issn | 1743-4440 | - |
dc.identifier.uri | http://informahealthcare.com/doi/abs/10.1586/17434440.2014.940312 | - |
dc.identifier.uri | http://bura.brunel.ac.uk/handle/2438/9793 | - |
dc.description.abstract | Before releasing a product, manufacturers have to follow a regulatory framework and meet standards, producing reliable evidence that the device presents low levels of risk in use. There is, though, a gap between the needs of the manufacturers to conduct usability testing while managing their costs, and the requirements of authorities for representative evaluation data. A key issue here is the number of users that should complete this evaluation to provide confidence in a product’s safety. This paper reviews the US FDA’s indication that a sample composed of 15 participants per major group (or a minimum of 25 users) should be enough to identify 90–97% of the usability problems and argues that a more nuanced approach to determining sample size (which would also fit well with the FDA’s own concerns) would be beneficial. The paper will show that there is no a priori cohort size that can guarantee a reliable assessment, a point stressed by the FDA in the appendices to its guidance, but that manufacturers can terminate the assessment when appropriate by using a specific approach – illustrated in this paper through a case study – called the ‘Grounded Procedure’. | en_US |
dc.description.sponsorship | The authors acknowledge support of this work through the MATCH programme (EPSRC Grants: EP/F063822/1 EP/G012393/1), although the views expressed are entirely their own. | en_US |
dc.language.iso | en | en_US |
dc.publisher | Informa Plc | en_US |
dc.subject | Evaluation cohort | en_US |
dc.subject | Five-user assumption | en_US |
dc.subject | Medical devices | en_US |
dc.subject | Product safety | en_US |
dc.subject | Usability testing | en_US |
dc.title | How many testers are needed to assure the usability of medical devices? | en_US |
dc.type | Article | en_US |
dc.identifier.doi | http://dx.doi.org/10.1586/17434440.2014.940312 | - |
pubs.organisational-data | /Brunel | - |
pubs.organisational-data | /Brunel/Brunel Staff by College/Department/Division | - |
pubs.organisational-data | /Brunel/Brunel Staff by College/Department/Division/College of Engineering, Design and Physical Sciences | - |
pubs.organisational-data | /Brunel/Brunel Staff by College/Department/Division/College of Engineering, Design and Physical Sciences/Dept of Computer Science | - |
pubs.organisational-data | /Brunel/Brunel Staff by College/Department/Division/College of Engineering, Design and Physical Sciences/Dept of Computer Science/Computer Science | - |
pubs.organisational-data | /Brunel/Brunel Staff by Institute/Theme | - |
pubs.organisational-data | /Brunel/Brunel Staff by Institute/Theme/Institute of Materials and Manufacturing | - |
pubs.organisational-data | /Brunel/Brunel Staff by Institute/Theme/Institute of Materials and Manufacturing/Design for Sustainable Manufacturing | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/Brunel Business School - URCs and Groups | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/Brunel Business School - URCs and Groups/Centre for Research into Entrepreneurship, International Business and Innovation in Emerging Markets | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/School of Health Sciences and Social Care - URCs and Groups | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/School of Health Sciences and Social Care - URCs and Groups/Brunel Institute for Ageing Studies | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/School of Health Sciences and Social Care - URCs and Groups/Brunel Institute of Cancer Genetics and Pharmacogenomics | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/School of Health Sciences and Social Care - URCs and Groups/Centre for Systems and Synthetic Biology | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/School of Information Systems, Computing and Mathematics - URCs and Groups | - |
pubs.organisational-data | /Brunel/University Research Centres and Groups/School of Information Systems, Computing and Mathematics - URCs and Groups/Multidisclipary Assessment of Technology Centre for Healthcare (MATCH) | - |
Appears in Collections: | Dept of Computer Science Research Papers |
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