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Involving user perspective in a software risk management process

Lindholm, Christin LU (2015) In Journal of software: Evolution and Process 27(12). p.953-975
Abstract
More and more user groups are using medical devices. Heart starters are, for example, available in public

places and used by non-professionals. Different mobile medical applications, designed to help people

manage their own health, are now being added to the medical device spectra. Users handling medical

devices make errors, but by involving users in the risk management process, it is possible to lower the risk

of these errors. This paper presents an evaluation of the value of complementing a traditional risk management

process with an emphasised user perspective. A medical device software risk management framework

is being designed, and the risk management process should be regarded as... (More)
More and more user groups are using medical devices. Heart starters are, for example, available in public

places and used by non-professionals. Different mobile medical applications, designed to help people

manage their own health, are now being added to the medical device spectra. Users handling medical

devices make errors, but by involving users in the risk management process, it is possible to lower the risk

of these errors. This paper presents an evaluation of the value of complementing a traditional risk management

process with an emphasised user perspective. A medical device software risk management framework

is being designed, and the risk management process should be regarded as the first part of the framework.

The main goal of the evaluated risk management process is to integrate users and user perspective into

the risk management process. The results indicate that the use of use cases as input at risk meetings makes

the discussions more focused, saving effort and time. When users attend the risk meetings, user perspective

and domain knowledge are brought into the process, affecting risk identification and risk assessment.

The results also show that the use of usability testing gives valuable input to the risk management process. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
risk management, user perspective, medical device development, software development, usability testing
in
Journal of software: Evolution and Process
volume
27
issue
12
pages
953 - 975
publisher
John Wiley & Sons
external identifiers
  • wos:000368551300002
  • scopus:84955706910
ISSN
2047-7481
DOI
10.1002/smr.1753
language
English
LU publication?
yes
id
5a5754c9-72b0-4139-8226-ec707b5d3675 (old id 8410547)
date added to LUP
2015-12-21 14:01:11
date last changed
2017-04-09 03:02:25
@article{5a5754c9-72b0-4139-8226-ec707b5d3675,
  abstract     = {More and more user groups are using medical devices. Heart starters are, for example, available in public<br/><br>
places and used by non-professionals. Different mobile medical applications, designed to help people<br/><br>
manage their own health, are now being added to the medical device spectra. Users handling medical<br/><br>
devices make errors, but by involving users in the risk management process, it is possible to lower the risk<br/><br>
of these errors. This paper presents an evaluation of the value of complementing a traditional risk management<br/><br>
process with an emphasised user perspective. A medical device software risk management framework<br/><br>
is being designed, and the risk management process should be regarded as the first part of the framework.<br/><br>
The main goal of the evaluated risk management process is to integrate users and user perspective into<br/><br>
the risk management process. The results indicate that the use of use cases as input at risk meetings makes<br/><br>
the discussions more focused, saving effort and time. When users attend the risk meetings, user perspective<br/><br>
and domain knowledge are brought into the process, affecting risk identification and risk assessment.<br/><br>
The results also show that the use of usability testing gives valuable input to the risk management process.},
  author       = {Lindholm, Christin},
  issn         = {2047-7481},
  keyword      = {risk management,user perspective,medical device development,software development,usability testing},
  language     = {eng},
  number       = {12},
  pages        = {953--975},
  publisher    = {John Wiley & Sons},
  series       = {Journal of software: Evolution and Process},
  title        = {Involving user perspective in a software risk management process},
  url          = {http://dx.doi.org/10.1002/smr.1753},
  volume       = {27},
  year         = {2015},
}