Involving user perspective in a software risk management process
(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:
https://lup.lub.lu.se/record/8410547
- author
- Lindholm, Christin LU
- organization
- publishing date
- 2015
- 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 Inc.
- 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
- 2016-04-01 09:54:42
- date last changed
- 2022-01-25 17:52:51
@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}},
keywords = {{risk management; user perspective; medical device development; software development; usability testing}},
language = {{eng}},
number = {{12}},
pages = {{953--975}},
publisher = {{John Wiley & Sons Inc.}},
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}},
doi = {{10.1002/smr.1753}},
volume = {{27}},
year = {{2015}},
}