The term ‘Open Source’ is commonly associated with software
due to its proven success, encompassing a user’s ability to review and modify
the underlying source code, to disseminate modified or unmodified versions to
others, and to use it without facing the prospect of legal repercussions (Siedlok,
2001). In the context of product design, namely medical device design, the
concept remains relatively novel with no prior research being reported. A study of
applying the open source concept to medical device design by developing a web
based infrastructure for its facilitation is reported here.
Results: The stakeholder requirements are captured using a semi-structured
questionnaire and validated through cross referencing responses to questions
with other responses from stakeholders of the same or similar occupation. The
most prominent responses are selected as the key stakeholder requirements and
utilised in conjunction with the functional system requirements outlined in the
System Requirements Specification (SyRS), both sets of requirements provide
the foundation for the open source web based infrastructure development.
Conclusion: The comprehensiveness of the requirements indicate that the open
source web based infrastructure will support the design of all medical devices
that are classified as high risk, medium risk or low risk devices, whilst devices
external to this scope remain a future certainty
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