Agile Scrum in Medical Device Software Development Process
Ahmed, Sernaz Naeena (2021)
Ahmed, Sernaz Naeena
2021
Informaatioteknologian ja viestinnän tiedekunta - Faculty of Information Technology and Communication Sciences
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Hyväksymispäivämäärä
2021-06-30
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-202106215997
https://urn.fi/URN:NBN:fi:tuni-202106215997
Tiivistelmä
Because of the advancement of information technology, the medical industry has been integrated with innovative technologies such as automated devices and software to control their functionalities. Therefore, the traditional medical industries now develop more lightweight software systems and complex regulatory systems. This new dimension creates a scope for implementing new design methods and different frameworks for the medical device industry.
Medical Device Software Industry has international quality assurance standards; authorized organizations regulate all the development works. Adopting agile practices is often a source of concern for the developers of safety-critical software where there is a high risk of financial cost uprise and loss of control. The number of regulatory standards that medical device software development companies must meet before selling their software is often overwhelming. Standards and guidelines have been established for various regions to help businesses comply with regulatory requirements. Nonetheless, medical device software development companies face a significant challenge in adhering to the stringent regulatory requirements imposed due to the domain's safety-critical nature and maintaining productivity in the software development process.
This research is initiated for exploring the implementation of Scrum as a framework of the Medical Device Software Development in compliance with the regulatory environment. The purpose of this study is to identify the complications of implementing Scrum for developing Medical Device Software and proposing feasible solutions to mitigate the complications. A literature review is performed, and interviews are conducted to understand the current practices. Thesis findings are reviewed by comparing the results of the interviews, and the results are reported in conjunction with feedback from practitioners.
The research outcome shows that adopting Scrum in the medical device domain may have complications. Those complications can be mitigated by integrating the regulatory concerns into the development lifecycle of medical device software. By taking the necessary measures such as defining products considering regulatory compliance, balancing the flexibility and restrictions to make changes, integrating risk management activities, introducing roles to monitor the development from a regulatory
perspective, it is possible to implement Scrum and comply with the regulatory requirements successfully.
Medical Device Software Industry has international quality assurance standards; authorized organizations regulate all the development works. Adopting agile practices is often a source of concern for the developers of safety-critical software where there is a high risk of financial cost uprise and loss of control. The number of regulatory standards that medical device software development companies must meet before selling their software is often overwhelming. Standards and guidelines have been established for various regions to help businesses comply with regulatory requirements. Nonetheless, medical device software development companies face a significant challenge in adhering to the stringent regulatory requirements imposed due to the domain's safety-critical nature and maintaining productivity in the software development process.
This research is initiated for exploring the implementation of Scrum as a framework of the Medical Device Software Development in compliance with the regulatory environment. The purpose of this study is to identify the complications of implementing Scrum for developing Medical Device Software and proposing feasible solutions to mitigate the complications. A literature review is performed, and interviews are conducted to understand the current practices. Thesis findings are reviewed by comparing the results of the interviews, and the results are reported in conjunction with feedback from practitioners.
The research outcome shows that adopting Scrum in the medical device domain may have complications. Those complications can be mitigated by integrating the regulatory concerns into the development lifecycle of medical device software. By taking the necessary measures such as defining products considering regulatory compliance, balancing the flexibility and restrictions to make changes, integrating risk management activities, introducing roles to monitor the development from a regulatory
perspective, it is possible to implement Scrum and comply with the regulatory requirements successfully.