A Systematic Approach to Diagnostic Laboratory Software Requirements Analysis
Genetics plays an ever-increasing role in medical diagnostics. The requirements for laboratory diagnostics are constantly changing due to new emerging diagnostic procedures, methodologies, devices, and regulatory requirements. Standard software already available for laboratories often cannot keep up...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-03-01
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| Series: | Bioengineering |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2306-5354/9/4/144 |
| _version_ | 1797436925758406656 |
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| author | Thomas Krause Elena Jolkver Paul Mc Kevitt Michael Kramer Matthias Hemmje |
| author_facet | Thomas Krause Elena Jolkver Paul Mc Kevitt Michael Kramer Matthias Hemmje |
| author_sort | Thomas Krause |
| collection | DOAJ |
| description | Genetics plays an ever-increasing role in medical diagnostics. The requirements for laboratory diagnostics are constantly changing due to new emerging diagnostic procedures, methodologies, devices, and regulatory requirements. Standard software already available for laboratories often cannot keep up with the latest developments or is focused on research rather than process automation. Although the software utilized in diagnostic laboratories is subject to regulatory requirements, there is no well-defined formal procedure for software development. Reference models have been developed to formalize these solutions, but they do not facilitate the initial requirements analysis or the development process itself. A systematic requirements engineering process is however not only essential to ensure the quality of the final product but is also required by regulations such as the European In Vitro Diagnostic Regulation and international standards such as IEC 62304. This paper shows, by example, the systematic requirements analysis of a system for qPCR-based (quantitative polymerase chain reaction) gene expression analysis. Towards this goal, a multi-step research approach was employed, which included literature review, user interviews, and market analysis. Results revealed the complexity of the field with many requirements to be considered for future implementation. |
| first_indexed | 2024-03-09T11:09:35Z |
| format | Article |
| id | doaj.art-ef14d604ced847aeb3ef6cd041ec5e7c |
| institution | Directory Open Access Journal |
| issn | 2306-5354 |
| language | English |
| last_indexed | 2024-03-09T11:09:35Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Bioengineering |
| spelling | doaj.art-ef14d604ced847aeb3ef6cd041ec5e7c2023-12-01T00:49:14ZengMDPI AGBioengineering2306-53542022-03-019414410.3390/bioengineering9040144A Systematic Approach to Diagnostic Laboratory Software Requirements AnalysisThomas Krause0Elena Jolkver1Paul Mc Kevitt2Michael Kramer3Matthias Hemmje4Faculty of Mathematics and Computer Science, University of Hagen, 58097 Hagen, GermanyFaculty of Mathematics and Computer Science, University of Hagen, 58097 Hagen, GermanyResearch Institute for Telecommunication and Cooperation (FTK), 44149 Dortmund, GermanyImmBioMed Business Consultants GmbH & Co. KG, 64319 Pfungstadt, GermanyResearch Institute for Telecommunication and Cooperation (FTK), 44149 Dortmund, GermanyGenetics plays an ever-increasing role in medical diagnostics. The requirements for laboratory diagnostics are constantly changing due to new emerging diagnostic procedures, methodologies, devices, and regulatory requirements. Standard software already available for laboratories often cannot keep up with the latest developments or is focused on research rather than process automation. Although the software utilized in diagnostic laboratories is subject to regulatory requirements, there is no well-defined formal procedure for software development. Reference models have been developed to formalize these solutions, but they do not facilitate the initial requirements analysis or the development process itself. A systematic requirements engineering process is however not only essential to ensure the quality of the final product but is also required by regulations such as the European In Vitro Diagnostic Regulation and international standards such as IEC 62304. This paper shows, by example, the systematic requirements analysis of a system for qPCR-based (quantitative polymerase chain reaction) gene expression analysis. Towards this goal, a multi-step research approach was employed, which included literature review, user interviews, and market analysis. Results revealed the complexity of the field with many requirements to be considered for future implementation.https://www.mdpi.com/2306-5354/9/4/144laboratory diagnosticsrequirements engineeringgene expressionqPCRmedical diagnostics |
| spellingShingle | Thomas Krause Elena Jolkver Paul Mc Kevitt Michael Kramer Matthias Hemmje A Systematic Approach to Diagnostic Laboratory Software Requirements Analysis Bioengineering laboratory diagnostics requirements engineering gene expression qPCR medical diagnostics |
| title | A Systematic Approach to Diagnostic Laboratory Software Requirements Analysis |
| title_full | A Systematic Approach to Diagnostic Laboratory Software Requirements Analysis |
| title_fullStr | A Systematic Approach to Diagnostic Laboratory Software Requirements Analysis |
| title_full_unstemmed | A Systematic Approach to Diagnostic Laboratory Software Requirements Analysis |
| title_short | A Systematic Approach to Diagnostic Laboratory Software Requirements Analysis |
| title_sort | systematic approach to diagnostic laboratory software requirements analysis |
| topic | laboratory diagnostics requirements engineering gene expression qPCR medical diagnostics |
| url | https://www.mdpi.com/2306-5354/9/4/144 |
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