Abstract
Nowadays, medical devices rely on software whether completely such as mobile medical applications or as embedded software into medical chips such as tele surgery systems. Medical device software usually developed by using traditional development methods such as V-model and Waterfall model as these methods are straightforward and has the ability to comply with regulatory requirements such as documentation that ensures traceability. However, these methods could take a long time, could be costly, and these are inappropriate in case of requirements changing. In contrast, agile processes have several benefits such as producing a product of a high-quality with low cost and in short period with the capability to embrace change during development. Therefore, companies that develop medical device software can benefit from adopting agile practices. While the adoption rate of agile practices in software development in different industries is increasing, healthcare industries still have a low rate of agile adoption. This due to the gaps between agile practices and the stringent requirements of healthcare regulations such as documentation, traceability, and formality. The main question of this research is how capable are Agile processes can be in dealing with MDR requirements? This paper will investigate the capability of agile processes to support European Medical Device Regulation (MDR) requirements by extracting the MDR requirements that are related to software development life cycle. Then investigating the robustness of agile processes, to support MDR regulations. These objectives will be conducting by comparing and analysing the most popular agile processes (XP, Scrum, and FDD) to identify the gaps between MDR requirements and agile processes. The analysis revealed that XP is inappropriate for MDR requirements since it lacks the fixed up-front planning and also have insufficient documentations for treatability, Scrum has a model status report can be used for traceability but also it has insufficient documentation for MDR, and FDD is the closest agile practices to satisfy MDR requirements because it has a develop overall model phase which can be considered as semi-fixed up-front planning as well as has more documentations than the XP for traceability purposes such as UML modelling.
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References
Heeager, L., Nielsen, P.: A conceptual model of agile software development in a safety-critical context: a systematic literature review. Inf. Softw. Technol. 103, 22–39 (2018)
Mehrfard, H., Pirzadeh, H., Hamou-Lhadj, A.: Investigating the capability of agile processes to support life-science regulations: the case of XP and FDA regulations with a focus on human factor requirements. In: Lee, R., Ormandjieva, O., Abran, A., Constantinides, C. (eds.) Software Engineering Research, Management and Applications 2010. Studies in Computational Intelligence, vol. 296. Springer, Heidelberg (2010). https://doi.org/10.1007/978-3-642-13273-5_16
Özcan-Top, Ö., McCaffery, F.: A hybrid assessment approach for medical device software development companies. J. Softw.: Evol. Process 30, e1929 (2017)
VersionOne: The 11th annual State of Agile Report (2017)
Özcan-Top, Ö., McCaffery, F.: To what extent the medical device software regulations can be achieved with agile software development methods? XP—DSDM—Scrum. J. Supercomput. (2019)
Poth, A., Sasabe, S., Mas, A., Mesquida, A.: Lean and agile software process improvement in traditional and agile environments. J. Softw.: Evol. Process 31(1), e1986 (2018)
Nazir, N., Hasteer, N., Majumdar, R.: Barriers to agile adoption: a developer perspective. In: Kapur, P.K., Klochkov, Y., Verma, A.K., Singh, G. (eds.) System Performance and Management Analytics. AA, pp. 87–95. Springer, Singapore (2019). https://doi.org/10.1007/978-981-10-7323-6_8
AAMI, AAMI TIR 45:2012: Guidance on the use of Agile practices in the development of medical device software (2012)
Mc Hugh, M., Mc Caffery, F., Casey, V.: Barriers to using agile software development practices within the medical device industry. In: European System, Software & Service Process Improvement & Innovation, Vienna, Austria (2012)
Mc Hugh, M., Mc Caffery, F., Casey V.: Barriers to adopting agile practices when developing medical device software. In: Mas, A., Mesquida, A., Rout, T., O’Connor R.V., Dorling, A. (eds.) Software Process Improvement and Capability Determination, SPICE 2012 (2012)
Alsaadi, M., Qasaimeh, M., Tedmori, S., Almakadmeh, K.: HIPAA security and privacy rules auditing in extreme programming environments. Int. J. Inf. Syst. Serv. Sect. 9(1), 1–21 (2017)
Demissie, S., Keenan, F., McCaffery, F.: Investigating the suitability of using agile for medical embedded software development. In: Clarke, Paul M., O’Connor, Rory V., Rout, T., Dorling, A. (eds.) SPICE 2016. CCIS, vol. 609, pp. 409–416. Springer, Cham (2016). https://doi.org/10.1007/978-3-319-38980-6_29
Beck, K.: Extreme Programming Explained. Addison-Wesley, Boston (2010)
European Commission: Regulation (EU) 2017/745 of the European parliament and of the council of 5 April 2017 on medical devices, amending directive 2001/83/EC, regulation (EC) no 178/2002 and regulation (EC) no 1223/2009 and repealing council directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union (2017)
Pressman, R., Maxim, B.: Software Engineering, 8th edn, pp. 66–86. McGraw-Hill Education, New York (2015)
Palmer, S., Felsing, M.: A Practical Guide to Feature-Driven Development, 1st edn. Pearson Education, London (2002)
Khramtchenko, S.: Comparing eXtreme Programming and Feature Driven Development in academic and regulated environments. Final paper for CSCIE-275: Software Architecture and Engineering. Harvard University (2004)
Cleland-Huang, J.: Traceability in Agile Projects. In: Cleland-Huang, J., Gotel, O., Zisman, A. (eds.) Software and Systems Traceability, pp. 265–275. Springer, London (2011). https://doi.org/10.1007/978-1-4471-2239-5_12
Abrahamsson, P., Salo, O., Ronkainen, J., Warsta, J.: Agile soft-ware development methods: review and analysis, VTT Technical report (2002)
Mc Hugh, M., Mc Caffery, F., Coady, G.: An agile implementation within a medical device software organisation. In: Mitasiunas, A., Rout, T., O’Connor, R.V., Dorling, A. (eds.) SPICE 2014. CCIS, vol. 477, pp. 190–201. Springer, Cham (2014). https://doi.org/10.1007/978-3-319-13036-1_17
Ge, X., Paige, R., McDermid, J.: An iterative approach for development of safety-critical software and safety arguments. In: 2010 Agile Conference (2010)
Cawley, O., Wang, X., Richardson, I.: Lean/Agile software development methodologies in regulated environments – state of the art. In: Abrahamsson, P., Oza, N. (eds.) LESS 2010. LNBIP, vol. 65, pp. 31–36. Springer, Heidelberg (2010). https://doi.org/10.1007/978-3-642-16416-3_4
Mc Hugh, M., Cawley, O., Mc Caffery, F., Richardson, I., Wang, X.: An agile v-model for medical device software development to overcome the challenges with plan-driven software development lifecycles. In: 2013 5th International Workshop on Software Engineering in Health Care (SEHC), pp. 12–19. IEEE (2013)
Manjunath, K., Jagadeesh, J., Yogeesh, M.: Achieving quality product in a long term software product development in healthcare application using Lean and Agile principles: software engineering and software development. In: 2013 International Mutli-Conference on Automation, Computing, Communication, Control and Compressed Sensing (iMac4s) (2013)
Oshana, R.: Software Engineering for Embedded Systems: Methods, Practical Techniques, and Applications. Elsevier, Waltham (2013)
Fitzgerald, B., Stol, K., O’Sullivan, R., O’Brien, D.: Scaling agile methods to regulated environments: an industry case study. In: 2013 35th International Conference on Software Engineering (ICSE) (2013)
Ferriter, A.: Medical Device Recall Report FY 2003- FY 2012. [ebook] Division of Analysis and Program Operations Office of Compliance Center for Devices and Radiological Health (2014). http://fmdic.org/wp-content/uploads/2014/04/Medical-Device-Recall-Report-amf-2.pdf. Accessed 22 Mar 2019
Trustworthy Medical Device Software: Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report. Washington (DC): National Academies Press (US) (2011). https://www.ncbi.nlm.nih.gov/books/NBK209656/. Accessed 22 Mar 2019
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Alsaadi, M., Lisitsa, A., Khalaf, M., Qasaimeh, M. (2019). Investigating the Capability of Agile Processes to Support Medical Devices Regulations: The Case of XP, Scrum, and FDD with EU MDR Regulations. In: Huang, DS., Huang, ZK., Hussain, A. (eds) Intelligent Computing Methodologies. ICIC 2019. Lecture Notes in Computer Science(), vol 11645. Springer, Cham. https://doi.org/10.1007/978-3-030-26766-7_53
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