Mobile medical app development with a focus on traceability

Today, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers, as medical device software is normally developed in a manner that will also ensure the production of regulatory documentation that is essential to market such devices. In this paper, we identify the need for a mobile medical application development framework, the key criteria for such a framework, and describe how the results were collected through performing a Medical Device Software Development workshop. Furthermore, we describe how MDevSPICE together with an agile software development approach can be tailored to support a mobile medical applications development framework. We detail one of the key criteria for mobile medical application development framework—traceability.

[1]  Gilbert Regan,et al.  Research Findings from an Industrial Trial of a Traceability Assessment and Implementation Framework , 2016, 2016 IEEE/ACM International Conference on Software and System Processes (ICSSP).

[2]  Fergal McCaffery,et al.  Medical Device Software Traceability , 2012, Software and Systems Traceability.

[3]  Patrick Mäder,et al.  Acquiring Tool Support for Traceability , 2012, Software and Systems Traceability.

[4]  Fergal McCaffery,et al.  A software process improvement lifecycle framework for the medical device industry , 2005, 12th IEEE International Conference and Workshops on the Engineering of Computer-Based Systems (ECBS'05).

[5]  Jeff Sutherland,et al.  Future of scrum: parallel pipelining of sprints in complex projects , 2005, Agile Development Conference (ADC'05).

[6]  Fergal McCaffery,et al.  Development of MDevSPICE® – the medical device software process assessment framework , 2015, J. Softw. Evol. Process..

[7]  Fergal McCaffery,et al.  MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software , 2014, SPICE.

[8]  Jack Wong,et al.  Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific , 2013 .

[9]  Fergal Mc Caffery,et al.  Adept – A Software Process Appraisal Method for Small to Medium-sized Software Development Organisations , 2006 .

[10]  Marion Lepmets,et al.  Medical device software as a subsystem of an overall medical device , 2015 .

[11]  Klaas-Jan Stol,et al.  Scaling agile methods to regulated environments: An industry case study , 2013, 2013 35th International Conference on Software Engineering (ICSE).

[12]  A A Lee,et al.  There has to be a better way. , 1979, RN.

[13]  Fergal McCaffery,et al.  Balancing Agility and Discipline in a Medical Device Software Organisation , 2013, SPICE.

[14]  Jon W. Spence,et al.  There has to be a better way! [software development] , 2005, Agile Development Conference (ADC'05).

[15]  Barg Upender.  Staying agile in government software projects , 2005, Agile Development Conference (ADC'05).

[16]  Gilbert Regan,et al.  The Development and Validation of a Traceability Assessment Model , 2014, SPICE.

[17]  Patrick Mäder,et al.  Software traceability: trends and future directions , 2014, FOSE.

[18]  Tim Hughes,et al.  Adopting Agile in an FDA Regulated Environment , 2009, 2009 Agile Conference.

[19]  A. Coronato.  ISO 14971: medical devices - application of risk management to medical devices , 2018 .

[20]  Victor Rodrigues,et al.  Agile Development in a Medical Device Company , 2008, Agile 2008 Conference.

[21]  Mustafa Degerli,et al.  Yazilim Muhendisligi ve Sistem Muhendisligi Sureclerinin Harmanlanmasi: ISO/IEC 12207: 2008'in Getirdikleri ve Degisikliklerin Etkilerine Yonelik Degerlendirmeler (Blending Software Engineering and Systems Engineering Processes: Changes Introduced by ISO/IEC 12207: 2008 and Evaluations on Effects of , 2017, UYMS.

[22]  Peter Axel Nielsen,et al.  Agile software development and its compatibility with a document-driven approach? A case study , 2009 .

[23]  Richard Baskerville,et al.  Investigating Information Systems with Action Research , 1999, Commun. Assoc. Inf. Syst..

[24]  En Iso,et al.  DECLARATION OF CONFORMITY TO COUNCIL DIRECTIVE 93/42/EEC (INCLUDING DIRECTIVE 2007/47/EEC) CONCERNING MEDICAL DEVICES , 2010 .

[25]  Andre A. Pekerti,et al.  Augmentation of information in educational objects: Effectiveness of arrows and pictures as information for actions in instructional objects , 2013 .

[26]  Antonio Coronato,et al.  IEC 62304: medical device software - software life-cycle processes , 2018 .

[27]  Robert Phaal,et al.  Technology roadmapping—A planning framework for evolution and revolution , 2004 .

[28]  Kitija Trektere,et al.  Tailoring MDevSPICE® for Mobile Medical Apps , 2016, 2016 IEEE/ACM International Conference on Software and System Processes (ICSSP).

[29]  Gilbert Regan,et al.  A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps , 2014, EuroSPI.

[30]  Pekka Abrahamsson,et al.  New directions on agile methods: a comparative analysis , 2003, 25th International Conference on Software Engineering, 2003. Proceedings..

[31]  Lee Aa,et al.  There has to be a better way. , 1979 .

[32]  Megan.  From Waterfall to Agile - How does a QA Team Transition? , 2007, AGILE.

[33]  Fergal Mc Caffery,et al.  Implementation of Traceability Best Practices within the Medical Device Domain , 2013 .

[34]  Fergal McCaffery,et al.  Mobile Health & Medical Apps: Possible Impediments to Healthcare Adoption , 2015, eTELEMED 2015.

[35]  Gilbert Regan,et al.  Assessing traceability—practical experiences and lessons learned , 2015, J. Softw. Evol. Process..

[36]  Martin Mc Hugh,et al.  Integrating Agile Practices with a Medical Device Software Development Lifecycle , 2012 .

[37]  Shane Warden,et al.  The art of agile development , 2007 .

[38]  Gilbert Regan,et al.  The Development and Validation of a Roadmap for Traceability , 2015, SPICE.

[39]  Fergal McCaffery,et al.  An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles , 2013, 2013 5th International Workshop on Software Engineering in Health Care (SEHC).

[40]  Fergal McCaffery,et al.  Barriers to Adopting Agile Practices When Developing Medical Device Software , 2012, SPICE.

[41]  Oisín Cawley,et al.  Lean/Agile Software Development Methodologies in Regulated Environments - State of the Art , 2010, LESS.