The Development and Validation of a Roadmap for Traceability

Organisations who operate in the safety critical domains such as the medical device, avaition, and automotive domains must ensure their software is safe and provide objective evidence to this effect. One way of achieving this is by adhering to domain specific regulations and guidelines which specify a comprehensive implementation of traceability. However there is a gap between regulatory traceability requirements and what is implemented in practice. This lack of compliance means that organisations find it difficult to assess the safety of their software and thus ensure its safety. One reason for non-compliance with regards to traceability is a lack of guidance on what traceability to implement or how to implement it. In this paper we present the development and validation of a roadmap for the implementation of traceability in the medical device domain. The roadmap will provide medical device organisations with a pathway for effective traceability implementation.

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

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

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

[4]  Andrea Zisman,et al.  Software and Systems Traceability , 2012, Springer London.

[5]  David Probert,et al.  Technology Roadmapping: Frontier Experiences from Industry-Academia Consortia , 2003 .

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

[7]  O. H. Bray,et al.  Fundamentals of technology roadmapping , 1997 .

[8]  Paul Mason.  On traceability for safety critical systems engineering , 2005, 12th Asia-Pacific Software Engineering Conference (APSEC'05).

[9]  David Probert,et al.  Frontier Experiences from Industry-Academia Consortia: Corporate Roadmappers Create Value with Product and Technology Roadmaps , 2003 .

[10]  Robert Phaal,et al.  Technology Roadmapping: Starting-Up Roadmapping Fast , 2003 .

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

[12]  S. Jamieson.  Likert scales: how to (ab)use them , 2004, Medical education.

[13]  Whole Grain Label Statements.  Guidance for Industry and FDA Staff , 2006 .

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

[15]  O. H. Bray,et al.  Technology roadmapping: the integration of strategic and technology planning for competitiveness , 1997, Innovation in Technology Management. The Key to Global Leadership. PICMET '97.

[16]  Andrea De Lucia,et al.  Information Retrieval Methods for Automated Traceability Recovery , 2012, Software and Systems Traceability.

[17]  Fergal Mc Caffery,et al.  Med-Trace: Traceability Assessment Method for Medical Device Software Development , 2011 .

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

[19]  Gilbert Regan,et al.  A Methodology for Software Process Improvement Roadmaps for Regulated Domains - Example with IEC 62366 , 2013, EuroSPI.

[20]  Ilka Philippow,et al.  Motivation Matters in the Traceability Trenches , 2009, 2009 17th IEEE International Requirements Engineering Conference.