Medical device companies must ensure that they comply with medical device regulations and must produce a design history file detailing the software components and processes undertaken in the development of their medical devices. Due to the safety-critical nature of medical device software it is important that efficient and effective software development practices are in place within medical device companies.
To this end, the Center for Devices and Radiological Health CDRH) has published guidance papers for industry and medical device staff which include risk -based activities to be performed during software validation, pre-market submission and when using off-the-shelf software in a medical device. Although the CDRH guidance documents provide information on which software activities should be performed, including risk based activities; they do not enforce any specific method for performing these activities.
Medi SPICE aims to define a conformity assessment approach for the medical device industry to support first, second and/or third party assessments which may be recognised by the regulatory bodies and pave the way for a more streamlined pathway towards compliance.
The overall approach also aims to provide an efficient and effective mechanism for assessing and improving processes for medical device software irrespective of conformity assessment and requirements for compliance.
Medi SPICE will develop a Process Reference Model (PRM) and Process Assessment Model (PAM) for Medical Device Software that is conformant to the requirements of ISO/IEC 15504 (ISO/EIC 330xx series) that integrates relevant standards as determined by the stakeholders. Relevant standards include the FDA and European Council guidelines and associated standards (e.g. FDA 21 – CFR Part 820, 93/42/EEC, ISO 14971, IEC 60601-1-4, IEC 62304, IEC 80002-1 (the replacement for TIR 32) and ISO 13485).
The overall approach will be to define the set of processes that will cover the complete medical device software development and maintenance lifecycle including the eleven software development areas defined by the FDA, the European Council, and the main process groups that are defined in IEC 62304.
As safety is a primary issue for Medical Device Software, Medi SPICE will provide an integrated approach to the use of the safety integrity levels and the safety life cycle from IEC 61508 (the international standard for the “functional safety” of electrical, electronic, and programmable electronic equipment) and the safety extensions that are defined as part of ISO/IEC 15504-10.
Medi SPICE is an initiative of the SPICE User Group. The Medi SPICE project is hosted by the Regulated Software Research Group (RSRG) at the Dundalk Institute of Technology (DkIT)
in Ireland. Dr. Fergal McCaffery (DkIT) is the international Project Leader.
The governance structure with relevant roles and responsibilities is defined in a Modus Operandi. The following are key roles.
The Advisory Board comprises Senior Executives and Advocates within the Medical Device Software industry with a strong interest in the success of Medi SPICE.
The Steering Group comprises key stakeholders from the Advisory Board, the Project Team, the Extended Project Team, the SPICE User Group and the SPICE Academy.
The Secretariat is provided by the SPICE User Group.
The Project Team includes
- Project Leader - Dr. Fergal McCaffrey from DkIT.
- Core team - that includes key resources from DkIT and Lero in Ireland
- Extended team - that includes individuals or international Collaboration Teams providing a major contribution to project resources
From the community at large.
Regulated Software Research Group (RSRG)
The Regulated Software Research Group (RSRG) is within the Software Technology Research Centre at Dundalk Institute of Technology (DkIT).
RSRG’s core mission is to engage in regulatory focused software engineering research in selected domains – with medical devices being the primary domain.
The RSRG comprises of academic staff and researchers from DkIT and Lero (the Irish Software Engineering Research Centre), together with a number of visiting scientists and leading experts in the field.
The RSRG benefits from having strong national and international collaborators that include Lero, the SPICE User Group, UCC, UU, VTT (Finland), Griffith University (Australia), the Irish Medical Device Association, BioBusinessNI, Vitalograph, Boston Scientific, and NTE (Spain).
The RSRG has been successful in attracting funding in a range of basic and applied research projects that include:
• Development of a Global Software Development (GSD) Framework for the medical device industry;
• Development of a Software Process Improvement (SPI) model for the medical device industry;
• Improving Verification and Validation software development procedures for the medical device industry;
• Integrating agile and lean practices into medical device software development practices;
• Improving Traceability within medical device software development;
• Reducing the overhead of achieving medical device software regulatory compliance;
• Development of an ideal environment for safety-critical embedded software with a focus on the medical device industry;
• Development of a methodology for developing software process models;
• Adaptive Software Process Improvement;
• Extending Acceptance Test Driven Development.
The RSRG is headed by Dr Fergal Mc Caffery who is supported by Science Foundation Ireland (SFI) under the Principal Investigator and Stokes Lectureship Programmes.
Dr Fergal Mc Caffery is a member of the SPICE Academy and the designated international Project Leader of Medi SPICE. He has published more than 75 papers in leading international journals, books, and peer-reviewed conferences.