Medical IT Networks

The use of networked medical devices can provide a number of benefits such as improved patient safety, reduced costs of care and a reduction in adverse events. While medical devices are stringently regulated and tested, the incorporation of a medical device into an IT network can introduce additional risks, compromising the safety, effectiveness and the security of the IT network. IEC 80001-1:2010 was developed as a step towards addressing these risks. However, Healthcare Delivery Organisations (HDO) face challenges when implementing the requirements of this standard.

Research on the risk management of medical IT networks and Health Information Technology systems is led by Dr Silvana Togneri Mac Mahon.

Silvana works closely with the standards community in the development and validation of a framework (MedITNet), published as ISO TR 80001-2-7: 2015.  She is also the author, editor and international project leader for this technical report and has attended and presented at standard meetings and presented her research at international conferences. The framework focuses on assessing improve the risk management of medical IT network at any HDO. Silvana is a recognised Irish Expert and a member of the ISO TC 215 IEC SC 62A Joint Working Group 7 Leadership team and has devised the approach to the revision of the IEC 80001-1 standard and is currently leading the process aspects of the revision of the standard.

Software Traceability

Traceability is an important component in developing quality software. In addition to regulatory requirements, organisations operating within the safety critical domain must employ an effective traceability process to ensure their software is safe. However, traceability implementation is problematic as most existing software systems lack explicit traceability links between artefacts. This problem has been highlighted in the medical device domain by an analysis of the traceability documents submitted to regulators in the United States as part of the medical device approval process.  

This research is being led by Dr Gilbert Regan  

The research of the RSRC focuses on the development and validation of a traceability assessment to assist medical device Small to Medium Enterprises (SMEs) to overcome the identified challenges.  A framework called Traceability Assessment and Implementation Framework (TAIF) was developed from a PhD research at RSRC and The framework enables the assessment of a medical device SMEs current traceability status in addition to providing a pathway for improvement.

Medical Device Software Process

Regulated Software Research Centre (RSRC) perform medical device software engineering research and have developed a medical device software process assessment model MDevSPICE® to reduce the overhead associated with adhering to all the medical device specific standards and regulations by bringing them together into a single model. Developing MDevSPICE® required the RSRC to have a significant international standards engagement and part of this work lead to the development of IEC 80002-3 (Process Reference Model for IEC 62304), published in May 2014. IEC 80002-3 represents the culmination of many years of dedicated work by the RSRC, creating important new standards within the working groups of both the ISO and the IEC. Through working with international standards working groups such as IEC SC62A/ JWG3, IEC SC62A/JWG7 and ISO/IEC JTC1 SC7 WG10, the RSRC has advanced other standards, including IEC 80001-1-7 (Process Assessment Model for IEC 80001-1) and IEC 80001-2-8 (Guidance on standards for establishing Security Capabilities identified in IEC/TR 80001-2-2).
MDevSPICE® will for the first time concentrate the accumulated medical device software best practices from all leading sources, while also supporting the industry and regulators in consistently and accurately evaluating software process implementation. This is good news for regulators, as a robust and thorough framework grounded in international standards will exist for assessing medical device software producers. And it is good news for the producers too, as all the medical device know-how will for the first time be assembled in a single, authoritative framework.

This research is being led by Dr Fergal McCaffery

Peter Rust is conducting research in the development of a roadmap for IEC 62304. Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical device software -- Software life cycle processes, is a standard that defines the processes  that  are  required  to  be  executed  in  order  to  develop  safe  software. Demonstrating  compliance  with  IEC  62304  can  be  problematic  for  organizations that are new to or have limited experience in the domain. The standard defines  what  processes  must  be  carried  out,  but  does  not  state  how.  This  research is focused on generating a roadmap that will guide organizations in the implementation of IEC 62304.

Agile Software Development

Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. The research that has been conducted in agile software development includes:

• Integrating agile practices with a traditional plan-driven SDLC.
• Extending the MDevSPICE® framework with agile practices to enable medical device software development to be performed in a more flexible manner. MDevSPICE® is a medical device software process assessment framework that integrates the regulatory requirements from the relevant medical device software standards.

Software Testing

At RSRC the research in the of the field of  Software Testing focuses on the development of a testing framework for the medical device industry. The research focuses on the integration of medical device specific verification and validation practices into established testing frameworks. We look at what practices organisations having an established testing framework in place would need to implement to satisfy the verification and validation requirements as described in the medical device regulations for software. Currently, three research students working on software testing for medical device software. 

Hamsini Ketheswarasarma Rajaram is  performing research in the area of the use of taxonomy based tesing in the development of medical device software. She is working with the Association for the Advancement of Medical Instrumentation in the deevlopment of an international standard ANSI/AAMI SW91:2018 Classification of defects in health software. This defect taxonomy will be used for taxonomy based testing. A framework is being developed to allow medical device software development companies to implemnet taxonomy based tesing as part of their software development process.

Andzej Beniamin Bujok is performming research in the devlopment of a testing framework for use by medical device software development companies. The framework combines international stanadards for the development of medical device software with software testing best practice as defined in current international standards. The framework will be validated by expert review from both medical device software companies and testing companies.

Mohammad Anjum is preforming research to investigate the effectiveness of the use of Behaviour Driven Development in the medical device software domain. He is investigating the use of Agile techniques for the definition of requirements and testing of medical device software. This reserach is being performed in close collaboration with industry partners.