How Can Software SMEs Become Medical Device

The amount of software content within medical devices has grown considerably over recent years and will continue to do so as the level of complexity of medical devices increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a medical device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transitio

The future of software development methods

Most of the software development methods in use today are founded on concepts that emerged in the early decades of the software industry – the systems development life cycle, object orientation, agile and lean methods, open source, software product lines, software patterns – the list goes on. However there are several disruptive elements present in the current software landscape – software ecosystems, servitization, the Internet of Things, parallel processing, cognitive computing, quantum computing – that pose significant challenges in terms of the software development methods that might be appropriate. We suggest that these disruptive elements highlight the need to create new software development methods more appropriate to the needs of the current development environment

An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs

Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software

Development and Validation of the MedITNet Assessment Framework: Improving Risk Management of 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. Traditionally, medical devices were placed onto a proprietary IT network provided by the manufacturer of the device. Today, medical devices are increasingly designed for incorporation into a hospital’s general IT network enabling devices to exchange critical information. However, this can introduce risks and negate the potential benefits to patients. While the IEC 80001-1 standard has been developed to aid Healthcare Delivery Organisations (HDOs) in addressing these risks, HDOs may struggle to understand and implement the requirements. The MedITNet framework has been developed to allow HDOs to assess the capability of their risk management processes against the requirements of IEC 80001-1. MedITNet provides a flexible assessment framework enabling HDOs to gain a greater understanding of the requirements of the standard and to improve risk management processes by determining their current state and highlighting areas for improvement. This paper examines the challenges faced by HDOs in the risk management of medical IT networks and briefly explains the components of the MedITNet framework and how the framework addresses these challenges. This paper also details how Action Design Research (ADR) was used in the development and validation of MedITNet

Adopting Agile Practices when Developing Medical Device Software

Agile methods are gaining momentum amongst the developers of non-safety critical software. They offer the ability to improve development time, increase quality and reduce development costs. Despite this, the rate of adoption of agile methods within safety critical domains remains low. On face value agile methods appear to be contradictory to regulatory requirements. However while they may appear contradictory, they align on key values such as the development of the highest quality software. To demonstrate that agile methods could in fact be adopted when developing regulatory compliant software they were implemented on a medical device software development project. This implementation showed that not only can agile methods be successfully followed, but it also revealed that benefits were acquired. For example, the medical device software development project was completed 7% faster when following agile methods, when compared to if it had been completed in accordance with a plan-driven approach. While this implementation is confined to a single project, within a single organization it does strengthen the belief that adopting agile methods within regulated domains can reap the same benefits as those acquired in non-safety critical domains

The MedITNet Assessment Framework: Development and Validation of a Framework for Improving Risk Management of Medical IT Networks

Medical devices are increasingly designed for incorporation into a hospital’s IT network allowing devices to exchange critical information. However, connecting devices in this way can introduce risks potentially negating the benefits to patients. While the IEC 80001-1 standard has been developed to aid Healthcare Delivery Organisations (HDOs) in addressing these risks, HDOs often struggle to understand and implement the requirements. The MedITNet framework has been developed to allow HDOs to assess the capability of their risk management processes against the requirements of IEC 80001-1. MedITNet provides a flexible assessment framework enabling HDOs to gain a understanding of the requirements of the standard and to improve risk management processes by determining their current state and highlighting areas for improvement. This paper examines the challenges faced by HDOs in the risk management of medical IT networks and explains the components of the MedITNet framework and how the framework addresses these challenges. The use of Action Design Research (ADR) in the development and validation of MedITNet are also discussed focusing on a pilot implementation of the assessment method and expert review of the overall framework. The changes to the framework and its components as a result of the validation process are also discussed

Medical Device Regulations, Industrial Capabilities, and Affordable Healthcare Technology Development: Case Studies from the United Kingdom and South Africa

This thesis concerns the influence of healthcare systems regulation on firm-level capabilities and affordable healthcare technologies. Regulatory change is highly contentious, critics arguing that regulatory changes interfere with the efficiency of the market, and advocates arguing that well designed regulatory changes make markets more efficient and ensure market outcomes are more equitable. To date, very few studies analyze the influence of regulatory change on the medical device industry, and its ability to manufacture and supply affordable healthcare technologies. To respond to this gap, this research employs the Sectoral Systems of Innovation (SSI) approach as a theoretical framework to analyze the influence of regulatory changes on industrial capabilities in medical device industries and affordable healthcare technologies in South Africa and the United Kingdom. A mixed-method approach, focusing on three cases of regulatory change, emphasised documentary analysis and questionnaire-guided interviews to collect primary and secondary data from different sources in the healthcare systems of the two study countries. Regulatory changes facilitated some firms to create new strategies and innovative capabilities. Regulatory changes enabled some firms to develop close collaborative linkages with external providers in search of competitive advantage and improved market positioning. One reactive regulatory change, in particular, illustrated negative influence on innovative capabilities. Smaller firms were at a particular disadvantage in adapting to regulatory change. In the South Africa case, the more stringent regulatory requirements made it hard for domestic suppliers to enter the supply chain and led to joint ventures mainly with multinational corporations. The thesis argues, with empirical evidence, that a more enabling and discriminating regulation that takes into consideration of firms’ technological capabilities can achieve intended goals more efficiently and effectively, than constraining and indiscriminate regulation