Integrating Agile Practices with Plan-Driven Medical Device Software Development

The popularity of Agile software development is growing rapidly with an increasing number of projects being developed following Agile methodologies such as Scrum and XP [1]. Research has revealed that following Agile practices when developing software can have a significantly positive impact in reducing development time, reducing cost and increasing overall quality [2-4]. Whilst Agile practices can have a positive impact on a development project there are incompatibilities between Agile methodologies and the plan driven approaches followed when developing safety critical software [5, 6]. However, it has been recognised that “formal techniques may be used in an agile way” [5]. Case studies have been performed in organisations developing safety critical software which validate this statement [7-9]. This Ph.D. is focusing on the area of medical device software development and integrating Agile software development principles into traditional plan driven lifecycles for use in developing medical device software

The Impact of Regulatory Changes on the Development of Mobile Medical Apps

Mobile applications are being used to perform a wide variety of tasks in day-to-day life ranging from checking email, to controlling your home heating. Application developers have recognized the potential to transform a smart device into a medical device, by using a mobile medical application i.e. a mobile phone or a tablet. When initially conceived these mobile medical applications performed basic functions e.g. BMI calculator, accessing reference material etc.; however, increasing complexity offers clinicians and patients a range of functionality. As this complexity and functionality increases, so too does the potential risk associated with using such an application. Examples include any applications that provide the ability to inflate and deflate blood pressure cuffs, as well as applications that use patient-specific parameters and calculate dosage or create a dosage, plan for radiation therapy. If an unapproved mobile medical application is marketed by a medical device organization, then they face significant penalties such as receiving an FDA warning letter to cease the prohibited activity, fines and possibly face criminal conviction. Regulatory bodies have finalized guidance intended for mobile application developers to establish if their applications are subject to regulatory scrutiny. However, regulatory controls appear contradictory with the approaches taken by mobile application developers who generally work with short development cycles and very little documentation and as such, there is the potential to stifle further improvements due to these regulations. The research presented as part of this paper details how by adopting development techniques such as agile software development, mobile medical application developers can meet regulatory requirements whilst still fostering innovation

Challenges Experienced by Medical Device Software Organisations while following a Plan-driven SDLC

Medical device software organisations face challenges not faced by generic software development organisations. These challenges include the adherence to regulatory controls. Regulatory bodies require medical device software organisations to provide objective evidence that the software they are developing is safe and reliable. To produce this, regulatory bodies require a number of deliverables which must be achieved. However, they do not dictate which Software Development Life Cycle (SDLC) must be followed in order to achieve these deliverables. Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven software development lifecycle. By conducting semi structured interviews with seven medical device software organisations, we gained a deeper insight into how the challenges experienced impact on the development of medical device software. The interviews also attempted to learn from the participants how they believe the challenges experienced can be overcome. The aim of this paper is to explain the methodology used to perform interviews with medical device software organisations and to present these interviews

Population Ageing and Government Health Expenditures in New Zealand, 1951-2051

The paper uses a simulation model to assess the effects of population ageing on government health expenditures in New Zealand. Population ageing is defined to include disability trends and “distance to death”; government health expenditures are defined to include both acute and long-term care. The model results suggest that population ageing is associated with a large increase in expenditure share of people aged 65 and over, which rises from about 29% of total government health expenditure in 1951 to 63% in 2051. Analysis of demographic and health trends over the period 1951 to 2002 suggests, however, that these trends account for only a small proportion of the total growth in health expenditure. Most expenditure growth is attributable to other factors, such as an expansion in the range of treatments provided, and increases in input prices such as wages. Growth in this non-demographic component of health expenditures has reached 3-4% per year over recent years. Projection results for the period 2002 to 2051 suggest that restraining government expenditure on health to 6-12% of GDP would require long-run growth rates for the non-demographic component of health expenditure that are significantly lower than current rates. In other words, future demographic changes may be less threatening than is often assumed, but it would still not be possible to maintain current growth rates for government health expenditure and avoid substantial increases in the ratio between expenditure and GDP.Fiscal projections; Government health expenditure; Health status; New Zealand

Profiling Rural America: A Guide to Data Sources and Analytical Techniques

Evaluating the economic conditions of local economies is an important input to the decisions of policymakers, firms, and individuals. General impressions of the condition of national or state economies obtained from aggregate data often mask important substate differences in economic performance. State economic profiles are useful tools for presenting the dynamics of substate economic change. Because their economic conditions and environments can be very different, rural and urban areas are often compared in such profiles. This report describes the major components of a complete economic profile, with special emphasis on rural-urban comparisons. A catalog of data sources and a discussion of their value and potential abuses is provided. Techniques for deriving and interpreting meaningful information from the data are also presented

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

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

Adopting Agile Practices When Developing Software for Use in the Medical Domain

Non-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting agile practices. Through performing a literature review, this research has identified the perceived barriers to following agile practices when developing medical device software. A questionnaire based survey was also conducted with medical device software developers in Ireland to determine the barriers to adopting agile practices. The survey revealed that half of the respondents develop software in accordance with a plan driven software development lifecycle and that they believe that there are a number of perceived barriers to adopting agile practices when developing regulatory compliant software such as: being contradictory to regulatory requirements; insufficient coverage of risk management activities and the lack of up-front planning. In addition, a comparison is performed between the perceived and actual barriers. Based upon the findings of the literature review and survey, it emerged that no external barriers exist to adopting agile practices when developing medical device software and the barriers that do exists are internal barriers such as getting stakeholder buy in

The Influence of Location on Productivity: Manufacturing Technology in Rural and Urban Areas

Policies to counter the growing discrepancy between economic opportunities in rural and urban areas have focused predominantly on expanding manufacturing in rural areas. Fundamental to the design of these strategies are the relative costs of production and productivity of manufacturing in rural and urban areas. This study aims to develop information that can be used to assess the productivity of manufacturing in rural and urban areas. Production functions are estimated in the meat products and household furniture industries to investigate selected aspects of the effect of rural, small urban, and metropolitan location on productivity. The results show that the effect of location on productivity varies with industry, size, and the timing of the entry of the establishment into the industry. While the analysis is specific to two industries, it suggests that development policies targeting manufacturing can be made more effective by focusing on industries and plants with characteristics that predispose them to the locations being supported

Integrating Agile Practices with a Medical Device SDLC.

The rate at which agile software development practices are being adopted is growing rapidly. Agile software development practices and methodologies appear to offer the silver bullet which can solve the problems associated with following plan driven software development lifecycles. Agile software development practices offer the possibility of achieving lower development costs, increased efficiency and improved software quality. However, there is currently a low rate of publicly available information that suggests there is widespread adoption of agile practices within the medical device software domain. This is largely due to the fact that software developed for medical devices includes challenges not faced when developing non safety critical software. As a result of these challenges, medical device software is typically developed using plan driven software development lifecycles. However, such lifecycles are quite rigid and cannot accommodate changes easily. Previous research has revealed that medical device software development projects can benefit from adopting agile practices whilst still maintaining the discipline associated with following plan driven development lifecycles. This paper outlines the challenges faced by developers when developing medical device software and how shortcomings in both agile and plan driven approaches can be resolved by following a mixed method approach to medical device software developmen