Safety-Critical Systems and Agile Development: A Mapping Study

In the last decades, agile methods had a huge impact on how software is developed. In many cases, this has led to significant benefits, such as quality and speed of software deliveries to customers. However, safety-critical systems have widely been dismissed from benefiting from agile methods. Products that include safety critical aspects are therefore faced with a situation in which the development of safety-critical parts can significantly limit the potential speed-up through agile methods, for the full product, but also in the non-safety critical parts. For such products, the ability to develop safety-critical software in an agile way will generate a competitive advantage. In order to enable future research in this important area, we present in this paper a mapping of the current state of practice based on {a mixed method approach}. Starting from a workshop with experts from six large Swedish product development companies we develop a lens for our analysis. We then present a systematic mapping study on safety-critical systems and agile development through this lens in order to map potential benefits, challenges, and solution candidates for guiding future research.Comment: Accepted at Euromicro Conf. on Software Engineering and Advanced Applications 2018, Prague, Czech Republi

Harnessing Openness to Transform American Health Care

The Digital Connections Council (DCC) of the Committee for Economic Development (CED) has been developing the concept of openness in a series of reports. It has analyzed information and processes to determine their openness based on qualities of "accessibility" and "responsiveness." If information is not available or available only under restrictive conditions it is less accessible and therefore less "open." If information can be modified, repurposed, and redistributed freely it is more responsive, and therefore more "open." This report looks at how "openness" is being or might usefully be employed in the healthcare arena. This area, which now constitutes approximately 16-17 percent of GDP, has long frustrated policymakers, practitioners, and patients. Bringing greater openness to different parts of the healthcare production chain can lead to substantial benefits by stimulating innovation, lowering costs, reducing errors, and closing the gap between discovery and treatment delivery. The report is not exhaustive; it focuses on biomedical research and the disclosure of research findings, processes of evaluating drugs and devices, the emergence of electronic health records, the development and implementation of treatment regimes by caregivers and patients, and the interdependence of the global public health system and data sharing and worldwide collaboration

The Value of Information Technology-Enabled Diabetes Management

Reviews different technologies used in diabetes disease management, as well as the costs, benefits, and quality implications of technology-enabled diabetes management programs in the United States

A safer place for patients: learning to improve patient safety

1 Every day over one million people are treated successfully by National Health Service (NHS) acute, ambulance and mental health trusts. However, healthcare relies on a range of complex interactions of people, skills, technologies and drugs, and sometimes things do go wrong. For most countries, patient safety is now the key issue in healthcare quality and risk management. The Department of Health (the Department) estimates that one in ten patients admitted to NHS hospitals will be unintentionally harmed, a rate similar to other developed countries. Around 50 per cent of these patient safety incidentsa could have been avoided, if only lessons from previous incidents had been learned. 2 There are numerous stakeholders with a role in keeping patients safe in the NHS, many of whom require trusts to report details of patient safety incidents and near misses to them (Figure 2). However, a number of previous National Audit Office reports have highlighted concerns that the NHS has limited information on the extent and impact of clinical and non-clinical incidents and trusts need to learn from these incidents and share good practice across the NHS more effectively (Appendix 1). 3 In 2000, the Chief Medical Officer’s report An organisation with a memory 1 , identified that the key barriers to reducing the number of patient safety incidents were an organisational culture that inhibited reporting and the lack of a cohesive national system for identifying and sharing lessons learnt. 4 In response, the Department published Building a safer NHS for patients3 detailing plans and a timetable for promoting patient safety. The goal was to encourage improvements in reporting and learning through the development of a new mandatory national reporting scheme for patient safety incidents and near misses. Central to the plan was establishing the National Patient Safety Agency to improve patient safety by reducing the risk of harm through error. The National Patient Safety Agency was expected to: collect and analyse information; assimilate other safety-related information from a variety of existing reporting systems; learn lessons and produce solutions. 5 We therefore examined whether the NHS has been successful in improving the patient safety culture, encouraging reporting and learning from patient safety incidents. Key parts of our approach were a census of 267 NHS acute, ambulance and mental health trusts in Autumn 2004, followed by a re-survey in August 2005 and an omnibus survey of patients (Appendix 2). We also reviewed practices in other industries (Appendix 3) and international healthcare systems (Appendix 4), and the National Patient Safety Agency’s progress in developing its National Reporting and Learning System (Appendix 5) and other related activities (Appendix 6). 6 An organisation with a memory1 was an important milestone in the NHS’s patient safety agenda and marked the drive to improve reporting and learning. At the local level the vast majority of trusts have developed a predominantly open and fair reporting culture but with pockets of blame and scope to improve their strategies for sharing good practice. Indeed in our re-survey we found that local performance had continued to improve with more trusts reporting having an open and fair reporting culture, more trusts with open reporting systems and improvements in perceptions of the levels of under-reporting. At the national level, progress on developing the national reporting system for learning has been slower than set out in the Department’s strategy of 2001 3 and there is a need to improve evaluation and sharing of lessons and solutions by all organisations with a stake in patient safety. There is also no clear system for monitoring that lessons are learned at the local level. Specifically: a The safety culture within trusts is improving, driven largely by the Department’s clinical governance initiative 4 and the development of more effective risk management systems in response to incentives under initiatives such as the NHS Litigation Authority’s Clinical Negligence Scheme for Trusts (Appendix 7). However, trusts are still predominantly reactive in their response to patient safety issues and parts of some organisations still operate a blame culture. b All trusts have established effective reporting systems at the local level, although under-reporting remains a problem within some groups of staff, types of incidents and near misses. The National Patient Safety Agency did not develop and roll out the National Reporting and Learning System by December 2002 as originally envisaged. All trusts were linked to the system by 31 December 2004. By August 2005, at least 35 trusts still had not submitted any data to the National Reporting and Learning System. c Most trusts pointed to specific improvements derived from lessons learnt from their local incident reporting systems, but these are still not widely promulgated, either within or between trusts. The National Patient Safety Agency has provided only limited feedback to trusts of evidence-based solutions or actions derived from the national reporting system. It published its first feedback report from the Patient Safety Observatory in July 2005

An exploratory survey of current practice in the medical device industry

This article is (c) Emerald Group Publishing and permission has been granted for this version to appear here. Emerald does not grant permission for this article to be further copied/distributed or hosted elsewhere without the express permission from Emerald Group Publishing Limited.Purpose – This study seeks to examine the extent to which mainstream tools and strategies are applied in the medical devices sector, which is highly fragmented and contains a high percentage of small companies, and to determine if company size impacts on manufacturing strategy selection. Design/methodology/approach – A questionnaire was developed and disseminated through a number of channels. Responses were received from 38 companies in the UK and Ireland, describing 68 products taken to market in the past five years. Findings – Because of the limited scope of the survey, the findings are indicative rather than conclusive, and interesting trends have emerged. New to the world products were much more likely to exceed company expectations of market success compared to derivative products. It was found that the majority of these innovative products were developed by small companies. Large companies appear to favour minor upgrades over major upgrades even though these prove – on the data presented – to be less successful overall. Practical implications – These results provide those engaged in this sector with comparative information and some insights for further improvement. The reported trends with respect to company size and product complexity (or degree of novelty) are particularly illuminating. Academically, this sets some expected trends on a firmer footing and unearths one or two unexpected findings. Originality/value – It is believed that this is the largest survey of determinants of success in UK medical device companies and it provides a comparison with other sectors

Shared Value in Emerging Markets: How Multinational Corporations Are Redefining Business Strategies to Reach Poor or Vulnerable Populations

This report illuminates the enormous opportunities in emerging markets for companies to drive competitive advantage and sustainable impact at scale. It identifies how over 30 companies across multiple sectors and geographies design and measure business strategies that also improve the lives of underserved individuals