Medical device technologies: Who is the user?

A myriad of medical devices deployed by many users play an essential role in healthcare, and they, and their users, need to be defined, classified and coded effectively. This study provides definitions of terms frequently employed to describe the users of medical device technologies (MDT) as well as a classification of such users. Devices are widely used, developed and assessed by many others than clinicians. Thus, users of medical devices need to be classified in various relevant ways, such as primary and secondary users; user groups such as healthcare professionals, patients, carers, persons with disabilities, those with special needs, as well as professionals allied with healthcare. Proper definition and classification of MDT users is particularly important for integrating the users’ perspectives in the process of MDT development and assessment, as well as in relation to the regulatory, health and safety, and insurance perspectives concerning MDT

Developing medical device technologies from users' perspectives: A theoretical framework for involving users in the development process

Objectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP).Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP.Results: The suggested framework comprises two streams of users' involvement in MDT development, that is, what might be called the end users' stream and the professional users' stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users' involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented.Conclusions: Development of medical devices from users' perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users' requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users' involvement at different stages of the MDTDP

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

Modelling mobile health systems: an application of augmented MDA for the extended healthcare enterprise

Mobile health systems can extend the enterprise computing system of the healthcare provider by bringing services to the patient any time and anywhere. We propose a model-driven design and development methodology for the development of the m-health components in such extended enterprise computing systems. The methodology applies a model-driven design and development approach augmented with formal validation and verification to address quality and correctness and to support model transformation. Recent work on modelling applications from the healthcare domain is reported. One objective of this work is to explore and elaborate the proposed methodology. At the University of Twente we are developing m-health systems based on Body Area Networks (BANs). One specialization of the generic BAN is the health BAN, which incorporates a set of devices and associated software components to provide some set of health-related services. A patient will have a personalized instance of the health BAN customized to their current set of needs. A health professional interacts with their\ud patients¿ BANs via a BAN Professional System. The set of deployed BANs are supported by a server. We refer to this distributed system as the BAN System. The BAN system extends the enterprise computing system of the healthcare provider. Development of such systems requires a sound software engineering approach and this is what we explore with the new methodology. The methodology is illustrated with reference to recent modelling activities targeted at real implementations. In the context of the Awareness project BAN implementations will be trialled in a number of clinical settings including epilepsy management and management of chronic pain

Innovation in Mobile Learning: A European Perspective

In the evolving landscape of mobile learning, European researchers have conducted significant mobile learning projects, representing a distinct perspective on mobile learning research and development. Our paper aims to explore how these projects have arisen, showing the driving forces of European innovation in mobile learning. We propose context as a central construct in mobile learning and examine theories of learning for the mobile world, based on physical, technological, conceptual, social and temporal mobility. We also examine the impacts of mobile learning research on educational practices and the implications for policy. Throughout, we identify lessons learnt from European experiences to date

mHealth Research Applied to Regulated and Unregulated Behavioral Health Sciences

Behavioral scientists are developing new methods and frameworks that leverage mobile health technologies to optimize individual level behavior change. Pervasive sensors and mobile apps allow researchers to passively observe human behaviors “in the wild” 24/7 which supports delivery of personalized interventions in the real-world environment. This is all possible because these technologies contain an incredible array of sensors that allow applications to constantly record user location and can contextualize current environmental conditions through barometers, thermometers, and ambient light sensors and can also capture audio and video of the user and their surroundings through multiple integrated high-definition cameras and microphones. These tools are a game changer in behavioral health research and, not surprisingly, introduce new ethical, regulatory/legal and social implications described in this article