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

Developing a conformance methodology for clinically-defined medical record headings:a preliminary report.

Background: The Professional Records Standards Body for health and social care (PRSB) was formed in 2013 to develop and assure professional standards for the content and structure of patient records across all care disciplines in the UK. Although the PRSB work is aimed at Electronic Health Record (EHR) adoption and interoperability to support continuity of care, the current technical guidance is limited and ambiguous. Objectives: This project was initiated as a proof-ofconcept to demonstrate whether, and if so, how, conformance methods can be developed based on the professional standards. Methods: An expert group was convened, comprising clinical and technical representatives. A constrained data set was defined for an outpatient letter, using the subset of outpatient headings that are also present in the ep-SOS patient summary. A mind map was produced for the main sections and sub-sections. An openEHR archetype model was produced as the basis for creating HL7 and IHE implementation artefacts. Results: Several issues about data definition and representation were identified when attempting to map the outpatient headings to the epSOS patient summary, partly due to the difference between process and static viewpoints. Mind maps have been a simple and helpful way to visualize the logical information model and expose and resolve disagreements about which headings are purely for human navigation and which, if any, have intrinsic meaning. Conclusions: Conformance testing is feasible but nontrivial. In contrast to traditional standards-development timescales, PRSB needs an agile standards development process with EHR vendor and integrator collaboration to ensure implementability and widespread adoption. This will require significant clinical and technical resources

Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical

Chronic back and neck pain is a prevalent disability, often caused by degeneration of the intervertebral disc. Because current treatments for this condition are less than satisfactory, a great deal of effort is being applied to develop new solutions, including regenerative strategies. However, the path from initial promising idea to clinical use is frought with many hurdles to overcome. Many of the keys to success are not necessarily linked to science or innovation. Successful translation to clinic will also rely on planning and awareness of the hurdles. It will be essential to plan your entire path to clinic from the outset and to do this with a multidisciplinary team. Take advise early on regulatory aspects and focus on generating the proof required to satisfy regulatory approval. Scientific demonstration and societal benefits are important, but translation cannot occur without involving commercial parties, which are instrumental to support expensive clinical trials. This will only be possible when intellectual property can be protected sufficiently to support a business model. In this manner, commercial, societal, medical, and scientific partners can work together to ultimately improve patient health. Based on literature surveys and experiences of the co‐authors, this opinion paper presents this pathway, highlights the most prominent issues and hopefully will aid in your own transational endeavors

Medical records and record-keeping standards

The structure of medical records becomes ever more critical with the advent of electronic medical records. The Health Informatics Unit (HIU) of the Royal College of Physicians has two work streams in this area. The Record Standards Programme is developing generic standards for all entries into medical notes and standards for the content of admission, handover and discharge records. The Information Laboratory (iLab) focuses on Hospital Episode Statistics and their use for monitoring clinician performance. Clinician endorsement of the work is achieved through extensive consultations. The Generic Medical Record Keeping Standards are published in this issue of Clinical Medicine

Standardising medical records: improving patient care and informing the evidence base

Poor organisation and partial or inaccurate completion of clinical notes can cause problems ranging from frustration to litigation. Despite this, no country has processes in place to regulate record-keeping across medical facilities. In our Guest Editorial, Iain Carpenter, Mala Bridgelal Ram, and John G. Williams contemplate how new initiatives in the UK to standardise recording of clinical details could not only improve patient health care but also perhaps fill the gaps in the evidence not answered by RCTs

Why it is essential to go on the records

Medical records are at the heart of good patient care and an essential component of understanding what went wrong and if things do go awry

A methodology for a structured survey of the healthcare literature related to medical device users

This article reports on the structured literature survey methodology, which was used to identify how and at what stage users of medical devices are engaged in the medical device technology cycle, including methods and tools for evaluating device outcomes.This was not a conventional systematic review of the literature.The stated purpose of the survey is broader than synthesizing best evidence to inform an area of practice and policy, as undertaken in a conventional systematic review.The survey was systematic in the sense that an explicit search strategy was used with inclusion and exclusion criteria to minimize sampling bias. An established qualitative methodology, framework analysis, was used to organize and synthesize major findings from a broad range of healthcare literature.The search strategy and thematic analysis are presented, to contribute to the literature on review strategies, together with the major findings concerning users and medical device

A user-centred approach to requirements elicitation in medical device development: a case study from an industry perspective

The healthcare industry is dependent upon the provision of well designed medical devices. To achieve this it is recommended that user-centred design should begin early, and continue throughout device development. This is a challenge, particularly for smaller companies who may lack the necessary expertise and knowledge. The aim of this study was to conduct a rigorous yet focused investigation into the user requirements for a new medical imaging device. Open-ended semi-structured interviews were conducted with potential clinical users of the device to investigate the clinical need for the device and the potential benefits for patients and clinical users. The study identified a number of new and significant clinical needs that suggested that the concept of the device should be fundamentally changed. The clinical and organisational priorities of the clinical users were identified, as well as a number of factors that would act as barriers to the safe and effective adoption of the device. The developers reported that this focused approach to early requirements elicitation would result in an improved product, reduce the time to market, and save the time and cost of producing and evaluating an inappropriate prototype