In recent years, interest in additive manufacturing has increased. To overcome challenges such as the correct use of the technology, guidelines are needed to help the user in the fabrication process. However, such guidance is not currently available for all applications. This paper dives into design methods in AM and their transfer to an application example in the field of medical technology. The aim of this paper is to analyse the transferability of a design method for vessel models to small vessel models. To this end, an initial printing study is carried out on simplified hollow structures.

In 2020, during the early days of the COVID-19 pandemic, the British Journal of Psychiatry (BJPsych) established a series of free online teaching sessions called BJPsych Journal Clubs. Their educational purpose is two-fold: (a) to provide junior psychiatrists with a friendly but large-scale platform to evaluate and critically appraise recent articles published in the BJPsych and (b) to present new research findings in an open and accessible manner. In this paper, we discuss our framework, the challenges we encountered, how the original model is evolving based on feedback from trainees, and tips for success when delivering international online journal clubs.

Email is a major means of communication in healthcare and it facilitates the fast delivery of messages and information. But email's ubiquity has brought challenges. It has changed the way we get things done, and working days can be dictated by the receipt and reply of multiple email messages, which drown out other priorities. This article examines email's advantages and disadvantages and, with a focus on healthcare professionals, examines what individuals and organisations can do to ensure email works for us, rather than – as can seem the case – the other way around.

Across medicine, key scientific advances in the past couple of decades have deepened knowledge of fundamental mechanisms of disease, leading to new treatments and the possibility of increased personalisation of care. Some of the most important developments in fields as diverse as immunology, the microbiome, genetics, stem cells and artificial intelligence are summarised in this article to raise awareness among psychiatrists and to help understand the opportunities and challenges they may present for mental healthcare in the future.

Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public–private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) clearances and innovative product introductions. An overview of the mTBI problem and landscape was performed. A detailed situation analysis of an example of a PPP yielding an innovative product was further demonstrated. The example of PPP has led to multiple FDA clearances and product introductions in the TBI diagnostic product category where there was an urgent military and public need. Important lessons included defining the primary public and military health objective for new product introduction, the importance of the government–academia–industry PPP triad with a “collaboration towards solutions” Quality-by-Design (QbD) mindset to assure clinical validity with regulatory compliance, the development of device comparators and integration of measurements into a robust, evidence-based statistical and FDA pathway, and the utility of top-down, flexible, practical action while operating within governmental guidelines and patient safety.

The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the “translational valleys of death” requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine–engineering–industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.

Background: The adoption of new medical devices and diagnostics is often hampered by lack of published evidence which makes conventional health technology assessment (HTA) difficult. We now have 5 years’ experience of the Medical Technologies Advisory Committee of the National Institute for Health and Care Excellence (NICE) in the United Kingdom, addressing this problem. This committee assesses devices and diagnostics against claims of advantage, to produce guidance on adoption for the health service.

Methods: We have reflected on the practical, technical, and intellectual processes we have used in developing guidance for the health service.

Results: When scientific and clinical evidence is sparse, promise and plausibility play an increased part in decision-making. Drivers of promise include a clear design and mechanism of action, the possibility of radical improvement in care and/or resource use, and improving health outcomes for large numbers of patients. Plausibility relates to judgements about the whether the promise is likely to be delivered in a “real world” setting. Promise and plausibility need to be balanced against the amount of evidence available. We examine the influence they may have on decision-making compared with other factors such as risk and cost.

Conclusions: Decisions about adoption of new devices and diagnostics with little evidence are influenced by judgements of their promise and the plausibility of claims that they will provide benefits in a real-world setting. This kind of decision making needs to be transparent and this article explains how these influences can be balanced against the use of more familiar criteria.

Objectives: The Centers for Medicare and Medicaid Services (CMS) issues National Coverage Determinations (NCDs) for medical interventions expected to have a significant impact on Medicare, the health insurance program for US citizens aged 65 years and older and certain people with disabilities under the age of 65 years. The objective of this study was to evaluate NCDs issued from 1999 to 2013 to identify key trends, and to discuss implications for future CMS policy.

Methods: We used the Tufts Medical Center Medicare National Coverage Determination Database to examine characteristics of NCDs from 1999 through 2013. We examined various characteristics of NCDs, including: whether the intervention under review is used for prevention or treatment of disease, the type of intervention considered, evidence limitations cited by CMS, and coverage determination outcome. We evaluated longitudinal trends in categorical and continuous variables in the database, using Cochran-Armitage trend tests and linear regression, respectively.

Results: We found that NCDs increasingly focus on preventive care (p = 0.072), pertain to diagnostic imaging (p = 0.033), and evaluate health education/behavioral therapy interventions (p = 0.051). CMS increasingly cites the lack of relevant outcomes (p = 0.019) and the lack of applicability of study results to the Medicare population (p < 0.001) as evidence limitations. CMS less often restricts coverage to certain population subgroups in NCDs (p < 0.001), but increasingly applies coverage with evidence development policies (p < 0.001).

Conclusions: Identified trends reflect broader changes in Medicare as CMS shifts its focus from treatment to prevention of disease, addresses potentially overutilized technologies, and attempts to issue flexible coverage policies.

Objectives: Medical technology is a large and expanding industry. Introducing new medical devices is important but several challenges exist in implementing the optimal method of evaluation. Both objective and subjective measures can be used for evaluation. The former is the mainstay of evaluation, yet subjective assessment is often the basis for the introduction of new medical technology. The aim of this study was to determine the interaction and concordance between objective and subjective assessment of new medical technology.

Methods: This study used both objective performance measures and subjective user perceptions in the evaluation of a new medical device designed to improve the accuracy of gravity-assisted delivery of intravenous fluids, compared with the current, widely used “roller-clamp” device. The concordance of objective and subjective assessments was evaluated using comparative analysis.

Results: Objective assessment of the accuracy of intravenous fluid delivery revealed no difference between the two devices (p = .636). Subjective assessment revealed that the new device was perceived to be significantly more accurate (p = .001). This lack of concordance can be partially explained by both device and demand characteristics.

Conclusions: This case study reveals a significant discordance between the objective and subjective assessments. It provides some explanation for why new medical devices are adopted without objective evidence of benefit. This phenomenon has been termed “persuasive design” and its influence should be controlled for in the evaluation, purchase and introduction of new medical devices. This should help reduce the risk and associated cost of premature introduction.

This paper was originally written for a conference entitled ‘The Future of Medical History. Now it ought to be clear – certainly to historians – that the future of anything is hard to predict; but at least in the short term, any future for medical history seems likely to include the history of disease, and the history of coronary heart disease (CHD) provides an excellent example of what the history of disease has to offer to a wide range of audiences.

The article gives a global overview of the 14 years of signposting experience of the Health Council of the Netherlands. The Council signals new health care technologies and emerging health care problems in briefs, comprehensive reports, and bulletins. Its main purpose is to provide the government with timely information to support rational policy decision making.

Objectives: This study describes the diffusion of advanced diagnostic devices in India and assess implications for efficiency in resource use and equity.

Methods: Commodity-level import statistics, household survey data, and interviews with medical device sellers are used to assess the spread of diagnostic devices. Published qualitative evidence, case studies of diagnostic service providers, and cross-country analyses are used to identify the reasons underlying the spread of medical devices in India. Case studies of public and private providers and data from 150 hospitals in one Indian state are used to assess efficiency in resource use and the distributive impacts of diagnostic devices.

Results: High-end medical device inflows rose during the 1990s, with both supply- and demand-side factors influencing this trend. Although our results suggest that the overall quantity of advanced diagnostics in India is not excessive, there is some evidence of inefficiency in public facilities and possibly unethical practices in private diagnostic facilities. The unequal geographical distribution of magnetic resonance imaging facilities, coupled with inefficient use of medical devices in public facilities suggests inequality in access.

Conclusions: The study points to major regulatory gaps and health system inefficiencies and suggests ways in which these gaps can be addressed.

Objective: To analyze the rates and influences on the adoption of three selected health technologies: statins, coronary stents, and magnetic resonance imaging (MRI).Methods:A retrospective diffusion study using primary care prescribing data and questionnaire responses from acute hospital trusts in the West Midlands region (population 5.3 million or 10% of England).

Results: The selected technologies had markedly different diffusion curves. Statins diffused rapidly soon after launch. Coronary stents were initially used 6 years after first availability, but within 2 years all responding hospitals reported using them. MRI scanners were initially purchased 6 years after first availability with a subsequently slow rate of diffusion, and are still absent from some hospitals. Influences on the adoption of each technology were different. Commercial marketing was reported as a major influence on the diffusion of statins but not at all on MRIs. Cost impact was a major negative influence on the diffusion of MRI scanners and statins, whereas enthusiastic individuals were key to the diffusion of stents.

Conclusions: Influences on adoption and consequent diffusion rates are very different for different health technologies. It is not at all clear that such diffusion patterns relate well to an optimum timing rate. This has important implications for technology gatekeepers in health care.

Eleven percent of the U.K. population holds private health care insurance, and £2.2 billion are spent annually in the acute sector of private health care. Although isolated from policy discussions about new medical technology in the National Health Service, the private sector encounters these interventions regularly. During 18 months in one company, a new medical technology was encountered on average every week; 59 leading edge technologies were submitted for authorization (18 on multiple occasions). There are certain constraints on purchasers of health care in the private sector in dealing with new technology; these include fragmentation of the sector, differing rationalities within companies about limitations on eligibility of new procedures while competing for business, the role and expertise of the medical adviser, and demands of articulate customers. A proactive approach by the private sector to these challenges is hampered by its independence. Poor communication between the public and private sectors, and the lack of a more inclusive approach to policy centrally, undermine the rational diffusion and use of new medical technology in the U.K. health care system.