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The European Union (EU) Medical Device Regulations (MDR) 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study aims to investigate the impact of these strengthened requirements on medical device manufacturers by investigating the challenges they encounter while generating an MDR-compliant clinical evaluation report.

A systematic literature review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method of peer-reviewed literature and various government jurisdictional reports and legislation.

The findings from the study understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant clinical evaluation report. Resulting from the challenges they are facing, manufacturers of certain CE-marked medical devices are planning to remove (and have removed) devices from the EU market upon expiration of their certificate, and in the case of new and innovative devices, some manufacturers are planning to launch in other markets ahead of the EU. These challenges will lead to a potential shortage of certain medical devices in the EU and a delay in access to new devices, thereby negatively impacting patients’ quality of life.

This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the EU. A limitation is the lack of literature analysing the regulations and their effects.

This study has both theoretical contributions in that, to the best of the authors’ knowledge, it is the first detailed and systematic review of the new MDR Regulations and has implications for practice as manufacturers and policymakers can leverage it alike to understand the challenges of the new MDR.

This study aims to provide insights into the scale and use of information and communication technology (ICT) in managing medical devices in the National Health Service (NHS), with a focus on reverse exchange (RE) systems as a part of the broader reverse logistics (RL) systems, within which medical devices are returned and exchanged.

Two case studies were conducted with NHS Hospital Trusts, whilst another was built upon secondary resources. Primary findings were triangulated with the information collected from the NHS Trusts’ reports, direct observation and a preliminary round of consultations with 12 health-care professionals working in other NHS Trusts or Integrated Equipment Community Services.

The findings of this paper suggest that the sophistication of ICT implementation increases with the risks and value associated with medical devices. Operational attributes are derived from ICT implementations which can positively affect RE performance. The forces that drive the adoption of ICT in the NHS include pressure from government, business partners and patients; competitive pressure; perceived benefits; organisation size; top management support; and the availability of sufficient resources. Obstacles are mainly centred around the lack of sufficient resources.

Although the trusts that participated in this research are representative of different regions, the generalisation of the study results may be limited by the size of the sample organisations, so the results can only provide insights into the research problem. As this work is exploratory in nature, there is insufficient data on which to form definitive recommendations.

NHS Trusts may use the six operational attributes identified and verified by the case studies to benchmark their ICT implementation for device management. The actual and potential benefits of ICT implementation could inform technology development and encourage the uptake of ICT in healthcare. Governmental bodies can utilise this information to develop directives to actively drive ICT adoption in device management and the associated RE system. A well-considered training programme is needed to improve staff ICT skills to fully realise the potential of ICT systems which support the effective RE of medical devices.

The results of this paper suggest that the reverse management of medical devices backs up the supply chain attained through using ICT, which in turn reduces capital costs, medical risk and increases the finance available for frontline medical treatment.

Medical device industry in India is a niche sector with few key players but it possesses huge potential for both domestic and international trade. In recent years, a number of regulatory relaxations have been provided to medical device manufacturers in India to enhance production and further trade especially exports. Though the industry is highly dependent on imports, the purpose of this paper is to identify key medical devices using the revealed comparative advantage, which can be exported from India by identifying new markets.

For the selected medical devices, India’s exports to the world and the newly identified markets are forecasted using the autoregressive integrated moving average model of regression.

It is seen that three major medical devices emerge to be the ones where India has the capacity and potential to manufacture and export. These medical devices are electro-cardiographs, magnetic resonance imaging apparatus and oscilloscopes and oscillographs being exported to the USA, Australia; China and the USA, respectively, which is rising in recent years.

As the forecasted values indicate that there is an increasing potential in exports from India to the world of the selected medical devices, there is an urgent need to develop this industry and enhance exports from India. Very few studies have been carried out to examine and forecast exports from specific sectors or industries which is the need of the hour now.

The paper also provides suggestions to exporters and policymakers on leveraging the future export potential of selected medical devices.

Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD).

Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation.

Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research.

A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 – “Medical Devices – Quality Management System – Requirements for Regulatory Purposes” – in the perspective of medical device industries in Malaysia. The study is focused on the Malaysian Small and Medium Enterprises (SMEs) which currently have accredited to ISO 9001:2000 quality management systems.

Literature research and comparative analysis between ISO 13485:2003 and ISO 9001:2000 standard and requirements. A reference model is developed to assist the Malaysian SMEs towards ISO 13485:2003 accreditation.

Unlike ISO 9001:2000, ISO 13485:2003 stresses the safety and efficacy of medical devices that are being produced. For this reason risk management is an essential process that needs to be adopted into the ISO 13485:2003 quality management system. Moreover, to demonstrate the effectiveness of the ISO 13485:2003 implementation, this standard has placed great emphasis on documentation requirements which are more prescriptive in insisting on the use of formal procedures.

The paper provides guidelines to ISO 13485:2003 implementations as well as risk management approaches for small and medium‐sized businesses of Malaysian medical device manufacturers, which at the same time maintains its ISO 9001:2000 certification.

The purpose of this paper is to familiarize the reader with the capabilities of EFAB technology, a unique additive manufacturing process which yields fully assembled, functional mechanisms from metal on the micro to millimeter scale, and applications in medical devices.

The process is based on multi‐layer electrodeposition and planarization of at least two metals: one structural and one sacrificial. After a period of initial commercial development, it was scaled up from a prototyping‐only to a production process, and biocompatible metals were developed for medical applications.

The process yields complex, functional metal micro‐components and mechanisms with tight tolerances from biocompatible metals, in low‐high production volume.

The process described has multiple commercial applications, including minimally invasive medical instruments and implants, probes for semiconductor testing, military fuzing and inertial sensing devices, millimeter wave components, and microfluidic devices.

The process described in this paper is unusual among additive fabrication processes in being able to manufacture in high volume, and in its ability to produce devices with microscale features. It is one of only a few additive manufacturing processes that can produce metal parts or multi‐component mechanisms.

The purpose of this paper is to examine knowledge creation and technological diversity management by medical device manufacturers, to identify strategic directions for innovation in the medical device field.

This paper uses two types of data to assess the importance of multiple technologies and technological diversity in product development: patent applications and approvals of medical devices for sale and use in medical treatment. Additional perspective is provided by the results of a survey of management styles.

While knowledge‐creating innovation frequently combines multiple technologies, the scope of technological diversity, the variety of types of technology combined may be wider in low‐risk than in high‐risk innovation.

The sample size is too small to justify claims of statistical significance. This research should be extended to incorporate more cases and explore the theme in greater depth.

Companies that choose a high‐risk strategy are likely to be more focused on related multiple technologies with which their researchers are already familiar. Conversely, companies that choose a low‐risk strategy may have more room to experiment since, if something goes wrong, the risk to patient health is lower. Innovative medical device enterprise to seek high‐risk device development is proposed to manage optimal diversity for it.

This paper analyses two case studies relevant to growing interest in technological diversity and knowledge management in knowledge‐driven innovation in the medical device industry in Japan.

The purpose of this paper is to investigate the factors associated with consumer’s intention to adopt wearable technology in healthcare, and to examine the moderating effects of product type on consumer’s adoption intention.

An integrated acceptance model was developed based on unified theory of acceptance and use of technology 2 (UTAUT2), protection motivation theory (PMT), and privacy calculus theory. The model was tested with 462 respondents using a survey.

Consumer’s decision to adopt healthcare wearable technology is affected by factors from technology, health, and privacy perspectives. Specially, fitness device users care more about hedonic motivation, functional congruence, social influence, perceived privacy risk, and perceived vulnerability, but medical device users pay more attention to perceived expectancy, self-efficacy, effort expectancy, and perceived severity.

This study is among the first to investigate healthcare wearable device from behavioral perspective. It also helps to comprehensively understand emerging health information technology (HIT) acceptance from technology, health, and privacy perspectives.

Aims to review polymeric materials used as adhesives and the related bonding procedures applicable in the medical industry.

The main types of polymeric materials used as adhesives are described. Details and the main points of the adhesive bonding processes are also described with comments on their adaptability to automated assembly. Finally, typical examples of the use of adhesives in medical device applications are provided.

Review paper with examples of applications of adhesives in assembly of medical materials and devices.

The appropriate selection of adhesive types and bonding parameters are critical for successful application of this technology in joining medical materials. Most currently available medical grade adhesives are only suitable for short‐term (<30 days) implantable application. The users must ensure that the properties of the selected adhesives, particularly the relevant biocompatibility and toxicity data are available and fully comply with any specific medical device application and regulation.

Although this is a general review paper, it contains information about new materials and processing techniques applied in successful application of adhesive bonding technology in medical devices. The information provided is expected to be of significant benefit to material scientists and design engineers evaluating and identifying suitable joining techniques for the assembly of medical devices.

Medical device users are one of the principal medical device technology stakeholders. The involvement of users in medical device technology development and assessment is central to meet their needs. This study aims to examine this issue.

A structured review of the literature published from 1980 to 2005 in peer‐reviewed journals was carried out from a social science perspective to investigate user involvement practice in the development and assessment of medical device technologies. This was followed by a qualitative thematic analysis.

Medical device users include clinicians, patients, carers and others. Different kinds of medical devices are developed and assessed by user involvement. The user involvement occurs at different stages of the medical device technology lifecycle and the degree of user involvement is in the order of: design>testing and trials>deployment>concept stages. The methods most commonly used for capturing users' perspectives are usability tests, interviews and questionnaire surveys.

The relevant engineering, medical and nursing literature, which might have been useful, was not reviewed. However, useful findings emerge that apply to health care generally.

This study shows that medical device users are not homogeneous but heterogeneous in several aspects, such as needs, skills and working environments. This is an important consideration for incorporating users' perspectives in medical device technologies.