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The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way.

When a company comes up with an innovation in medical device technology, where can it go from there to transfer its product into the hands of consumers? If the technology is patented, the company has the option to license it. Alternatively, the company may want to move forward with further product development and marketing on its own (whether patented or not). Getting a medical device into any market typically requires regulatory approval, which cannot be obtained without a quality system. This paper focuses on the foundations of establishing a quality system and obtaining certification and regulatory approval in Canada, the EU, and the USA, and is directed towards small medical device manufacturers. It describes the process within four phases that cover the initial start up, implementation of procedures, certification and regulatory approval, and continual improvement.

Establishing a quality system is a monumental task for any company, but especially so for a small one. However, the benefits of implementing a quality system outweigh the initial setbacks associated with doing so. The descriptions of phases in tandem with the DIY tips presented in this paper are intended to be of help to a small medical device manufacturer wanting to bring their innovative technology to consumers within a major marketplace.

This is an original paper written for the Third Canadian Quality Congress.

The purpose of this paper is to examine a unique marketing and legal problem that manufacturers of prescription drugs and medical devices face in the USA, under the theory of “overpromotion” and the Learned Intermediary Doctrine (the LID), and suggests a solution to the problem.

The study uses a critical review of the literature and decided legal cases to analyze the problem of direct-to-consumer advertising of prescription drugs and medical devices under the LID and “overpromotion” doctrines.

The study suggests a different approach to advertising drugs that divides the audiences into primary and secondary targets to immunize drug and medical device manufacturers against liability.

Because the laws guiding advertising are different in different countries, the findings of this study are relevant only to the US market.

The paper gives practical guidance on an alternative communication strategy that could immunize drugs and medical device manufacturers against liability.

The study uses knowledge of law and marketing to tackle an issue that, even though is useful and relevant, is rarely discussed in the marketing literature.

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 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.

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 analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the Centers for Medicare and Medicaid Services (CMS) national coverage determinations (NCDs) of medical devices.

The paper analyzes the impact of Parallel Review on medical device innovation, focusing in particular on the causes for low popularity of the program among medical device manufacturers. Program outcomes are evaluated in the light of its intended goals.

The paper identifies four reasons for the program’s limited impact. First, few devices are eligible to participate. Second, most manufacturers prefer to seek Medicare reimbursement at the local level as less risky than the CMS NCDs. Third, participation in the Parallel Review might actually delay the marketing of the device. Fourth, the program does not address numerous obstacles that device sponsors currently encounter. While giving the appearance of support for the medical device innovation, the policy falls short on its intended goals.

This paper elucidates the challenges to internal reform and serves as a reminder to political economists and health care researchers that to make disruptive innovation possible, we must continue to illuminate the otherwise unseen cost of marketing delays and document the ability of emergent market mechanisms to protect consumer safety.

The purpose of this paper model and prioritizes barriers to product development in medical device manufacturing industries using an integrated “structural equation modelling” (SEM) and “fuzzy technique for order performance by similarity to ideal solution” (FTOPSIS) framework.

Barriers to medical device development (MDD) are adopted from literature. The initial structural model is proposed, exploratory factor analysis and confirmatory factor analysis are used to determine factor loading and model fit, respectively. Further, FTOPSIS is used to rank the barriers and sensitivity analysis is carried to check the robustness of results. The results are discussed in detail and the recommendations to overcome the barriers are presented.

Barriers analysed and prioritized in this research significantly hinder the MDD. The expert survey is used to develop an initial structural equation model of barriers to MDD, find the reliability and validity of the model. Based on the opinion of the experts, the barriers are divided into three categories – internal, policy and induced barriers. FTOPSIS is applied to rank and prioritize the barriers based on views from these three classes of experts. More reliance on imported devices leading to increased imports (B11) and lack of uniform regulatory standards (B6) are found to have the highest rank together, indicating these to be the most important barriers from the perspective considered here. Sensitivity analysis indicates that the factors are less sensitive to the weights of criteria further confirming the reliability of the initial solution.

The prioritization of barriers may vary based upon experts. Policymakers, existing and new device developers need to give utmost importance to these barriers, which will help to accelerate the indigenous development of medical devices to overcome the present dependence on imports.

This paper demonstrates an integrated structural based modelling and prioritization technique for statistical modelling and prioritization of barriers to MDD. The results and recommendations will help policymakers and manufacturers to increase the indigenous share of medical devices. The integrated methodology can be effectively applied where the need for the combined quantitative and qualitative approach is there.

This paper demonstrates an effective structural based modelling and prioritization technique. It can be effectively applied in various fields, it will help policymakers and manufacturers to increase the indigenous share of medical devices.

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.

Successful device development brings substantial revenues to medical device manufacturing industries. This paper aims to evaluate factors contributing to the success of medical device development (MDD) using grey DEMATEL (decision-making trial and evaluation laboratory) methodology through an empirical case study.

The factors are identified through literature review and industry experts’ opinions. Grey-based DEMATEL methodology is used to establish the cause-effect relationship among the factors and develop a structured model. Most significant factors contributing to the success of MDD are identified. An empirical case study of an MDD and manufacturing organisation is presented to demonstrate the use of the grey DEMATEL method. Sensitivity analysis is carried out to check robustness of results.

The results of applying the grey DEMATEL methodology to evaluate success factors of MDD show that availability of experts and their experience (SF4) is the most prominent cause factor, and active involvement of stakeholders during all stages of MDD (SF3) and complete elicitation of end-user requirements (SF1) are the most prominent effect factors for successful MDD. A sensitivity analysis confirms the reliability of the initial solution.

The findings will greatly help medical device manufacturers to understand the success factors and develop strategies to conduct successful MDD processes.

In the past, few success factors to MDD have been identified by some researchers, but complex inter-relationships among factors are not analysed. Finding direct and indirect effects of these factors on the success of MDD can be a good future research proposition.

Infection and cross-contamination have been massive concerns in the medical field. This study aims to investigate consumers’ awareness and their choices of endoscopes, which may deter them from the cross-contamination problem.

A discrete choice experiment survey was administered to 166 respondents in Penang, Malaysia. Participants were asked to make hypothetical choices and estimate their preference for endoscopes. The multinomial logit model was used to estimate the assumptions based on the stated preference data collected.

Only two-fifths of respondents are aware of their rights regarding endoscope selection. The findings are consistent with utility theory, where choices are made to maximise personal satisfaction. If given the choice, consumers preferred the single-use endoscope over the reusable or the doctor’s preferred endoscope. Price, insurance coverage and personal income are significant determinants of the consumer’s choice of endoscopes.

This study only investigates subjects living in Penang. Other possible important attributes to endoscope choices, such as environmental and device availability may be considered in future study.

The findings may create awareness among consumers about their rights when choosing medical devices. It may also improve health-care institutions’ (users’) and device manufacturers’ (industry players’) understanding of consumer needs and demands from socioeconomic perspectives.

The research offers insights into consumer rights and awareness of health-care services. Ultimately leading to better policy to protect consumers’ rights and safety.

This study contributes to the rare literature on consumer rights toward medical devices, in particular, the consumer’s awareness of the choice of endoscopes.