Symba : an exploration of appropriate medical device design for the South African context

Abstract: Medical devices are essential for the successful delivery of almost every form of health care. The medical device industry is currently one of the fastest-growing and dynamic sectors of the global economy. However, the global market is heavily dominated by high-income countries (HICs) with low to middle-income countries (LMICs) constituting only 13% of the global market. As a result, up to 80% of medical devices in LMICs are donated or imported. A medical device needs to be appropriate for the context in which it is intended. Imported medical devices, which are manufactured for use in high-income countries, however, are often inappropriate and ineffective when used in low-resource settings. This results in approximately 40% of donated/imported medical devices being out of service, 70–90% never functioning as intended, and up to 98% broken within five years. The lack of appropriate medical devices in LMICs suggests the need for a shift towards a more human-centred, design-orientated medical device industry, which promotes local manufacture. Like many LMICs, South Africa’s local medical device industry is underdeveloped. Approximately 90-95% of medical devices in South African hospitals are imported/donated. However, in a 2014 World Health Organisation feasibility study, South Africa showed great capacity to support the local production of medical devices. Furthermore, recent success stories such as Jed Aylmer’s Symba paediatric bed indicate that local designers and manufacturers can successfully compete with international suppliers of sophisticated equipment - highlighting an opportunity for increasing medical device design in South Africa. This paper presents the design process followed in the development of Symba in the form of a retrospective case study. The purpose of the paper is to share appropriate local design strategies, which better enable local industrial designers to pursue more appropriate medical device design outcomes in the South African context

How the domestic industry of Costa Rica became more competitive in the US market. Antecedents and Trends

Purpose - The aim of this work is to study the reorientation that the export industrial sectors in Costa Rica have experienced during the last 20 years. Research design, data, methodology - The study employs the Cluster Analysis with the export data (20 years of cut-off period) from Costa Rica to the U.S-market. To make the predictions, the technique of the time series was used, with official data (from 2001 to 2010) from the U.S. Department of Commerce and the U.S. International Trade Commission. Results - The Cluster Analysis, show how the economic sectors of traditional products exports of Costa Rica have progressively become in exporters of non-traditional products, meanwhile,the time series confirms that this trend will continue, at least during the next five years. Conclusions - The industry of traditional products exports of Costa Rica (dressmaking, vegetables, coffee, mate, species, etc.) will progressively become in exporters of non- traditional products with a high-tech component (i.e., mechanical equipment and devices, electronic devices and medical equipment),as a consequence of the Chinese (Costa Rica’s main competitor) economy´s presence in the Organization for Economic Co-operation and Development (OCDE). This fact has enabled the potential improvement of Costa Rica’s international competitiveness in the U.S. market

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

Liability in the medical sector : the ‘breast-taking’ consequences of the poly implant prothese case

The article deals with the liability of third-party certifiers in the medical sector and especially focuses on the role of TuV Rheinland in the recent Poly Implant Prothese (PIP) breast implant case. The aim of the contribution is twofold. Firstly, it provides an overview of the different challenges that courts face when having to decide on the liability of certifiers of medical devices towards third parties. These, for instance, relate to the strict conditions under which certifiers can incur third-party liability under national law. Whether product certifiers can be held liable depends on the jurisdiction where the claims have been filed. Therefore, the PIP breast implant case is also interesting from a private international law perspective. Third-party certifiers can be sued before the courts of their domicile. Whether they can be brought before courts in other Member States depends inter alia on the interpretation of the place of the damaging event and the place of the damage. The difficulty to pinpoint these locations not only emerges in the field of jurisdiction but also manifests itself within the search for the applicable law as identical connecting factors are employed in that area of private international law. Secondly, the article examines the decisions that have been issued by national courts in the PIP breast implant case. Rulings in France and Germany denied compensation for patients who purchased the defective breast implants. The PIP case is currently pending before the European Court of Justice (ECJ). It thus remains to be seen what stance the ECJ will take and especially what the consequences might be for certifiers in the medical sector. Based on the analysis of these decisions, the contribution puts forth a number of reasons why the threat of liability seems the most effective way to guarantee that third-party certifiers issue accurate and reliable certificates. This in turn ensures that only safe medical devices are placed on the European market and safeguards the health of consumers. Future scandals with medical devices might in this way be prevented

Complexity stage model of the medical device development based on economic evaluation-MedDee

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost-time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents' responses, were conducted. The authors have proposed the complexity model MedDee-Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.Web of Science125art. no. 175

An exploratory survey of current practice in the medical device industry

This article is (c) Emerald Group Publishing and permission has been granted for this version to appear here. Emerald does not grant permission for this article to be further copied/distributed or hosted elsewhere without the express permission from Emerald Group Publishing Limited.Purpose – This study seeks to examine the extent to which mainstream tools and strategies are applied in the medical devices sector, which is highly fragmented and contains a high percentage of small companies, and to determine if company size impacts on manufacturing strategy selection. Design/methodology/approach – A questionnaire was developed and disseminated through a number of channels. Responses were received from 38 companies in the UK and Ireland, describing 68 products taken to market in the past five years. Findings – Because of the limited scope of the survey, the findings are indicative rather than conclusive, and interesting trends have emerged. New to the world products were much more likely to exceed company expectations of market success compared to derivative products. It was found that the majority of these innovative products were developed by small companies. Large companies appear to favour minor upgrades over major upgrades even though these prove – on the data presented – to be less successful overall. Practical implications – These results provide those engaged in this sector with comparative information and some insights for further improvement. The reported trends with respect to company size and product complexity (or degree of novelty) are particularly illuminating. Academically, this sets some expected trends on a firmer footing and unearths one or two unexpected findings. Originality/value – It is believed that this is the largest survey of determinants of success in UK medical device companies and it provides a comparison with other sectors

User involvement in healthcare technology development and assessment: Structured literature review

Purpose – Medical device users are one of the principal stakeholders of medical device technologies. User involvement in medical device technology development and assessment is central to meet their needs. Design/methodology/approach – A structured review of literature, published from 1980 to 2005 in peer-reviewed journals, was carried out from social science perspective to investigate the practice of user involvement in the development and assessment of medical device technologies. This was followed by qualitative thematic analysis. Findings – It is found that users of medical devices 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 stage > testing and trials stage > deployment stage > concept stage. Methods most commonly used for capturing users’ perspectives are usability tests, interviews and questionnaire surveys. Research limitations/implications – We did not review the relevant literature published in engineering, medical and nursing fields, which might have been useful. Practical implications – Consideration of the users’ characteristics and the context of medical device use is critical for developing and assessing medical device technologies from users’ perspectives. Originality/value – This study shows that users of medical device technologies are not homogeneous but heterogeneous, in several aspects, and their needs, skills and working environments vary. This is important consideration for incorporating users’ perspectives in medical device technologies. Paper type: Literature review