Medical Device Link.

DESIGN

Seeking best practice in innovation

New product development (NPD) is critical to the ongoing success of the medical device and related health-care industries. Companies constantly need to update their product portfolio to remain competitive in the global market that characterises this sector. Whereas the pharmaceutical sector has a well-defined route to market, the medical device industry would seem to have a less cohesive approach to NPD. This could be because of the differing backgrounds of companies and the diversity of medical devices. To more effectively understand the procedures and processes that are prevalent in the medical device manufacturing industry, a survey of current approaches to NPD in the United Kingdom (UK) and Ireland has recently been undertaken. This study is being conducted as part of the research activities of the Engineering and Physical Sciences Research Council (www.epsrc.ac.uk), which is funding the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH ) programme (www.match.ac.uk). MATCH is a collaboration of five UK universities and a cohort of industrial partners with the aim of developing tools that can enhance the timely introduction of health-care products to the market.

Method

The survey took the form of a questionnaire that was distributed via the October 2005 issue of Medical Device Technology and also mailed directly to a range of medical device manufacturers. The aim of the questionnaire was to identify those factors, which, in the experience of the respondents, contributed most to the market uptake of a new medical device. Respondents were asked to answer questions on up to two products launched in the past five years that had differing degrees of market success. The questionnaire was structured into three interrelated sections. The first section requested general information on the respondent’s company. The second and third sections asked questions relating to the product development process of specific products and how this related to their market success or otherwise. The survey received data on 70 products. This article provides an overview of some of the major points identified during the preliminary analysis of the returns. A full appraisal of the data produced by the study will be published, see end for details.

The three factors of success

Figure 1: (click to enlarge) The internal factors that contributed most to a product’s success.

Respondents were asked to select and rank the three factors under the company’s (internal) control and three factors external to the company that contributed most to the commercial success of a new product. They were also asked if internal or external factors had the greatest bearing on the success of the product. Approximately 77% of respondents stated that internal factors had a greater effect on success than those outside the company’s control. Figure 1 shows the relative contributions of the factors concerned.

Overall, product quality, relative to competitors (as defined by the customer), was ranked as the most important factor in how the product performed in the market. Product “value” compared with that of competitors and the clinical effectiveness of the product were then ranked as the next most important aspects, respectively. The relative importance placed on these three factors illustrates the competitive nature of the sector and the role of competitor analysis. The amount of management support provided was cited as the next most critical factor. This highlights the company-wide nature of NPD and the positive effect that support from the highest level can have on a project.

Figure 2: (click to enlarge) The factors external to the company that contributed most to a product’s success.

Of the factors outside the company’s control, the level of competition and the size of the market were reported to have the greatest impact on product success followed by an unforeseen change in the market (see Figure 2). It is interesting to note that a change in the market was ranked by 22% of respondents as the most important external factor that affects success. The mean development time for products in the survey was 28 months, and hence market changes during this period must be accounted for to mitigate this risk as far as possible.

Despite the highly regulated nature of the medical device industry, regulatory issues were only cited as the most important external factor by 3% of respondents. It is interesting that no large companies in the survey ranked regulatory issues amongst the top three contributors to the comparative success of the products.

US and European differences

Figure 3: (click to enlarge) : (a) The development time, by class, of medical devices regulated by the Medical Device Directive; (b) the development time, by class, of medical devices regulated by FDA.

Figure 3(a) and (b) show the average time taken to develop devices that fall into the different classes of risk in the Medical Device Directive and United States Food and Drug Administration (FDA) regulations. As expected, in the CE-marking process, Class IIb and Class III devices take longer to develop than Class I or Class IIa. However, the real differences in mean development time are relatively small. This indicates that the increased regulatory burden associated with a higher-class device does not have a disproportionate influence on development time. Interestingly, the survey also found that within the European system, the class of device did not have a bearing on whether or not development was on schedule, that is, Class III products were no more likely to be behind schedule than lower class devices.

In the case of FDA-regulated devices, Class III products take on average 8–15 months longer to develop than a Class I or Class II. This reflects the differences in the Class III premarket approval (PMA) and Class I and II premarket Notification (510(k)) routes to market.

Overall, it was deemed to be the complexity of a new product that had a greatest effect on the time required for its development, rather than its regulatory classification per se. For example, a minor update of an existing product took on average 15 months to develop compared with 30 months required for a major upgrade to an existing device; or the provision of a new product using existing technology; or the development of a new product using a new technology.

Summary of findings

The initial findings of the study have confirmed that the medical device market is highly competitive and that product quality and increased value compared with competitors have the greatest effects on the likely success of a new product. The market size and level of competition are also vital elements in predicting success. Not unexpectedly, engagement of management plays a critical role in supporting development projects. The regulatory environment does not seem to have an overbearing impact on the sector. Manufacturers were able to control the effect on development time of the increased regulatory controls that exist for the higher risk classes of device.

Although the initial phase of the survey has been completed, there is still an opportunity to contribute to the ongoing aspects of the study. The survey is available to complete online at www.match.ac.uk or a paper copy is available by sending an e-mail request to: d.dixon@ulster.ac.uk

Dr D. Dixon* is a Lecturer, A. Brownis a Research Fellow, andProfessor B.J. Meenan is Professor of Biomedical Materials at the Northern Ireland Biomedical Engineering Centre, University of Ulster, Shore Road, Newtownabbey BT37 0QB, Northern Ireland, tel. +44 2890 368 925, e-mail: d.dixon@ulster.ac.uk and Dr J. Eatock is a Research Fellow at the School of Information Systems, Computing and Mathematics, Brunel University, Uxbridge UB8 3PH, UK.

* To whom all correspondence should be addressed.