Medical Device Link.

MARKETPLACE

Fears over device purchasing

The effects of the two important changes introduced by the Italian Ministry of Health (MoH), the Ministero della Salute,¹ on 16 March 2007 are yet to be seen. First, the MoH has approved the national classification of medical devices, the Classificazione Nazionale dei Dispositivi Medici. Second, there is a new registration procedure for medical devices at the MoH’s data bank, the Repertorio.

Companies submitting medical device tenders to the Italian national health service, the Servizio Sanitario Nazionale (SSN) must comply with the new procedure, which comes into force on

• 1 August 2007 for medical devices being sold in Italy for the first time
• 1 January 2009 for all other medical devices currently registered under the former procedure.

After those dates, the SSN will not be able to buy, use or provide any medical devices that have not been registered in the Repertorio according to the new procedures. Registration requires a payment of €100 for each “single” device. “Single” device is defined as each technical file. Further explanation of the requirements will be available on the MoH’s web site: www.ministerosalute.it

With these new regulations, the MoH aims to increase SSN’s supervision of medical devices. It also seeks to give hospitals a tool to better control their expenses, one that allows them to compare the features of the products available on the market. These products will be grouped homogenously according to the new national medical device classification system. Overall, the measures are designed to control health-care expenses in Italy, which in 2005 increased to €92.8 million, equivalent to a per capita spend of approximately €1,600. Spending on medical devices increased although this sum represents less than 5% of total health-care expenditure.

Industry is concerned that with this new classification system competitive advantage in terms of the efficacy of some medical devices will be scarcely visible by the SSN, because medical devices will mostly be grouped homogeneously in their main product classifications. Manufacturers fear that the lowest price will become the decisive factor in purchasing decisions.

The local perspective

The Mirandola biomedical district (province of Modena, Northern Italy) is composed of more than 70 companies and 4,300 employees and has a total turnover of approximately €700 million.² After a slowdown in 2005, the growth recorded in 2006 was 10.4% with an increase of 7.8% in orders from abroad. ³

The district is characterised by a variety of companies that cover the majority of the production chain. They include manufacturers of medical devices, medical equipment and components for medical devices; and subcontractors involved in the assembly of medical devices and medical equipment, and moulding and sterilisation services.

Production in Mirandola has always shown great capabilities for technological innovation and an international perspective. These elements, combined with the need to create new opportunities by exchanging technical and scientific knowledge and information, prompted the institutions in the area to create the “Quality Center Network” project. Participating organisations include the hospitals of the Province of Modena, entrepreneurial associations and the University of Modena and Reggio Emilia. The main goal of this project is to educate students studying for their degrees or specialising in advanced biomedical technologies. Companies will have a source of qualified personnel and will have a reference point for collaboration when defining the criteria for clinical and preclinical testing of new generation biomedical products. Performance, efficiency, safety, and economic and organisational skills are the common interests of the parties involved in the project as they work together on developing and testing new medical devices.

Events

Other initiatives to support the development of local production of medical devices through collaboration between research and companies have become firmly established. These include the
following events.

• ImpresaModena e Ricerca⁴ is a series of technical and scientific seminars with some sessions dedicated to the medical industry, for example, packaging, innovative materials and surface treatment and biocoatings.
• R2B Research To Business⁵ is an annual event that will take place in Bologna, Italy, on 3–4 May 2007. Many of the leaders in Italian and international research will present technological innovation, research results, prototypes and new products as well as services for entrepreneurs. Also attending will be financiers willing to support technology transfer.
• RIMAT Biomed⁶ will hold its annual meeting on 26–27 October 2007. The event will focus on research, medical devices and researchers, manufacturers and users are invited to attend.

Looking to the future

Some companies have already concentrated their production on higher added value undertaken locally and moved production of standardised, less valuable products abroad where labour costs are lower. Other companies will do the same in the coming years. Innovation does not take great leaps, but rather follows incremental progression. Time will tell if the initiatives designed to support the increase of technological and scientific capabilities of local companies will help to increase the value of the Mirandola biomedical district. The companies are, however, aware that increasing the range of products they offer and those of the market they serve are the way to be more competitive in the future.

Paolo Galavotti is General Manager of Nexion srl, Via 2 Giugno 111, I- 41037 Mirandola, Modena, Italy, tel. +39 0535 27880, e-mail: paolo.galavotti@nexion.ws