Biomedical, the Italian health industry starts from Mirandola

With 502 active companies, almost 17 thousand employees, more than half of whom are university graduates, and 130 million euros invested in research and development (12.9% of the national total), Emilia-Romagna confirms itself as a strategic hub for the medical device industry. A supply chain that in the region generates 660 million euro of annual production, employs 13% of the national workforce in the sector, and has in the Mirandola district, known as the Italian biomedical 'Silicon Valley', the leading European hub for disposable devices, third in the world after Minneapolis and Los Angeles. An excellence not only in terms of volume, but of technical know-how and capacity for integration between manufacturing, research and healthcare that has attracted the largest foreign multinationals in half a century.

It is from here, from Modena, that Confindustria Dispositivi Medici has chosen to launch the national roadshow 'Together for a Country in Health', celebrating the association's 40th anniversary. "It is not a symbolic choice," explains president Nicola Barni, "but the recognition of an advanced, resilient and deep-rooted industrial model. Large groups and innovative SMEs, universities and research centres, advanced technical training and advanced manufacturing coexist in Mirandola. It is an industrial laboratory where high added-value solutions capable of competing in the world are born. Our priority now is to enhance these aggregations and strengthen the strategic identity of the sector for Italy'.

According to the Confindustria Dispositivi Medici Study Centre, 68% of biomedical companies in Emilia-Romagna operate in direct production, a record in manufacturing presence. Likewise, the figure of almost 9% of the total workforce working in R&D is out of the norm, with a level of qualification among the highest in the entire manufacturing sector (51.6% of workers have at least a university degree, 3.4% a doctorate) and with an anomalous gender balance for a sector perceived as technical and male: 44% of the workforce is female, in a sector that is still. 'Investing in medical devices means investing in health, and therefore in the competitiveness of the entire country system,' Barni reiterates. "It is a supply chain that touches all areas of care, from surgery to diagnostics, from cardiology to home treatments. Yet today it is still treated as a marginal item in the healthcare system, rather than as a strategic lever for industry and research'.

The sector, however, is today put at risk by excessively rigid European regulations, a penalising taxation system, and a mechanism that is 'crazy in the eyes of any international investor, such as the payback', is the chorus in unison that rises from the headquarters of Confindustria Emilia Area Centro, which hosted the first stage of the roadshow. 'We have already presented proposals to overcome the payback to the government,' says Guido Beccaguti, the newly appointed general director of Confindustria Dispositivi Medici, 'but we need a political breakthrough. In Germany I met my counterpart a few days ago and he told me that the sector has been recognised as strategic by the new Chancellor Merz. In Italy, on the other hand, we have to deal with an unfair regulation and an additional 0.75 per cent taxation on supplies to private individuals'. Adding to the difficulties are the European regulatory rigidities: 'We cannot wait two years for a CE mark. The regulatory agencies are thinking about fast track, we need a real alignment between industrial policy and health regulation'.

The alarm resounds loudly in the Modena district. "In Mirandola we manufacture 80% of the world's cardiopulmonary machines. Here there is unique know-how on plastics and medical production. But we need rules that allow those with good ideas to turn them into businesses in competitive times," points out Luciano Fecondini, founder of Medica: "Today it costs five times more time to innovate than in the past. We have made it because we have passed the critical threshold, but many SMEs cannot withstand the impact of an MDR (Medical Device Regulation in force from 2021, ed.) designed like a pharmaceutical regulation'. For Franco Poletti, historic manager of the Livanova group, "Mirandola is confirmed as a global production centre, we manage the cardiopulmonary business from here with 1,770 employees and investments in R&D worth 10% of the 800 million euro turnover. The district has unique know-how in plastics and industrial integration. But the risk is that these skills will be dispersed if we do not ensure continuity in the supply chain'.