Biomedical, the Italian health industry starts from Mirandola

With 502 active companies, almost 17 thousand employees, more than half of whom are graduates, and 130 million euros invested in research and development (equal to 12.9% of the national total), Emilia-Romagna confirms its strategic position for the medical device industry. A supply chain that in the region generates 660 million euros 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 first European hub for disposable devices, third in the world after Minneapolis and Los Angeles. An excellence not only in terms of volumes, but of technical know-how and ability to integrate 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 Healthy Country”, which celebrates the 40th anniversary of the association. “It is not a symbolic choice – explains the president Nicola Barni – but the recognition of an advanced, resilient and rooted industrial model. In Mirandola, large groups and innovative SMEs, universities and research centers, high technical training and advanced manufacturing coexist. It is an industrial laboratory where high added value solutions are born that are able to compete in the world. Our priority now is to enhance these aggregations and strengthen the strategic identity of the sector for Italy”.

According to the Confindustria Medical Devices Study Center, 68% of biomedical companies in Emilia-Romagna operate in direct production, a record in manufacturing. Just as abnormal is the figure of almost 9% of total employees working in R&D, with a level of qualification among the highest in the entire manufacturing sector (51.6% of workers have at least a 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 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 health system, rather than as a strategic lever for industry and research".

The sector, however, is currently put at risk by excessively rigid European legislation, penalizing taxation and a mechanism that is "crazy in the eyes of any international investor, such as payback", is the unison chorus that rose from the headquarters of Confindustria Emilia area Centro, which hosted the first stage of the roadshow. "We have already presented the proposals to overcome payback to the Government - says the new director general of Confindustria Dispositivi Medici, Guido Beccaguti - but a political change is needed. In Germany I met my counterpart a few days ago and he told me that the sector has been recognized as strategic by the new Chancellor Merz. In Italy, however, we find ourselves having to deal with an unfair regulation and an additional taxation of 0.75% on supplies to private individuals". Adding to the difficulties are the rigid European regulations: "We cannot wait two years for a CE mark. The regulatory agencies are thinking about fast track, a real alignment between industrial policy and health regulation is needed".

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