Medical Device Link.

Originally Published EMDM September 2002

REGIONAL FOCUS

Northern Italy

Northern Italy has a well-deserved reputation for medical innovation. A strong base of suppliers combined with the presence of leading multinational OEMs makes Mirandola the focal point of this region's medical industry.

Benjamin Lichtman

Sidebar: Safety in Numbers

Since the early 1960s, northern Italy has been an important area in Europe's medical industry, leading the way in the development of plastic disposables and other devices for such fields as haemodialysis, transfusion, cardiovascular surgery, and anaesthesia. Located 30 km north of Modena, the quiet town of Mirandola has served as the nexus of this activity. Mirandola is home to more than 70 companies active in the medical sector, including 36 subcontracting firms. In 2000, these companies produced combined revenues of approximately $515 million, according to a study carried out by the research institute R&I S.r.l. (Carpi, MO).

It could be argued that any attempt to understand the strength of Mirandola's medical network must include a discussion of family (this is Italy, after all). And as anyone from Mirandola can tell you, the father of the biomedical industry in northern Italy is Mario Veronesi.

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A pharmacist by training, Veronesi began as early as 1962 to lay the groundwork for what was eventually to become Italy's "Plastic Valley" in Mirandola. In his work with local hospitals, Veronesi saw a nascent market for plastic disposables to be used in IV sets. Over the next several years, he founded multiple companies to supply the medical market with components for infusion, haemodialysis, oxygenation, and related applications. The firms Miraset, Sterilplast, Dasco, Bellco, and Dideco were all started by Veronesi. As the medical industry took hold in Mirandola, a group of suppliers with highly developed technical skills has emerged to support these companies—and the rest is history.

Not only do most of the medical firms in Mirandola owe their existence to a common source, many of the local companies are also family owned and operated. Moreover, they benefit from a high concentration of skilled workers drawn from various generations in Mirandola. "In every family here, at least one person works in the biomedical field," estimates Luciano Fecondini, founder and director of Tecnoideal S.r.l., a local supplier of testing and assembly equipment. Fecondini notes that children in Mirandola are exposed to technical subject matter from an early age, a fact that contributes to the region's large pool of skilled labour. "There is added value here, and that is our knowledge base," he says.

Mirandola's medical suppliers, in turn, function as a tightly knit group of companies that can take a product from design to prototype, to production, and beyond. Dozens of highly specialized firms offer services such as moulding, extrusion, subcontracting, assembly, sterilization, instrument manufacture, and consulting. "We operate as a network in Mirandola," says Cesare Galavotti, general manager of the local contract manufacturing firm Probio S.r.l. Galavotti's cousin Paolo, who heads a local consulting agency called Nexion S.r.l., says it's not unusual to walk out of church in Mirandola on a Sunday afternoon and overhear fellow parishioners discussing engineering problems on the main piazza.

Networking comes naturally to Enki S.r.l., an extruder of medical-grade microtubing. The company was formed early this year as an offshoot of its sister firm, RI.MOS. S.r.l. Enki, which is based in Mirandola, uses special microextrusion equipment developed by a neighbouring company. "Our technical staff has 17 years of experience in the extrusion and production of catheters," says Elena Calzolari, customer service representative at Enki. "It's not just owning the machine; it's knowing how to use it," she adds, noting that the company leverages its technical know-how to produce feasibility studies, prototypes, and production simulations for its clients. According to Calzolari, thanks to its staff's extrusion expertise, customers of the company's microextrusion equipment supplier ask Enki to run tests for them to calibrate their machines.

Small Town, Big Companies

This network of interconnected suppliers, or indotto, as it is called in Italian, works because it offers manufacturers real advantages: the opportunity to bring products to market quickly while avoiding the investments associated with vertical integration. In recognition of the success of this type of decentralized approach to manufacturing, many of the industry's leading manufacturers have come to Mirandola.

"There are quite a few big multinationals here that have invested a lot of money, which is a good sign and has also made people more optimistic about locating here," says Probio's Galavotti, citing Gambro and Baxter as examples. Other multinationals with plants located in Mirandola include B. Braun, Fresenius, Snia-Sorin Biomedica, and Mallinckrodt Medical.

The presence of such influential multinational firms has certainly contributed to Mirandola's economic growth. But there have also been other, less tangible benefits. "We now understand the importance of having a network, and of making the final product in the shortest possible time," says Galavotti.

Focus on the End-User

Located in Mirandola, Probio S.r.l. offers assembly, packaging, and sterilization services to device OEMs. The company recently moved to a facility equipped with a Class 10,000 cleanroom.

Suppliers in Mirandola are also particularly sensitive to the needs of medical OEMs because in many cases, they are manufacturers themselves. Many of Mirandola's medical suppliers are also developing their own end-use products, from diagnostic imaging devices to filled IV bags. Such companies have discovered that they can leverage their expertise in the high production standards of the medical sector to give themselves a competitive edge over conventional suppliers.

An example of this type of evolution is seen in the history of the firm Aries S.r.l. The company's founder originally worked as a salesman for Becton Dickinson and founded Aries in 1996 as a distributor of anaesthetic disposables and infusion sets. The company eventually made the transition into component production by purchasing moulds for manifolds and stopcocks. Today, Aries is a supplier of plastic components for a variety of medical applications, including nutrition, infusion, and transfusion. "The key in our case was that the demand started from doctors," says Mauro Mantovani, the company's president, attributing his firm's growth trend to its focus on the needs of the end-user. "We knew the market, and we predicted where it would go," he says. Indeed, Aries is expanding; the company now has two cleanrooms and recently bought two new stockrooms. The company's strategy is now focussed on the development of proprietary devices rather than stock components.

Fecondini of Tecnoideal says that his company benefits from a similar strategy. "Tecnoideal has the mindset of a medical OEM [because of its relationship with] Medica," he says, referring to Tecnoideal's parent company, a manufacturer of finished devices and medical equipment. "So, in this way, we can anticipate our customers' needs," he adds. "In fact, we know exactly what the market wants."

The future of the medical industry in Mirandola looks bright; R&I S.r.l. forecasts a 10.5% increase in the region's revenues for 2001. In the meantime, manufacturers seeking suppliers in northern Italy may want to consult the following pages, where they will find companies from Mirandola to Milan supplying medical-grade products and services.

Copyright ©2002 European Medical Device Manufacturer