Marketing technical medical devices is becoming increasingly difficult, especially for small companies. A closer look.
Cloé Houriet, director of the ocular technology company Fabrinal, has been trying for the past two years to market a new shunt designed to prevent ocular hypertension. However, her company has run into some hurdles. “The Swiss compliance evaluation body that we first contacted lost its accreditation. We had to start over from square one!” complains the director, whose company is based in La Chaux-de-Fonds.
In the wake of the defective breast implant scandal involving French manufacturer Poly Implant Prothèse (PIP), the European Commission decided to tighten the requirements for marketing technical medical devices. This change primarily affected certification organisations, which are tasked with certifying the product’s compliance based on the risk category it falls under. “Because of the relatively small size of the Swiss market, the country’s regulations for all types of medical devices have to be in line with the regulations in the rest of Europe,” says Bernhard Bichsel, head of the medical device division of Swissmedic, the authority in charge of market surveillance for therapeutic products in Switzerland. As a result, the country must conform to this decision by revising the requirements for compliance evaluation bodies.
These conditions are especially problematic for small companies like Fabrinal.
“Major companies have teams in place to deal with these issues, whereas smaller businesses often have trouble managing such changes,” notes Bernhard Bichsel.
Besides the additional human and financial resources that are required, companies also have a harder time obtaining the CE marking since the instrument being developed is entirely innovative and doesn’t have any equivalent on the market.
Although Switzerland wants to obtain safer and better quality medical tools through these measures, they actually risk encouraging Swiss companies to move abroad. In fact, that’s what Cloé Houriet and her team decided to do when they selected a European organisation.
“We chose the body that was most skilled in our field, ophthalmology, and picked one of the two largest to be sure we could complete the entire process,” explains the director of Fabrinal.
Despite the switch, the CE marking is still delayed because the organisation is being inundated with applications. In the United States, however, the certification procedure is faster. For this reason, Fabrinal decided to start selling its medical device there before trying to market it in Europe later on.
The association Swiss Medtech, which helps protect the interests of Swiss medical technology, says it is assessing the situation. “There are only two certification bodies left in Switzerland, and it’s hard to say if they’ll remain,” explains Jorg Baumann, legal director and deputy manager of the association. In order to help young businesses market their products and comply with new regulations, Swiss Medtech created an information and discussion platform coordinated by Peter Studer, a senior regulations expert. The organisation plans on hosting seminars to offer start-ups guidance, thereby safeguarding and encouraging the Swiss medical technology industry.