Between regulation and poetry: Giuseppe Forestan, the electronic engineer who is fond of Whitman

“In 30 years, I have had two different but connected roles: Technical Manager for the first 15 years and today Quality and Regulatory Manager. It is impossible to say which of the two suits me best, because I have been, and still am, interested in both, and this has led me to want to deepen certain topics both out of personal interest and professional necessity. However, designing equipment certainly stimulated my more creative side”.

Creativity gave way to rationality, rigour and practicality in Forestan's current role, which has led him to be amongst those who managed to obtain the EU MDR certification. A certificate that, as he says

“is essential for a Company like ours”. In order to be able to sell medical devices in Europe, it is essential for a third-party body to validate their features, especially in terms of safety, functionality and performance. The EU MDR certification consists precisely of this and, compared to the previous directive, represents a radical change. In fact, the parameters on which it is based are much more stringent and the management it requires is more structured too”.

However, the impact of the activities to obtain it was, for ASA, 

“much less overwhelming than for other companies. In fact, the Company had already met many of the requirements for some time. And the remaining ones were already on the radar and it was simply a matter of speeding things up. Teamwork was decisive in order to achieve the result as well”.

This result, which was officially achieved in spring 2023, had its challenges of course.

“A major setback was the real difficulty of finding research that was scientifically rigorous and concerned devices like those produced by the Company. Clinical validation and actual evidence of their effectiveness were indeed some of the requirements to obtain the MDR. Despite the complexity of the request, we managed to provide adequate material within the defined time and in the defined ways”.

Satisfaction for ASA and for Forestan himself, who has collected other reasons for pride in his professional history.

“Certainly, seeing that some of the devices designed, as well as structures and working methods introduced in the past, are still present as best practices, makes me very proud. As does the MLS^® patent, which we worked hard for: a commitment that has been compensated by the results achieved, which have contributed significantly to the development of the Company.

However, a long career does not stop him from developing new projects to help ASA grow. 

“We certainly cannot ignore the revolution introduced by artificial intelligence. It is now a matter of understanding not only how and whether we can apply it to improve the performance of our devices, but also whether it can give added value to our Therapeutic Solutions”.