m4m Center, in short – meets the requirements of ISO standard 13485:2016; it is thus allowed to produce implants and instruments for human patients. The starting signal for promising projects with Swiss SMEs: The partner network already comprises 45 companies and research institutions.
The goal of the Swiss m4m Center in Bettlach in the canton of Solothurn is to promote ideas 3D printing has made possible in medicine. Only opened in September 2020, it has now been successfully certified – according to the demanding ISO 13485:2016 standard for medical devices. This step allows the m4m experts to fabricate real products for patients with a production line they installed and tested in the past months.
Freshly printed pelvic support rings for hip surgery before further processing: The thread-like structures serve as supports during the printing process and are removed later on.
3D Printing Products and Exhibitors
Are you interested in additive manufacturing? In the COMPAMED catalog you will find interesting products and exhibitors:
The technology is complex: Three massive 3D printers are ready to go – supplemented by several "colleagues" that are just as necessary for the operation. For instance, a refrigerator-sized device to sift and clean the raw material for the printer, such as a powdered titanium alloy. The "depowdering" machine, which rotates and turns finished workpieces under vibration until every last grain of powder has trickled down. And a "furnace", in which printed parts are gradually heated to 600 to 800 degrees: stress-relieving annealing to eliminate internal stresses that heated 3D printing leaves in the material.
The extensive equipment park shows two things: First, 3D printing is more complex than it appears at first glance. And second, it is costly: According to Nicolas Bouduban, CEO of the Swiss m4m Center, the investment amounts to around two million Swiss francs. These investments are additionally supported by all partners with a goodwill for open cooperation, says Bouduban: "Everyone contributes – and gets visibility, project orders or know-how in return."
So it's a give-and-take, with benefits for everyone: material manufacturers, equipment manufacturers, software developers for process and quality management, potential users such as clinics that can use novel medtech products. And above all for Swiss SMEs that neither own such equipment nor have the required know-how to operate it. For them, the Swiss m4m Center should become a "breeding ground" for industrializing innovative joint or dental prostheses and other medical products – from A to Z, from the idea to market analysis and transfer all the way to serial production.
COMPAMED-tradefair.com; Source: Empa – Materials Science and Technology