"Swiss m4m Center" successfully certified according to ISO 13485

The idea is as appealing as it is obvious: After a diagnosis of painful hip joint arthrosis, imaging procedures create a high-resolution 3D image of the joint - and thus the basis for an individually adapted implant: The data is processed further and finally ends up as a digital blueprint in a 3D printer, which produces the individual piece with a precise fit and at optimized cost.

ISO 13485:2016 for medical devices

The Swiss m4m Center in Bettlach in the canton of Solothurn aims to promote these and other ideas that make 3D printing possible. Only opened in September 2020, it has now been successfully certified - according to the demanding ISO 13485:2016 standard for medical technology products. Only this step allows the experts to manufacture real products for patients with the production line that they have installed and tested in recent months.

The technology is elaborate: Three massive 3D printers are ready to go - supplemented by several "colleagues" that are just as necessary for operation. For example, a refrigerator-sized device for sifting and cleaning the printer raw material, 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 distortions that hot 3D printing leaves in the material.

The equipment park shows two things: firstly, 3D printing is more complex than it appears at first glance. And secondly, costly: according to CEO Nicolas Bouduban, the investments amount to around two million Swiss francs. These investments are additionally supported by all partners with a cooperation goodwill, says Bouduban: "Everyone makes a contribution and gets visibility, project orders or know-how back in return."

Geared to the needs of SMEs

So it's 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 innovative medtech products. And above all for Swiss SMEs that neither own such equipment nor have the necessary know-how to use it. For them, Swiss m4m should become a "breeding ground" for industrializing innovative joint or dental prostheses and other products - from A to Z, from the idea to market analysis to transfer to series production.

Concrete ideas? Yes, says CEO Bouduban, they already exist. For example, precisely fitting spinal implants to replace intervertebral discs based on three-dimensional patient data. But before such projects, there is always the question of whether an idea is suitable for 3D at all, explains board member Andreas Wenger, General Manager of Precipart SA, a company that supplies companies worldwide with medical technology components.

"With the hype around 3D printing today," Wenger says, "it's important to know where this technology effectively makes sense." After all, there are proven competing processes in metalworking. Take milling, for example: if a desired product can be manufactured efficiently with it, the expert explains, 3D printing is often already no longer competitive because it is too time-consuming and therefore too expensive. "The development engineers have to think in 3D in order to get the most out of this new technology," says Wenger, "we pass on this know-how at the Swiss m4m Center."

For complex workpieces, the process can bring significant advantages - for example, when an implant is formed in just one pass without the need for subsequent drilling or milling. There is also great potential in applications where several parts are combined and produced into a single component.

As an example, Wenger cites an implant that is currently being co-designed in Bettlach - with tubular structures inside: hidden channels that provide cooling. "You can't produce that in one step with any other process". His conclusion: 3D printing can be a worthwhile solution for demanding requirements; for small to even high volumes - an opportunity for SMEs in the supply chain and also for medical technology companies. There is plenty of potential in Switzerland: The medtech sector, strongly represented in the southern foothills of the Jura, sold products and services worth almost 18 billion Swiss francs in 2019 - thanks to around 1400 companies and the know-how of 63,000 employees.

Much support from the industry

The interest in Swiss m4m Center is consequently high. 45 partners have come on board since the opening in September 2019. On platforms such as LinkedIn, the followers are steadily increasing. And a webinar by Swedish titanium powder manufacturer Sandvik, where CEO Bouduban appeared, was watched by several thousand people. "The project seems to be hitting a nerve," says Empa director Pierangelo Gröning, who was instrumental in setting up the Swiss m4m Center as a co-founder of the AM-TTC initiative. "a non-profit production line with open access for SMEs: this has never existed in Switzerland before."

In addition to technology transfer, Swiss m4m Center will also focus strongly on knowledge transfer. A training concept has been developed together with the Höhere Fachschule Technik Mittelland. Empa offers advanced training courses with the experts in Bettlach and will also send apprentices there for training in additive manufacturing. The Swiss Foundation for Microtechnical Research (FSRM) in Neuchâtel is also offering a course. A training manager has recently been employed specifically for such training and further education courses.

The response so far makes Nicolas Bouduban confident, even if the work, after the creative and sporty build-up phase, is really only just beginning. Whether implants for patients who have suffered complicated fractures, whether in oral surgery or for custom-fit prostheses: Individualized solutions are a growth market for the specialist. "The possibilities in the medtech sector are far from exhausted," says the CEO, "and more and more companies want to gain a foothold in this area."

Source: Empa

Switzerland-wide network for technology transfer

The "Swiss m4m Center" is part of the "AM-TTC Alliance" (Advanced Manufacturing Technology Transfer Centers, see below) and is funded from several sources. The funds for the start-up phase 2019-2020 came from the ETH Board. In addition, the Federal Department of Economic Affairs, Education and Research, which classified the "Swiss m4m Center" as a "research institution of national importance" towards the end of last year, is contributing funding until 2024. In addition, the cantons of Bern and Solothurn as well as numerous partners from the business world are supporting the project.

For more info: www.am-ttc.ch