Mass production plays an important part in getting new medical devices to the marketplace, but with machines making hundreds of components every minute, efficiency and reliability play key roles in maintaining production volumes. Jean-François Bauer, head of marketing and business development at Mikron Automation, explains how effective assembly solutions rely upon careful design, testing and ongoing support.
Jean-François Bauer: Mikron is a Swiss company that has been active for over 100 years. Our core business is high-precision, high-speed automation and machining solutions, split between our two divisions, Mikron Machining and Mikron Automation. Mikron Automation offers high-performance automation design and manufacturing solutions for the assembly and testing of medical devices, of sizes you can hold in your hand. Our machines run at very high speeds, delivering up to 400 parts a minute, and millions of parts a year.
Mass production of medical devices is far from straightforward. How can you help customers establish a reliable automated assembly line?
We offer a full service, from 'proof of principle', to clinical pilot lines, to fully automated solutions. Customers will come to us with a new device that they would like to manufacture in high volumes - for example, a pen injector for diabetics. We might build proof of principle benches (using just one or two critical assembly stations) to prove that the proposed manufacturing process is capable of working at commercial manufacturing speeds. The next step is to produce a pilot line. We aren't looking at mass production at this point, because the customer is still in product development, conducting clinical trials and seeking FDA and regulatory approvals, and may only need about 100,000 units at this stage.
The final step is designing and building a fully automatic assembly solution for mass production, helping our customers to ramp up production volumes and send the product to market. We set clear, defined milstones and processes during the execution of the project, working with customers to analyse the design and manufacture processes in order to avoid mistakes that could harm volumes later on.
Absolutely. Mikron Automation offers support during the entire lifespan of the machine. It's important to us that we are not just a supplier, but a partner.
Because assembly machines produce hundreds of parts a minute, a breakdown can cause huge production losses, so you need to act quickly to find solutions. This means providing strong training in the first place, which is something we're really focused on: machines can only run efficiently if they have highly trained operators. We also offer systems that allow our customer service team to access customers' machines remotely via modem.
Finally, we offer a constant improvement programme: during the 10-15 year operational lifespan of our machines, we often develop efficiency savings that add up to a significant increase in annual volumes, so we offer regular machine upgrades.
Switzerland is well known for its skilled workers, and that is as true today as ever; but we also offer a stable, reliable workforce, free from delays caused by industrial action. The Swiss industry also benefits from strong relationships with the country's excellent technical academies.
Because we know we are operating in country of high labour costs, Mikron is focused on driving innovation and offering advanced solutions that other competitors cannot. For example, we can offer complex assembly at high speeds, because we have the know-how to mitigate the associated risks. That means our customers can expect products delivered on time and on budget, but also machines that will go on producing those devices reliably, every day.
When a major new process or machine is created, it can be seen as a 'disruptive innovation', because it replaces some or all of the current production philosophy. By contrast, an innovation that improves the functionality and efficiency of a machine helps it to evolve without delaying production. So, while Mikron is known for its big innovations, we will only unveil these maybe every decade or so, when we know they will benefit our customers. In the meantime, we regularly make small, helpful improvements.
We are present in the US, Asia and Europe with our own manufacturing facilities. We qualify all our machines in line with GAMP 5 regulations, and we ensure that international teams are harmonised. We collect all mechanical and electrical testing information as we go, so it is already carefully compiled at the time of machine delivery, saving customers a huge amount of time and effort later on.