Automation allows device manufacturers to increase efficiency and better meet quality requirements. The devices' increasing complexity also increases complexity in automation systems development. Jean-François Bauer, head of marketing and business development at Mikron Automation, discusses how industry standards are best met.
Medical device production, under the watch of regulatory authorities, requires the manufacturers to demonstrate that patient safety, product quality and data integrity are guaranteed, and all this while the products grow increasingly complex.
Production line automation offers a viable solution to address this, and proving process consistency and product quality to industry authorities remains possible -if not necessarily easy. Once automated systems are in place, even the more complex devices can be produced more efficiently, saving on the costs.
Implementing an effective automation system, however, can be challenging, according to Jean-François Bauer, head of marketing and business development at Mikron Automation: "Indeed, the more complex a device is, the more extensive the assembly system development and related validation efforts will be," he says.
"On the development side, there is a need for advanced abilities in software and mechanical engineering, but also high flexibility in order to take in new technologies and particular processes."
"Consequently, for the validation aspects, proving a system is fit for its intended use requires abilities and knowledge of the regulations in line with the complexity of the automated system to be developed; guidelines such as GAMP are certainly helping on these topics."
"The growing complexity is partly because of the continuing increase we are seeing, particularly in disposable medical devices, for self-administration by patients. With no expert staff present, products have to be more user-friendly and reliable. But it is also because of technical evolution allowing new functionalities. All this adds to the design challenge."
Plan ahead
The key to adapting automation processes to meet these demands is to pay close attention to the design for assembly (DFA) considerations and the practicalities of manufacturing; all must be carefully planned.
With more than 40 years' experience in the industry, Mikron is able to offer expert advice to medical device manufacturers
on automating their production processes. The firm has installed more than 3,000 assembly and testing systems, and has more than 550 staff in offices around the world.
"We often help companies with DFA issues," says Bauer. "Usually, only a fairly simple adjustment is required. For example, if you want to put a round cap over a pen injector, the problem is how to orient the cap – it's circular, so it's usually done manually.
"But it's possible to incorporate correct orientation in an automated system. One easy solution would be to put a small dot on the plastic moulded part. This would allow a simple sensor to detect the correct position."
The right to assemble
Mikron has a thorough understanding of industry regulations. The company is able to advise companies on how to meet the current standards and help develop automated processes successfully.
"We work with our customers to understand which of the processes are critical to a device. We then develop a proof of principle, producing maybe 1,000 pieces to demonstrate the feasibility of the assembly. Then, we will design a pilot line that will assemble the critical processes in an automatic mode, together with the other non-critical processes that will be made manually in order to give a low quantity of devices that will be representative of the future high-speed line.
"A good example is our work with Novo Nordisk," he continues. "We carried out test trials for some new pens and identified some critical processes that could cause trouble if we were to build a fully automatic line. So we worked with Novo Nordisk to validate those processes. The end result was that the customer product was safer, and we also feel better because everything is properly under control."
Mikron also supports its customers beyond the initial test phases, offering assistance throughout the machines' life cycle. The company explains how to run production lines as efficiently as possible, thus reducing the client's learning curve.
In future, Bauer sees a continuation of the trend towards growing product complexity, creating fresh challenges for automated production. Specifically, he predicts an increase in the popularity of electronic devices used by patients, in line with the growing complexity of self-injected drugs.
"You now have the kind of drugs that can't be taken in one quick shot, they have a higher viscosity and can take several minutes to inject," he says. "Consequently, you need an electronic motor inside the device to dispense the drug over a longer period. It can't be done by just pressing a button on the side. This increasing level of sophistication is what the future holds. We're looking forward to the challenge."
