Flexible and Scalable Assembly Solutions: How Automation Meets Manufacturing’s Most Pressing Challenges

With stricter regulatory standards, shorter product life cycles and more competition than ever before, the medical device industry is changing at an unprecedented rate. New technologies, new markets and new patient requirements are emerging, as well as a growing demand for self-diagnosis and treatment devices. To keep pace with such a dynamic and demanding market, manufacturers must take the right approach to building assembly systems.

“Manufacturers need to reduce their development time, speed up validation processes and launch their devices according to changing market needs,” says Jean-François Bauer, Marketing and Business Development Manager at Mikron Automation, the main assembly solutions partner.

“Today’s market belongs to the assembly solution provider that can incorporate flexibility and scalability. Rapidly changing market demand requires Mikron to be more agile than ever and accelerate our customers’ production capabilities, while helping customers maximize their investment.

Process equivalence: the power to scale

The medical device market is expected to grow from $455 billion in 2021 to $658 billion in 2028, according to Fortune, fueled by an increasing number of surgical and diagnostic procedures. And manufacturers are investing more in innovation than ever before, with Johnson & Johnson investing around $12 billion in R&D in 2020.

As the medical device market grows and diversifies, with more complex devices and players emerging than ever, manufacturers face fierce competition. It is increasingly important to reduce time to market, and assembly solutions often have to be designed before all the details of a new device are even known. Assembly solutions must keep up with both growing market volumes and progressive financial investments.

Since the 1970s, Mikron has been known for designing standardized assembly platforms based on “building blocks”, as well as mastering complex assembly processes. This unique feature set forms the basis of Mikron’s scalable automation solutions.

“A huge advantage of Mikron’s scalability concept is that we develop and validate processes in the initial phase,” says Bauer. “This ‘process equivalence’ allows manufacturers to start small, achieving their first launch using a semi-automatic line in as little as four months.

“Thanks to our concept of ‘building blocks’, they can reuse already validated processes as they evolve towards more sophisticated and automated lines. This is very important in the pharmaceutical industry, where once something is validated, it is difficult to change.

Mikron Automation sites offer scalable platforms based on specific market needs, enabling the gradual increase in automation and production volume. Giving manufacturers the flexibility to adjust their capacity based on market demand greatly reduces their risk.

Speed ​​and agility

Manufacturers are also increasingly recognizing the importance of a flexible production line in order to stay competitive and react to market demands.

“Manufacturers today need more flexibility than ever before,” says Bauer. “Over the past ten years, generic drugs have entered the market, opening up new markets with new patient needs.

“The number of medical device variants has increased and batch sizes have decreased. There is a new demand to run different products on the same line, which means manufacturers need to be able to adapt and retool the system quickly.

As the production line expands, flexibility can be built in. The challenge is to incorporate flexibility without losing productivity, adds Bauer: “Speed ​​and flexibility are usually a contradiction,” he says.

Where more flexibility is needed, servo-driven technology, robotics, flexible conveyor systems and intelligent control systems can be integrated into the line, allowing different product variants or devices to be run on the same production line. production. Line and tooling flexibility is complemented by Mikron’s flexible feeding system, Polyfeed.

“The key is finding the balance between several different types of technology to allow for flexibility while maintaining productivity,” says Bauer.

The Mikron difference

The Swiss company Mikron Automation specializes in flexible, scalable and customized assembly solutions that evolve with the product life cycle, from product development to production of maximum performance.

Mikron has 50 years of expertise in the development of complex processes, helping customers to mitigate their risks when the device enters the industrialization phase. To support customers in the early stages, Mikron not only offers assembly systems, but also a complete set of services, from DFX (design for assembly, design for manufacturing) to pFMEA (process failure mode and effects analysis), PoP (proof of principle) supported, clean room assembly testing and validation support. These services allow the client to mitigate their risk both technically and financially.

For customers, Mikron is a one-stop-shop to develop and scale their assembly solution as the product develops, eliminating the risk of involving different partners and giving manufacturers the agility they need to respond to the market.

Mikron is known for producing high quality, high performance assembly solutions, purpose-built in close partnership with its customers. As the medical device market continues to become more complex and competitive, scalability, flexibility, expertise and premium services promise to become increasingly crucial to manufacturing success.

To learn more about Mikron Automation solutions, download the white paper.

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