Medical Device Design for Automated Assembly
Traditionally, medical device manufacturers assemble prototypes manually or, more rarely, semi-automatically. Once the product receives market approval and the manufacturer wants to ramp up quantities, however, manual, or semi-automated production quickly reaches its capacity limits. The solution is obvious: a fully automated assembly of the medical devices or semi-automated production in order to produce at least specific critical processes with the necessary accuracy, quality and quantity.
Product Design facing unpleasant challenges when it comes to automation
But when it comes to implementation, manufacturers often realize that the defined product design is an impediment to automated assembly. Michel Milionis, Senior Sales Manager Life Science Technology at ASYS Group knows from everyday practice: "Manufacturers of medical devices often experience unpleasant surprises when they want to automate their production." This problem arises from the fact that selected individual parts and their interaction are not evaluated and tested regarding automated production during the product development process, and thus critical components and process steps are not identified.
As a result, when it gets to automation, significant changes and adaptations must be made to the product design, which in turn usually means at least a re-qualification of the device. In short, there are significant delays and unexpected cost rises.
Expanding the human-centered design approach by automation-friendliness
Michel Milionis therefore recommends involving assembly automation experts in the product development process at an early stage. “Of course, when it comes to medical devices, human beings remain at the center of the design task”, he points out. “But if the human-centered design approach is supplemented with expertise in assembly automation, critical individual parts or process steps can be identified early in the design process – and be adjusted or replaced with alternatives more suitable for automated manufacturing. Due to our numerous projects and installations in medical technology worldwide, we can share this experience and competence with our customers.” This improves the process stability, which in turn increases productivity and reduces costs.
Examples of automation-friendly components & processes
Automation-friendly product design starts with the analysis of individual parts and components and extends to the selection of suitable verification processes. As the ASYS Group we support medical device manufacturers in product design and for example recommend avoiding flexible parts.
Flexible parts such as tubes or seals are easy to assemble by human hand, but gripping robots struggle with grabbing these components. This can lead to errors in the process. In diagnostic cassettes, for example, tubes are installed as fluid channels. Laser-engraved foils with fluid channels or injection-molded rigid channels can be used as an alternative. In case of flexible seals more automation-friendly choices would be O-rings, dispensing of sealant or 2-component injection molding with an integrated seal in the component.
The alignment of the assembly movement and the number of sides from which assembly is carried out should also be considered early in the development process. Regarding automation, linear assembly movements and a single-sided assembly are much more recommendable, as complexity can be reduced and thus costs can be lowered.
Empowering collaboration in interdisciplinary teams
"In practice, there is often too little exchange between product development and production planning. This results in a lack of communication regarding the challenges associated with specific parts or process steps", notes Michel Milionis. "However, products can only be designed to meet automation requirements if the expertise of various departments is incorporated into the development process." This includes product owners and engineering, as well as part suppliers, manufacturing and automation experts. It is this interdisciplinarity that enables medical device design that suits the user's needs and is optimized for automated assembly.
As an example, here you can see how – thanks to the automation-friendly design – 20 individual parts are assembled and laser-welded into a functional Point-of-Care (POC) cartridge in a cycle time of less than 20 seconds. Of course, other options are also possible.
The example shown here is a fully automated life science assembly line used for the assembly of POC diagnostic cartridges. The ASYS Group offers an almost limitless variety of process combinations: whether robots, axis systems, joining, dispensing or depaneling processes, laser technology or image processing systems. Optionally available: an add-on module for conditioning the interior of our systems regarding to cleanroom classes (ISO 5-8), temperature and humidity.
Do you have any questions? We will be happy to help you.
Michel Milionis
Senior Sales Manager Life Science Technology