Automated assembly for fast-track design verification of YpsoMate platforms

Ypsomed has introduced a new semi-automated in-house system featuring a fully automated process for the final assembly of samples used in design verification testing. This new system streamlines workflows, eliminates complex logistics, and significantly reduces verification times, allowing customers to bring their products to market faster and more efficiently.

To understand the significance of this project, we spoke with Reto Maffioli, Manager Industry Collaboration at Ypsomed.

An interview with Reto Maffioli, Manager Industry Collaboration at Ypsomed.

What inspired Ypsomed to introduce new final assembly equipment for the design verification process, and how does it benefit customers?

We introduced this new equipment in order to provide equivalent final assembly processes that are as close as possible to later clinical and commercial processes. While our classical approach remains a trusted and reliable solution, we saw the need for a faster, more automated alternative for projects where time and logistics are critical. Traditionally, Ypsomed and customers had to coordinate subassembly shipments globally, which was time- and effort-consuming, logistically complex, and could lead to delays or increased costs.

By bringing the process in-house and automating it, we have streamlined the workflow, cutting verification time by several months in most cases. Customers can now simply send us their syringes, and we handle the rest in a fully controlled, automated environment. This eliminates the need for multiple shipments and reduces the effort and involvement required on their part. Automation ensures consistent, high-quality results by performing precise quality checks and flagging any deviations in real-time, making the final assembly process faster and more reliable. For many customers, this acceleration allows them to focus on other priorities while we handle the final assembly for them.

How does the new system enhance precision for design verification?

The new system was developed collaboratively with Mikron and is equipped to handle almost unlimited geometrical variants of all existing YpsoMate configurations on the same machine, including YpsoMate 1 mL, YpsoMate 2.25 mL, YpsoMate 2.25 Pro, and YpsoMate 5.5 mL devices and its customised variants. It is easy to use thanks to its recipe management system. For tooling changeover the system guides the operators through each step with built-in checks to ensure the right tooling and parts are used. This minimises training requirements and ensures consistent results.

What role does automation play in ensuring regulatory compliance?

Design verification is a compulsory regulatory step. The new process ensures full compliance by automating every stage of assembly and quality control. The system flags and rejects any parts that do not meet strict parameters, ensuring that only fully compliant devices move forward, thereby reducing potential human errors. For later clinical and commercial stages, replicating the same process and fulfilling the same requirements can be achieved effortlessly.

How does this offering strengthen Ypsomed’s position in the market?

This new fast-track design verification process is an example of our commitment to innovation and customer-centric solutions. Addressing specific pain points like time, logistics, and precision adds significant value to our customers’ workflows. It is part of our ongoing mission to help our customers bring their products to market faster and with greater confidence.

Does the new automated final assembly process for design verification replace the classical one, and why might some customers still prefer the classical approach?

Not at all. The classical final assembly for design verification at our B2B-partners or their CMO remains an important option. While the new automated process provides a faster and more convenient option for customers who prioritise speed and streamlined workflows, the classical way is ideal for those who prefer more involvement or customisation. For example, some customers have specific logistical workflows or testing setups that align better with the classical approach. By offering both options, we ensure that all customers can choose the solution that best suits their unique project needs, with both processes meeting the same high standards of quality and compliance.

Could you share any project highlights that you would like to elaborate on?

Collaboration is central to Ypsomed's approach, enabling us to deliver ready-to-order solutions that streamline workflows and meet the specific needs of our customers. A standout example is how some customers have chosen to acquire and industrialise the same equipment as we developed and use. This allows them to replicate the same processes for their clinical and commercial production, significantly reducing timelines and enhancing efficiency. Through our network of strategic partners, we provide access to off-the-shelf options that ensure flexibility and efficiency for a variety of customer needs.