Developeration

It all began with a phone call in December 2019. Developeration’s founder and CEO, Johan Ungerstedt, was looking for a partner capable of taking the company’s product from prototype to serial production—preferably with full responsibility, from material sourcing and manufacturing to delivery of a sterile product. The requirements were high and time was limited. In such situations, few can deliver like Cenova.

Initially, the full focus was on finalizing the design, with particular emphasis on product safety and production efficiency. During this phase, Cenova played an active role in the development process and took major responsibility for developing critical functions such as vacuum indication and the product’s sterile barrier. In parallel, approximately 20 injection molding tools were developed. Thanks to Cenova’s fully equipped workshop, this work was carried out efficiently, allowing rapid iteration and fine-tuning toward functional requirements.

– It’s incredibly exciting to be involved in a project of this complexity, especially one that includes every aspect of development. It’s fantastic to see the results and that the product is now about to be used clinically, says Fredrik Gremar, Design Engineer, Cenova AB

Next steps

In the next phase, all necessary infrastructure was developed to enable serial production. This included welding fixtures for sterile barriers, adhesive fixtures, leak testing equipment, and more. At the same time, production preparation was carried out, covering everything from traceability documentation to labeling.

Another key part of the project was ensuring cleanliness and, ultimately, a sterile product. With Cenova’s extensive experience in packaging design, material selection, and partnerships for all sterilization methods, this phase was also completed quickly and efficiently.

 – This project is a shining example of the breadth and expertise that Cenova possesses. It’s a project perfectly suited to us, where we get to utilize our full range of capabilities, says Johannes Kask, Project Manager and Head of Sales, Cenova AB

Now, a few years later, we stand here having gone from a product in a CAD environment to a sterile medical device ready for approval and market launch. Is it difficult? Yes. Are there few who can manage it? Yes. Is it impossible? No—and certainly not for Cenova!

– The collaboration with Cenova has been absolutely crucial for the transition from prototype to final product. The development work they have carried out has been professional, fast, and efficient. We have also greatly appreciated Cenova’s expertise and willingness to help establish the correct production documentation for our quality system, says Johan Ungerstedt, Founder and CEO, Developeration AB.