Case Study

Making next generation medical device manufacturing easy

Learn how we helped launch a surgical device for knee reconstruction procedures

Knowing well its Design for Manufacturability (DFM) expertise and process precision, a major player in the orthopedic medical device market wanted to leverage exceptional prior customer relations with the Spectrum Plastics Group to launch an innovative new surgical device for knee reconstruction procedures.

Spectrum had established such a fundamental connection with the customer that the typical bottlenecks which often occur during the sales process – ones that can delay project initiation or even worse, result in failure to launch – were no obstacle to immediate action. The customer was able to contact Spectrum's Medical team directly, and from there begin the exciting back and forth process of designing the perfect tool.

From Components to Products:
Eight tools, eleven part numbers. Compared to other projects these figures may seem modest, but behind them is a complexity that highlights Spectrum’s design for manufacturability expertise and how this exclusive knowledge helped mold the project and the parts themselves into the perfect fit. It is very rare that a molder receive all the components of a medical device at once – the customer usually chooses to outsource pieces to a selection of specialty molders – but because of our elite design team and an established relationship the customer trusted Spectrum to deliver.

The main challenge centered on how moldable the parts actually were, as the drawings generated by the customer only represented rough ideas. The designs were initially un-moldable – the parts were not designed to release out of a mold and would have gotten stuck.

Spectrum's engineering design team made themselves readily available to receive drawings and offer DFM recommendations that would yield parts which could be manufactured consistently.

One stage of the project, for example, required insert molding over a very small diameter of wire; it was difficult to make the part design and the tool to accommodate it. Through close collaboration with the customer and after many rounds of attempts, Spectrum eventually designed a moldable solution.

Another part required having a metal insert glued into it. Spectrum rose to this challenge as well by developing special assembly equipment and outsourcing the glue to an adhesive expert. The answer here depended upon Spectrum’s strong relationships with top outside sources.

Additionally and of equal importance, Spectrum sub-assembled the part onsite. The entire project – from start to finish – was handled with such an impressive, professional and swift approach that the customer’s Senior Supply Chain Manager commented: “Way faster than I expected. Another fantastic turnaround from the Spectrum Plastics Group team.”

A New Level of Simplicity, Safety and Speed:
The result? A device designed to be as atraumatic to the meniscus as possible. This unique application for knee reconstruction drastically reduces time in the operating room versus the first generation device. Patients benefit by ultimately saving time and money due to the condensed process, and surgeons benefit from the design’s one-handed use with minimal deployment steps.

Key Takeaways:

  • Mutual respect and ready support
  • Flexibility in options for design solutions
  • Inveterate engineering knowledge and the ability to apply to distinct scenarios
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