Overcoming Challenges: How Trelleborg Helped a Global Medical Device Manufacturer Thrive

A leading global medical device manufacturer needed to consistently produce a critical component that met stringent visual, reliability, and FDA requirements. By partnering with Trelleborg Medical Solutions, the client not only solved the immediate manufacturing issue but also benefited from innovative improvements and reduced reject rates and costs.

The client operates in urology and its devices have been instrumental in restoring functionality and dignity to tens of thousands of patients worldwide. However, the company faced a significant hurdle in developing a new device intended for permanent implantation into patients' bodies. Despite its ability to manufacture most of the device in-house, one critical component required an external supplier due to the stringent visual, reliability, and FDA standards it had to meet.

The problem
The medical device company initially identified a supplier that provided a seemingly viable solution. The manufacturer secured FDA approval and anticipated capturing a substantial market share. However, a problem soon emerged: 75% of the produced components failed to meet the necessary standards. The manufacturer hoped to reduce this high scrap rate before full-scale production, but despite multiple adjustment attempts, the supplier could not resolve the issue to make mass production financially feasible.

That left the manufacturer facing a reputational risk due to its inability to meet growing demand. Competition in the market was intensifying, adding pressure to find a reliable solution quickly. The device company began the search for another supplier while having to incur the additional cost of sorting and scrapping from their current supplier.

The solution
The manufacturer discovered Trelleborg, known for its expertise and reliability in the industry. Under significant time pressure, Trelleborg worked closely with the device company to exceed the required quality standards consistently.

Trelleborg implemented a custom manufacturing solution designed to meet exact specifications and achieve scale effectively. Their innovative approach not only resolved the initial issue but also enhanced the overall device performance by improving the critical component.

Results
The collaboration with Trelleborg yielded:

The manufacturer not only overcame its immediate production challenge but also strengthened its market position and ensured the continued satisfaction of its end-users. Patients who received the improved device experienced significant health benefits, bolstering the manufacturer’s reputation for quality and innovation.

Conclusion
This case study highlights the transformative impact of partnering with a reliable and innovative supplier. By addressing critical manufacturing challenges head-on, Trelleborg enabled its client to maintain a competitive edge, achieve substantial cost savings and enhance patient outcomes.

As the medical device manufacturer continues to collaborate with Trelleborg on future projects, the partnership exemplifies how strategic alliances can drive industry-leading solutions and sustained growth.