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Case Study: Seamless Transition to Distron for Class 2 Medical Device Manufacturing

THE CHALLENGE

A leading medical device company faced significant challenges when their existing EMS provider, which had been assembling their Class 2 medical device for years, was acquired by a large corporation. This new parent company decided to relocate production to a subsidiary in Canada, deeming the medical device company non-strategic.

The medical device company was uncomfortable with this decision for several reasons:

  • They had developed their processes and procedures with the local facility, fostering efficient collaboration and oversight.
  • The relocation would complicate quality control and operational oversight.
  • They preferred to maintain local manufacturing for proximity and logistical ease.

As discussions with the EMS provider broke down, the company sought a new manufacturing partner with the necessary certifications, technical expertise, and a proven track record of delivering high-quality results while ensuring a seamless transition.

THE DISTRON SOLUTION

Distron stepped in as the ideal partner and implemented a series of tailored steps to ensure the transition was successful and uninterrupted.

  • Documentation and Process Development:

    Distron fully re-documented and developed new processes and procedures, customizing them to align with the medical device company’s requirements.

  • Achieving Quality Certifications:

    Distron secured all necessary medical quality certifications, including passing rigorous audits such as those conducted by the FDA, ensuring compliance with strict regulatory standards.

  • Rapid Ramp-Up to Full Production:

    Distron transitioned the project from prototypes to full-volume manufacturing in less than 8 weeks, minimizing downtime and meeting the company’s market demands.

  • Collaborative Support:

    Distron maintained open communication and close collaboration with the medical device company throughout the transition, ensuring their unique needs and concerns were addressed. 

Medical device manufacturing

THE RESULTS

Distron’s collaboration with the medical device company resulted in a seamless transition with no disruption to production. Key outcomes included:

  • Local Manufacturing Support: The medical device company retained the oversight and proximity they valued, enabling continued efficient collaboration.
  • Enhanced Quality Control: The re-documented processes and adherence to quality standards improved the reliability of the manufacturing process.
  • Rapid Scale-Up: Distron’s expedited production ramp-up ensured the company could meet market demands without delay.

Distron’s expertise in navigating complex transitions in medical device manufacturing allowed the company to maintain their production schedule and uphold their reputation for delivering high-quality products. This case study highlights Distron’s capability to deliver reliable, efficient manufacturing solutions, even in challenging circumstances, while meeting strict regulatory standards and customer needs.

Ready to Achieve Results Like These?

At Distron, we turn complex manufacturing challenges into streamlined, high-quality solutions that accelerate your product’s success. Whether you’re launching a new line, optimizing for cost-efficiency, or enhancing product reliability, we’re here to support your vision with proven expertise.

Let’s discuss how we can bring your project to life.

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