Medical Device Contract Manufacturing

Case Study

Manufacturing of a Sophisticated Surgical Instrument

Our customer required contract manufacturing services for the realization of an innovative device used in spinal surgery, enabling safer and more efficient dural repairs even in tight spaces.

The manufacturing partner needed to be able to provide a combination of medical injection molding capabilities, sophisticated manual assembly, as well as packaging services and supply chain management capabilities.

This product requires injection molding various device components, overmolding a wire component, ultrasonic welding of a complex functional assembly, careful hand assembly of delicate parts, packaging in sealed trays, and final packaging of the shipping units

Röchling Medical as Experienced Single Source Partner

As a contract manufacturer, Röchling Medical Lancaster was able to offer the complete implementation of this device from a single source.

At the Lancaster site we take care of molding five components of the device ourselves, in addition to an overmolded component. This allows us to optimally control quality and cost efficiency.

For all subcomponents not manufactured in-house, Röchling Medical Lancaster handles the full supply chain management for the customer.

A crucial part of the assembly process for this product is hand-loading sutures into the instrument. Our dedicated personnel takes care of this step with particular care and precision to ensure proper functionality of the device during surgical procedures.

For ultrasonic welding the shaft assembly including a multi-component actuation mechanism needed to be carefully placed in between the two parts of the handle. We are experienced in ultrasonically welding multi-component assemblies with precision, taking care not to damage any inner components and ensuring that the functional parts, such as actuation mechanisms have free play.

The completed device is then carefully packed in a tray with lid, tighly sealed to ensure reliable sterilization.

Streamlined Medical Device Manufacturing from a Single Source

Advantages for our customers:

Full-service contract manufacturing partner, with capabilities in cleanroom injection molding, precision assembly and packaging
Complete handling of the supply chain for all subcomponents
Complete project management
Ability to produce large quantities involving complex manual assembly processes without compromising on quality
Reducing time-to-market and cost

Röchling Medical Competences

Our Expertise, Your Benefit

Our customers benefit from our extensive expertise in plastics and metal processing, but also from our many years of experience in medical device and pharma. As your solution partner, we are familiar with both the regulatory and practical requirements of creating components and products for the healthcare sector tailored to your needs. We meet the highest quality and hygiene standards and operate in strict compliance with relevant regulations, such as the Medical Device Regulation (MDR).