MRPC, a single-source provider of medical device components and assemblies, recently released a new overview sheet highlighting their molded part design and tooling capabilities for implantable medical device components, those meant for long-term implementation inside the human body.
MRPC began manufacturing implantables in 2008, when they built their first Class 7 (10,000) cleanroom. This room is dedicated to molding both thermoplastic and liquid silicone rubber (LSR) implantable materials. Adding a Class 7 cleanroom to the facilities allowed MRPC to shift additional focus onto implantable devices, a process that demands traceability, repeatability and consistency from molders.
“Turning our focus to implantable medical device components was a logical next step for MRPC,” said Jeff Randall, Vice President of Engineering at MRPC. “It was a natural progression to increase our level of product and service offering for our medical device customers, which has also allowed us to target additional markets that require medical device components certified for implantation.”
Since beginning to manufacture implantables, MRPC has created many high-quality components for long-term implantation inside the human body, including components for cardiac rhythm management, neuromodulation, orthopedic surgery, sports medicine and dental implants. These device components are made of a variety of materials certified for long-term implantation, such as polyether ether ketone (PEEK), polyphenylsulfone (PPSU) and liquid silicone.
In addition to the Class 7 cleanroom, MRPC has implemented a higher level of contamination control in their facilities, further training for their employees and additional cleaning and gowning procedures.
“MRPC has strict controls in place when handling implantable materials,” Randall said. “We need to be able to trace our raw materials and adhere to process controls that allow us to manufacture high-quality implantables with consistency and certainty. We’ve laid the groundwork and had success with molded implantable medical devices, and we look forward to ramping up our production.”