Making Next Generation Medical Device Manufacturing Easy
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 Pexco to launch an innovative new surgical device for knee reconstruction procedures.
Pexco 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 Pexco’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 Pexco’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 Pexco 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.
Pexco’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, Pexco eventually designed a moldable solution.
Another part required having a metal insert glued into it. Pexco rose to this challenge as well by developing special assembly equipment and outsourcing the glue to an adhesive expert. The answer here depended upon Pexco’s strong relationships with top outside sources.
Additionally and of equal importance, Pexco 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 Pexco 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.
- Mutual respect and ready support
- Flexibility in options for design solutions
- Inveterate engineering knowledge and the ability to apply to distinct scenarios
Based in Atlanta, Georgia with several manufacturing plants across the United States and Mexico, Pexco is a North American leader in the design and fabrication of specialty plastics products. It provides standard and custom products and components to manufacturers and end-users for a broad range of market applications, including the Aerospace, Medical, Filtration, Lighting, and other Industrial sectors. Pexco offers a full range of design, engineering and fabrication services. It operates six Class 7 & Class 8 medical clean rooms. Pexco meets the requirements of ISO 9001:2008, and holds ISO 14001, ISO 13485, 21 CFR 820, OHSAS 18001, GMP, AS9100C, ITAR and other registrations and/or certifications for its manufacturing operations. Pexco is your trusted plastics advisor for specialty plastic products and solutions. For more information, visit www.pexco.com or contact 404-564-8560.
One of a kind design facilitates reduced surgery time
Pexco has been offering assembly to compliment our Cleanroom molding for more than fifty years.
Innovative technology deploys small implants with limited needle exposure.