From Prototypes to Production Run, from Welding to Supply Chain Management
Bringing a medical device or surgical product to market is arduous. From initial designs to prototype to testing and validation and eventual 510K FDA approval, the process takes years. And rightly so—the end goal is to deliver a product that is safe and efficacious, and hopefully within projected cost and on a timeline.
EB Industries has provided welding, and a lot more, to a number of Tier 1 and OEM medical companies that have developed new medical devices. One particular example, which highlights the value we can bring to these sorts of endeavors, was our involvement on a large project with Stryker.
The part was a surgical needle assembly used to repair damaged knee joints. It is a fascinating bit of technology. We worked with a Tier 1 supplier from the outset of the program, making prototypes and providing numerous suggestions for improving the process.
This particular part required a lot of special tooling, which we developed and built in-house. Final testing involved the part meeting specific, critical dimensions, so we designed and constructed a fixture that allowed us to quickly test 100% of the parts we welded. This ensured that there would not be any quality issues for those dimensions—one less thing for our customer to worry about.
Initially, we were tasked with welding and inspection, but as the program developed, our role expanded. We found ways to improve and better manage the supply chain, including purchasing some of the components involved, and working with passivation houses and a local EDM provider. We went even further, designing and fabricating custom tooling for parts being worked on off-facility to ensure quality and consistency.
As one can imagine, the level of documentation required to bring a medical part to market is staggering. We collaborated with our customer and Stryker to generate an AQL plan to ensure finished part quality and thorough documentation. Our plan was followed for the duration of the program and helped to minimize any quality issues that arose.
The product development process that lasted for several years reached production, which ramped up exponentially based on the success of the part in the field. During the height of the program, we were shipping thousands of parts every week to our customer to meet demand. Our welding and testing processes scaled easily, as did the supply chain we established.
Not only can we be an integral part of your supply chain, we have the knowledge and experience to manage the entire process and lift some of that burden off your shoulders. We have a great network of suppliers and sub-contractors that have earned our trust, working with us on numerous projects. We are certified to ISO 13485 for medical devices, which makes our customer’s lives a lot easier.
If you have any projects that are in the prototype stage or in production and require multiple steps to assemble, please reach out to our sales team. We can discuss ways we can make your job easier by handling the supply chain, providing enhanced testing, and/or developing better welding processes.