Medical devices need to work exactly as expected. There’s no room for error – whether performing procedures or conducting tests, lives are on the line. Engineers, tool makers and technicians work together to design, test and perfect all the assets needed to produce parts, assemblies and final products. Tight tolerances and precise performance are business as usual.
The Challenge: Manufacture a Proven Product Line Without Supplied Tooling
It’s not unusual for Hi-Tech to partner with other contract manufacturers and OEMs. It is very unusual, however, to be asked to replicate a successful product line without tooling or even tooling plans. But that’s exactly what we did.
Long-time customer Primo Medical Group asked Hi-Tech to partner on an RFQ for a product line that was purchased by one of their clients. Hi-Tech would be manufacturing parts for an Intrauterine Endometrial Ablation System. These devices are used in a precise and delicate procedure to remove a thin layer of tissue that lines the uterus.
It appeared to be a straightforward job, but there was a catch: the tooling to make the products wasn’t included in the sale. The original manufacturer used a proprietary methodology to make a mesh component. The tooling to produce that component and the mesh overmold were considered trade secrets and were not included in the sale. Hi-Tech was faced with a three-part challenge: find an acceptable mesh supplier, reverse engineer the overmold component and design injection mold tooling to make it happen.
A Higher Degree of Engineering and Manufacturing Expertise
Hi-Tech tapped its partner network and found the right mesh supplier for the job. Hi-Tech engineers developed part models of the overmold component and designed the injection mold tooling. They created a manufacturing process that called for inserting mesh onto the tooling and then molding the overmold component over the mesh.
The original manufacturer did supply two mold tools that were not part of the proprietary process. Hi-Tech was able to qualify the two supplied molds and worked with samples from the mesh supplier to qualify the new mold involved in the overmolding process. Once all parts were available, Hi-Tech was able to build ultrasonic welding tooling and develop a process to weld all parts together
Quality Products from Quality-Proven Manufacturing
The last step in this engineering and manufacturing solution was to perform a leak test on 100% of the components produced. Hi-Tech employed a new proprietary testing capability that is incorporated in the manufacturing process. Once a nominal process was developed to produce all components, the parts and process were qualified by completing an IQ, OQ and PQ.
Hi-Tech Thrives on Figuring Things Out – We Can Do it for You
This reverse engineering and manufacturing process engagement is just one example of how Hi-Tech can handle even the most challenging Medical Manufacturing requirements. Hi-Tech is ISO9001 and ISO13485 certified. We take pride in our Quality Management System, which is regularly validated by Customer and Accreditation audits. Contact Us today if you’d like more information on this project or if you want to improve the reliable manufacturability of your parts and assemblies.
