Synthetic Polyisoprene Dip-Molded Diaphragm
Multi-billion dollar medical device company.
An international medical device manufacturer – and current Kent Elastomer Products customer – came to us to update a component within a device it manufactured and marketed. The company needed a non-latex material to replace an existing latex material. The part had been sourced as a shelf item from an off-shore supplier. While it functioned properly, it wasn’t engineered for this specific device.
Changing any medical device brings with it additional scrutiny and FDA regulations that are essential for product safety and protecting lives. We also had a very short window of time to have the new part functioning and delivered at quantities sufficient to keep the customer’s vital product line up and running. We needed to:
- Recommend and qualify the new non-latex material.
- Source the prototype tools to qualify part design and material.
- Source more than 2,000 production tools.
- Configure and mount 2,000 tools to optimize production.
- Validate tooling, program the dipping equipment and validate the process.
- Supply initial samples.
- Provide production quantities of 100,000 per month within 60 days.
We assembled a cross-functional team to recommend, source, qualify, and document the new part and process. We specified using our K440 synthetic polyisoprene, an alternative to natural rubber used for many applications in the medical industry. K440 has proved to be a reliable and highly durable material while meeting strict biocompatibility standards in the medical industry. Within six weeks, we supplied the first 100,000 production parts, updating a product with a better part and material.
Are you interested in non-latex materials to replace existing latex materials? We can help provide a better part for your product line. Contact us today for more information.