Critical tolerances, Bio- and chemo-compatibility

The Challenge

A global manufacturer of medical devices was developing a new implantable drug-delivery system. Extreme demands for reliability, precision, and absolute seal were matched by the already strict regulatory requirements for biocompatibility and compatibility with the drugs the new system was dispensing within the body.

As an implanted device, achieving zero-leakage tolerances (5 x 10^-9scc/sec helium) and extended cycle life were essential to the long-term success of the new device. Further, a light spring rate was required in order to work in concert with the entire component.

The Solution

For this customer, and their “bet-the-company” project, we designed a unique, commercially-pure titanium bellows assembly. We created special diaphragms—sized and engineered specifically to provide a light and consistent spring rate.

Within our Massachusetts facility, we built a dedicated manufacturing cell to enable high-volume production of this precision part. Our team’s ability to execute welds on less than .002” of material was relied upon. Rigorous QC ensured that each bellows assembly met all of our customer’s stringent requirements—and those of their regulators.