When a clinician successfully locates the epidural space, the Episure AutoDetect syringe provides objective, visual confirmation.
When a medical device design requires both rubber and plastic molding, the manufacturer will usually have to go to separate manufacturing sources. Not so for Indigo Orb Inc. (Irvine, CA; www.indigo-orb.com), the designer of the Episure AutoDetect syringe. Its partnership with the Hi-Tech Group Inc. (Anaheim, CA; www.hi-tech-group.com) meant simplifying the process.
Formed three years ago, as a combined enterprise between Hi-Tech Rubber, Inland Technologies, and A.C. Hoffman Engineering, the Hi-Tech Group is unusual in the medical product manufacturing industry as a company that provides both rubber (or silicone) molding services and plastic molding services. The company engineered the plastic used for the barrel of the Episure AutoDetect syringe, and the rubber used as part of the plunger mechanism. The transition from low- to high-volume production was also managed, in part, by the Hi-Tech Group.
“With both injection- molded plastic and rubber capabilities, the Hi-Tech Group was able to support this project within the same company structure, easing burden on supplier management,” says Kevin Kirchner, a research and development product manager at Indigo Orb. The Hi-Tech Group eased the burden further with its project management concept, says Shubroto Chattopadhyay, a marketing manager for the Hi-Tech Group.
“The project management concept is very important to the company,” Chattopadhyay says. “The customer doesn’t have to call five different people to get the information he wants, rather, the company calls one specified person who then provides up-to-date information.”
The result of the collaboration is a device designed to address what Indigo Orb believes is a specific need in the natal labor and delivery area. With standard loss of resistance (LOR) syringes used for epidurals, there is subjective “feel” required of the anesthesiologist in determining whether or not the epidural space has been located. With the Episure AutoDetect syringe, the plunger automatically depresses when the needle enters the epidural space, providing an objective, visual confirmation. The syringe also allows the user to keep both hands on the epidural needle during advancement to provide greater user control and sensitivity than with standard LOR syringes, according to Indigo Orb.
An internal compression spring applies a precise and constant force on the plunger, regardless of the amount of saline drawn. The company believes the syringe improves safety by reducing the chance for dural punctures.
Kirchner credits other suppliers as well. “Apex Engineering (Torrance, CA; www.apexeng.net) was an essential partner for supporting the design and development of our injected-molded parts and developing bridge tooling,” he says. “Venture Manufacturing (Santa Clara, CA; www.vmgroupinc.com) played an important role in incubating the company, managing early prototype developments and regulatory approvals.”