In the fall of 2005, Bob Elson, vice president of engineering at Coapt Systems Inc, wanted to develop their design for a new cosmetic surgical device, known as the Surgiwire Incisionless Dissector, into a finished product ready for shipment to surgeons. The concept, was to provide a disposable surgical instrument to allow minimally invasive dissection of tissues.
Strand Products Inc. specializes in unique cable assemblies for a wide range of customers. About five years ago, Strand recognized the booming medical device market would need someone with the expertise to fabricate assemblies with small cables that were sometimes produced from exotic materials. Knowing that medical device cables would need a special environment, Strand built a Class 10,000 cleanroom capable of housing the wide variety of equipment required. Further, Strand recognized that the requirements of the medical device community, with respect to material, mechanical, and process certification would require ISO 9001 certification.
Coapt and Strand engineers worked through several iterations of cable construction and hypodermic tubes to develop a suitable configuration. During this process, Coapt guided Strand through the process of upgrading from ISO 9001 to ISO 13485. This qualified Strand for complete production and packaging of surgical devices. The total time from concept of the Surgiwire by Coapt to development and delivery of the qualified product by Strand was under six months. Elson stated that “Strand always goes the extra mile to help keep us on schedule. No effort was too great for them to meet our project demands.”
The Surgiwire is a specially designed Ø0.01in. stranded stainless steel wire rope that is swaged to two hypodermic lancet tubes. It is threaded under the facial skin, out and looped back under the skin, and then through the original perforation. The surgeon is then able to move the cable back and forth to separate the tissue from the skin without an incision.