PTA Corp. is the first injection molding company to be certified for plastics assembly by MedAccred, a supply chain oversight program managed by the medical device industry to prevent product defects.
Founded in 1953, PTA manufactures products such as complicated housings and paddles for defibrillators and challenging parts for portable systems that deliver single-pulse magnetic stimulators to treat migraines. The company does business as PTA Plastics.
The employee-owned company specializes in low- to medium-volume product runs and assembles plastic components made of polycarbonate, nylon, ABS, PC/ABS blends, polyester and acetal using thermal technology, ultrasonic welding, heat staking, adhesives and other processes.
PTA's site in Longmont, Colo., received the accreditation for plastics mechanical assembly after participating in a pilot program to differentiate itself from other medical molders. The company will seek the certification at its other site, which is in Oxford, Conn., according to Greg Fish, a PTA quality assurance manager.
In all, 10 U.S. companies have obtained certifications from MedAccred, which is administered in the United States by the Warrendale, Pa.-based Performance Review Institute, with eight going to businesses for injection molding and one to a medical tubing manufacturer for extrusion in addition to PTA's for plastic assembly.
The names of the certified companies are put on a MedAccred "qualified manufacturers list" to increase their visibility in the supply chain.
PTA began the accreditation process, aimed at improving product quality and patient safety, in fall 2018.
"We did a deep dive into the criteria and working with PRI learned that they had a new area that they were pursuing regarding plastics assembly," Fish said in an email.
PTA officials were interested in that pursuit, too, especially after finding out the company already assembled numerous products for MedAccred subscribers, who turn to the program for assurance that industry specifications are met and best practices for manufacturing are followed.
"During the pilot, auditors selected examples of the various types of mechanical assembly over the course of a week," Fish said. "They audited each one starting from setup of each job, how it was controlled, applicable instructions and in minute detail the step by step that PTA goes through to produce each part."
The company had to take some corrective actions that were reviewed and approved by MedAccred staff engineers and later by the customers. PTA President Rich Dorans described the changes as "new quality requirements that generate a new discipline for our employees and command new best practices for our customer."
The certification at PTA Plastics is valid through October 2020.
The other companies with MedAccred certification are extruder Sunlite Plastics in Germantown, Wis., and injection molders BMP Medical, which is a division of Biomedical Polymers Inc., in Sterling, Mass.; Elmo Technologies in Vicksburg, Mich.; Hilco Technologies in Grand Rapids and Dutton, Mich.; Kaysun Corp., in Manitowoc, Wisc.; PTI Engineered Plastics in Macomb, Mich.; Pliant Plastics in Spring Lake, Mich.; and Wilbert Inc., in Bellevue, Ohio.