The industry was buzzing when Stryker announced in July that it would require its future suppliers of critical manufacturing processes to be accredited by MedAccred, a medical supply chain oversight program formed in 2010 by the Performance Review Institute.
The program is gaining traction as more medtech OEMs are beginning to require accreditation, but Stryker’s policy may force more suppliers to seek accreditation sooner in order to stay competitive — especially if other medical device companies follow Stryker’s lead.
“MedAccred will be a game changer for the industry,” says Connie Conboy, director of the program. “The companies that really understand how [accreditation] is going to impact them are trying to roll it out as quickly as they can.”
Accredited companies range in size from privately owned companies like Solar Atmospheres and Global Technologies to very large, multinational organizations like Flex and Bodycote. Conboy says that the supplier companies gaining accreditation are also leaders in the industry, noting that these companies are seeing opportunities for new medical device business as the result of their MedAccred accreditations. “We have been having almost daily discussions with new suppliers interested in learning more about how to prepare for and achieve MedAccred accreditation. Because the program is still in its early stages (MedAccred began conducting audits in 2015),” she says, “there is an excellent opportunity for suppliers who achieve MedAccred accreditation to set themselves apart from their competitors and gain new business.”
Conboy says they expect to conduct approximately 60 audits this year around the globe. Plants are already accredited in six countries. So far, accreditations are offered in eight critical processes: cable and wire harness, heat treating, plastics extrusion, plastics injection molding, printed board, printed circuit board assemblies, sterilization, and welding. The number of areas accredited will increase based on input from industry and FDA.
“FDA’s CDRH has been very supportive of the MedAccred program from the start, and the agency continues to evaluate how they plan to utilize it in their oversight of the industry,” says Conboy. In addition to Stryker, other OEMs are also asking suppliers to gain MedAccred accreditation. Conboy notes that industry support for the program continues to grow, and that major companies such as Philips, Johnson & Johnson, Baxter, Medtronic, GE Health Care, BD, and Flex along with many others have been very active in the program. Is MedAccred part of your future?
TMBG, MDG Launch Medtech Event
Tech Briefs Media Group (TBMG) and Medical Development Group (MDGBoston) have formed a partnership to benefit the medical technology community. The two groups will jointly produce a full-day medical technology conference next year in Boston. In addition, MDGBoston will get national exposure through TBMG’s Medical Design Briefs magazine and digital properties, and Medical Design Briefs will have a presence at MDGBoston’s monthly Forums.