The medical device industry’s accreditation program, MedAccred®, is continuing to grow and more and more major device makers are now on the list of subscribers. These medtech OEMs — which includes Bausch Health, Baxter, Edwards Lifesciences, Becton Dickinson, Boston Scientific, Johnson & Johnson, Medtronic, Philips Healthcare, Roche Diagnostics, and Stryker — fund and manage the accreditation program as well as determine audit criteria, interview and select auditors, and determine who is granted accreditation.
MedAccred director Connie Conboy notes that when one or two medtech and supplier companies continue to want to raise the bar, it raises the bar for everyone. “It’s an ideal way to keep improving and optimizing what we are doing,” she says.
Available accreditations currently include plastics injection molding, plastics extrusion, plastics mechanical assembly, cable and wire harness, printed circuit board assemblies, printed boards (bare boards), sterilization, sterile device packaging, heat treating, and welding. New critical process accreditation areas continue to be developed, such as the newest one labeling and printing, with one to two new processes introduced each year based on industry and FDA input.
This year the program added new sterile device packaging criteria, for example. “Everyone is very pleased with the rigor of our sterile device packaging audit criteria,” says Conboy. “The first MedAccred Accreditation for Sterile Device Packaging was awarded to Quality Tech Services, LLC (QTS) based in Bloomington, MN. QTS is now one of an elite group of companies who hold MedAccred Accreditation,” she says.
To gain accreditation, QTS has been recognized by medical device manufacturing industry experts as having demonstrated their ability to meet all the rigorous requirements of the new sterile device packaging audit criteria. The audit criteria were developed by BD, Boston Scientific, Medtronic, Johnson & Johnson, Philips, and Stryker.
As more OEMs sign on as subscribers to the program, it is providing greater operational efficiency and continuous improvement as well as greatly improved control over the supply chain.
Elizabeth Gaipa, VP Quality Management – Supplier Quality for BD, says that the company uses MedAccred accreditation as part of its sourcing process.
“A key consideration during the selection process is whether or not a supplier has received certification from the accreditation organization,” she says.
The MedAccred URL can be found in the bidding tool used by BD. “Suppliers are able to learn more about the MedAccred program by clicking the link to the PRI Web site,” says Gaipa. “This provides visibility to the MedAccred program and drives greater awareness of this accreditation opportunity.”
More than a Competitive Edge
Supplier companies that have received accreditation can gain much more than a competitive edge. Contract manufacturer and technology solutions provider Benchmark is one such example. “The MedAccred program allows us to prove our commitment to reliability and quality through accreditation and present legitimacy to our various industry partners,” says Todd Martensen, vice president, Medical Technologies Sector, Benchmark.
Martensen notes that one of Benchmark’s goals is to align itself with companies that share MedAccred subscriber’s values. “We’ve always maintained a high level of production quality. However, within large medical device manufacturers, you might have multiple divisions. And instead of having multiple auditors at each of our facilities coordinated by different divisions, we now have a baseline certification that those organizations understand. MedAccred has certified us at a certain industry level that allows us to reduce the number of audits, but also to increase the confidence that each organization has in a partner such as us. For these reasons, it was critical for us to become a part of this program. We’ve had three of our global design and manufacturing facilities certified — one in Thailand and two in Minnesota.”
Conboy adds that MedAccred is seeing this happen with other accredited supplier companies. “They may be supplying one or two divisions within the subscribing company, and accreditation opens doors to other divisions within that same company.”
“The value of this accreditation for a subscriber like Medtronic or Stryker is that it really transitions beyond the tiers of traditional supply chain,” adds Martensen. “And that really has great value because no company staffs the number of auditors needed to see all these suppliers to ensure the robust quality required by this industry.”
Martensen also believes that MedAccred accreditation provides other benefits to smaller companies in particular. “In addition to our large established partners, MedAccred gives us unique visibility to emerging technology companies that demand quality, accredited manufacturing services. MedAccred enables them to get to know us a little better as a potential partner. It allows us to have a higher level of exposure.”
One of the major OEM subscribing companies is very publicly talking about its requirement for accreditation. “For their new product business, they are requiring MedAccred Accreditation for direct suppliers for all products that require the critical manufacturing process areas accredited by MedAccred,” says Martensen.
Through MedAccred, the industry is now able to conduct rigorous audits of critical processes deep within the supply chain. The success and rapid growth of MedAccred is largely due to the value that the medical device industry places on the program’s contributions to enhanced quality and improved patient safety.
Sidebar: WHAT IS MEDACCRED?
MedAccred Merit Excellence
Contract manufacturer Flex is the first company to achieve “Merit” status for each of its six global MedAccred Accredited printed circuit board assembly (PCBA) manufacturing facilities. This special designation is granted to a company’s manufacturing facility that has consistently demonstrated its capability to meet the rigorous MedAccred accreditation audit requirements and achieved process excellence over a minimum of three years. Being awarded Merit status extends a company’s regular MedAccred audit frequency from 12 months to 18 months.
Sampling of Companies Actively Participating in the Program
- Applied Thermal Technologies
- Baxter Healthcare
- Benchmark Electronics, Inc.
- BMP Medical
- Boston Scientific Corporation
- Edwards Lifesciences
- Eimo Technologies
- Elytone Electronic Co.
- Fabrik Molded Plastic
- GE Healthcare
- Global Technologies
- GW Plastics
- Hansen Balk
- Haerterei Gerster
- Hilco Technologies
- Hoffer Plastics
- Johnson & Johnson
- Kaysun Corp.
- Kimball Electronics
- Mack Molding
- Metalworx Inc
- Microtech Welding
- Midwest Thermal-Vac
- Paulo Products
- Plastic Plus Technology
- Pliant Plastics
- Plexus Corp.
- PTA Plastics
- PTI Engineered Plastics
- Quality Tech Services, LLC “QTS”
- Schupan & Sons
- Segue Xiamen Manufacturing Services
- Sinbon Electronics
- Solar Atmospheres
- Sunlite Plastics
- TG3 Electronics
- Vac-Met, Inc.
- Vaupell Midwest Molding and Tooling
- Zimmer Biomet