MedMMAP Newsletter 1

MedMMAP Newsletter 1

Medical Manufacturers MedAccred ® Accreditation Pathway

March 2018

What is MedAccred ® ? An industry managed supply chain oversight program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. MedAccred is ad- ministered by Performance Review Institute (PRI). Visit p-r-i.org/medaccred for more information. U.S. Medical Device Manufacturer Challenges OEMs are beginning to talk of requiring MedAccred accreditation as a requirement for new business, and foreign based facilities are aggressively pursuing accredita- tion as part of their strategy to capture market share in the US. A significant loss of domestic share in the markets is forecast without a substantial change in US supplier competitiveness. Domestic supply chains offer significant ad- vantages in terms of lead time, innovation and on time performance. MedAccred accreditation enables those companies to also provide a preeminent position re- garding quality of product supplied, a major factor contributing to total cost of own- ership and supplier selection .

“Eventually, the direction is to be making business decisions based on MedAccred. Awarding business based on ac- creditation [to MedAc- cred] is the end goal.”

- Scott Goolsbey Stryker Corp

MedMMAP — An MEP National Network Program Q: What is MEP? A: MEP is a public-private partnership with Centers in all 50 states dedicated to enabling U.S. manufacturers to identify opportunities that will accelerate and strengthen growth and competitiveness in the global marketplace. Q: What is the mission of MedMMAP? A: To provide manufacturers with effective audit preparation for MedAccred accreditation, to increase competitiveness of U.S. medical device and medical instrument manufacturers, decrease industry costs, and improve patient safety.

In This Issue  What is MedAccred?  U.S. Medical Device Manufacturer Chal- langes  MEP and MedMMAP  Impetus for Action  Reducing Costs

Heat Treating is one area of critical process accreditation (Photo: Solar Atmospheres)

MedAccred Critical Processes Currently these processes can be MedAccred accredited:

 Cable & Wire Harness

 Heat Treating

 Plastics Extrusion

 Plastics Injection Molding

 Printed Boards

The Accreditation Process

 Printed Circuit Board Assembly

MEP, MedMMAP, and You For the past 30 years, the MEP National Network TM has equipped small and medi- um-sized manufacturers with the resources needed to grow and thrive. Our indus- try experts work side-by-side with manufacturers to reduce costs, improve efficien- cies, develop the next generation workforce, create new products, find new mar- kets and much more. Together, they strengthen communities and U.S. manufac- turing. Last year, MEP Centers interacted with 26,313 manufacturers, leading to $12.6 billion in sales, $1.7 billion in cost savings, $3.5 billion in new client investments, and helped create and retain more than 100,000 jobs. Many manufacturers, particularly those who are small to medium sized, are re- source constrained and do not have the bandwidth to efficiently and effectively prepare for MedAccred accreditation with internal staff alone. That is why Med- MMAP has been created, as a service within the MEP National Network. Determining what you need MedMMAP’s industry experts will perform a pre-audit assessment to the MedAc- cred ® standards and work with you to develop a plan to address each area of need. Getting you where you need to be MedMMAP’s industry experts have the resources of the MEP National Network to help you close the gaps identified in the pre-audit, mentoring your staff in the ac- creditation process.

 Sterilization

PCBA (Photo: EMSCO)

A few of the companies actively participating in the MedAccred program: Abbott Applied Thermal Technol- ogies Baxter Healthcare BD BMP Medical Bodycote Boston Scientific Corpo- ration Celestica HealthTech DJO Global DSM Biomedical Flex GE Healthcare Global Technologies GW Plastics Hansen Balk Harterei Gerster Industrial Metal Finishing Johnson & Johnson Kimball Electronics Lake City Heat Treating Mack Molding Medtronic Metalworx Inc Microtech Welding Midwest Thermal-Vac MTD Micro Molding Nypro Healthcare Paragon Medical Paulo Products Philips Plastic Plus Technology Plastikos RTE Sanmina

Photo Courtesy of Performance Review Institute

A Call to Action MedAccred is an industry managed, consensus-driven approach focused on im- proving patient safety by preventing product defects through a critical manufactur- ing process audit. MedAccred Accreditation is designed to help medical device companies identify suppliers who provide superior manufacturing processes. MedAccred is a global program and locations in Europe and Asia have already achieved accreditation. With OEMs such as Stryker requiring accreditation for

new business awards, there is merit to the posit that those who achieve accreditation early have the best opportunity to grow their business. MedMMAP wants that new business to go to U.S. facilities to grow invest- ment and jobs here. The time for U.S. medical device and medical instrument manufactur- ers to act is now.

SINBON Electronics Solar Atmospheres STERIS Stryker Synergy Health Techmetals Tecomet Vention Medical Zeus

Opportunity to Reduce Costs Medmarc ® , a leading medical device industry insurer specializing in product liability risks facing medical technology and life science companies, has outlined how it believes programs like MedAccred’s critical process supply chain accredita- tion system are helping the medical device industry to establish, according to Medmarc, “better supplier controls” which “could, over the long term, result in fewer recalls, fewer adverse events, and overall greater quality of products for the indus- try as a whole.”. “Medmarc recognizes the value of a supply chain accreditation program, such as MedAccred, and considers the integrity of an applicant’s supplier controls as part of the underwriting process.” MedMMAP Bottom Line—Growing Top Line Revenue MedMMAP, backed by the power of the MEP National Network, can help U.S. medical device manufacturers improve their competitive advantage and growth capability by adding MedAccred accreditation to their critical processes.

Contact Us Seven MEP Centers are leading the MedMMAP program. Give us a call for more information about how MedMMAP is helping manufacturers achieve MedAccred accreditation, or visit us at: MedMMAP.org

California California Manufacturing Technology Consulting ® (CMTC) Chris Buthe 310.634.2908 Georgia Georgia Manufacturing Extension Partnership (GaMEP) Tim Israel 404.894.2272 Indiana Purdue Manufacturing Extension Partnership (Purdue MEP) Chris Pearson 317.388.5124 Michigan Michigan Manufacturing Technology Center (The Center) Robert Lyscas 734.451.4228 New Jersey New Jersey Manufacturing Extension Program, Inc. (NJMEP) Bob Salamone 973.998.9801 Texas TMAC Mona Elkhatib 469.767.4305 Virginia and Nationwide GENEDGE Anthony Cerilli 804.517.1235