While rooted in plastic injection molding since its inception in 1920, Mack has long since been more than a molder. Vertically integrated into a number of other core competencies, Mack offers design, prototyping, metal fabrication, full product assembly and direct order fulfillment. Specifically for medical customers, the company has also recently added product refurbishment, complaint investigation, and obsolescence management.
ARLINGTON, Vt. – Mack Molding Co. has formed a new medical products group, MackMedical.
“We have been aggressively developing the medical manufacturing sector of our business for the past nine years by refining quality and supply management systems, hiring specialized staff, and adding new technology,” says Jeff Somple, president of Mack Molding’s Northern Division. “As a result, the medical market now represents a full 30 percent of our business, including several Class III medical devices, surgical equipment, and disposables for the orthopedic market. After this significant investment of time and resources, we now have all the markers in place to legitimately call ourselves MackMedical.”
Located at Mack’s headquarters in Arlington, Vt., MackMedical is a focused group of staff --product development, program management, quality, regulatory, document control, purchasing, sales and production -- that is skilled in medical manufacturing. They manage all medical accounts, from upfront engineering through final manufacturing and distribution. “This is an engineering-intensive team with a medical manufacturing culture that understands the industry,” explains Kevin Bradley, business unit director. “The customer doesn’t have to spend time bringing us up to speed on the stringent requirements of this market.”
More Than A Molder
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While rooted in plastic injection molding since its inception in 1920, Mack has long since been more than a molder. Vertically integrated into a number of other core competencies, Mack offers design, prototyping, metal fabrication, full product assembly and direct order fulfillment. Specifically for medical customers, the company has also recently added product refurbishment, complaint investigation, and obsolescence management.
“We have developed a robust medical products group within Mack Molding that represents a rapidly growing segment of our overall business,” adds Somple. “Medical manufacturing will grow to 50 percent of our business in the near future, as we anticipate adding large-part clean room molding and other medical design services.
“We have demonstrated to the medical market that we’re in this business to stay,” concludes Somple, “which is particularly important during this period of economic uncertainty. Given the length of the medical product development cycle, it’s critical for OEMs to deal with contract manufacturers that have the financial and staff bandwidth to stay the course. Mack remains debt-free and financially strong. And we continue to make investments in people, equipment and technologies that will collectively keep us and our customers moving forward together.”
Quality Gold Standard For Medical Manufacturing
The quality management system of Mack Prototype, Inc is certified to be in compliance with the requirements of the ISO 13485 international quality standard for medical device manufacturing.
The International Organization for Standardization (ISO), a prestigious network of national standards institutes from over 150 countries, created the standard to provide medical devices that consistently meet applicable customer and regulatory requirements. NSF International Strategic Registrations (NSF-ISR), an accredited registrar, carried out the third-party assessment and certification.
“Achieving this quality hallmark uniquely positions us as a prototype house and low-volume manufacturer,” says President Ric Perry, “as many manufacturers our size are not certified to this stringent medical standard. It will put us at the table with major medical OEMs, who require suppliers to be certified to ISO 13485 in order to quote new projects. It will assure customers we are continually driving toward quality system improvement. And based on customer needs, it will allow us to partner with Mack Molding, which is FDA registered and has been certified to ISO 13485 for several years, to provide a low-volume solution for major medical OEMs.”
Mack Prototype is a low-volume manufacturing company that specializes in SLA rapid prototyping, CNC machining, LIM polyurethane, and injection molding. The Gardner location houses eight injection presses (10-230 ton) for low volume, small-to-medium part molding.
Mack Prototype complements Mack’s growing list of vertically integrated services, which includes product design and development, custom injection molding, sheet metal fabrication, printed circuit board assembly, and full product assembly and order fulfillment.
ISO is a non-governmental organization that has been developing voluntary technical standards over almost all sectors of business, industry and technology since 1947. To learn more, go to www.iso.org.
NSF-ISR offers a comprehensive portfolio of management systems registration solutions to meet the demands of the global marketplace (www.nsf-isr.org). Headquartered in Ann Arbor, Michigan, with offices in Taiwan, Europe, China, Brazil and Canada, NSF-ISR performs audits and provides management systems registration for more than 6,000 clients throughout the world.
For more information visit www.mack.com.