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Medical molding: Marman Industries' ISO 13485 certification fuels growth

Plastics molder and contract manufacturer Marman Industries Inc. (La Verne, CA) announced at last week's MD&M/PLASTEC West trade show in Anaheim that it has been recommended for ISO 13485 certification to perform medical manufacturing in accordance with FDA policies.

Clare Goldsberry

February 16, 2011

3 Min Read
Medical molding: Marman Industries' ISO 13485 certification fuels growth

Plastics molder and contract manufacturer Marman Industries Inc. (La Verne, CA) announced at last week's MD&M/PLASTEC West trade show in Anaheim that it has been recommended for ISO 13485 certification to perform medical manufacturing in accordance with FDA policies.

Achieving this certification wasn't easy. In fact, Marman started the process several years ago after it inked a contract with a major medical customer in the biopsy/diagnostics industry for manufacturing its products. "We started down the road to our 13485 certification about three years ago, and what a road it's been," commented Dwight Norman, general manager of Marman. "We've had to write procedures for every aspect of our operation, provide constant training to our employees, and even hire a regulatory affairs manager.

Marman even received help from a customer that brought in a quality team to help Marman develop an assembly line. Marman's quality engineers then learned how to validate an assembly line. "Now we can validate anything from molds to molded parts to assemblies," said Norman. "It took us one year to get an assembly line up and going, but it made us a much better company. All of our engineers are proficient in validating these assembly lines, and that has proven to be a major differentiator for us."

Marman's foundation is in mold manufacturing for the ocular lens industry, making molds for lens replacements used in cataract surgery. "We still do lot of work in that area, and we'll be attending the implant show later this year in Southern California," Norman noted.  "There's a lot of growth in that area." Recently, Marman invested $1.5 million in new robotic equipment for its mold manufacturing department. The payoff was that Marman's mold lead times went from 14 weeks to eight weeks, and from four to six weeks for small medical molds. "Reduced lead times-that's the name of the game to stay ahead of China," commented Norman.

Marman added injection molding about 16 years ago for mold sampling and preproduction runs. It didn't take long for the company to become a full-service custom molder and contract manufacturer. Today, Marman operates 24 injection molding machines ranging from 35-150 tons in a Class 100,000 (ISO Class 8) cleanroom environment. "The level of our quality has improved significantly over the past few years due to the stringent quality systems we've implemented, but it's really paid off," said Norman, adding that the company's 2010 sales were the highest in the company's history.

Marman is deeply involved with the medical industry, which represents 65% of its business. Norman says the company's ISO 13485 certification will help Marman differentiate itself once again in terms of its capabilities, and in particular the validation process for medical manufacturing. "Once you validate a tool here, the customers don't want to move the mold because they have to revalidate it, which takes a long time and adds costs," said Norman. "So they're here for the lifecycle of the product. The fact that we're ISO 13485 certified gives us a good foundation for expanding our medical business." —Clare Goldsberry

About the Author(s)

Clare Goldsberry

Until she retired in September 2021, Clare Goldsberry reported on the plastics industry for more than 30 years. In addition to the 10,000+ articles she has written, by her own estimation, she is the author of several books, including The Business of Injection Molding: How to succeed as a custom molder and Purchasing Injection Molds: A buyers guide. Goldsberry is a member of the Plastics Pioneers Association. She reflected on her long career in "Time to Say Good-Bye."

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