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June 20, 2008

http://www.biotechblog.com/2008/05/29/promote-your-expertise/#comment-5992 

by Costas Chantzis, injection molding and medical device manufacturing consultant.

Title: Injection molding HOT TIPS for high end productivity, quality and profitability

The injection molding business is highly fragmented. Companies that are joined-at-the-hip with the end marketer and customer, provide upfront part design/development services, know how to build robust tooling matching a part's specs., know how to identify and control the Critical Process Parameters (CPPs) of a manufactured part, offer sub-assembly services and have in-place adequate quality systems (preferably FDA-compliant) are poised to outlive their competitors in the US and abroad and make double percentage digit profits year after year. Unfortunately, there are very few companies that could provide the TOTAL PACKAGE to the end-customer using the win-win business principle. So, everyone is trying and hoping to find the best solution alternative but with very little luck. Injection molding manufacturers have to rethink in "what type of business" they are in: Are they in the injection molding business?" or are they in the "contract manufacturing business"? I believe they should want to be in the contract manufacturing business similar to being in the transportation business instead of being in the famous "railroad business"!

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Our President, Costas Chantzis, made news again on July 8, 2008. The Plastic News cited his presentation at a Medical Day Conference in York, PA on June 18 and 19, 2008, when it wrote:  

"Strict regulations and high standards will certainly deter competition from overseas.

The U.S. Food and Drug Administration (FDA) is paying close attention to the medical-device molding industry, said Costas Chantzis, president of Stewartsville, New Jersey-based consultancy TechnoBusiness Solutions. “You either go for FDA compliance or suffer great pain,” he said in a presentation."  
 

The complete article and URL follows:

http://www.plasticsnews.com/china/english/headlines2.html?id=1214953156


PLASTICS NEWS STAFF
Nina Ying Sun

YORK, PENNSYLVANIA (July 8, 2008) -- As the auto market in North America sinks more due to the economic slowdown, foreign competition and gas price hikes, injection molders that supply the industry are losing margin, being pushed to the edge, and, in some cases, out of business.

The solution for them may be to switch to the medical-molding business, a high-margin, economic-downturn-insulated and outsourcing-proof sector. With that in mind, about 100 attendees -- mostly molders -- gathered June 18 to 19 at press maker Engel Holding GmbH’s North American headquarters in York for the company’s symposium on medical molding.

Steve Braig, president and chief executive officer of Engel North America, pointed out the looming trend of auto molders moving into the medical sector.

“A lot of contract molders, who are a good base of our customers, are looking to diversify and move away from automotive, appliances and consumer goods,” he said
in a June 19 interview. “Medical devices and health-care products are growing and less cyclical. We clearly see a trend there.”

So does Robert Carpenter, a first-time attendee at Engel Machinery Inc.’s Medical Day symposium. Carpenter is the president and chief executive officer of second-tier
auto supplier Infinity Molding & Assembly Inc. of Mt. Vernon, Indiana. 

“We must upgrade technology and the business,” he said. A former employee of Guardian Automotive Corp., he understands the hardship associated with today’s auto molding and already has set up some medical-molding business.

The $15 million (102.9 million yuan) company makes casing, plugs and test strips for medical devices such as the Accu-Chek home-use blood-glucose-monitoring system.

But Carpenter is considering expanding the medical division to balance its main business in auto. He hopes to make higher-level medical parts and products that 
require Food and Drug Administration approvals and stringent control.

Strict regulations and high standards will certainly deter competition from overseas.

The U.S. Food and Drug Administration (FDA) is paying close attention to the medical-device molding industry, said Costas Chantzis, president of Stewartsville, New Jersey-based consultancy TechnoBusiness Solutions. “You either go for FDA compliance or suffer great pain,” he said in a presentation.

European molders fear FDA regulations and feel that the U.S. market is hard to break into, according to Christoph Lhota, vice president of the medical business unit 
at Engel Austria GmbH. Asia, on the other hand, is making commodity medical products but won’t be on par with the West for high-end medical business any time soon.

“High-end medical molding will stay in America for quite some time,” Braig said.

Another speaker, Andrew Sargisson, also expressed optimistic views of medical molding in North America. “I see massive potential in the U.S. market. I’ve seen dramatic
change in the last two years … molders are bigger, smarter, working more efficiently, and looking for better ways to do it. The potential is staggering.” Sargisson is
export sales director with Waldorf Technik GmbH & Co. KG, an automation equipment supplier in Engen, Germany.

But entering medical molding is not easy. 

“People are typically very concerned with regulatory issues,” Braig said.

Once in compliance with industry standards, quality control is more important than ever in medical molding. Lives depend on the parts to be accurate and repeatable,
Donna Bibber told the audience. She is a technical partner of microPEP, a subsidiary of Precision Engineered Products Inc. of Charlton City, Massachusetts.

Molding microparts for the medical industry, she said, requires unconventional tooling tolerances as well as special inspection techniques and equipment. Her company uses
tools from both in-house production and outsourcing.

Sargisson also warned about the risk of over-investment in medical molding. “Europe has gone through this change,” he said. “The U.K. market, for example, is a disaster.
Every week you open the newspaper, there’s [medical] companies closing.”

Sargisson advised companies to “take a hard look and the right steps.”

What Europe went through -- intense competition reshaping the market -- is perhaps not a bad thing, he added. The quality of products and customers has increased. 
Businesses that have survived the shrink are left in a strong core market. “I think the same will happen in the U.S.”

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