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WESTLAKE, OHIO (April 21, 12:45 p.m. ET) -- Plastics processors expecting to
enter the medical device market would be well warned to do their homework.
“The challenge of this marketplace is that there are very big barriers to entry.
There’s long gestation periods across the whole spectrum of medical devices, but
as you get into drug delivery systems, because of the nature of the products,
[there are] a lot of FDA regulations, a lot of clinical trials, a lot of
hurry-up–and-waiting,” Brenan Riehl, president and CEO of custom injection
molder GW Plastics Inc. in Bethel Vt., told attendees at the recent Plastics in
Medical Devices conference in Westlake.
Riehl and Len Czuba, president of product development firm Czuba Enterprises
Inc. in Lombard, Ill., ran a workshop April 12, the first day of the three-day
conference, which was geared toward injection molders looking to get into
production of medical devices.
According to Czuba and Riehl, medical devices will be a $250 billion industry by
2012, with U.S. consumption accounting for 45 to 47 percent of the global
market. The U.S medical device market is a $90 billion industry, with four big
firms taking up 40 percent of total revenue — yet there are 8,000 medical device
companies in the country, Riehl said.
He added that in 2005, 20 percent of medical device manufacturing was outsourced
by original equipment manufacturers, compared to just 10 percent in 2002:
“There’s a lot of outsourcing opportunity and I believe it’s just going to
continue to grow, as medical devices companies — OEMs — spend more of their time
on innovation and [research and development] and less time on manufacturing.”
Riehl said GW Plastics — Plastics News’ Processor of the Year for 2009 — spent
about 10 years in the late 1990s and 2000s switching its operations from
primarily automotive products to about 75 percent medical-related parts. The
company is ISO 13485 certified and registered with the Food and Drug
Administration for medical device manufacturing, and has six, ISO-class clean
rooms for molding and assembly.
But Riehl said clean room requirements — ISO 100,000 and ISO 10,000 — shouldn’t
be a barrier to molders looking to enter medical; they could start with white
rooms, which don’t require as sophisticated air-quality monitoring and
filtration system, but will satisfy many medical device manufacturing
requirements.
Czuba agreed, and like Riehl, said automation and scientific monitoring of
production were the keys to taking high U.S. labor costs out of medical device
manufacturing.
“It shouldn’t make any difference whether [manufacturing is in] China or India,
or South America or Europe, or in Vermont: Whatever quality you put into place,
it should be the same,” Czuba said.
He said a bright spot for the plastics industry is that although cost-conscious
insurance companies and medical providers are looking into more reuse and
reprocessing of medical devices, most major manufacturers are leery of it, since
patients who suffer complications from recycled, improperly sterilized devices
would sue the manufacturers. So there should be plenty of demand for resin and
newly-molded products.
But Czuba cautioned molders who aren’t familiar with FDA regulations regarding
medical devices to get to know them — even if they aren’t planning on making
parts in North America.
“The FDA is now being much more proactive and they’re starting here in the
states, but there also doing it overseas. So if you have foreign manufacturing
facilities, don’t think that you’re immune to the FDA showing up at your
doorstep and asking to see your records on medical devices. Because they have
that right,” he said.
Len Czuba’s brother, John, director of quality at Czuba Enterprises, said in an
April 12 interview that smaller molders just entering the medical device
industry are giving the brothers plenty of consulting business.
“Many people just don’t understand what it takes to get it out there. The
problems that occur are fixable. They want help, but they’re afraid to ask. A
lot of these people have been doing plastics for automotive or retail or
pharmaceuticals,” he said.
Several such companies were represented at the Cleveland conference, including
custom molder Plastics Components Inc. of Germantown, Wis. — which won Plastics
News’ 2009 Processor of the Year award.
Marketing Manager Teresa Schell was among about 300 attendees at the conference,
and said since the start of the recent economic downturn, PCI has looked to
broaden its customer base beyond making small engines, plumbing, appliance- and
automotive-related parts.
“We are focusing on one particular area, because we don’t want to be everything
to everybody. We are focusing on one particular [medical] segmentation,” she
said. Schell would not disclose the medical products that PCI plans to make. The
company in early April received ISO 13485 certification, she said. “The next
step will be changes operationally, whether that’s putting in a white room,
which would be followed by a clean room, so systems are in place quality-wise,
systems will be in place operationally, we’re already working on new
market opportunities — so I think that all of that, bound together, will help.”
Schell said.
PCI has 42 injection molding machines and 46 employees, “so we are going to find
an application that is going to fit our business model that doesn’t require a
body at the press,” she said.
Room-in-room options or portable press-side clean rooms are cost effective
alternatives for many medical applications molded in multi-market facilities,
Riehl said in his presentation.
Riehl and Czuba urged molders to invest in zero-defect, robust tooling and
molds, and to become familiar with hot runner systems to increase productivity
before they get into making medical devices.
Time is of the essence: Riehl pointed out that by 2020, 54 million people
globally will be 65 or older, about a 54 percent increase over the 35 million
who fit that demographic in 2000.
Czuba pointed to increased use of alternative outpatient site treatments
(“shopping malls instead of hospitals,”) and increased replacement of metal and
glass by plastics as additional reasons for molders to get into the space. He
also pointed to the trend of medical devices being designed to be left inside
the human body, where they would last a long time — or in the case of some
bioplastics, dissolve and be harmlessly absorbed, as some of the exciting trends
emerging in the industry.
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