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December 30, 1999
9 Min Read
Quality is an important part of every market served by injection molders, but when it comes to medical applications the bar is raised a little higher. Terms like GMP and FDA rule the landscape. And a product’s ability to perform in the emergency room or on the operating table could mean the difference between life and death. Manufacturers and OEMs in this market have distinct and specific requirements for the next few years.
Sink or Swim
One of the most outspoken, opinionated, and frank experts in the field of medical molding is Bob Alvarez, consulting engineer in plastics engineering at Ethicon Endo-Surgery, a unit of Johnson & Johnson and manufacturer of specialty surgical products. Bob is a frequent speaker at conferences and seminars, and rarely hesitates to offer his opinion on what molders should and should not be doing to enhance their business. He’s a staunch proponent of new and emerging technologies that might help molders, and subsequently Ethicon, gain an edge on the competition.
The statements Alvarez issues are at times startling. Take your pick:
“If you’re not building lights-out factories within 10 years, you’re not in the ball game.”“If you’re inspecting parts in five years by the side of the press, you’re doing something wrong.”“Just running machines does not make someone a profitable molder anymore.”
His core message is consistent: A molder has to be more innovative and offer more services to his or her customers to make the grade at companies like Ethicon. As is happening elsewhere in the industry, Ethicon is trimming its supplier list. There were 38 molders making parts for the company just five years ago. Now there are five.
Volumes, meanwhile, are increasing. A smaller number of molders are being asked to do much more. In return, those molders get a bigger slice of the pie in the form of a business commitment from Ethicon. So how do you become one of the chosen few?
A Wish to be Different
At the top of the Alvarez molding wish list is specialization. “One of the things that really bothers me about the industry is that everyone is trying to build a universal factory that’s going to fit all customers,” he says. “That is an archaic way of doing business.”
A molder, he contends, should pick one market, develop a specialty, keep plants to less than 20 presses, and then build value-added services around that niche. “You have to get into plants that are more specialized with work cells that are more cost-effective,” Alvarez says. “The plant must truly reflect the needs of all of the market. You must do what the market wants.”
For the medical market, Alvarez says the most-needed service is design. Medical product life cycles over the last decade have shrunk such that OEMs don’t have the time, money, expertise, or desire to dedicate staff to design. Time to market is critical, and Alvarez says manufacturers want to be able to take a concept to a molder who will then carry the ball.
“The involvement of the molder early on in design concepts is critical,” he says. “That means that molders need to have design capabilities in-house. If you don’t have that, you’re going to be left behind in the pack.”
Mold, Machine, Global Trends
Another irksome trend that Alvarez warns medical molders against is high cavitation. Although medical molders have been moving to lower cavitation in recent years, Alvarez would like to see more. “The heavy investment in capital, which is the way the industry has traditionally driven down cost, is just not going to be allowable,” he says.
Following reduced cavitation is the demand for interchangeable cavities—not just within one plant, but within an entire organization, whether the mold’s running in a press in Iowa or in Taipei. Moldmakers, he recommends, should set their sights on streamlining production. “Moldmakers,” he says, “are going to have to be able to take solid model technology and transfer it directly into tool design and toolpathing without a lot of construction time.” This means a solid model should be able to go directly to high-speed milling and CNC.
The next requirement is globalization. Alvarez strongly recommends that molders either build alliances with overseas firms, or establish overseas operations. Companies like Ethicon, he says, want to be able to source parts from multiple regions around the world with a guarantee that mold and part quality will not vary from location to location.
In the coming decade Alvarez also sees the molding process becoming more computerized, diminishing the role of the press. “Computer capabilities within injection molding are going to drive this industry in the next 10 years,” he says. “I hate to say this, but the injection molding machine is becoming nothing but a specialized pump that the computer hangs off of.”
To that end, he suggests molders invest heavily in new technology that enhances the performance of the mold. This means using cavity pressure transducers, scientific molding techniques, gas assist, and automation.
The Model Molder
So what does Alvarez’s model molder look like?
It would be a company that knows that most of its money doesn’t come from molding, but from providing a package of services. It would perform medical molding only and provide market expertise. “Invest in personnel for upfront costs instead of running a factory,” he says.
It would have complete in-house design facilities and services, or partnerships with experienced medical design firms.
It would partner with experienced medical moldmakers who can cut steel from a CAD file and produce interchangeable cavities and cores.
It would have facilities overseas or alliances with other molders in Europe and Asia to which cores and cavities could be sent, installed, and run with minimal qualification or startup.It would run highly automated production cells in a true lights-out environment. Tool changes would be performed by robots without human intervention. Parts would emerge from the press within spec, thanks to the use of cavity pressure transducers or other advanced technology. “A lights-out factory is one that can run 20,000 parts or 10 million parts and not know the difference in cost,” says Alvarez.
It would provide assembly expertise, along with JIT shipping services to almost any location in the world.
Some of this may seem like pie-in-the-sky, but Alvarez says he’s seen such plants and knows more can be built. But it will require heavy investment over the long term from committed molders and moldmakers. “I have some molders tell me that they can’t afford to do this,” Alvarez reports. “I tell them that they can’t afford not to do this.”
The regulatory hurdle: Oh, the horror!Unlike mobile phones, dishwashers, and toys, not every medical product can be tooled in record time, molded at the speed of sound, and rushed to market in time to reap the monetary rewards of being the first on the shelf. Time lines for some products are protracted, extended, and drawn out by the regulatory process. Drugs have to be tested, trialed, poked, prodded, and approved. Speed to market is still critical, but it can be years, not months, before a product reaches the consumer.
Dura Pharmaceuticals in San Diego is in that boat right now, going through the development and regulatory approval phase of a new generation injection molded inhaler that’s expected to start production in 2001. James Boyles is an engineer at the company working on the project. He says that his biggest qualm with medical molders is their apparent unfamiliarity with the quality requirements imposed by Dura and the regulations that apply to its products.
“Most molders talk a good talk,” he says, “but when you really go in and start doing an audit, talking to people, meeting them, seeing what they do day to day, you find that most of them really don’t get it. They just don’t understand that when it comes to quality, what they say they do and what they actually do have to be the same. Without quality we can’t even do business with them.”
Although Dura has its own product design department, Boyles says the next most critical issue is technology transfer. The increased use of CAD has given many designers new license to develop products that do many wonderful things, but when it comes to molding, the expertise and experience thins. Molders, says Boyles, could make a stronger effort to bridge the gap between commercial operations and design.
“The key is being able to walk that delicate line between what the design engineer wants and needs,” he says. “But a lot of times, a design is just not manufacturable. You can draw it, but you can’t mold it.”
Inside outFinding a small stable of reliable and reputable molders is the goal of a major medical OEM in southern California (anonymity requested). At the company’s manufacturing facility the firm has always done some of its own molding, with generous help from custom shops in the region. But in the last few months the company has begun the gradual process of moving its molding business entirely outside, leaving the OEM with design and some assembly responsibilities.
A senior manufacturing engineer at the plant says the company relies heavily on help from outside molders and moldmakers and is looking over the next year to settle on two to three molders who will form business alliances with the medical OEM. Each molder must have medical market experience, ISO 9002 certification, cleanroom capability, and either in-house or alliance capability to produce soft preproduction tools.
It’s somewhat of a tall order, especially the demand for soft tooling capability, the engineer says, but the company is committed to trimming its supplier base. Either way, gone are the days when this plant was served by as many as eight molders. “It’s just more cost-effective and easier to manage a smaller group of suppliers,” he says.
As James Boyles at Dura echoes, this OEM’s number one priority is quality. And you can add timeliness to the list. “The only time we really ever just cut off a supplier is when it wasn’t delivering on time,” says the engineer. “The high-end, high-tech medical market doesn’t really nickel and dime people. The question is whether you can deliver a quality product for a three-year period and not cause us grief. If so, we’re willing to spend money on that service.”
Unfortunately, the number of molders shopping their services exceeds this OEM’s supply. “We’ve got a lot of molders approaching us saying the same thing: ‘We’re looking for an alliance,’” says the engineer. “But I’ve got six of them knocking, and only one of them is going to win with full service.”
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