The main use of medical plastics is in the manufacturing of medical instrumentation. Use of these instruments together with computerization and miniaturization has enabled doctors to deliver care that is less invasive and easier on the patient, according to Len Czuba, principal of Czuba Enterprises, Inc., a product design and development firm. Czuba also is president of the Society of Plastics Engineers.
According to Czuba, "Operations used to center around open surgery, which required incisions that had to be sewed up afterwards. Now, for example, tiny laparoscopic instruments at the end of long tubes enable surgery to be performed through the abdominal wall, resulting in less recovery time. Sutures and incisions are often what cause long recovery times."
Czuba cites the use of plastics as "a huge trend in medicine today." He says the need to replace metal in implants is driving an ever-increasing appetite for new innovations; advances in bioresorbable (absorbed by the body) and biodegradable materials are powering progress in bone and skeletal treatments. "Plastic shaped like a bone can be substituted for damaged or defective bone," says Czuba. "The implant dissolves as the bone grows back."
Another area of growth is the use of biopolymers to replace petroleum-based products, Czuba says. Biopolymers are starch-based materials that are used to develop a medical package that will eventually dissolve, eliminating a lot of residual waste. Engineering polymers are also continuing to evolve. He says these are very good options to replace more expensive materials like metal and glass. In many cases, an instrument made from metal can be replaced by an engineering polymer made of plastic. Use of molded plastic components can often replace metal in operating room cutting tools at much lower cost. For example, a scalpel consisting of a metal handle and blade can now have a molded plastic handle, which gives it a softer grip. A number of these same engineering polymers are fulfilling the specific requirements of medical devices manufacturers as they continue to make devices smaller.
Regarding site selection, Czuba says finding a good labor force trained to make the products needed is the primary requirement: "The best companies are the ones that train employees on an ongoing basis and encourage their involvement with professional societies."
Lean manufacturing is focused on the elimination of waste through strategies that provide customer value and operational excellence, according to Kevin Duggan, principal of Duggan & Associates, Inc., an advanced lean educational and advisory firm.
"Lean manufacturing principles are a must for today's medical device manufacturers to respond to changing customer and market demands," he says. "It involves creating lean value streams that flow at the `pull' or demand of the customer and are clearly evident so that each employee can see the flow of value to the customer and fix it if it breaks down."
Duggan cites three approaches to establishing lean value streams:
• Create a continuous, one-piece flow system that moves one product at a time
• Create a first-in, first-out flow system
• Create a pull system that connects all of the manufacturing processes together
"If you can't do a continuous one-piece flow, then go to first-in, first-out or the pull system," he advises.
The end objective is to produce high-quality products in small batches dovetailing with the rate of customer demand. That's in contrast to traditional practices where standard batches are delivered at standard times to distributors regardless of demand. He recommends a four-step approach for medical device manufacturers in developing a new production plan:
• Identify the value stream in your office operations and shop floor
• Map the flow from the existing value stream
• Create a new value stream using lean principles
• Develop an implementation plan for the new value stream
Types of waste that can be eliminated include making the wrong product, overproduction, inventory (it's waste, although you may need it, he concedes), waiting transportation, and scrap. "The last thing you want to do is a layout drawing, rather than the first thing," he advises.
Duggan says site selection decisions for medical design and manufacturing firms should be based on where they can locate to best respond to customers and where they should be in relation to their supply chain. "Also, you need access to urban hospitals to test new technology and professional resources for information," he adds.
Taken as a whole, it's clearly evident that medical design and manufacturing is on the cutting edge of new technologies and procedures that could scarcely be imagined a few years ago.