Medical Design & Manufacturing Breakthroughs
Once the stuff of science fiction, today's technologically advanced products can increase both the length and quality of our lives.
John Bell (April/May 06)

Medical design and manufacturing, one of the nation's fastest-growing industries, is targeting new advances to fight many of our most costly and harmful diseases. Reflecting its rapid growth, the medical technology industry, currently an $80 billion market, is projected to reach $140 billion by 2010, according to the Advanced Medical Technology Association (AdvaMed). The industry's products include pacemakers, defibrillators, orthopedic implants, diagnostic imaging equipment (such as ultrasound computer tomography), and magnetic resonance imaging (MRI) machines, as well as diagnostic tests that detect disease.

Mark Brager, AdvaMed's director of communications, says one of the major trends in medical design and technology is miniaturization, which allows implants to be smaller and produces less hospital time for faster recovery. He also cites mapping of the human genome (DNA). "It's an important scientific milestone that will lead to incredible breakthroughs in medical diagnostic technology," he says. In addition, advances in materials sciences are increasing the durability of implants. According to Brager, implants that used to last 10 years are now lasting 15 to 20 years and in the future will last 40 to 50 years. "It's important because people are living longer," he says. He also cites health information as one of the more important areas of technology, enabling providers to get rid of paper records, generate fewer medical errors, and increase efficiency.

In terms of site selection, Brager and others say medical design and manufacturing companies tend to group together in clusters of concentration, to avail themselves of reciprocal services, technical support, and professional resources. Brager lists the "Big Three" areas as Boston, the Twin Cities (called "medical alley"), and Southern California. Smaller versions of the Big Three are coming in Warsaw, Ind., Philadelphia, and areas of New Jersey.

It's no secret that today's medical manufacturing environment is a fast track, with the rapid emergence of new developments that can change market trends virtually overnight. Innovative products usher in new trends while older technology fades away. With that in mind, Medical Design Technology magazine, in its January 28, 2006 issue, pinpoints five different medical manufacturing sectors in the forefront of new trends: combination products, electronic miniaturization, nanotechnology, medical plastics, and lean manufacturing.

Combination Products
A combination products is one that combines more than one element, such as a medical device coated with a drug. The combination nature enables the product to perform its function more effectively, according to Barry Sall, senior consultant at PAREXEL International, providers of expertise in biopharmaceutical and medical device development to manufacturers worldwide. There's a wide variety of combination products, most being prescription products used by physicians. One that has enjoyed particular success is the drug-coated stent - a tube one-eighth of an inch in diameter and coated with a medication, which can be threaded into a blocked artery. The stent clears up the blockage and the drug prevents it from coming back by killing the cells that were creating it.

There's a trend toward increasing use of combination products because they provide greater insight into how medical devices react with the body. "As researchers gain additional understanding of these reactions, they can use drugs or biologies to enhance that interaction or reduce the possibility of an adverse reaction," says Sall. In general, combination products are more complex than traditional medical devices, he says, "so more complex manufacturing techniques are required to produce them. They require a lot of technical decisions which may involve process engineers or chemical engineers in some cases."

Sall says the industry involves many small entrepreneurial companies that want to be close to sources of venture capital, as well as intellectual resources in the form of schools and teaching hospitals. "Getting the right people together with the right knowledge is the main thing," he says.

Electronic Miniaturization
Electronic miniaturization is in the industry forefront today as medical device companies continue to push the envelope to make their implants smaller and less invasive, according to Jim Ohneck, director of sales and marketing at Valtronic USA, a company specializing in miniaturized electronic design and assembly. How small are these devices? Ohneck says a device two millimeters in diameter and one millimeter in length can contain an entire electronic assembly: "It's part of a move in the medical industry to make devices smaller and more compatible for the end user."

New trends are emerging in the electronic packaging industry, including so-called bare die packaging techniques such as COB or FC within a folded flex or flex-rigid design. They give the designer considerably more space in which to work, usually resulting in smaller size and more features. That typically improves the performance of the device, Ohneck points out.

All components within the electronic assembly are made biocompatible, and radio frequency capability is added so the implant can collect information and transmit it to the outside world. In addition to making existing devices smaller, another trend is to manufacture electronic drug delivery devices the size of a tiny pill that are implanted or swallowed. Biocompatibility is very important here, as is the ability to survive in a harsh environment such as the stomach.

Manufacturers are also seeking new ways to power small circuits, including powering implants from outside the body. In addition, they're putting more electronic features on products.

Nanotechnology
When it comes to small, there's nothing smaller on the medical front than nanotechnology. Probing still deeper into the microscopic world, it's the science that deals with the making and understanding of extremely small materials. These improve products by making them more cost effective or easier to use, according to Bruce Gibbins, Ph.D., chairman and CTO of AcryMed, a medical research and manufacturing firm that uses nanotechnology.

"One of the main benefits of nanotechnology is miniaturization," he says. "The first battery-powered pacemaker was about the size of a dishwasher and had to be transported on casters. Now, a dozen pacemakers fit into the palm of the hand."

Gibbins cites applications of nanotechnology in several medical-related industries:

• Electronics: Nanotechnology is used to make smaller and smaller components. By definition, things that fall into nanotech's realm are those less than 100 nanometers in their largest dimension. A particle of this diameter is less than 1/7,000 the size of an object visible to the human eye. For comparison, one inch contains around 25 million nanometers. "We may eventually be able to see a single atom," he says.

• Health care: Nanotechnology leads to devices able to deliver drugs where they're needed in the system, across cell membranes without harming cells.

• Diagnostics: Nanotechnology is used to improve product diagnostic testing. Some prototypes are being tested in which a single drop of blood flowing through miniature channels in credit-card size devices pass over nanodots of detector chemicals. The nanodots are able to screen for more than 1,000 different markers of disease. The results, interpreted by a computer reader, may identify abnormalities long before clinical symptoms are present in the patient.

In addition, medical devices are already being marketed that use nanotechnology to help them resist microbial infection.

"Nanotechnology was once only a concept of science fiction but now it's proving to be a key component of our everyday lives," says Gibbins.

Medical Plastics
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
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.

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