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An MD&DI May 1997 Column

SNAPSHOT

Robert Thompson on developing medical packaging.

It started with the complaint that gastroenterologists couldn't read labels in their darkened labs. The physicians, who view the internal organs of a patient on a video monitor, couldn't turn the lights on to read, because it took too long for their eyes to readjust to the dark when they turned them off again. To help these physicians use medical products in this setting, Robert Thompson, manager of the package engineering department at Boston Scientific Corp. (Watertown, MA), created packaging with phosphorescent labeling. Not only did the physicians welcome this feature, but the Institute of Packaging Professionals (IoPP) recognized Thompson's efforts with an AmeriStar award and the World Packaging Organization gave him a WorldStar award.

"Listening to a customer is often the best way to design a package," explains Thompson, who has been designing packages for medical devices and diagnostics for a decade. "Customers know what they're looking for and can give you the best information to help you develop the package design." The phosphorescent labeling was the result of such communication.

Before focusing solely on medical devices, Thompson, who holds several U.S. and international patents, designed packaging and packaging systems and equipment for pharmaceutical, food, medical device, and industrial products for various clients. Such experience prepared him for his position as senior packaging engineer at American Cyanamid Co., Davis & Geck Div. (Danbury, CT), where he developed packaging for sutures, wound-closure devices, bioabsorbable bone screws and pins, and operating room products. To design such packaging, he had to understand how extreme heat and high doses of gamma, E-beam, and EtO sterilization affect packaging.

Over the years Thompson has come to believe that a good package does more than just hold a product. "A good package meets end-user preferences, offers convenience, protects a product, meets regulatory requirements, addresses environmental concerns, and satisfies manufacturability and cost issues," he explains.

In order to heed the environmental call to reduce, reuse, and recycle, Thompson says, designers are producing packages that use less material. "Due to health issues, a large percentage of medical waste is not recycled. Source reduction is the best way to lessen the impact of medical packaging on the environment," he says. "Whenever we can, we do try to make packages recyclable." The thermoformed-tray-and-lid system designed to protect Boston Scientific's Symphony nitinol stent, for instance, was made from recyclable materials. Thompson's efforts secured him an IoPP merit award in 1996.

Influencing how Thompson develops packages is the industry's move toward a global market. In order to obtain the CE mark, necessary for selling devices in the member states of the European Union, manufacturers must label their devices with instructions in the languages of the targeted markets. "To deal with this trend, most of the industry is using a multilingual labeling format," Thompson observes. "This challenges the packaging developers to deal with limited real estate--it's very difficult to fit all the necessary languages on the package."

Another trend, driven by changes in regulatory and quality control requirements, is the push for designers and engineers to validate the process as well as the package. "In the past, packages were developed and then tested for applicability and performance," explains Thompson. "Today, most companies are also validating the systems that develop the package. You therefore have a greater assurance that the package is going to be effective."

This trend has fostered a relationship in which packaging component suppliers and developers work together to validate the entire packaging supply chain, including the processes for making packaging components. "This helps ensure that the components the suppliers provide meet the developer's needs," Thompson says.

Thompson also sees a continued move toward using less-invasive medical devices and early interventional procedures. "Ailments that once required surgical repair are often being corrected at an earlier stage with minimum trauma to the patient. These procedures are being performed by radiologists, cardiologists, and others. The packaging designer must understand the various needs of these physicians and the environments in which they work."

To keep up with these trends, the packaging designers of the future must wear many hats--"engineering, regulatory, and marketing hats," explains Thompson.

Daphne Allen is associate editor for MD&DI.

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