Who better to run a machine an the people who built it? Doyen Medipharm hopes that will prove to be a winning sales pitch as it builds its business of contract packaging for medical devices. The 11-year-old company has branched from construction and sales of medical packaging machinery into packaging of gloves, dressings, transdermal patches, in-vitro test devices and other medical devices and equipment.

Currently, Doyen Medipharm’s contract packaging operation consists of two rooms at its facility in Lakeland, Fla., where equipment is shuttled in and out as needed. One room is designated the “cleanroom” and one the “dry room,” although in fact they both have washdown and air-filtration capabilities necessary to cleanroom operations. The company has recently received a large-scale contract to package alcohol-soaked pads; as a result, Doyen is adding a third, high-volume contract packaging area.
That customer contracts out all its manufacturing. Most packaging contracts are going to be for projects that are just getting under way, Doyen executives say.

By the time a product reaches a critical volume, pharmaceutical and medical companies “know what the product is, they know what it’s going to look like, they can justify assigning work stations,” says Ray Johnson, president of Doyen’s U.S. operations. “But the introductory volumes can be a complete goose chase. Why should they gear up and have FDA validation on an operation for 10,000 units? The market results could come back terrible, and they often do. Ninety percent of our customers are guys who hope the thing will go to a million units, but they don’t know if it ever will.”
Such small-volume customers can be roughly divided into two categories, says Martin Beriswill, vice president of operations. Some are at the beginning of the development process and need packaging for clinical trial samples. Others have received all the necessary approvals but can’t for the moment justify buying the packaging equipment outright.

Doyen is hoping that its experience and expertise as one of the leading manufacturers of medical-device packaging machinery will serve as a major attraction for con tract packaging customers. The company, whose revenues exceeded $10 million last year, started in 1991 as a sales agent for machine producers Bodolay Pratt and Datum Technical; it purchased Bodolay Pratt in 1995 and Datum in 1997.

Machine expertise

Doyen offers a basic line of five machines: The 4SS (four-side-seal) and the HDW (high-dwell wrapper) for gloves, dressings, sutures and other small devices; the MT2500 thermoformer for larger devices such as syringes, catheters, gowns and tubing; the GPM (glove packaging machine) for wrapping gloves and other devices in interior “wallets”; and the TD (transdermal), which infuses medicine into a membrane, then seals, die-cuts and packages it.

Making the machinery puts Doyen in a good position for contract packaging, which the company started offering in 2000. Customers who start out contract packaging have the option of bringing the Doyen machine in-house, once the product is established.

In some cases, the customer can actually buy the machine that was used to create market samples, saving a significant amount of time on machine delivery and process validation. This scenario happened just recently. “That machine had been used for market sampling of a new style of packaging that one of our customers was developing, and the market studies determined it was marketable,” Beriswill says. “After we ran the samples and they did their marketing evaluation, they came back and actually bought the machine.”

Streamlining the validation process is one of the biggest advantages of buying a machine, or an entire line, after it’s been operated by a contract packager. The Food and Drug Administration (FDA) requires detailed validation for medical/pharmaceutical packaging; manufacturers who avoid going through the process twice gain a considerable advantage. (See accompanying article above.)

Quality is vital

Packaging of surgical and other medical gloves is one of the most common large-scale operations for Doyen customers, both machinery buyers and users of Doyen’s contract packaging services. Doyen claims to have a 90% market share of glove-packaging machinery. Malaysia, the site of Doyen’s Asian sales office, is also the site of extensive glove manufacturing operations, mostly due to its status as a leading producer of latex rubber.

Gloves are more or less a commodity item, meaning that costs must be held down at every stage of production and packaging for them to be competitive. Most gloves are packaged in an inner “wallet” of paper, either folded or fully splayed, and enclosed in flexible secondary packaging. This secondary packaging can be paper or film, depending on various customer considerations, including price points and sterilization method. (Most gloves are sterilized with gamma radiation, the quickest and least expensive alternative.)