Originally Published MPMN September 2008

TECH UPDATE

Contract Manufacturers Get Active with Combination Products

Stephanie Steward

Most contract manufacturers are adept at juggling and coordinating a variety of design, testing, and manufacturing tasks. This skill set is put to good use when tackling an OEM’s combination product, which can present double the challenges and regulatory requirements of typical devices. Among the challenges that contract manufacturers face are keeping up with the latest developments in drug delivery and adopting new technologies to get customers’ designs to market.

As combination products have become more sophisticated, so have methods of drug delivery. Tapemark (West St. Paul, MN) is a contract manufacturer that specializes in custom converting of medical devices and components utilizing such materials as films, nonwovens, and foils. In its work with transdermal combination products, the company has embraced new design techniques that enhance drug delivery, according to Julie Karlson, marketing manager. Some of these techniques include adding batteries or iontophoresis. For example, a transdermal patch that incorporates iontophoresis uses a small microprocessor-controlled electrical charge to deliver a drug. The microprocessor can enable dosing to be programmed into the device or controlled by the patient. “All of these techniques reflect the strong trend toward active, rather than passive, transdermals,” Karlson says. The company is also noticing a related trend of manufacturers focusing on how to make transdermal patches more comfortable and safer for patients to wear for extended periods of time, she adds.

In addition to getting involved in manufacturing noninvasive, active transdermals for applications like pain therapy, many contract are also monitoring the emerging orthobiologics market. One such company is WuXi AppTec (St. Paul, MN), which specializes in testing medical devices but also offers manufacturing services for devices as well as cellular therapeutics, tissue-based products, and more. “Drug-enhanced devices drove the initial growth of the combination product market, but demand for more-localized drug-delivery products is driving the next wave of combination devices,” says Dean Enrooth, vice president of business development, medical devices, at WuXi AppTec.

Because of the massive aging population, the orthobiologics field, in particular, is demonstrating major growth potential, according to Enrooth. Orthobiologics are products that combine traditional orthopedics, such as knee and hip implants, with bone-growth stimulators such as bone morphogenic proteins.

Synthetic bone-graft substitutes and bone-growth stimulators do not require donated human tissue, therefore reducing the risk of disease transmission. The field is rapidly gaining acceptance because of its potential to improve quality of life and reduce health costs. It already makes up 13% of the $33 billion orthopedic market and sales are expected to double by 2013, according to a report from market research firm Espicom.

In addition to the projected growth of fields like orthobiologics and active transdermals, the forecast for the combination products market as a whole is optimistic. “The total market for drug-device combinations worldwide is expected to rise at an average annual growth rate of 13.6% to $11.5 billion in 2010,” states a report from BCC Research.

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