Combination Product Testing

A combination product consists of two or more different types of medical products such as a pharmaceutical drug, device, and/or biological agent with one another.

The demand for combination products is growing rapidly. Approximately one-third of all medical products developed today are combination products. These novel devices blur the lines between traditional medical devices, pharmaceuticals, and biologics, which brings new challenges to development and testing of these products and requires a unique approach for regulatory approval.

STEMart provides a full range of testing services to investigate the safety of each component of the product and how these components interact.

Our scientists have rich experience with combination products in the following types:

• A medical device enhanced by a chemical component (e. g. a drug-eluting stent)
• A pharmaceutical or biological product with a delivery device and a container closure system (e. g. an inhalation product)
• Medical device coated with or otherwise combined with a drug or biologic
• A pharmaceutical enhanced by a biologic component (e. g. a monoclonal antibody combined with a therapeutic drug)
• A vaccine or drug vial co-packed with a sterile syringe (e. g. a prefilled syringe)
• Liquid medication with dose-dispenser
• A surgical tray containing various instruments, drapes, antimicrobial agents and anesthetic drugs
• Photosensitizing drug and activating laser or light source
• Light-activated biological products not co-packaged but labeled for use with a specific light source device

STEMart has the breadth and depth of knowledge and experience in medical device, pharmaceutical, and biologic testing to develop customized testing programs that will efficiently and effectively position your combination products for regulatory clearance and timely launch. If you want to learn more detail about our combination product testing services, or would like to consult with the experts at STEMart, please feel free to contact us.