Growth Of Drug-Device Combination Products Impacting The Way Drugs Are Developed

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist;  Medical Devices / Diagnostics
Article Date: 31 Jul 2008 - 4:00 PDT

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As the point-of-care for drug therapy shifts from the clinic to the home, drug developers are learning the importance of design integration, ergonomics, and concurrent engineering. Welcome to the age of combination products, an age where the drug is one part of a therapeutic product designed to meet the needs of a specific therapy or patient group.

Recognizing the growing impact of combination products, the U.S. FDA established a new organizational entity in December of 2002 to coordinate the regulatory process for the rising number of applications comprised of two or more regulated components. The integration of drug and delivery device results in a synergistic merging in which therapeutic benefit is increased and outcomes are improved.

The growth of combination products is having a significant effect on the way drugs and devices are developed. Cooperation between device designers and drug developers is occurring much earlier in the drug development cycle, allowing device designs in many cases to be tailored to the bioavailability targets and pharmacokinetic profiles of specific drug therapies. The new devices are patient-friendly, easing compliance concerns, which have a non-negligible effect on drug formulations and delivery decisions, and are a significant factor in the prescribing decisions of most physicians.

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