Combining Drug Delivery and Device Technologies: Challenges and Opportunities

摘要

The pharmaceutical industry has been challenged with an evolving set of design criteria for new drug products that has resulted in a critical evaluation of the commercial feasibility of novel drug-delivery systems and drug-enhanced devices. Currently, the criteria for a marketable new drug product is that it must be safe and efficacious, fill an unmet medical need, and be cost effective and easy to use when compared to other products available to treat the approved indication. The novel drug-based drug delivery and drug-enhanced device platforms utilize more sophisticated materials and electronic components compared to earlier drug delivery systems. The challenges associated with the development of these more sophisticated combination products have largely been technical in nature but now also include the requirement to demonstrate a high benefit to risk ratio and defect-free manufacturability and performance while maintaining a low cost to the patient and convenience to the health care provider.