Drug device combination products, also known as drug-eluting or drug-coated medical devices, refer to medical products that combine drugs with medical devices to provide enhanced therapeutic benefits. These innovative products leverage drug delivery mechanisms along with modern device technologies to provide more effective treatments for various medical conditions. Drug device combinations have revolutionized treatments in areas like cardiovascular medicine and are poised to transform therapies in other domains in the coming years. This article discusses the evolution of drug device combination products, their various types, benefits and the regulatory landscape surrounding these innovative therapeutic modalities.

Evolution of Drug Device Combination Products

The concept of leveraging drug delivery through medical devices can be traced back to the 1960s when researchers started experimenting with drug-coated cardiac pacemakers and implantable drug infusion pumps. However, it was in the 1990s that drug device combinations began gaining widespread acceptance due to advances in materials science, polymer engineering and device miniaturization. One of the early breakthrough products was drug-eluting coronary stents that delivered antiproliferative drugs locally to prevent restenosis post angioplasty. The astounding success of drug-eluting stents opened up a new era of combination products that have now permeated several therapeutic areas. Over the past few decades, continuous technological progress has enabled more sophisticated and effective drug device combination product designs.

Types of Drug Device Combination Products

There are mainly three types of Drug Device Combination Products based on how the drug component is incorporated:

Drug-coated/drug-eluting devices: These involve coating or impregnating drugs on the external surfaces or in porous matrices of medical implants and catheters. Examples include drug-eluting stents, drug-coated neuronal catheters, etc.

Drug-impregnated devices: Here, drugs are embedded homogeneously within the bulk material of implantable or insertable medical devices. Spinal cord stimulators containing bupivacaine and contraceptive implants releasing levonorgestrel fall under this category.

Drug delivery systems: These are devices like infusion pumps, transdermal patches, and inhalers that administer drugs at regulated rates using various drug release mechanisms like diffusion, osmosis or electrotransport. Insulin pens and nicotine patches are common examples.

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