Originally Published MDDI January 2007 DRUG AND DEVICE COMBINATIONS
Drug-Device Combination Classifications
Traditional drug-delivery systems combine or package drugs together with injection devices to improve convenience of administration. This includes prefilled syringes, pen-based delivery systems, drug pumps, and autoinjectors. Because the drug-device interface is relatively simple in these products, the components can be developed separately and then integrated during later stages of their development cycles. These components can also be regulated separately using the established regulatory regimes for drugs and devices.
Novel drug-delivery systems (e.g., patches, transdermal or intradermal injections, inhalation devices, sprays, and drug-eluting disks) typically combine existing drugs with new delivery devices. These are designed to improve convenience and comfort of administration, improve drug effectiveness through localized administration, or enable delivery of a drug through a nontraditional route (other than oral or subcutaneous and intramuscular injections). Although the complexity of these products is typically moderate, changes to administration, drug formulation, and bioavailability can increase the technology of drug development. Because their primary therapeutic mode of action is drug related, these products are primarily governed by the regulatory pathway for drugs.
Drug-enhanced devices, such as drug-eluting stents, coated catheters, antiinfective sutures, bone cements with an antimicrobial agents, and other devices with antimicrobial coatings enhance the functionality, efficacy, or performance of devices. In many cases, these products combine existing devices with existing drugs. Although the complexity of the device component could vary depending on its function, the drug-device interface is often novel and is critical to the performance of the combination product. Consequently, development is much more complicated than similar device-only products. Because the primary therapeutic action stems from devices, device regulators primarily govern these products, with a secondary review from drug-related regulatory agencies.
Regenerative medicinal products combine devices with biologically active substances to facilitate healing and regenerate damaged tissues. The device often serves as the scaffolding for the growth of the biologic component and the product is often an implant. Examples include Dermagraft (human fibroblast-derived dermal substitute), coated absorbable meshes for bone growth, spinal fusion cages with recombinant human bone morphogenic proteins, and the artificial replacement organs (e.g., bioartificial pancreas). These are the most complex combination products because they have to take into consideration the interaction between the product and the body’s response to it. The development process for such products is also the most complicated and integrated because the components under development must be tightly coupled. The primary mode of action varies on a case-by-case basis, as does the lead review and oversight agency.
Copyright ©2007 Medical Device & Diagnostic Industry
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