The development and approval of drug-device combination products have been increasing steadily over the last decade. These combination products aim to provide innovative therapies that integrate pharmaceutical and medical device technologies to more effectively diagnose, treat, or prevent diseases and medical conditions. With growing research and investments, drug-device combination products are poised to transform healthcare and become a major part of the medical therapeutics landscape in the coming years.

What are drug-device combination products?

A drug-device combination product is a product that combines a drug with a device and is intended for use in the diagnosis of disease or other medical conditions, or in the cure, mitigation, treatment, or prevention of disease. Some common examples of Drug Device Combination Products currently in use are drug-eluting stents, metered-dose inhalers, auto-injection pens, and infusion pumps.

The drug component provides the therapeutic effects, while the device component delivers or enables the administration of the drug in a manner suited for the intended treatment. Together, they act synergistically to achieve a common clinical purpose that is greater than either alone. These combination products allow for better patient compliance through simplified drug administration and improved efficacy through targeted drug delivery.

Regulatory Perspective on Combination Products

Due to their hybrid nature, drug-device combination products fall under the shared regulatory jurisdiction of the US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The FDA uses a ‘Regulatory Flip Model’ to determine which of the two Centers will have primary oversight over a combination product based on its Primary Mode of Action (PMoA).

The PMoA is determined based on an evaluation of the totality of product characteristics and intended clinical effect. If the drug component provides the major therapeutic effect, CDER assumes the primary role. Whereas if the device component plays a significant role, CDRH takes the lead. This determination directs the regulatory pathway and requirements for approval applicable to that specific combination product.

Areas of Innovation in Combination Products

Here are some major therapeutic areas where drug-device combinations are driving innovation:

Diabetes Management: Insulin pens, insulin pumps, and continuous glucose monitors integrated with automatic insulin delivery systems are revolutionizing diabetes care.

Oncology: Implantable drug delivery devices and bioelectronics for targeted cancer therapies are being developed.

Cardiology: drug-eluting stents, implantable cardioverter-defibrillators, and cardiac resynchronization therapies improve the treatment of heart diseases.

Respiratory Therapies: Inhalers with novel formulations for chronic respiratory illnesses deliver drugs directly to airways.

Neurological Disorders: Implantable drug infusion pumps for movement disorders and pain; non-invasive neuromodulation devices are areas of active research.

Wound Care: Advanced wound dressings integrated with antimicrobial drugs promote healing.

Challenges in Developing Combination Products

While drug device combinations hold therapeutic promise, their development faces unique technical, regulatory, and commercial challenges:

Complex interdisciplinary R&D: Combination product development requires cross-functional expertise in pharmaceutical, medical device, and engineering domains.

Rigorous Safety and Efficacy Testing: Extensive preclinical and clinical testing is needed to establish the safety and performance of both drug and device components independently, as well as their combined use.

Uncertain Regulatory Pathways: Determining the correct regulatory pathway and requirements upfront requires extensive agency engagement, which increases development timelines and costs.

Manufacturing Complexities: Combination products have intricate design and manufacturing processes require specialized facilities, equipment and validated procedures.

Evolving Intellectual Property Strategies: Combination products raise novel IP strategy questions around patenting individual components as well as the integrated system.

With expected advancements in materials, microfabrication, biologics, drug delivery technologies and digital innovations, the next generation of combination products can deliver transformative benefits to patients. Sustained investment in interdisciplinary R&D infrastructure and streamlining regulatory harmonization will be critical to realizing the full potential of these therapeutics. If challenges around development, manufacturing and commercialization can be effectively addressed, drug-device combination products have immense potential to play a leading role in Advancing global health outcomes.