Up until recently, medical devices and pharmaceuticals represented independent segments of the life sciences industry, with each sector charting its own growth path. Their interactions were rare and limited to basic drug delivery instrument such as injections and more recently, advancements such as drug eluting stents that treat cardiovascular disease.
However, the changing state of health care delivery and the growing convergence of these sectors indicate that the future is very clearly in combining drugs and devices. Implantable pumps, transdermal patches and pre-filled syringes are increasingly entering the drug-delivery product pipeline. Market research finds
that the global market for combination devices is growing at nearly 8 percent and will likely exceed the growth of individual medical device and pharmaceutical markets.
Revolutionizing drug delivery systems
Combination devices have opened up new frontiers in the health care sector in individualized medicine and the treatment of chronic diseases. Drug delivery methods are now more targeted and hence more effective. The continuous glucose monitor, for instance, tracks blood glucose levels in a patient on a continuous basis. When this monitor is combined with an external or implantable insulin pump to form a closed loop system, the combination can deliver controlled amounts of insulin. This makes the management of the disease more effective and also provides increased mobility to the patient.
Likewise, we now have devices that can be implanted in a patient’s body to reach a target area and deliver the drug it carries, thereby maximizing the efficacy of the drug. Such innovative combination devices are helping move traditional diagnosis and treatment to prediction and prevention of disease.
Convergence drives growth in both industries
Partnering with device companies for combination devices offers new growth potential for pharmaceutical companies, which face increasing cost pressures, lower margins and increased competition from generic drug manufacturers as patents expire. Scientific advances such as genomics, regenerative medicine or tissue engineering and biologic drugs that need to be injected rather than taken in the pill form, have motivated pharmaceutical companies to work with device manufacturers to create the most optimal drug delivery solutions. For device manufacturers too, this trend has helped them develop new products in an industry where commoditization is a constant threat.
The coming together of these two independent industries has presented unique challenges. Most pharmaceutical companies have little or no experience working with devices and likewise, device manufacturers have little or no experience working with the drug to be combined with the device. It requires both sides to step out of their comfort zones and be willing to learn about and talk to people from both sides.
Another major challenge for combination devices is the regulatory pathway. The Food & Drug Administration (FDA) has three groups overseeing combination devices — devices are regulated by the Center for Devices and Radiological Health (CDRH), drugs by the Center for Drug Evaluation and Research (CDER) and biologics by the Center for Biologics Evaluation and Research (CBER). For combination devices, the most critical decision is to evaluate which group of the FDA gets the jurisdiction over the product. This is largely based on the primary mode of action for the product (PMAO), which attempts to determine the most important way a product achieves its intended use. Clinical trials are also more complex, since combination device manufacturers need to establish both efficacy and safety.
Nevertheless, the future for combination devices continues to grow and evolve. The FDA has approved several combination devices in the recent past and these devices in the future will be driven by miniaturization to make them more effective for diagnostic and therapeutic use. Patients and health care providers are happy with the promise of early detection, prevention and more effective treatment. For pharmaceutical companies as well as device manufacturers, this sector opens up new market segments and allows them to remain competitive and viable.