Converging Technologies Yield Efficiencies
Engineered from a mix of drug, device, or biologic components to form a single product, combination products represent a relatively new therapeutic and treatment approach, which is proving to be more effective for both pharmaceutical and device companies. Drug-device combinations are more appealing to both healthcare sectors simply because, in many cases, a single combination product containing both drug and device components can be more effective than either one of the components acting alone.
Drug-eluting stints are prime examples of such combination products. Approved by the FDA in 2003, the Cypher Sirolimus-eluting stint was designed to prevent or minimize restenosis (reoccurrence of narrowing of blood vessels) and to hold open narrowed arteries in cardiovascular applications. In this device, a time-release drug component incorporated as a coating for bare metal stints is used to prevent and minimize the risks and complications associated with typical non-drug, stand-alone stints.
Inhalation devices, drug-delivery pumps, drug-impregnated films and some wound care products also provide examples of successful combination products. Today, in many orthopedic devices, it is becoming customary to infuse implants with special proteins to facilitate bone growth and tissue regeneration.
Collaboration between drug and device companies is multiplying. The combination products currently in the market have already proven to be profitable. In recent years, more device and drug companies are reaching out to one another to develop better products to remain competitive technologically. According to a Navigation Consulting Inc. study, the global market for combination products would reach an estimated value of $9.5 billion by 2009. The big question is why more companies are not investing in this area.
Challenges and Hurdles
Perhaps the biggest challenges to collaboration between drug-device companies, are the fundamental cultural difference between the two industries-different mind-sets, practices, and business strategies. A second hurdle is identifying and recognizing target markets for combination products. For instance, device companies typically focus on hospitals and healthcare environments, whereas combination products are primarily intended for direct consumer uses.
Regulations and FDA approval are perhaps the most challenging obstacle for combination products because they require approval from more than one FDA medical agency. Furthermore, it becomes more challenging to figure out how combination products get classified, which ultimately results in more ambiguity and delay to market the product.
As a result of the Medical Device User Fee and Modernization Act of 2002, the Office of Combination Products (OCP) currently handles these products and regulates the jurisdictions of an alphabet soup of agencies that includes the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH). The OCP determines a combination product's primary mode of action and then assigns it to the appropriate FDA agency. In 2006, 231 original applications for combination products were submitted to FDA.
Establishing the OCP was a big step toward better handling of combination product assessments and approvals. However, ambiguity surrounding regulation and manufacturing protocols still exists. Companies manufacturing these combination products often have to deal with additional regulatory rules and compliance with more FDA agencies.
While drugs need to adhere to the FDA's "current good manufacturing practices," and medical devices need to follow "quality system" regulations, combination products must comply with both sets of regulations. Therefore, companies developing combination products need to understand each set of regulations, as well as developing manufacturing protocols and quality systems that meet both drug and device requirements. To speed up the process and avoid last-minute surprises, the FDA strongly recommends that manufacturers of combination products discuss the regulations with the agency to understand how they pertain to their products at very early development stages.
Beyond FDA Regulations
Successful collaborations between drug and device companies also require adjustments. Complete evaluations of how these combination products work for end users, are required, along with additional in vivo clinical studies. The companies must understand the interactions between the drug and the device when used by patients. And they must estimate potential side effects. All these tasks can delay the product development process, but it is crucial that companies understand that adding an additional pharmaceutical component to a device can adversely affect the device's performance and potentially cause unwanted results. And if an already-approved device or drug is to be used in another part of the body, additional preclinical safety and clinical studies are needed to evaluate how it functions in the new environment.
In addition, combination products typically need sterilization and packaging procedures different from standard operations for individual drugs and devices. Companies developing combination products must adopt appropriate manufacturing protocols, and focus on internal business requirements much earlier in the development process.
Looking Ahead
The union of drug and device companies can offer tremendous therapeutic and financial advantages and bring patients more effective and efficient medical treatments. Many experts predict that the healthcare industry will see more mergers and acquisitions among drug and device companies in the near future, requiring significant learning across the two industries. The device company must learn how the drug works before delivering it through the device, while the drug company needs to become more familiar with FDA medical device regulations, how the devices work, and what factors may affect performance.
The term convergent technology is being used more frequently in the healthcare industry than ever before. Companies specializing in drug or device segments are evaluating options to combine multiple technologies to create better products. And the convergence is not limited to drug and device manufacturers as more electronics are being interwoven into devices. Orthopedic manufacturers are looking into using chips embedded in human bones to facilitate and support bone growth. Advanced pain management systems incorporate implantable devices that use transceivers to facilitate communication and data transfer to ultimately improve patient outcomes. In many cases, open innovation is the key, where development of products drawn from the expertise of different technologies, can serve various purposes. This holds immeasurable promise in the healthcare industry, which is simply too good to overlook.
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