Challenges facing approval of combination products

As the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics components is expected to become even more challenging and complex. According to the US Food and Drug Administration, some estimate the total global value of the drug-device combination sector will grow to $11.5 billion in 2010, more than double the $5.4 billion in 2004.

"Given the convergence of technologies, combination product manufacturers - often either medical device or pharmaceutical companies 'crossing over to the new market' - must ensure their products meet current Good Manufacturing Practices, as well as pass muster with the FDA, the International Organization for Standardization and the US Pharmacopeia," said Steven Richter, president of Microtest Laboratories, and a former FDA official. "The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements. The process, already complex, is likely to become even more so," he warned.