Combination drug and device products offer many potential advantages to patients and manufacturers including improved clinical outcomes and differentiated product lines.
However, successful development of combination products also presents regulatory, clinical, and technical challenges. Despite these challenges, the global market for combination products is growing at a CAGR of 5.6% and anticipated to reach $144.1 billion by the year 2017. The largest segment is transmucosal technologies which accounts for roughly 27% of the total combination products market.
In response to an increasing number of complex medical products being developed, the FDA Office of Combination Products was formed in 2002. The nine-person staff is tasked with facilitating the review and approval of combination products. Combination products are designated to lead centers based on primary mode of action but must satisfy regulatory requirements for both drug and device components.
The medical device development expertise that exists within Minnesota’s Medical Alley presents unique opportunities for partnership and co-development.
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