Innovative medical device manufactures have discovered that the benefits of combining a drug, biologic or tissue with their device to create a new product may improve clinical outcomes for patients and provide a distinct competitive advantage. Unexpected regulatory compliance issues, however, and the technical challenges of combination products can confound plans, resulting in delays and unexpected costs. To avoid missteps during combination product development, medical device firms new to developing combination products should be aware of these three common misconceptions.
1. The Legacy Device
2. The Me-Too Approach
3. Underestimation of Expertise and Time Required
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