Executive Summary Combination products-integrating drugs, devices, and often biologics-have transformed the medical devices industry, driving innovation, partnerships, and new regulatory frameworks. Since the early 2010s, this sector has experienced exponential growth, fueled
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Once a product is confirmed as a combination product, the next step is identifying its Primary Mode of Action (PMOA). This is defined as the single mode of action that provides the
In an increasingly complex global healthcare landscape, cross-sector collaboration has become essential to solving the systemic challenges we face in the medical device industry. The future of healthcare will be defined not
Medical device innovation is complex by nature, but many of the most persistent problems in product development are avoidable. One of the most common and costly mistakes in terms of both time