A UK-based medical device manufacturer specializing in diagnostic equipment aimed to enter the U.S. market with credibility and efficiency. Their primary objective was to achieve FDA clearance and establish partnerships.
• Complicated FDA 510(k) submission process
• Gaining hospital administrators’ trust in a competitive environment
• Demonstrating real-world benefits for patient outcomes
Conducted a regulatory readiness audit, identifying key improvements in documentation
Teamed with an affiliate healthcare institution for a pilot study demonstrating a 20% decrease in patient screening time
Coordinated introductions to hospital decision-makers, facilitating early product trials
• Achieved FDA 510(k) clearance ahead of schedule
• Secured pilot programs at five hospital networks across three states
• Realized a 15% increase in physician adoption within the first quarter post-launch
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