A medtech startup typically focuses on two key legal needs: (1) ensuring that its technology has proper and thorough intellectual property protection, and (2) outlining a detailed pathway for FDA clearance. Those two priorities are understandable. The areas of intellectual property protection and a regulatory pathway are threshold issues that every potential investor wants addressed before funding a company. The hypothetical risk of future product liability litigation is not as high a priority for startup companies who have yet to commercialize. However, with the recent surge in such litigation pursuing the life sciences industry, companies are on notice to start prioritizing product liability risk management.
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