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Short answer: FDA rejection is rarely about bad data. It is usually about answering the wrong question. Most companies that struggle during FDA review did generate data. They ran studies. They collected results. They invested money.

Direct answer: most medical devices do not fail FDA review because the science is weak. They fail because the strategy was weak. In many cases, the engineering works. The bench testing looks solid. The prototype performs as expected. But the submission fails because the development plan was not aligned with how the U.S. Food and Drug Administration evaluates risk, evidence, and benefit

Short answer: marketing similarity is not the same as regulatory substantial equivalence. Many founders believe that if their device “looks like” something already on the market, they can file a 510(k). That assumption is one of the most common regulatory mistakes in medical device development.