Regulatory Approval Delays: Merit Medical operates in a highly regulated industry, and delays or failures in obtaining necessary regulatory approvals (e.g., FDA, CE Mark) for new products or product line extensions could significantly impact its ability to commercialize innovations and generate revenue.

Product Liability Litigation: The company faces inherent risks of product liability claims if its medical devices are alleged to cause injury or death, potentially leading to substantial legal defense costs, damages, and reputational harm, even if claims are unfounded.

Intense Market Competition: Merit Medical competes with numerous domestic and international companies, some larger with greater resources. Aggressive pricing, rapid technological advancements by competitors, or the introduction of superior products could erode its market share and profitability.