Regulatory Compliance Challenges: The highly regulated medical device industry requires continuous adherence to global standards, and any failure could lead to product recalls, market withdrawals, fines, or operational suspensions, impacting revenue and reputation.

Product Liability and Safety Concerns: Defective products or adverse patient outcomes can result in costly lawsuits, significant reputational damage, and the need for expensive product recalls, directly affecting financial performance and market trust.

Intense Market Competition and Pricing Pressures: Smith & Nephew operates in a highly competitive market against larger players and innovators, leading to constant pressure on pricing, market share, and the need for significant investment in differentiation and sales efforts.