Regulatory Compliance Risk: Adherence to a complex and evolving global regulatory landscape, including FDA and international health authorities, is critical, and non-compliance could lead to significant penalties, product recalls, or market withdrawal.

Product Liability and Safety Risk: Potential for product defects, quality issues, or user errors in medical devices and pharmaceuticals could result in patient harm, leading to costly litigation, product recalls, and damage to reputation.

Intense Competitive Pressure Risk: Facing aggressive competition from other large medical device and pharmaceutical companies, as well as new market entrants, could lead to pricing pressure, loss of market share, and reduced profitability.