Regulatory Compliance & Approvals Challenges: The company operates in a highly regulated global industry, subject to extensive laws, standards, and approvals from bodies like the FDA, necessitating significant resources for compliance and risking fines or market restrictions for non-adherence.

Intense Competition & Pricing Pressures: GEHC faces aggressive competition from established industry players and new entrants, which can lead to pricing pressures, erosion of market share, and increased investment requirements for research and development to maintain competitiveness.

Supply Chain Disruptions & Material Shortages: Reliance on a complex global supply chain for components, raw materials, and finished goods exposes GEHC to risks from geopolitical events, natural disasters, supplier failures, and logistical bottlenecks, potentially impacting production and delivery schedules.