Competitive Market Pressures: Insulet operates in a highly competitive diabetes device market, facing pressure from established companies and new entrants that could impact market share and pricing.

Regulatory Approval Challenges: The company must navigate complex and evolving regulatory landscapes globally to obtain and maintain product approvals, which can lead to delays or increased compliance costs.

Manufacturing and Supply Chain Dependence: Reliance on third-party manufacturers and a complex global supply chain exposes Insulet to risks of production delays, quality control issues, or raw material shortages.