This episode delves into the critical role of insurance for medical device companies in the USA. We explore the two main facets: securing product liability insurance to mitigate operational and legal risks, and navigating the health insurance reimbursement landscape to ensure patient access and commercial viability. We cover key steps like FDA approval, coding, coverage determination by payers including Medicare and Medicaid, and the importance of demonstrating clinical and economic value.

Key Questions:

• What types of insurance are essential for medical device companies in the US?

• How does product liability insurance safeguard manufacturers from lawsuits and financial loss?

• What are the critical steps to get a new medical device covered by US health insurance?

• Why are FDA approval and billing codes (HCPCS/CPT) vital for reimbursement?

• How do Medicare and private insurers decide which medical devices to cover?

• What challenges do companies face in securing payment levels for their devices?

• How can MedTech companies effectively demonstrate value to payers?

• What should companies consider for add-on coverage beyond standard product liability?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.