Contact

Without Robust Evidence, Innovation Stalls - We Keep You Moving

Generating Evidence That Meets the Highest Standards of HTA and Market Needs

Robust and actionable evidence is essential to secure market access and demonstrate the value of your MedTech innovation. Without the right evidence, even the most groundbreaking innovation can face significant hurdles in regulatory approval and decision maker acceptance. With the upcoming EU HTA requirements for selected MedTech products, generating the right evidence has never been more critical. At IGES MedTech, we specialise in delivering targeted evidence that aligns with the relevant standards of HTA and market needs. By identifying clinical and economic requirements, addressing gaps with tailored strategies, and leveraging Real-World Evidence, we ensure your device meets the expectations of decision makers and HTA agencies.

A clear understanding of evidence requirements is the foundation for successful market access. IGES MedTech identifies the clinical and economic data needed to meet regulatory and payer expectations, ensuring your strategy is focused and effective.

Evidence gaps can delay market entry and affect reimbursement outcomes. IGES MedTech develops targeted strategies to close these gaps, whether through new studies, real-world data, or meta-analyses, ensuring that your evidence package meets the required standards.

Leveraging EU-specific data is key to demonstrating your product’s value in European healthcare markets. IGES MedTech integrates and analyses regional data sets to provide a comprehensive view of your product’s impact, ensuring alignment with local market and regulatory demands.

Real-World Evidence (RWE) offers insights into how your innovation performs in everyday clinical settings. IGES MedTech incorporates RWE into your evidence plans, enhancing the relevance and credibility of your data for payers and regulators.

With the forthcoming EU HTA regulations set to apply from January 2025, IGES MedTech assists in preparing comprehensive submissions for selected MedTech products. Our expertise ensures that your documentation meets the stringent requirements of joint clinical assessments, facilitating smoother market entry across EU member states.