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Comprehensive Market Access in MedTech
A 5-Step Strategic Approach
Mar 10, 2025
Comprehensive Market Access in MedTech: A 5-Step Strategic Approach
Achieving market access in MedTech requires a structured, end-to-end approach that integrates regulatory, commercial, and technological considerations. The IQVIA MedTech Market Access Navigator© provides a roadmap for successfully navigating this complex landscape, ensuring compliance, reimbursement, and sustained market presence. This blog provides you with a high-level view of the 5-step framework utilised by leading medical device and in vitro diagnostics companies.
For further information or to arrange a consultation, click the CONTACT US button on this page.
Step 1: Market Assessment
Before entering a market, MedTech companies must evaluate the potential for their product. Key considerations include:
- Market Size & Demand: Assess the number of potential users and the overall market opportunity.
- Competitive Landscape: Identify existing competitors, pricing strategies, and barriers to entry.
- Market Trends & Adoption Patterns: Understand usage trends and emerging innovations.
- Unmet Needs: Define the key challenges within the market and determine how the device fulfills these needs.
- Value Proposition: Assess the added value of the device compared to current market solutions.
With over 500,000 medical technologies available in the global market and an industry expected to grow at a CAGR of 5.8% over the next five years according to IQVIA MedTech forecasts, companies must thoroughly analyze demand, competitive dynamics, and regional regulatory variations to ensure successful market entry.
Step 2: Market Authorization
Over 8,000 new regulations and reference documents are added annually and 44% of global requirements are published in non-English languages. Gaining regulatory approval is a crucial step toward market entry! Companies must engage with key regulatory organizations such as the FDA, CE-mark (EU), and UKCA (UK) to secure approval. Key actions include:
- Engagement with Regulatory Bodies: Proactively interact with agencies to understand requirements and approval pathways.
- Technical Documentation & Conformity Assessment: Ensure all required documentation is completed according to the specific geography’s regulatory standards.
- Compliance with Local Regulations: Address country-specific variations in regulatory requirements to prevent delays in approval.
Approval timelines vary significantly by region, with countries like China requiring 12–24 months, Russia 12–22 months, and Brazil 9–12 months for regulatory reviews. Proper planning and digital tools can streamline submission processes and reduce compliance risks.
Step 3: Evidence Assessment
Once regulatory approval is obtained, companies must gather and present evidence that supports the clinical and economic value of their device. This includes:
- Clinical Trial Evidence: Collect data that demonstrates safety, efficacy, and performance.
- Real-World Evidence (RWE): Supplement clinical trials with real-world usage data to showcase long-term benefits.
- Health Technology Assessment (HTA): Leverage evaluations from relevant agencies to strengthen evidence-based positioning.
- Device-Specific Evidence: Generate targeted data to address the specific indication and application of the device.
AI-driven regulatory insights and automated compliance tracking can help companies manage the increasing volume of required documentation and accelerate market readiness.
Step 4: Reimbursement Strategy
Establishing a successful reimbursement strategy ensures financial viability and market adoption. Key aspects include:
- Regional Differences in Reimbursement: Understand variations in coverage policies and reimbursement criteria across markets.
- Funding Sources: Determine whether the product will be covered by public health systems, private insurance, or out-of-pocket payments from patients.
- Stakeholder Engagement: Collaborate with national and regional health authorities, private insurers, and patient advocacy groups to support reimbursement negotiations.
Factors such as HTA outcomes, real-world evidence collection, and national policy variations influence reimbursement. Engaging with payers early and integrating data-driven insights into reimbursement applications enhances the likelihood of securing favorable coverage.
Step 5: Post-Market Strategy and Lifecycle Management
After securing market access, companies must focus on maintaining and expanding their presence. Ongoing efforts include:
- Regulatory Compliance Monitoring: Continuously track and ensure adherence to evolving regulations.
- HTA & Reimbursement Updates: Adapt to new policies and optimize reimbursement strategies.
- Payer Negotiations & Coverage Expansion: Engage with payers to broaden access and secure favorable coverage terms.
- Product Lifecycle & Improvement: Collect market feedback to drive product enhancements and innovation.
- Regulatory Label Expansion: If necessary, pursue label updates to extend indications and increase market reach.
With regulatory changes occurring every 20 minutes globally and AI and software-based regulations evolving rapidly, continuous monitoring and adaptation are critical. Companies should leverage digital solutions such as those provided by IQVIA MedTech to ensure compliance and optimize market positioning.
Conclusion
A well-structured market access strategy is essential for success in the MedTech industry. By following the 5-step framework whilst utilising IQVIA MedTech’s therapeutic area expertise and technologies, companies can effectively navigate regulatory, clinical, and commercial challenges. Implementing a strategic, data-driven approach will optimize market entry, secure reimbursement, and support long-term growth in a competitive landscape. For further information or to arrange a consultation, click the CONTACT US button on this page.
There is no single perfect market access strategy that applies to all MedTech companies. However, a universal navigator can guide us in asking the right questions at the right time and tailoring the best approach in a well-prepared and structured manner.”
Zhen Nie
Head of Med Devices, Global Consulting
IQVIA MedTech
Head of Med Devices, Global Consulting
IQVIA MedTech
An end-to-end structured strategy for market access helps transform complexity into clarity, ensuring MedTech clients successfully navigate regulatory, reimbursement, and adoption hurdles”
Alejandra Toro
Global Consulting
IQVIA MedTech
Global Consulting
IQVIA MedTech