ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Overview
In the rapidly evolving healthcare landscape, gaining market access for medical devices is a complex process. It involves not only regulatory approval but also the acceptance of the device by healthcare providers, payers, and patients. Key considerations for market access include clinical effectiveness, cost-effectiveness, and alignment with healthcare policy and patient needs.
Key Considerations for Market Access
Clinical Effectiveness
The device must demonstrate a clear clinical benefit over existing alternatives. This is typically demonstrated through clinical trials or real-world evidence.
Cost-Effectiveness
Payers and healthcare providers are increasingly focused on the value for money of medical devices. Devices must demonstrate cost-effectiveness, considering both the cost of the device and the potential savings in healthcare costs.
Alignment with Healthcare Policy and Patient Needs
The device must align with current healthcare policies and priorities, and meet the needs of patients. This includes considerations such as ease of use, patient preference, and the ability to improve quality of life.
Artixio’s Services
Artixio provides a range of services to support medical device companies in achieving market access and reimbursement.
Market Access Strategy
We help companies develop a comprehensive market access strategy, including identifying target markets, understanding regulatory requirements, and developing a value proposition for payers and healthcare providers.
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Market Analysis: Identifying target markets and understanding their specific needs and challenges.
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Regulatory Strategy: Understanding and navigating the regulatory requirements in each target market.
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Value Proposition Development: Developing a compelling value proposition that clearly communicates the benefits of your device to payers and healthcare providers.
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Competitive Landscape Analysis: Understanding the competitive landscape and positioning your device effectively.
Health Economics and Outcomes Research (HEOR)
Our team of health economists and outcomes researchers can support the generation of evidence to demonstrate the clinical and cost-effectiveness of your device.
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Economic Modeling: Developing economic models to demonstrate the cost-effectiveness of your device.
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Real-World Evidence Generation: Collecting and analyzing real-world data to demonstrate the effectiveness of your device in a real-world setting.
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Systematic Literature Reviews: Conducting systematic reviews to understand the current evidence base for your device.
Reimbursement Strategy
We can help you understand the reimbursement landscape and develop a strategy to achieve optimal reimbursement for your device.
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Reimbursement Landscape Analysis: Understanding the current reimbursement landscape in your target markets.
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Reimbursement Strategy Development: Developing a strategy to achieve optimal reimbursement, including identifying potential reimbursement pathways and developing a compelling case for reimbursement.
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Payer Negotiation Support: Supporting you in negotiations with payers to achieve favorable reimbursement terms
Stakeholder Engagement
We can support you in engaging with key stakeholders, including healthcare providers, payers, and patients, to understand their needs and preferences and to communicate the value of your device.
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Stakeholder Mapping: Identifying key stakeholders and understanding their needs and preferences.
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Communication Strategy Development: Developing a communication strategy to effectively communicate the value of your device to stakeholders.
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Stakeholder Engagement Activities: Organizing and facilitating stakeholder engagement activities, such as advisory boards and patient focus groups
At Artixio, we understand the challenges of gaining market access for medical devices, and we are here to support you every step of the way. Contact us today to learn more about how we can help you achieve your market access goals.
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