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NAMSA
NAMSA APEX Program™

A proven development solution for successful Medtech commercialization

 

100 +

Programs successfully delivered

30 %

Time Savings Up To

50 %

Cost Savings Up To

Medical device development is complex. In today’s value-based environment, the commercial challenges are more numerous than ever as regulatory approval does not guarantee market adoption. To mitigate risk, preserve capital and ensure the most efficient path to commercial success, development functions must be aligned with an integrated strategy that considers multiple factors and stakeholders.

The NAMSA APEX Program™ is designed with the above objectives in mind. We help you achieve success through our people—the top Subject Matter Experts in the MedTech industry—and our processes—proven, integrated services and tools that deliver predictable planning, phase overlap and vertical integration of all product development phases. This ultimately delivers Sponsors significant time savings, cost reduction and accelerated commercialization.  

Take the first step to accelerate regulatory approval and commercialization today. Schedule your consultation here.

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When partnering with NAMSA, we pair you with the top experts in your therapeutic, geographic and regulatory categories to provide support through our proven solutions and help guide you throughout every phase of development.   

Starting with the end in mind, a dedicated Program Director guides a team of NAMSA experts to build a strategy and execution plan for market approval and adoption. This includes best-fit strategies for market access, reimbursement, clinical and regulatory objectives – all while optimizing timelines and costs as effectively and efficiently as possible.  

The NAMSA APEX Program provides:  

  • Integrated support across multiple services and phases of product development
  • A large depth and breadth of global strategic expertise and Subject Matter Experts at your fingertips
  • A dedicated, expert Program Director for easy communication, Sponsor advocacy and effective management of any outside suppliers and internal stakeholders
  • Guidance for challenges, opportunities and communication to all stakeholders in the development continuum — because we understand that regulatory strategy is only part of the success story
  • Real-time progress updates via customized dashboards: understand where you are in the development process anytime, anywhere  

When collaborating with NAMSA, your internal team will work across multiple services and phases of product development with one vendor. 

Sponsors experience the benefit of reduced timelines and costs, in addition to:    

  • Simplifying an often complicated development process 
  • Delivering predictability and 24/7, easy access to project status 
  • De-risking product development with early identification and mitigation plans 
  • Eliminating the need to engage with multiple vendors 
  • Helping tell the “right” story to the each stakeholder

Case Studies

Case Study
Virtual Vascular Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent
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Case Study
NAMSA APEX Program™ Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings
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