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NAMSA APEX PROGRAM
A Proven Way to Accelerate MedTech Commercialization and Lower Overall Costs
Why Companies Choose NAMSA
100+
Programs Successfully Delivered
30%
Shorter Time to Market
50%
Potential Cost Savings
What is the NAMSA APEX PROGRAM?
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.
The NAMSA APEX PROGRAM is designed with these objectives in mind. We help you succeed through our people—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. Our integrated product development approach ultimately delivers Sponsors significant time savings, cost reduction and accelerated commercialization.
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Ready to discuss your project?
How Does it Work?
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
- Depth and breadth of global Subject Matter Experts at your fingertips
- A dedicated, expert Program Director who you can trust as your development partner, Sponsor advocacy and effective management of any outside suppliers and internal stakeholders
- Real-time progress updates via customized product development plans and dashboards of NAMSA services: understand where you are in the development process anytime, anywhere
Program Benefits
When partnering 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
What Clients are Saying
As a start-up organization, CVRx had to secure the right partnerships to obtain clinical safety and effectiveness evidence required for FSA approval. We were fortunate to select NAMSA as our preferred clinical research partner–they were with us throughout the journey, continually providing their extensive statistical expertise and development support.
Today, CVRx is a successful, publicly traded company bringing life-saving technology to heart failure patients throughout the U.s. Undoubtedly, NAMSA played an integral role in this success and I would highly encourage any start-up organization seeking an experience clinical partner to consider NAMSA as their trusted partner.
Liz Galle, Former VP of Global Clinical Research, CVRxNAMSA’s knowledge and expertise with the U.S. FDA was a critical factor in helping us achieve unparalleled, accelerated results for our 510(k) device. This, coupled with their consistency, responsiveness and proactive nature, provided our firm the confidence we were making the right development decisions for long-term commercialization success.
Our partnership with NAMSA was not only key to achieving company milestones, but also to efficacious fundraising and driving company value. Any medical device organization seeking superior development results should have the confidence to select NAMSA as their trusted partner on the path to successful commercialization.
Dr. Troy Long, Interventional Radiologist, Co-Founder, ICHORFrom preclinical testing, clinical trial management and regulatory strategy, NAMSA is truly expert at delivering high-quality outcomes throughout the entire medical device development continuum. Start to finish, NAMSA understood the required activities for accelerated development and efficacious market introduction.
Shawn Shorrock, Former Global Director, Solvay Dental 360Case Studies
MedTech Chats: MEGA BIOPHARMA Partners with NAMSA to De-Risk Disruptive Dental Technology
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Virtual Vascular Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent
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NAMSA APEX PROGRAM Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings
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