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NAMSA
Product Development Strategy

STARTING WITH THE END IN MIND, WE BUILD AN EXECUTABLE STRATEGY TO ACCELERATE YOUR DEVELOPMENT EFFORTS

Equipping you with proven product development strategies to get ahead of the competition.
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35

Years Inside the FDA

280

Years of Industry Experience

600

Pre-Submissions Meetings Managed

650

Regulatory Submissions Managed

Whether you require support in one area of your medical device development program, or throughout the entire process, NAMSA has the expertise and capabilities to equip you with the resources you need, when you need them.

From concept to post-market, NAMSA’s Product Development Strategy (PDS) service offering provides proven solutions to assist clients with any development challenge, therapeutic area, reimbursement issue or regulatory environment. The PDS Team, comprised of cross-functional scientists and strategists who can support a multitude of medical devices, In Vitro Diagnostic (IVD) or drug/device combination programs, provides manufacturers a “next steps” strategy within any stage of the development continuum.

ARE YOU:

  • A start-up firm with limited resources and funds?
  • Unable to leverage the knowledge your team gains on preclinical studies to apply to your overall strategy?
  • Concerned with the time required to hire and train staff, but need the expertise today?
  • Looking for ways to reduce total development timelines and costs, and lessen burn rates prior to commercialization?

Serving as an extension of your internal team, our PDS experts understand how to align all stakeholders to proactively address development barriers and reduce risks. They serve as a guiding authority on how to most efficiently navigate intended global markets to safely and efficaciously get to market quickly, while saving you time and money.NAMSA understands the importance of aligning development stakeholders

Image: NAMSA understands the importance of aligning all product development stakeholders from the start.

By starting with the end in mind, NAMSA offers coordination of required development activities under one roof to achieve accelerated outcomes. We offer the following programs to meet medical device manufacturers where they are, delivering only the most needed services for efficacious device development.

 

Strategic Consulting

NAMSA’s cross-functional team of product development strategists provides assistance to clients when and where they need support on their path to product development and commercialization. Our highly knowledgeable and experienced team of strategists is leveraged by Sponsors to provide in-house expertise to streamline costs and speed product development and commercialization objectives.

Many strategic consulting options are available to clients, including consulting on an hourly basis, and in all functional areas of the product development continuum, including, but not limited to:

  • Biological Safety and Validation
  • Clinical Research
  • Medical Writing and Scientific Communications
  • Preclinical Testing
  • Regulatory
  • Reimbursement
  • Quality
Product Development Discovery Session

The Product Development Discovery Session is supported by a subset of key NAMSA strategic experts and focuses on early stage-gates to identify effective pathways to regulatory approval or clearance. This session provides direction on how to best meet commercial objectives through de-risking device development, distinguishing potential roadblocks and regulatory challenges, and identifying synergies and parallel paths to fast-track the path to commercialization. Approximate costs and timelines are clearly outlined for all pivotal activities, and sessions typically occur over 1-2 days.

Product Development Get-to-Market Strategy

NAMSA’s Get-to-Market Strategy provides a strategic assessment and summary of required activities pertaining to regulatory, quality, preclinical, clinical research, reimbursement and scientific communications to achieve approval for a specific product and therapeutic area. Our strategic experts are aligned to each client’s therapeutic, regulatory and geographic areas of focus, closely collaborating with all stakeholders to provide a detailed, actionable, achievable Get-to-Market Plan that integrates the key pillars of medical device commercialization pathways. Also addressed within this service offering are critical activities to align key stakeholders in an effort to reduce time and costs to approval and commercialization.

Product Development Strategy Execution (MRO Program)

NAMSA’s robust team of global scientific and strategic experts understand how to execute the Get-to-Market Plan to achieve cost-efficient, accelerated outcomes for your intended device requirements and business objectives. Simply put—we equip you with the tools and resources you need for success.

At NAMSA, we uniquely understand that medical device success is often measured by the critical components of cost-to-market and predictable development timelines. However, meeting these success measurements is frequently a challenge for device makers when utilizing the standard approach of engaging with multiple vendors to manage various development phases. Not only does this approach present uncoordinated starts and stops, it leaves device manufacturers susceptible to increased timelines and unplanned budgetary constraints.

NAMSA's MRO Program
NAMSA’s proprietary solution for these challenges is our MRO Program service offering. This approach is designed to offer the full continuum of Contract Research Organization (CRO) services to take your medical device from concept to post-regulatory approval with time savings of up to 30% over industry averages and cost minimization of up to 50%.

Find out how we do it! Watch our MRO video here.

Resources

Webinar
How to Use Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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White Paper
Human Factors: Global Considerations & Regulatory Requirements
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White Paper
Medical Device Reimbursement Strategy: How to Plan for Successful Market Commercialization
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White Paper
Effective Preparation & Implementation of Medical Device Quality Management Systems
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