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NAMSA
Product Development Strategy

MEDICAL DEVICE PRODUCT DEVELOPMENT CONSULTING & STRATEGY

EQUIPPING YOU WITH PROVEN MEDICAL DEVICE PRODUCT DEVELOPMENT STRATEGIES TO GET AHEAD OF THE COMPETITION.

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40 +

YEARS AT REGULATORY BODIES AND AGENCIES

400 +

YEARS OF INDUSTRY EXPERIENCE

100 +

ANNUAL FDA PRE-SUBMISSION MEETINGS MANAGED

10 +

ANNUAL MARKETING APPLICATION SUBMISSIONS MANAGED

Whether you’re seeking support for the expansion of an existing line or creating something brand new, NAMSA has the expertise to equip you with the medical device product development resources you need, when you need them.

From concept to post-market, NAMSA provides medtech and medical device product development consulting to assist clients with any new development challenge, therapeutic area, reimbursement issue or regulatory environment. The Product Development Strategy (PDS) Team — comprised of cross-functional scientists and regulatory, clinical and medical device development experts who can support a multitude of medical devices, In Vitro Diagnostic (IVD) or software as a medical device (SaMD). These experts provide manufacturers a “next steps” strategy within any stage of the development continuum.

 

WATCH NAMSA’S MEDTECH Product Development GET-TO-MARKET STRATEGY IN ACTION

 

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 medical device product development 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 efficiently get to market while saving you time and money.
NAMSA understands the importance of aligning development stakeholders

 

Strategic Consulting

NAMSA has formed an extensive, dedicated cross-functional team of product development experts to lead clients through their path to commercialization for their medical device. Our highly knowledgeable, experienced team offers deep and specialized knowledge on important topics related to the development and commercialization of medical devices and medtech products. They can guide you through the common complexities of product development, helping get your device to market faster.

  • Biological Safety and Validation
  • Clinical Research
  • Medical Writing and Scientific Communications
  • Preclinical Testing
  • Regulatory
  • Reimbursement
  • Market Access
  • Quality
Product Development Get-to-Market Strategy

NAMSA’s Get-to-Market Strategy provides a strategic assessment and summary of required activities pertaining to regulatory, 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.

Due Diligence

NAMSA’s Due Diligence service provides a comprehensive evaluation and analysis of the regulatory, quality, preclinical, clinical, reimbursement and scientific aspects of a medical device product or company. On behalf of venture capital or other investors, our experts conduct a thorough review of the available data, documents, processes and systems to identify potential risks, gaps, opportunities and recommendations for improvement. Whether you are looking to acquire, invest in, partner with or sell a medical device product or company, our Due Diligence service can help you make informed decisions and optimize your outcomes.

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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