We Know Medical Device Technology

NAMSA is the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated, expert end-to-end services.

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

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 device, 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, NAMSA’s PDS experts understand how to align all stakeholders to pre-emptively 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.

Image: NAMSA understands the criticality of aligning key stakeholders from the start.

Available PDS Programs 

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.

Program 1: Starting Smart Session
The Starting Smart Session begins with a “Starting Smart Acceleration Meeting,” which is a 4-8 hour strategic business session supported by a key senior NAMSA strategic expert backed by scientific subject matter experts. The focus of this session is on early-stage strategies to identify efficacious pathways to regulatory approval or clearance, and to also establish clear commercial objectives.

Deliverables: 

  • High-level Strategic Business Summary, including timelines and next steps.

Program 2: Strategic Landscape Assessment
The Strategic Landscape Assessment includes detailed information regarding NAMSA’s development  recommendations, as well as an analysis of the current market landscape to include key factors for success in bringing a medical device to the global marketplace. Included is a 1-day session, “Day of Discovery,” which provides in-depth information on regulatory pathway and market strategy assessments and review of timelines, strategic roadmaps, critical path items and high-level costing of the proposed program.

Deliverables: 

  • Strategic Landscape Analysis Report, which provides insight into the suggested regulatory path to market, reimbursement landscape and types of data required to support both scientific and marketing objectives for successful product commercialization.
  • Also included are timelines and estimated cost related to program execution.

Program 3: Get-to-Market Strategy 
The Get-to-Market Strategy provides a strategic assessment of the regulatory, design, clinical,
marketing, reimbursement, and scientific communication areas for a specific product  and therapeutic area. NAMSA’s strategic leaders in the client area of focus collaborate to provide a detailed get-to-market plan that will integrate the key pillars of medical device commercialization pathways. Also addressed are critical activities to align key stakeholders in an effort to reduce time and costs.

Deliverables: 

  • Detailed Get-to-Market Plan, including a recommended global regulatory strategy,
    clinical trial platform and trial designs, preclinical and clinical study cost and timelines, aligned engineering  and manufacturing, marketing strategy and market access information, KOL identification, publication plan and clinical claims matrix.
  • Additionally, NAMSA will assist with brand development, product reviews and customer and/or stakeholder messaging.
  • The deliverables include a full Project Plan, as well as key milestones and estimated project costs.

Interested in Learning More? 

If you are interested in learning more about NAMSA’s Product Development Strategy service offering, please get in touch:

Direct: namsa.com/contact-us
Phone (U.S.): +1-866-666-9455
Phone (Outside the U.S.): +1-419-666-9455