NAMSA Relaunches Medtech Outsourcing Solution

NAMSA has transformed and relaunched its integrated medtech commercialization solution: the NAMSA APEX Program. 
 
The APEX Program (Assess, Plan, Execute), is being re-introduced as the medtech industry experiences changing regulatory requirements and expanding clinical evidence demands. Sponsors are facing longer development timelines, putting them at risk for increased costs and lagged speed-to-market—often the key drivers of medtech success. Helping clinical trial sponsors plan for these challenges is the aim of NAMSA’s APEX Program: an approach that delivers integrated services and tools that provide predictable planning, phase overlap and immediate access to top subject matter experts in clients’ therapeutic, geographic and regulatory focus areas. This ultimately allows trial sponsors to proactively mitigate risk, preserve capital and create stakeholder alignment to accelerate commercialization.
 
“In today’s value-based environment, the commercial challenges are more numerous than ever as regulatory approval does not guarantee market adoption. This has placed increased demand on medtech sponsors to find trusted outsourcing partners to accelerate efficient clinical development of innovative medical products,” NAMSA Vice President of Strategic Programs Tim Mitchell said. “NAMSA’s APEX Program is one approach to help ensure an efficient path to commercial success. As a result of our work with more than 100 APEX Program clients, we understand how to set the stage for efficient product approval and market adoption through our established regulatory partnerships and utilization of only the most proven development strategies.”
 
Helping medical device Sponsors improve healthcare since 1967, NAMSA is a glocal medtech contract research organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes.