NAMSA has launched an in vitro diagnostic (IVD) development business to provide global manufacturers a proven resource for expedited commercialization outcomes delivered via NAMSA’s “Uniquely IVD” regulatory, quality, and clinical research services. NAMSA is a medical research organization (MRO) focused on accelerating medical device development through integrated laboratory testing, clinical research and regulatory consulting services.
“The IVD industry is expanding more quickly than ever, outpacing medical device industry growth in several geographies, and is expected to reach $69B globally by 2024 (GlobalData). Due to the increased demand by patients and healthcare providers for more rapid diagnoses and treatment plans, the need for novel and highly accessible IVD products will only intensify," says Katie Schaaf, general manager of NAMSA’s IVD business. "Sponsors, who have limited options for IVD-focused contract research organizations (CRO), will now benefit from this new service offering and the knowledge gained through our presence in every major IVD marketplace in the world.”
The IVD industry has experienced an increase in regulatory scrutiny with the publication of the European Union’s In Vitro Diagnostic Regulation (IVDR), taking effect May 2022, in addition to a growing need for clinical evidence to support international regulatory approvals. NAMSA, frequently collaborating with global regulatory bodies to understand expectations and new regulations, says it recognizes how to navigate the international regulatory landscape and is recognized by authorities as delivering trusted, highly reliable IVD development outputs related to regulatory, quality system and clinical research initiatives.
“We are uniquely positioned to empower IVD manufacturers with accelerated, cost-effective development outcomes. Unlike other CROs, our team of IVD experts are solely focused on providing proven solutions for the unique challenges and needs of in vitro diagnostic technologies," says Schaaf. "This not only allows manufacturers to achieve clinical endpoints more quickly, but also helps them make more informed decisions that fast-track global delivery of life-changing IVD technologies.”