NAMSA’s full continuum CRO development services and solutions are designed around one goal: achieving client success. From product development strategy—medical device testing—regulatory, reimbursement and quality consulting—and clinical research services, we are committed to helping clients overcome development hurdles, mitigate concerns and streamline development efforts. We are the CRO industry’s premier partner for accelerated, cost-efficient and efficacious development outcomes that lead to commercialization success.
ICHOR Vascular, Inc., a start-up firm focused on the treatment of Peripheral Arterial Disease (PAD) and Limb Ischemias, partnered with NAMSA for the development of the ICHOR Panacea Vascular Embolectomy Catheter System. Operating as a virtual start-up, ICHOR was tasked with the challenge of bringing a 510(k) device to the U.S. marketplace with limited development and regulatory knowledge, restricted resources and a desire to make a timely exit following clearance.
ICHOR, by applying The NAMSA APEX Program™ (formerly known as NAMSA’s MRO® Approach) throughout the development continuum, achieved a 30 percent savings in timelines while also shaving off $26M in costs throughout the development lifecycle.
Biom’Up®, a European-based medical device firm focused on collagen-based absorbable medical products for biosurgery, recently sought to obtain its first Class III Investigational Device Exemption (IDE) and Premarket Approval (PMA) in the United States.
Biom’Up, with the utilization of the NAMSA APEX Program™ (formerly known as NAMSA’s MRO® Approach) methodology, achieved record-breaking results of $17M in cost savings and 23 months in accelerated timelines.
Through the NAMSA APEX Program™ (formerly known as NAMSA’s MRO® Approach), clients around the world are realizing multiple time and cost efficiencies throughout all phases of medical device development.
Heraeus, a German-based services firm focused on providing innovative solutions to medical technology companies, recently partnered with NAMSA to conduct a pre-clinical development program. Utilizing NAMSA’s anatomic/bioskills services, multiple successes were achieved throughout, including significant acceleration of product development timelines and cost savings.
CVRx®, a Minneapolis-based cardiovascular medical device company, is dedicated to the development of proprietary active implantable technology for the treatment of high blood pressure and heart failure.
CVRx’s one-of-a-kind product, the Barostim neo™, is currently CE marked in Europe. The organization, requiring quick market access for a successive U.S. heart failure pivotal trial, quickly turned to NAMSA to help accelerate the process. Relying on NAMSA’s clinical and consulting services throughout, CVRx realized both cost efficiencies and time savings as a result of the partnership.