NAMSA
Accelerating Medical Device Commercialization

The world of medical devices is constantly evolving, with MedTech companies developing life-changing products that have the potential to reshape the future of healthcare. However, commercializing these devices is sometimes a difficult journey amid rising complexities around regulatory requirements, cost pressures, and the talent war. Companies are seeking Contract Research Organizations (CRO) equipped to provide complete strategic guidance to fast-track product development and to decrease time-to-market.

NAMSA is that trusted partner, helping MedTech companies accomplish their commercialization goals with its global, end-to-end medical device development services.

Driven by in-depth therapeutic knowledge and global regulatory expertise, NAMSA helps companies move their medical devices through the development lifecycle as efficiently and cost-effectively as possible.

“We are equipped to handle the full spectrum of services required by MedTech companies to achieve fast-paced, successful commercialization,” says Christophe Berthoux, CEO of NAMSA.

Whether medical device testing, regulatory, reimbursement, quality consulting, or clinical research services, NAMSA assists clients at every stage of product development.

All Under a Single Roof

In the Preclinical phase, NAMSA’s team of experts collaborate with clients to develop Class III medical devices for implantation into human bodies. Once the team clears the technical hurdle of implanting the new device, the company helps clients complete rigorous rounds of testing according to FDA directives.

An ISO 9001:2015-certified company, NAMSA adheres to all applicable global regulations and standards for patient protection and clinical data integrity. It also performs Biocompatibility testing to ensure the implanted devices are absent of harmful side effects.

At a time when regulatory bodies are demanding more compelling clinical evidence to approve a product, most MedTech companies are experiencing longer development timelines to accommodate an increasing number of clinical trials for Class II and III products.

NAMSA provides customized clinical trial consulting services to help organizations pass all stages of medical device commercialization—from concept to post-market.

The company’s regulatory, reimbursement, and statistical teams are empowered by clinical trial consulting expertise spanning technology, therapy, indication, and geography. Based on their extensive skillsets, the teams offer a wide range of services to help clients unlock the full potential of their trial protocols.

With well-established SOPs for planning, initiating, and conducting studies, NAMSA’s teams offer adaptive study design, clinical hypothesis consultation, health economics and reimbursement planning, literature review, and targeted biostatistics consulting services.

Cognizant of the talent war prevalent in the MedTech industry, NAMSA provides staffing solutions that help clients recruit the most skilled and talented consultants with adequate therapeutic and clinical development knowledge. Drawing on its collective experience of 55+ years in the CRO industry, the company enables clients to strategically hire and allocate resources with extensive therapeutic-specific expertise for Preclinical and Clinical trial consulting teams.

It handles enrollment of patients who need to undergo trials, ensuring they meet eligibility criteria through well-designed protocols implemented by the client.

In unison, NAMSA’s portfolio of services helps clients fast-track their development lifecycle, reduce costs, and boost development timelines to move their devices to commercialization.

Our Team Helps Clients Stay Up To Date With All Prerequisites For Regulatory Submissions And Proactively Plan For Product Approvals

The Catalyzers

A perfect blend of scientific prowess and subject matter expertise is the foundation of NAMSA’s highly talented workforce. Its toxicologists, analysts, and surgeons, who specialize in device implantation, have the solid therapeutic know-how critical to fast-tracking development and commercialization efforts.

Equally adept are NAMSA’s clinical trial and regulatory consulting experts. Comprising ex-FDA employees and consultants with in-depth knowledge of EMEA, MDR, and Japan’s PMDA guidelines, they stay abreast of latest medical device innovations and region-specific regulations.

“Our team helps clients stay up to date with all prerequisites for regulatory submissions and to proactively plan for product approvals,” says Berthoux.

While getting a device approved by any regulatory body is a challenge, setting the right pricing strategy can also be difficult. Price setting on an international scale is often complicated by multiple factors, including government regulations, customer demographics, and complex Request For Proposal (RFP)tender processes. The team at NAMSA provides indepth consultations around pricing and reimbursement strategies, enabling medical device companies to more effectively maintain profit margins.

The excellence of NAMSA’s services has been reaffirmed in recent strategic outsourcing collaborations with InspireMD, a company offering innovative stent designs for neurovascular protection and stroke prevention, and most recently, Terumo Aortic, a developer of aorta-focused medical devices.

NAMSA is helping InspireMD and Terumo Aortic accelerate product development efforts and establish a more efficient path to market by leveraging NAMSA’s entire continuum of development services and deeprooted cardiovascular and neurovascular expertise.

Both medical device developers continue to expand their global presence and bring much-needed medical technology advancements to patients worldwide. InspireMD plans to optimize NAMSA’s support to integrate more sophisticated technologies into medical devices that are part of the new industry standard for sustained neurovascular protection. Whereas, Terumo Aortic will receive immediate access for clinical study starts and capacity in addition to access to experienced teams of leading cardiovascular experts.

Charting the Future of Medical Device Development

Moving ahead, NAMSA aims to build on its exemplary track record of offering clients immediate access to therapeutic expertise and knowledge, providing multiple resource efficiencies, and accelerating development timelines with reduced costs.

Through its Global Training Center in Madrid, Spain, it encourages continued scientific innovation to take patient care to the next levels. It is looking to recruit bright young minds exploring careers in clinical research to foster greater interest in this domain. Depending on their professional experience and academic background, new hires are trained using intuitive training modules that nurture their skillsets, making them available for live projects as quickly as possible.

Apart from growing organically over the past few years, NAMSA has embarked on various M&A projects, with three in the U.S. and four in Europe. Having gained a strong market presence in the U.S., it aims to strengthen its full spectrum of integrated services by acquiring companies on the rise and expanding its footprint in Europe and Asia while actively contributing to the advancement of the medical device industry.

Medtech firms seeking to bring efficiency to the forefront of their product development lifecycle can end their search with NAMSA. It is the ultimate stop for every MedTech organization looking to go to market faster to have a more timely impact on patient outcomes and global healthcare.