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Friday, June 21, 2024

NAMSA: Streamlining the Nitty-Gritties of Medical Device Development

In today’s technology-drivenhealthcare sector, delivering a novel medical device to the market can be a tedious process, even when you’re familiar with the regulatory, reimbursement, and quality standards in the intended global markets. Besides, regulatory mandates and reimbursement systems are complex and vary widely across countries, making it critical for providers to understand potential barriers and the right means of reimbursing various devices. Consequently, many medical device manufacturersmay lack the properguidance and often find it hard toinitiate the best reimbursement strategies in their product development lifecycles.

However, having an experienced CRO with in-depth industry expertise as a partner can change the tide in their favor and can even bring in significant capitalsavings. Enters NAMSA. Driven by its global regulatory expertise and in-depth therapeutic knowledge, the company supports the full-cycle of product development, from concept to post-marketfor its clients. “NAMSA offers the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible,” states John Gorski, CEO and president at NAMSA.

As the first 100 percent medical device-focused CRO in the world, NAMSA’s global end-to-end solutions help medical device companies overcome development hurdles, mitigate concerns, and streamline their development efforts. Its full continuum CRO development services and solutions, from product development strategy, medical device testing, regulatory, reimbursement to quality consulting, and clinical research services, are designed toensure a successful product development for the clients.Furthermore, the company also provides a proprietary Medical Research Organization (MRO) program to accelerate creating robust products that elate healthcare services today and in the future. This bundles an array of CRO services to drive medical device development from conceptualization to first-in-human trial to post-regulatory approval.“We are the CRO industry’s premier partner for accelerated, cost-efficient, and efficacious development outcomes that lead to successful commercialization,” adds Gorski.

On similar lines, NAMSA’s Product Development Strategy (PDS) service solutions offer exceptional assistance to clients on any challenges they face inthe therapeutics, reimbursement,or regulatory environment. The PDS Team, comprising of cross-functional scientists and strategists,can support an array of medical device or In Vitro Diagnostic (IVD) programs, enabling manufacturers to adoptthe best strategy in every stage of development.Furthermore, NAMSA’s Test Navigator identifies the industry’s most common tests with thousands of unique testing services.At the same time, its Biocompatibility Strategy Navigator help clients sift through the labyrinth of tests required for each regulatory pathway.“Serving as a true extension of your internal team, our experts understand how to align all stakeholders to proactively address development barriers and reduce risks. This caters as the guiding beaconfor the clients to efficiently navigate their development lifecycle to garner on-time delivery of products into the market,” continues Gorski.

Established in 1967, NAMSA pioneers the medical device testing industry, enablingmanufacturers to introduce cost-effective and life-improving therapies to the people who need them. Unlike most of its competitors, the company manages all of its testing programs in-house, thereby ensuring direct oversight of test articles and consistent results.Moreover, NAMSA is well-equipped to drive successful regulatory submissions and outcomes through practical daily interactions with the U.S. FDA, Japan’s PMDA, Europe’s Notified Bodies, China’s NMPA, and other international authorities. Added to this, itsstandalone IVD business unit focusesexclusively on meeting thevarious product development needs of IVD manufacturers to help fast-track the commercialization of their products.

With extensive industry expertise spanning over 53 years, NAMSA’s global associate team is seasoned in every aspect of the reimbursement strategy, including payer relations, medical policy research, coverage advocacy, HCPCS and CPT code analysis/applications, health economic analysis, and more. Having offices located throughout Asia, Europe and North America, the company’s deep-rooted experience allows it to glean unparalleled results with consistency, responsiveness, and proactiveness. Whether clients require support in a specific area or throughout the entire medical device development program, NAMSA hones the unique capability to provide with all the resources, whenever and wherever you need them.

NAMSA’sability to deliver personalized, reliable and cost-effective testing solutions regardless of the technology, therapy, indication, or geography has bagged numerous accolades of excellence over the years.The company hasrecently won the third“CRO Leadership Award” last year for excellence in clinical research, thanks to the capability, compatibility, and quality of its services.Moving forward, NAMSA plans to continue to make considerable strides in the medical device development landscape, empowering clients with efficient, time-tested solutions to lead them on the right path to success.

“We are the CRO industry’s premier partner for accelerated, cost-efficient, and efficacious development outcomes that lead to successful commercialization



John Gorski
CEO and President


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