John Gorski, CEO and President
NAMSA has quickly become known as the CRO industry leader for end-to-end solutions that expedite safe, efficacious medical device development outcomes throughout the globe.
Over the last decade, the pharmaceutical and medical device industries have undergone significant transformative trends and innovations. These shifts have rapidly improved efficiency and lowered costs while bringing an increased focus to personalized patient care. According to a 2019 study by Research and Markets, sales in the pharmaceutical industry are expected to rise from $900 billion in 2019 to $1.2 trillion by 2024, While the global medical device market is expected to grow at a CAGR of 5.33 percent to $521.64 billion by 2022. This growth can be attributed to the broader availability of the Internet and medical device manufacturing solutions. Also adding to this upward trajectory are great strides in the development of personalized wearable technologies to diagnose, monitor and manage life-threatening conditions. However, in light of the COVID-19 pandemic, the European Commission has proposed to delay the date of application of certain provisions of Regulation (EU) 2017/745 on Medical Devices (MDR) by one year to 26 May 2021. The proposed delay would allow manufacturers additional opportunities to extend Medical Device Directive (MDD) certificates, make significant changes, and prepare their Quality Management Systems (QMS) to meet the stricter post-market vigilance and arrangements with Economic Operators requirements. The year 2021 is set to be a pivotal one for medical device companies to display clinical evidence and maintain robust compliance throughout the device lifecycle.
NAMSA, established in 1967 in Toledo, Ohio by Dr. Theodore Gorski, was the first independent company in the world to focus solely on testing medical device materials for safety. Today, the company is a leading contract research organization (CRO) 100 percent focused on the medical device industry, offering expert device testing, regulatory, reimbursement and quality consulting services, and clinical research support to aid clients at every stage in the medical device development continuum.
From Concept to Post-market, a Trusted Partner every Step of the Way
NAMSA’s services cover the full spectrum of medical device development activities. The organization applies a distinctive combination of disciplines to reduce cost and time-to-market while ensuring each client has a single point of contact throughout all development processes. Unlike other CROs, NAMSA uses a unique, “Medical Research Organization” (MRO) Approach™ that offers high quality, insightful expertise focused on identifying the best-fit strategy for each client to achieve an efficient, cost-effective path-to-market. The company’s methodology is designed to provide practical, integrated, end-to-end resources to support safety, efficacy and compliance from concept through post-market.
With 53 years of medical device development expertise, NAMSA encompasses a broad range of technologies, therapies and indications with a tight focus on medical devices, In Vitro Diagnostics (IVDs) and biologics. From regulatory, reimbursement and quality consulting to medical device testing and clinical research services, NAMSA possesses extensive knowledge and experience in all major therapeutic areas, including Cardiovascular, Orthopedics, Wound Care, Neurology, General Surgery, Ophthalmology and many more.
NAMSA, with a large cross-functional global team of seasoned Associates (clinical, regulatory, reimbursement, strategy, quality, biostatistics, data management) offers clients the ability to manage and mitigate concerns by delivering practical strategies and solutions guided by deep regulatory expertise. Utilizing the MRO Program, NAMSA ensures Sponsors have a coordinated team of experts attending to their needs throughout the entire development process, helping clients optimize the full potential of their device data while ensuring regulatory compliance.
Clinical Research: Experts at Adapting
We make sure the clinical trial design requirements are aligned with the ultimate endgame of getting our clients’ approval for the product so that their device can treat more patients in a safe and effective manner
As the global medical device landscape becomes increasingly complex, getting a new product or therapy approved requires compelling clinical evidence. NAMSA, with a dedicated focus on medical device and IVD products, has designed and conducted trials in every area of the world to address wide-ranging client objectives. Their clinical experts are uniquely positioned to understand what each client is up against, taking best practices and proven strategies from previous programs and applying them to evolving regulatory requirements for their specific study. NAMSA’s study management, biostatistics and data management experts distinctively understand when and how to adapt throughout each clinical trial program, delivering time and cost efficiencies while setting clients up for success.
The company’s clinical trial programs are designed and conducted to address varied client objectives—from first-in-human through post-market studies—whether the intent is to obtain market approval, improve reimbursement or to generate publications. Not only does NAMSA create and manage protocol design, but they also secure site selection and oversee patient recruitment. “We make sure the clinical trial design requirements are aligned with the ultimate endgame of getting approval for the client's product so that their device can treat more patients in a safe and effective manner,” explains John Gorski, President and CEO of NAMSA.
During the clinical trial phase, the company uses leading technology platforms to cater to each sponsor’s preferred data management requirements. Whether it’s electronic data capture (EDC), or electronic trial master file tools (ETMF), NAMSA partners with top industry leaders to provide solutions to facilitate trial design that accurately capture clinical evidence. The firm then helps clients with the database design and management of data to ensure that stored information is readily available for auditing or regulatory inspections at any point during the trial. Also, NAMSA’s team of biostatisticians assists clients with statistical analysis collected from the trials to determine if the device under review is substantially equivalent or more effective than a predicate device. “Through our effort, we provide value-added services to our clients who don’t have the opportunity to access a high level of expertise in-house,” states Gorski.
Building Regulatory and Reimbursement Strategies with Clinical Support
Commercializing a medical device can be a tedious and complicated process, even when clients are familiar with regulatory requirements. NAMSA provides post-market support to develop and implement global regulatory compliance strategies. “NAMSA is not only providing clinical research services, but also bringing in our regulatory experts at the beginning of trial design and at every step of the way for our clients,” comments Gorski.
The company’s dedicated team of regulatory specialists work alongside the clinical team to not only assure safety and efficacy, but to also identify the data required to submit to the intended regulatory agency to achieve regulatory approval. With established offices across five continents to serve the global market, NAMSA understands the complex compliance requirements of the U.S. FDA, European Notified Bodies, the Japanese Ministry of Health, Labor, and Welfare, and the China National Medical Products Administration, among other regulatory authorities worldwide. The company is certified to ISO 9001:2015 and operates with full accreditation to ISO/IEC 17025:2017 and AAALAC International.
“Reimbursement services are another element of what we provide to our clients that can assist them not only in getting regulatory approval, but also assuring that they get paid for their device,” elucidates Gorski. As a result of complex and varying reimbursement systems worldwide, global medical device manufacturers lack the proper context and contacts when distinguishing effective reimbursement and commercialization strategies. NAMSA offers a full continuum of reimbursement services and solutions for new and existing medical technologies. The company is comprised of experts in all aspects of reimbursement strategy, including payer relations, medical policy research, coverage advocacy, health economics analysis and much more.
Paving the way for a New Paradigm of CROs
NAMSA’s culture focuses on four key pillars—its Associates, clients, quality and growth. “We genuinely get excited when helping clients get their new products approved, which in turn allows them to help improve patient health around the globe,” elaborates Gorski.
"NAMSA is not just providing clinical trial services but also bringing in our regulatory experts at the beginning of trial design and at every step of the way for our clients"
The company’s team of medical device experts are dedicated to assisting clients in overcoming hurdles and mitigating development concerns by delivering proven and cost-effective strategies for each client. To illustrate, Gorski cites a recent case study, where ICHOR Vascular, 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, limited resources and a desire to make a timely exit following clearance. In NAMSA, ICHOR found a single partner to address all concerns. With the company’s MRO Approach program, ICHOR achieved a 30 percent savings in timelines while also reducing costs by $26M throughout the development lifecycle.
As NAMSA’s clients continue to expand across the world, the company has kept pace by establishing multiple offices located in the U.S., China, U.K., Japan, France, and Germany, with a commercial presence in Latin America, Israel and Korea. Its cross-functional teams and integrated approach helps provide clarity in terms of new regulations and requirements, such as the EU MDR and IVDR, among others, throughout the world. “Striving forward, it’s all about providing our clients the correct guidance for the changing regulatory environment,” says Gorski. The company aims to continue to invest in systems and communications that will help combine and execute technologies to accelerate R&D in various stages of the medical device development equation.
Furthermore, the increasing reliance by medical device development companies on CROs embarks on a new wave of relationships between the two industries, which might best be described as ‘strategic solutions.’ The relationship between CROs and their customers will inevitably change as the parties begin to reassess their respective competitive strengths, creating new opportunities and business models that are more virtually integrated than vertically integrated. This reassessment is taking place at a time when the traditional healthcare industry is reinventing itself in the face of price pressures and currently, the COVID-19 Pandemic, as well as competition in a progressively digital era.
As a core element of their culture, NAMSA intends to provide the best strategic guidance and tactical support at every step of the way throughout medical device development process, to help clients improve patient healthcare all over the world. “At the core of what we do, it’s about our Associates working together to help our clients develop and deliver innovative solutions to improve patient health that motivates us,” concludes Gorski.