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NAMSA has quickly become known as the CRO industry leader for end-to-end services that expedite safe, efficacious medical device development outcomes throughout the globe.

An Interview with John Gorski, NAMSA President and CEO

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 to $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.

Clinical Research: Experts at Adapting
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 to set clients up for success.

The company’s clinical trial programs are designed and conducted to address varied client goals—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 regulatory strategy to get our clients’ devices approved so they can treat more patients in a safe and effective manner,” explains John Gorski, President and CEO of NAMSA.”

Access PharmaTech Outlook’s full article here.

Leah Davidson, MA, MBA, PCM

Leah Davidson, MA, MBA, PCM

Leah has been with NAMSA since 2016 and currently serves as Senior Manager of Global Marketing Communications. She possesses nearly 25 years' experience within the medical device and healthcare technology industries and has worked in various marketing and communications capacities throughout her career. In her role at NAMSA, she is responsible for the development and implementation of brand strategies and marketing communications initiatives that help drive the organization's sales and organizational growth goals globally.