PharmaTech Outlook Magazine; June 2020
Interview with John Gorski, NAMSA President & CEO
“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.
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…”
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