TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services is pleased to announce the release of its 2018 Medical Device Landscape Report: Trends and Challenges in Clinical Research Outsourcing.
This report, conducted on behalf of NAMSA by the Avoca Group, is comprised of over 200 responses from global medical device Sponsors with responsibility for clinical research outsourcing. Contained within is newly-discovered market data surrounding medical device clinical research—an area that has grown 63% since 2012 (ClinicalTrials.gov)—and an in-depth look at outsourcing behaviors and the most significant drivers, barriers and opportunities for medical device development.
“We are extremely pleased to provide new information to the medical device marketplace surrounding the unique challenges and opportunities for clinical research and outsourcing. In comparison to the pharmaceutical industry, little data existed previously regarding medical device outsourcing obstacles and how they might be addressed to achieve stronger CRO/Sponsor partnerships,” commented Christopher Rupp, NAMSA’s Director of Global Marketing & Sales Operations. “With significant medical device growth expected globally—$619B by 2022 (GlobalData)—it is imperative that we find strategies to work together to efficiently bring novel technologies to market and to quickly deliver them to patients who need them most,” Rupp concluded.
NAMSA’s 2018 Medical Device Landscape Report Executive Summary findings demonstrate that medical device Sponsors are experiencing the following trends and challenges related to clinical research and outsourcing:
- Increasing prices, profitability pressures and access to funding continue to drive decision-making
- Growing costs of clinical trials is a significant driver for Sponsors’ need to outsource
- Expanding regulatory requirements related to the EU’s Medical Device Regulation (MDR) / In Vitro Diagnostic Regulation (IVDR) and International Standards ISO 10993-1:2018 / ISO 13485:2016 continue to commandeer internal resources and require updated expertise
- Rising utilization and reliance on IT solutions, such as Electronic Data Capture (EDC) tools and Clinical Trial Management Systems (CTMS), are increasingly required to conduct efficient clinical trials
- Emerging movement by Sponsors to partner with strategic CROs throughout the medical device development continuum
- Outsourcing spend by Sponsors has grown 55% in the last three years
- Rising budgets for outsourcing services are expected to grow by 30% in the coming years
NAMSA invites you to download our full report to gain access to this previously unavailable medical device clinical research outsourcing data. We anticipate that this information will serve as a beneficial tool as we work together to advance global patient healthcare through the delivery of life-improving medical technologies.
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About NAMSA
NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world.
NAMSA Press Release Contact
Leah Davidson, MA, MBA
612-615-6985
Marketing Communications Manager
ldavidson@namsa.com
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.