According to the World Health Organization (WHO), the demand and execution of medical device clinical trials have increased considerably in the past few years. However, meeting this demand in-house can be constrained by limited technical expertise. This is partly due to the significant investment needed to build the necessary infrastructure, capabilities, and changes in the regulatory environment, e.g., the introduction of rigorous quality assessments. Medical device developers increasingly work with contract research organizations (CROs) to outsource significant portions of their clinical research and management of regulatory affairs. Below we will discuss the evolution of CROs in the medical device clinical research market and how CROs have impacted medical device clinical trials.
Evolution of Medical Device CROs
A CRO’s primary goal is to help drug developers manage and run clinical trials with the goal of bringing a new therapy to market. CROs can design, monitor, audit, and manage clinical trials from start to finish and help sponsors navigate regulatory approvals and compliance with governing authorities. CROs provide clinical monitoring, data management, biostatistics, vendor management, legal representation, and consulting services. CROs help sponsors across therapeutic areas and indications. However, in recent years, the need for medical device CROs has increased.
A recent study reported that over 75 medical device CROs had been established since 2010. An analysis of the medical devices CRO market found that the number of medical device clinical trials has increased considerably over the past few years and is projected to continue growing. The study found that many device developers (both small and well-established) choose to outsource their clinical operations and regulatory affairs management to CROs. To better support the growing demand, medical device CROs have been assessing and expanding their capabilities to offer improved services. In addition, more than 55 acquisitions and strategic alliances were made between 2015 to 2022 to expand services and geographical reach.
To further distinguish themselves, CROs introduce and integrate novel technologies and tools, e.g., cloud computing, risk monitoring tools, real-world evidence, and advanced data analytics, into their processes. CROs have also inked collaboration and acquisition agreements with data management solutions providers in response to the demand for integrated data platforms to manage and analyze clinical data. In 2017, rapid advancements in mobile and sensor technology paved the way for large entrants like Google and Microsoft into the device market – blurring the line between medical devices and traditional tech.
How CROs Have Impacted Medical Device Clinical Trials
The global market currently offers approximately two million different medical devices, though not all have been approved by the US FDA. The MedTech industry is expected to capture more than 40% of the global market share, with projections of steady growth in the coming years. As a result, there has been a significant increase in medical device-focused clinical trials.
However, only a limited number of developers possess the technical expertise required to conduct in-house clinical research. Additionally, stringent regulatory guidelines impose rigorous quality assessments on medical devices, posing challenges for firms with limited financial resources to undertake research initiatives.
In this landscape, Contract Research Organizations (CROs) have emerged as key players in facilitating medical device clinical trials. With their specialized expertise and regulatory assistance, CROs have been able to support sponsors in conducting trials that are efficient, affordable, and effective. CROs possess the necessary technical proficiency and experience to navigate the complex landscape of medical device research, including the intricate regulatory requirements and quality assessments.
Regulatory Environment
Medical device CROs have evolved due to various factors, including a changing regulatory environment. In 2017, for instance, the European Commission (EC) updated the legal framework for medical devices and increased the requirements for clinical research. To support the performance and safety claims of the device, a mandatory conformity assessment is applied to all devices manufactured in the European Union (EU). CROs were assigned a more prominent role in providing scientific evidence and regulatory assistance throughout the journey toward market access.
CROs are well-versed in navigating the regulatory landscape governing medical device clinical trials. They possess in-depth knowledge of the regulatory guidelines and requirements, including those related to safety, efficacy, and data integrity. This enables CROs to ensure that the trials are conducted in compliance with the regulatory standards, minimizing the risk of delays or regulatory issues. CROs also have established relationships with regulatory agencies, which can streamline the approval process and facilitate efficient conduct of the trials.
Emerging Technologies
Advancements in artificial intelligence (AI) and access to extensive biological data have enabled drug discovery and development at lower investments of time, workforce, and costs. Similarly, CROs have adopted emerging technologies, e.g., big data analysis, AI, real-world evidence, and digital technologies, to increase efficiency and effectiveness and improve medical research and device development. In light of the changing business environment and their evolving competitors, legacy CROs are evaluating their operational models and business strategies to stay relevant.
Noteworthy CROs Impacting Medical Device Clinical Trials
In illustrating the evolution and positive impact of Contract Research Organizations (CROs) on medical device clinical trials, we present three noteworthy examples of CROs. These examples highlight the critical role that CROs play in driving advancements in the field of medical device research.
1. NAMSA
Founded in 1967, NAMSA first offered medical device laboratory testing services. In the following years, a medical device consulting practice was introduced to allow clients to engage earlier in product development. Sponsors were provided with in-vitro toxicology screening tools to reduce, refine, and replace in-vivo models. Through acquisitions, NAMSA added regulatory consulting, preclinical, clinical research, and quality support. In 2018, it added an analytical testing laboratory and, more recently, continued expanding its services in reimbursement, health economics, and market access. In the same year, NAMSA received the “CRO Leadership Award” for the second consecutive year. NAMSA continues to broaden its service offerings and, in early 2023, acquired a strategic consultancy providing global market research services.
2. IQVIA
The IQVIA medical devices CRO offers sponsors its data acquisition strategy, an eSource management solution with real-time bi-directional data collection. It streamlines the selection and deployment of medical devices, including sensors and wearables, ePRO (electronic patient-reported outcome) / eCOA (electronic clinical outcome assessment), vitals, and glucose monitoring, to collect and analyze data. In addition to direct device data integration, IQVIA offers remote device/study management, enhanced PC-based acquisition/analysis tools, and real-time data and reporting. Integrated processes include decentralized trials, statistical analysis, self-serve data availability, custom reporting and analytics, and risk-based monitoring.
3. Vial
Vial is a next-generation CRO that promises faster and higher-quality execution of clinical trials. The Vial CRO operates across multiple therapeutic areas (Medical Device CRO, Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Rare Disease CRO, and Digital Therapeutics CRO).
Vial delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial’s technology platform combines modern, intuitive eSource (electronic source), EDC (electronic data capture), ePRO (electronic patient-reported outcome), and eTMF (electronic trial master file). Historically, the TMF refers to the documents involved in a clinical trial from initiation to into one connected system, streamlining site processes and enabling considerable efficiencies. Vial helps connect sponsors to top-rated sites through their Preferred Site Network and reduces costs through fixed-fee pricing.
Conclusion
In summary, CROs have emerged as crucial partners in medical device clinical trials, offering the right technical expertise and regulatory assistance to sponsors. Their ability to provide cost-effective solutions, navigate complex regulatory requirements, and optimize trial design and data management makes them invaluable in driving the evolution of CROs and their impact on medical device clinical research.
Interested in Vial helping you save on your next medical device clinical trial? Contact a team member today!
