Concerns about the consistency of the post-marketing surveillance (PMS) for safety of medical devices is well known across the world. Only around 13% of post-marketing surveillance (PMS) clinical studies are completed on medical devices. This is because new products or line extensions are launched frequently, even before full clinical trials of the parent device are conducted. This forces the manufacturers to reconsider whether a clinical study is worth funding, especially if the study timeline may result in publications reporting results on a previous generation’s technology. Furthermore, demonstration of the effectiveness of a device in clinical trials is challenging since the outcomes depend highly upon the clinician’s training and healthcare settings. In addition to this, continual and rapid changes in device design, and challenges pertaining to the use of placebo and blinding techniques, contribute to the complexity in conducting medical device trials.
Another outcome of these challenges with medical device trials is the difficulty in conducting health technology assessments (HTA) of medical devices. Most healthcare systems across the globe have implemented value analysis mechanisms to assess the clinical and economic impact of medical devices to inform policy decisions. In line with this, HTAs of medical devices are increasingly required to ensure efficacy, and safety, and also to support funding, coverage, and reimbursement decisions or price negotiations. However, the quantity of clinical evidence generated through randomized controlled trials (RCTs) of medical devices is often less, making HTA difficult.[3,4]
These challenges with respect to the availability of clinical evidence resulted in an unmet need among device manufacturers to invest in collecting evidence from other sources. And one possible solution to these problems is in the form of harnessing the power of real-world evidence (RWD).
With advances in technologies, modern medical devices (especially wearables) are largely connective: this means that these devices have an inherent capacity to generate RWD enabling translation to real world evidence (RWE). RWE has already been used for safety assessment in the form of PMS studies of medical devices. In addition, it has been increasingly realized that RWE may also be used to support medical device development. These include RWE used as external control of a single test group, clinical evaluations leading to modification of clinical value and registrations of the device, humanitarian device exemptions (HDE), premarket approval applications, support device reclassification petitions, and expanded labeling claims. Also, RWE on medical devices is useful in studying disease epidemiology, validating biomarkers, and refining treatment patterns. RWE can assist in surveillance and early identification of device design issues or opportunities for improvements or product extensions. RWE has the potential to reveal failure modes that are not previously diagnosed in the pre-clinical analysis thereby motivating testing advancements.
Examples of using RWE in medical device development include using existing RWD of the control device during a prospective trial for a novel device; indication expansion of drug-eluting stents; some USFDA approvals, such as those of scoliosis devices, vertebral body tethering devices, the Sapien 3 device for transcatheter aortic valve replacement (TAVR); the report on incidence rates of Microbial keratitis in pediatric contact lens users, and so on.
Realising the importance of RWE in medical devices, the USFDA developed the National Evaluation System for health Technology (NEST) in 2016, with a mission to accelerate and translate new and safe health technologies leveraging RWE throughout the lifecycle of the medical device, thereby optimizing device healthcare. NEST currently consists of 12 network collaborators representing more than 195 hospitals and 3,942 outpatient clinics, responds to the research questions of stakeholders, including medical device manufacturers, and generates crucial RWE. In 2017, the Center for Devices and Radiological Health (CDRH) of the FDA issued a guidance document on the use of RWE in supporting regulatory decisions for medical devices. In 2021, the FDA published 90 examples of regulatory submissions on medical devices using RWE from 2012 to 2019 showcasing the growing role of RWE in medical devices.
In the UK, the ratification of the Medical Device Regulation MDR 2017/745 occurred in 2021, which requires Post-Market Clinical Follow-up (PMCF) of all medical devices continually and throughout the entire lifetime of the device that indirectly contributes to the robust data that are utilized for product advancements. The PMCF uses RWE to a large extent.
There are some challenges for the adoption of RWE in medical devices, the main ones being the data quality, lack of standard endpoints in data collection, and inability to assess the incremental value of the devices when multiple medical devices are used during a single procedure. To strengthen the RWD on devices, Unique Device Identifiers (UDIs) have been mandated by the FDA for all devices, simplifying the tracking of device impacts, thereby creating a robust RWD. Modern medical devices also contribute to robust RWE generation by reducing the site visits, increasing the cohorts through Federal data networking, and reducing costs & timelines in medical product development.[6,8]
Unlike drugs, the use of RWE in medical devices is in the embryonic stage and has the potential to boom in the coming years. With the complexities of RCTs of medical devices and the evolution of the regulatory process, making evidence requirements by regulatory bodies worldwide, manufacturers are paying more attention to their evidence generation plans for devices and diagnostics, and the benefit could be substantial.
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