Regulatory
is of sufficient quality to support a particular regulatory decision”. The ways RWD and RWE are used have changed a lot over time, and continues to do so. Much of this is in line with the FDA’s Real-World Evidence framework, which supports timely safety signal detection and potential labelling expansions. “The FDA welcomes the adoption and implementation of post-market surveillance efforts – by industry and others in the healthcare ecosystem – that leverage RWE as one of the tools for collecting data on medical devices once they are on the market,” an FDA spokesperson tells Medical Device Developments. “While the FDA can’t directly speak to specific efforts and regulations for leveraging RWE to inform post-market surveillance taking place in foreign countries, in general, RWE can be leveraged to deliver further understanding of the performance, clinical outcomes and benefit–risk profiles related to medical device use.”
The view on the ground So, what do those in the industry think about the recent movements, particularly from reactive oversight to more proactive, data-driven surveillance? “The current administration is introducing radical transparency to government processes, while also adopting a more technology-forward approach to approving new innovations in the pharmaceutical and medical device sectors,” says Marcel Botha, a product development leader with 20 years of experience.
“For this approach to remain intrinsically safe as we drive faster go-to-market strategies and increase patient access, it’s essential to double down on RWE, which is impossible without RWD. The future of both pharma and IoMT [Internet of Medical Things] requires a deep understanding of how this data is collected, segmented and tracked over time to provide valuable insights into patient use, efficacy, safety and marketed function.” Botha adds that this RWE future is “aligned with a macro trend of care moving out of hospitals, into clinics, mobile care solutions, and patients’ homes”. This, he feels, provides opportunity for the IoMT development and innovation community to step up and develop “modern, miniaturised, data-enabled medical devices that live and provide care closer to patients’ homes”.
He also cites many reasons why IoMT is unique. For instance, it enables continuous, passive data collection; device interconnectivity (including cloud, edge and remote monitoring); and high-volume, high- frequency datasets. This might be from wearables, smart inhalers or remote sensors.
www.medicaldevice-developments.com
RWE use cases for IoMT devices Use case
Post-market surveillance Label expansion Regulatory submissions Performance benchmarking Adaptive clinical trial designs Source: Marcel Botha
David Davidson, a board-certified health law attorney (US) in Dickinson Wright’s Fort Lauderdale office, agrees that analytics are becoming more integrated into the changing face of healthcare, both by providers and by regulators. Specifically, he notes that providers are “using data- driven compilations to improve patient care, and to gain efficiencies”.
“Regulators have used data-driven information for a longer period of time. For example, the government has used statistical extrapolation to calculate damages under the False Claims Act, at least since the 1990s, with courts approving that practice in the 2010s.”
understanding of the performance, clinical outcomes and benefi t–risk profi les related to medical device use.” FDA spokesperson
Patient safety is a key issue. According to Dr Brandi Niemeier, professor of behavioural sciences at New Anglia University, the future of this element lies in moving from retrospective analysis to real- time insight.
“By integrating IoMT-generated data, electronic health records and patient registries into regulatory surveillance systems, device manufacturers and regulatory bodies will be able to detect safety-related signals earlier, refine risk–benefit profiles continuously, and even identify opportunities for expanding device indications in real time,” says Niemeier.
“Just as high-fidelity simulation allows practitioners to learn in a controlled environment, robust real-time evidence frameworks allow regulators and manufacturers to ‘course-correct’ swiftly without waiting for adverse events to accumulate.” Niemeier also points out the proactive model, “embodied in EU MDR Article 83”, published in
21
RWE function Identify safety signals or device failures
Demonstrate eff ectiveness in broader populations
Support pre-market clearance or approval (if high-quality RWD is available)
Compare outcomes with existing standards of care
Enable hybrid trials using both RCTs and real-world streams
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