The medical device industry is gradually adapting to rising global expectations from both regulators and users for more comprehensive clinical data throughout the product lifecycle. In the United States, the FDA has increased its pre-market requirements for selected 510(k) submissions and emphasized the need for real-world evidence. In the European Union, the traditional reliance on clinical equivalence has become significantly more difficult under the MDR, with strengthened requirements for pre-market clinical data and enhanced Post-Market Clinical Follow-up (PMCF). China has also introduced more robust clinical data requirements, tailored to reflect the demographics of its population in both pre- and post-market phases. An increasing number of other jurisdictions are following a similar path, signaling a global trend toward more rigorous clinical evidence expectations.
In the late 2010s and early 2020s, the medical device industry, partly constrained by the global pandemic, primarily focused on enhancing existing clinical data. Manufacturers often refined their available clinical information and incorporated post-market studies aimed at market penetration and engagement with key opinion leaders. While these efforts provided some value for regulatory compliance, they were not always designed with that objective as the primary focus. In recent years, however, with the pandemic largely behind us and regulatory expectations continuing to evolve, there has been a noticeable shift. Manufacturers are increasingly investing in both pre-market and post-market clinical trials to generate robust clinical evidence that aligns more directly with compliance requirements.
From the analysis of the projects currently running in our Contract Research Organization (CRO), it appears, however, that this new energy to collect clinical data is not equally present throughout the various clinical therapy sections.
This trend can, in part, be attributed to the risk classification and duration of implantation associated with certain medical devices. For example, there is a notably high frequency of clinical trial activity in cardiovascular, wound care, and ophthalmic devices and implants. In these areas, the combination of higher risk profiles and the potential for serious or immediate health consequences, particularly in cardiovascular applications, drives the need for more robust clinical evidence. In contrast, while orthopedic devices are also typically classified as medium- to high-risk, there is a long-established culture of utilizing clinical registries in this field, which has historically supported post-market data collection and performance monitoring.
Figure 1: Type of CRO projects, divided by therapeutic area.
Source: Qserve CRO Project Database
If we look at the cardiovascular projects in a bit more detail, we notice that the split between pre- and post-market is nearly equal, with a bit more on the post-market side. The pre-market projects focus more on innovative devices or first devices of a type of a specific manufacturer, while the post-market projects aim to support keeping products on an existing market, or utilizing data to extend the product into other jurisdictions.
Figure 2: Breakdown type studies for Cardiovascular projects.
Source: Qserve CRO Project Database
As for the innovations, a clear demand is being enforced in the EU to collect sufficient clinical data. And for innovative devices that basically should include a powered pre-market clinical study.
Clinical data generated with pre-market or post-market clinical investigations outside the EU may be very valuable to support sufficient clinical data in the EU as long as the manufacturer can justify:
In case there are differences or gaps, at minimum an add-on clinical study in the EU is required. A similar principle applies for the US with the remark that the US FDA usually requires more clinical data from the US than a Notified Body will require from the EU
If a manufacturer intends to market a device in multiple jurisdictions and a pre-market clinical investigation is required, it is worthwhile to start early with a clinical strategy that considers all those jurisdictions. This will result in an as (cost) efficient as possible clinical program.
The pre-market studies historically were stand-alone studies, but we see a shift in companies trying to connect different studies into one multi-geography clinical effort.
Our CRO team is ready to support you on your journey to prepare a stronger clinical baseline. This may include a strategic review of your existing clinical data set towards specific market access, supporting a repositioning and/or rewrite of the clinical evidence, and/or supporting you in pre- and post-market clinical trials.
Contact us today to explore how our CRO experts can help strengthen your clinical strategy and accelerate your path to market.