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Clinical Trial Strategy / Study Design

MDCI will begin the design of your clinical trial with the formulation of appropriate study endpoints. Whether you need to collect data to support a pre-market submission, a scientific publication, or drive physician adoption and market acceptance, these endpoints will support the content of your study and help you to determine the appropriate number of patients and study sites, study duration and length of follow-up.

Additionally, the appropriate clinical trial strategy is dependent on where you plan to commercialize your medical device. European medical device requirements for clinical data can differ significantly from U.S. FDA requirements, so it is important to consider all these factors early in the development of your medical device clinical trial.

European Clinical Data Requirements for Medical Devices

In general, to support the European CE marking requirement, you must demonstrate that your device is safe, that it performs as intended, and that the level of risk is acceptable when weighed against the benefits. Within the European Medical Device Directives, the term "clinical data” encompasses everything from bench testing to clinical trials in human subjects. While some devices do require conduct of a specifically designed clinical investigation, it is often possible, for low- to medium-risk devices (Class I, IIa, and IIb), to prepare a compilation of relevant scientific literature to support the device’s intended use and the techniques employed.

U.S. Clinical Data Requirements for Medical Devices

The U.S. FDA clearance / approval process for medical devices is very different from the European CE marking process, especially in terms of the scope and size of clinical trials required for high-risk devices.

To market a device in the EU, you must demonstrate that the device is safe and that it performs in a manner consistent with the intended use. To market a class III high-risk (and some class II) device in the United States, you must demonstrate that the device is reasonably safe and effective. This typically requires a prospective, randomized controlled, adequately powered clinical trial involving hundreds of patients.

Working with your team, we will help you design a clinical study to meet your needs and identify the best data measurements to support your product claims. Our experienced clinical services professionals will advise you on how to best measure the effectiveness of your product, in the most clinically meaningful and cost-effective way possible.

Contact us to learn more about our clinical trial strategy services