Developing Med Tech Clinical Evidence: Challenges and New Approaches

An Axendia Voice of The Customer Report

The need for clinical evidence on medical devices is steadily increasing – for regulatory submissions, postmarket surveillance, reimbursement, outcomes research, and other purposes.  

A new Axendia research report, presented by Medidata, featuring industry executive insights examines current and emerging challenges and solutions to developing credible, actionable clinical evidence for medical devices.

The gold standard model prevalent in the pharmaceutical industry is often difficult or impossible with devices due to factors including operator variability and the inability to employ placebo controls.  Many devices are variations or improvements of existing devices, and the costly duplication of full-blown additional studies would pose unreasonable burdens and hamper the introduction of beneficial products.

There is a heightened emphasis on a patient-centric approach to evaluating new medical products, and designing studies that include a diverse subject population that accurately represents eventual real-world patients and circumstances.

New technologies and methodologies that are helping make med tech clinical evidence development more efficient, cost-effective, and reliable include the use of decentralized trials, telemedicine and remote monitoring, adaptive study designs, in silico trials, real-world evidence, artificial intelligence/machine learning, and improved data management and analysis.

This research examines the way that med tech clinical studies have changed and continue to change.

Request your copy of this report HERE.

To discuss how this initiative impacts your organization, schedule an inquiry with Axendia HERE.

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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