Planning publications for a medical device

A device publication plan communicates evidence across the product lifecycle, reaching the appropriate audience while the technology remains relevant. It coordinates preclinical and clinical evidence, publication deadlines and the work of the teams generating and communicating the data.

Evidence across the lifecycle

A device publication strategy tells the story of an invention and communicates important scientific data to the right audience at the right time. ^{1, 2} It should cover the entire lifecycle, including preclinical animal studies, clinical pre-approval studies and post-approval evidence. ^{1, 2} Early peer-reviewed publications support awareness among key opinion leaders and promote dissemination of the product after approval. ²

In 2018, the shift from healthcare professionals towards healthcare administrators as customers, together with new regulations, increased the importance of peer-reviewed clinical evidence throughout the device lifecycle. ¹ For manufacturers of class III devices, sufficient preclinical and clinical evidence also serves a commercial interest because physicians will consider only products supported by convincing clinical data. ³

Timing and scientific challenges

Short product lifecycles make timely publication difficult: by the time a primary study endpoint is reached and results published, devices are often close to outdated, making sound publication planning particularly important. ³ Task timelines can be organised around fixed dates such as congress abstract submission deadlines. ³

Limited device-study sample sizes and the transferability of animal data to humans remain areas of debate, and authorities may challenge the objectivity of industry-sponsored publications written solely by company employees. ² An effective strategy requires collaboration among medical affairs, clinical, regulatory, marketing, research and development, and medical writers. ² Medical writers can support authors across clinical-publication types in the postmarket phase. ² A 2018 expectation was that medical affairs would take a predominant role in evidence generation. ²

Journal publication before report disclosure

Ahead of the anticipated EUDAMED reporting system, planning advice identified an additional timing constraint: a sponsor wanting favourable study outcomes to appear first in a reputable journal would need to publish before mandatory clinical study report posting. ^{4, 5}