PURPOSE

: In the world of medical device surveillance, the processes of signal management (detection, discernment and evaluation) are complex and driven by dynamic convergence of device-, provider-, setting- and patient- related characteristics. This workshop will focus on identification of actionable factors for building the (1) capacity of device ecosystem to ascertain and characterize the signal; (2) efforts to utilize novel methods including artificial intelligence/machine learning (AI/ML) and blockchain; (3) transparent and timely communication between stakeholders; and (4) value of patient-centric, interdisciplinary approaches that integrate the medical product ecosystem.

DESCRIPTION

: Varying levels of unfamiliarity with real-world data (RWD), study designs, and analytic approaches appropriate for signal management has resulted different levels of trust across the medical device ecosystem, underscoring the need for education and training. This workshop will engage workshop participants in building an ecosystem-driven model for signal management, using examples from paclitaxel-coated devices for the treatment of peripheral arterial disease and diagnostics for identification of biomarkers for oncology treatments. Dr. Richey will discuss methodological capacity and identify needs, some early successes and introduce early- and long-term opportunities. Dr. Marinac-Dabic will present the integration of digital health solutions including blockchain and AI/ML algorithms to advance the value of RWD in active surveillance. Dr. Tieche will highlight the need for responsible transparency and communication across health care sectors and stakeholder perspectives. Dr. Wamble will detail the importance of characterizing new and ongoing risk-benefit balance from a market access perspective. The workshop participants will work interactively in four groups to identify tactical approaches in each of the four domains discussed (i.e., methodologic capacity, integration of digital solutions, communications, and interdisciplinary approach). Interested participants will then also be invited to join the post-workshop mirror stakeholder group to engage in further discussions on this topic.