Innovator Subprojects Core

PROJECT SUMMARY INNOVATOR CORE The goal of the Blueprint Medtech Program is “To accelerate patient access to groundbreaking, safe, and effective medical devices.” To assure that these investments are effective, however, requires frequent oversight and assistance. The Innovator Core (IC) will be responsible for providing this oversight, monitoring progress towards milestones, assisting with unexpected delays, and reducing or recommending to NIH to discontinue funding when it becomes clear that a project will not meet the expected outcomes. The NeuroTech Harbor (NTH) IC will provide close mentorship to funded teams during the tenure of the subproject, as well as oversee progress with project management tools, to successfully deliver first in human prototypes. The IC begins interacting with and managing a subproject once funding approval for that subproject is received. All subproject PIs will have a single point of contact in the NTH for all issues through the IC. At this point, the project milestones, timeline, and deliverables will have been defined. An assessment of the technology’s stage of development will be available after the Deep Dive analysis (Evaluation Core (EC)), identifying the critical areas of assistance necessary to achieve a prototype that is ready for first-in-human studies. Additional resources will also have been allocated. The crucial steps moving forward will be to work with the Innovators to develop and document a project management plan for the duration of the subproject and oversee its progress and that of the resources allocated to the subproject. Specifically, the IC will accomplish these goals with the followings aims: (OC Aim 1) To maximize subproject success, the Innovator Core will work closely with Innovators to monitor the progress of the subproject and any associated resources. (OC Aim 2) To mitigate the risk of failure, the Innovator Core, in collaboration with the Evaluation Core and the Steering Committee, will address any issues that could interfere with reaching identified milestones. (OC Aim 3) To continue to encourage Innovators to consider the principles of universal design throughout development to increase population served. The IC will identify a Dream Tech Team for each subproject which includes a project facilitator, as the single point of contact to NTH, a clinical advisor, commercialization advisor, steering committee mentor, and a project manager (PM) tool Trainer. The project facilitator will work with the subproject PI, using industry-standard project management tools, to document milestones, deliverables, and timelines (MD&T) for both the subproject and collaborate with the Resource Core (RC) to similarly document MD&T for funded Resources. The Dream Tech Teams will meet with Innovators at least monthly to monitor progress and identify any issues that might interfere with progress