Client: A Multi-Stakeholder Alliance Defining Ownership in a Fragmented System
Services: Conducted a structured assessment of the organ procurement system’s core failure points and mapped responsibility across the stakeholders managing each component of the process; identified gaps in ownership, opportunities to realign accountability, and priority areas where roles required greater clarity and refinement.
Result: Delivered key stakeholders and policymakers a comprehensive report outlining essential process improvements and clearly identifying who, at the federal and hospital levels, is responsible for strengthening the organ procurement system.
Client: A Nonprofit Turning Policy Priorities into Legislative Strategy
Services: Developed a targeted Hill engagement strategy that clearly articulated the group’s legislative priorities and advanced its advocacy agenda.
Result: Delivered a cohesive suite of advocacy tools for use in Hill meetings and briefings, strengthening the organization’s capacity to advance priority issues; strategically positioned the organization to cultivate new champions, deepen existing relationships, and identify ongoing opportunities for engagement on core policy goals.
Client: An AI Company Building the Regulatory Pathway for Multi-Finding AI
Services: Developed and advanced a regulatory strategy for the company’s device while preserving safety, flexibility, and a viable route to market.
Result: Scoped a partial exemption approach, pursued through the citizen petition process, for specific multi-finding AI devices with prior 510(k) clearances, enabling manufacturers to add related findings while preserving existing special controls and maintaining the traditional 510(k) pathway as an option; laid the groundwork for a broader strategic push to modernize federal AI regulatory policy.
Client: A Consortium Interested in Defining the Coverage Pathway for Brain-Computer Interfaces
Services: Convened the iBCI Clinical Utility Consortium to unite leading iBCI developers, clinicians, and patient advocates around a shared evidentiary strategy for Medicare and commercial coverage; hosted a series of structured work sessions to define clinically meaningful endpoints and articulate a coverage policy framework to guide payers in establishing predictable coverage and payment pathways.
Result: A consensus white paper that defined the clinical utility of iBCIs for payers and proposed specific, clinically meaningful endpoints to support coverage and payment decisions.
Rubrum Advising 
