The problem to solve
Rare-disease protocols can require participant interactions and measurements that do not fit comfortably into a generic electronic data-capture workflow. The challenge is broader than creating a questionnaire: the scientific intent has to survive patient burden, site practice, device behavior, data timing, and operational support. Kevin developed Rarify within Ultragenyx to bring these needs into a coordinated platform and delivery model.
Kevin’s contribution
Kevin created the strategy and business rationale for the internal capability, shaped the product vision and roadmap, and led the organization responsible for development, quality, deployment, and support. He coined the Rarify name and built the operating relationships with study teams and internal stakeholders. His scope included staffing, budgeting, SOP development, external services, intellectual-property coordination, and study-team alignment.
He did not treat the application as a stand-alone software release. The delivery model incorporated participant and site workflows, training, loaner-device logistics, connectivity, support, data management, and informatics. Those functions were part of making the clinical platform usable in practice.
Data and workflow architecture
Rarify supported collaborative web-based data capture by patients and site personnel, patient-reported information, clinical observations, and connected-device workflows. Application materials describe near-real-time collaboration for metabolic monitoring, ePRO collection, and study decision support. The architecture connected the people generating information with those responsible for reviewing and acting on it.
The platform used reusable software components and agile delivery to support varying study needs. Kevin’s CV describes a React-based application environment and computer software assurance practices. The important operating principle was repeatability: a shared foundation could support protocol-specific behavior while keeping quality and support responsibilities visible.
Study portfolio and execution
The Innovation Lab’s work included natural-history studies, longitudinal disease-monitoring programs, and interventional research. Rarify applications supported rare metabolic and bone-disease programs, with an EMEA pivotal Phase III application described in the 2024 CV. The wider organization supported Phase II–III trials and Phase IV work.
During the COVID period, Kevin’s organization integrated remote engagement, telehealth workflows, endpoint-data capture, participant feedback, device logistics, and support. The work connected study execution to what participants and sites could actually sustain outside conventional visits.
Quality and lifecycle ownership
QA, validation, change management, service expectations, and operational risk were incorporated into the delivery organization. Kevin worked with Quality Assurance and study stakeholders to align development choices with regulated use. The pre-pivotal Phase III audit with zero findings is part of his documented career account.
Lifecycle responsibility included deciding which capabilities were worth building, setting acceptance expectations, deploying into studies, learning from use, and maintaining support. A capability that met a demonstration requirement still had to function for sites and patients over time.
Dexcom mobile and cloud components: strategic purpose
As part of Rarify, Kevin led product strategy and development of mobile and cloud applications for a Dexcom sensor workflow. These particular components did not enter production. According to his account, approximately $150,000 in internal development created a credible threat of replacing an approximately $2.5 million IQVIA engagement and improved the vendor’s performance against study requirements. The components served that strategic vendor-management purpose. This is a component-specific maturity statement, separate from Rarify’s other operational applications; the vendor engagement value is not a savings figure.
What the work establishes
Rarify connects product leadership, clinical systems, operating-model design, global delivery, and patient-data strategy in one substantial project. It demonstrates experience taking an internal clinical technology capability from a business case into regulated operational use. Public LC-FAOD publication evidence supports Kevin’s participation in the associated rare-disease research environment; it does not replace the internal records for every Rarify feature or result.
Sources and record basis
- Conference abstractMolecular Genetics and Metabolism · ACMG 2021 supplement, eP029
The LC-FAOD disease-monitoring-program abstract lists Kevin McMahon among its authors. It is a conference abstract in an indexed supplement, not a full outcomes paper.
Dexcom-related Rarify mobile/cloud components created a credible IQVIA replacement threat; they did not enter production. That does not establish non-production status for Rarify’s broader platform.