Ultragenyx: building and leading the Innovation Lab
Built a global clinical technology organization connecting product, engineering, quality, informatics, and service operations around rare-disease research.
2019–2024
Kevin L. McMahon · Career & evidence archive
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Healthcare technology, product, and operations executive. Former Senior Director, Digital Clinical Development / Head of Innovation Lab at Ultragenyx.
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40 detailed records. Named projects, responsibilities, dates, source context, and cross-references.
Supporting record directory40 records
Rarify: a clinical platform from concept through study operations
Designed and deployed a GCP-aligned platform for collaborative patient/site data capture, decentralized research, and longitudinal disease monitoring.
2019–2024
eCOA and ePRO: requirements, sourcing, build decisions, and delivery
Led and developed a team responsible for selecting, building, validating, and supporting patient-reported clinical data capabilities.
Ultragenyx · 2019–2024
Dexcom and IQVIA: product management, strategy, negotiations, and CGM research
Led CGM product management, strategy, Dexcom licensing negotiations, and IQVIA vendor management. The Dexcom-related Rarify mobile and cloud components did not enter production but created a credible IQVIA replacement threat. Kevin reports that IQVIA’s Dexcom sensor data contributed to evidence supporting FDA accelerated approval of Genglycos (DTX401) for GSDIa.
Ultragenyx · 2019–2024; subsequent approval milestone · 2026
BEYONDXLH: longitudinal research and patient/site collaboration
Supported an Ultragenyx-sponsored disease monitoring program with Yale and the XLH Network, connecting longitudinal research to participant experience.
2019–2023
Rare-disease monitoring across metabolic and bone-disease programs
Brought patient-reported, clinical, device, and operational data together across natural-history, interventional, and long-term monitoring work.
Ultragenyx · 2019–2024
Clinical informatics, patient-data products, and operational insight
Connected data structures, provenance, business rules, quality monitoring, and decision workflows across patient, device, and study operations.
Ultragenyx · 2019–2024
Vendor strategy and buy-versus-build leadership
Evaluated technology in the context of clinical need, economics, implementation, quality, and continuing service responsibility.
Enterprise technology, Diabetech, and Ultragenyx
Quality, validation, and audit readiness in digital clinical development
Embedded quality and validation into development, release, change management, and continuing service operations.
Ultragenyx · 2019–2024
Global service delivery, device logistics, and participant support
Extended clinical technology delivery into site training, loaner devices, wireless connectivity, support, and operational accountability.
Ultragenyx · 2019–2024
Diabetech: founder, inventor, and operator
Built and commercialized connected diabetes devices, hosted data systems, clinical decision-support workflows, and remote-care programs.
2001–2018
GlucoMON and ADMS: device-to-cloud glucose telemetry
Integrated medical-device data capture, wireless networks, automated analysis, trend reporting, and family/caregiver notifications.
Diabetech · 2000s–2010s
HomeCheck-A1c: an at-home diagnostic service
Connected home sample collection, laboratory processing, digital results, patient onboarding, and follow-up into a usable diagnostic service.
Diabetech / remote-care programs
HealthCordia: virtual diabetes disease-management operations
Extended connected glucose telemetry into payer- and employer-facing care programs with diagnostics, logistics, engagement, clinical workflows, and reporting.
Operating phase emphasized in career records: 2007–2012
BellSouth / AT&T: remote diabetes program design and execution
Combined connected glucose data, home A1c, remote enrollment, patient support, physician participation, and payer-aware operations.
2006–2007
Texas Medicaid / McKesson: remote monitoring and intervention
Designed technology, research procedures, home diagnostics, patient materials, and behavior-support workflows within a Medicaid disease-management environment.
2009–2011 program period
Diabetes HouseCall and Blue Cross Blue Shield of Texas
Connected remote diabetes services to physician participation, patient support, clinical evidence, and commercial reimbursement.
Diabetech / HealthCordia era
Healthimo: community engagement and population-health infrastructure
Extended connected-care experience into community recruitment, health education, patient registries, and U.S./U.K. programs.
Primary scaling phase: 2012–2018; earlier platform activity documented
South Texas: family and community pathways into care
Designed community-health participation around family influence, low-friction enrollment, relevant messaging, and links to health services.
2009–2011 and subsequent scaling
NHS / Salford Royal: easySHARE remote monitoring programs
Adapted remote-monitoring and self-care workflows to pediatric diabetes and diabetes-in-pregnancy research in the U.K.
Pediatric T1D: 2010–2017; diabetes in pregnancy: 2010–2015
Kaiser Permanente: technology-mediated social support
Connected wireless glucose information with patient-selected supporters and behaviorally informed engagement.
2009–2011 research and publication period
Clinical research: protocol, investigator, and program responsibilities
Contributed to observational, interventional, remote-monitoring, and disease-monitoring research across diabetes and rare disease.
2002–2024
Driscoll and USDA: remote pediatric diabetes research
Helped develop a federally supported pediatric remote-monitoring program combining wireless glucose data, support, and outcomes analysis.
2006–2009
Patient journeys: access, activation, retention, and continuity
Designed the full set of interactions that allow a patient to enter a service, participate, receive value, and remain connected to care or research.
Across remote care, clinical development, and patient education
Postcards, SMS, devices, and people: hybrid engagement
Used physical and digital channels within one operating model so participation could fit the person rather than depend on a website.
Diabetech, Healthimo, and continuing program design
Patient advocacy, co-design, and clinical collaboration
Brought patient and family experience into product requirements, clinical program design, education, and sustained engagement.
Diabetes community and Ultragenyx portfolio
Product strategy, portfolio decisions, and execution
Turned clinical and commercial needs into roadmaps, funded capabilities, delivery organizations, partner decisions, and measurable operating work.
Enterprise platforms, connected health, and Ultragenyx
Commercial strategy, payer models, and partnerships
Connected product capability with channels, partner economics, reimbursed services, and commercially workable delivery models.
1990s–present
Enterprise technology: platforms, telecom, and strategic deals
Built an enterprise foundation in complex systems, procurement, mobile platforms, international customers, and integrated partner distribution.
1991–2002
Operational Telemetry: the C4I+T model for trial operations
Proposed a governed operating layer connecting cross-system data, trusted signals, interpretation, and accountable action across clinical trials.
March 2026 concept brief
AI governance, human review, and practical workflow design
Applied consent, provenance, human review, and controlled workflows to exploratory AI use in patient information and operations.
2024–2026 independent design work; earlier operating foundations
PatientStories.ai: patient narratives and longitudinal insight
Explored a consent-aware way to turn patient-authored narratives into useful health biographies and structured longitudinal information.
Independent work beginning in 2024
Sugar Surfing: co-authorship, CGM adoption, and patient/provider education
Co-authored Sugar Surfing with Stephen W. Ponder, supporting CGM use by people with type 1 diabetes and clinicians. Kevin reports that Dexcom purchased copies in bulk to educate its sales representatives and distribute to prescribing endocrinologists.
Published 2015; continuing patient/provider education and publishing
MediSelf Press: publishing as product and operating work
Manages the people, production, commerce, distribution, and customer experience required to turn specialist knowledge into published products.
Established publishing imprint; independent work continues in 2026
Artificial-pancreas systems: remote oversight and human context
Explored how sensors, delivery devices, communications, software, and human oversight fit into a broader automated-care system.
Early architecture work and 2014 educational presentation
Adaptive diabetes programs and the ACCESS / TEMPO context
Connects patient selection, intervention choices, devices, services, governance, and feedback into a care program that can adapt over time.
Historical operating experience; current design perspective in 2026
Public policy participation and practical access to care
Contributed to discussions about diabetes self-care, remote care, and the practical conditions under which patients could obtain support.
Texas diabetes-care advocacy · 2000s
Published research, authorship, and the public technical record
A traceable set of journal articles, conference abstracts, public records, and historical reporting supports the career narrative.
2002–2021 publication trail; continuing professional work
Trial Telemetry: governed signals across the clinical trial lifecycle
Extended Operational Telemetry into signal design, launch readiness, study execution, and traceable decisions across the trial lifecycle.
May 2026 paper and published website
Pre-FPI review: signal feasibility and operational readiness
A structured method for examining endpoint workflows, sources, devices, site burden, handoffs, and governance before first patient in.
Trial Telemetry framework · 2026