CAHIR

Technology Solutions

From Clinical insight to commercial impact

CAHIR Solutions helps MedTech innovators move beyond invention by

aligning regulatory planning, reimbursement strategy, hospital adoption, and go-to-market execution from the earliest stages of development.

Ideal clients

Clinicians, founders, hospital leaders, and industry teams.Especially organizations translating promising medical technology into adoptable, reimbursable solutions.

The CAHIR pathway

Model turns the innovation journey into a structured commercialization pathway for MedTech teams that need clarity, evidence, and execution discipline.

Commercialization planning

begins during discovery, not after clearance.We structure clinical, regulatory, reimbursement, and market adoption workstreams in parallel.

Engagement focus

Validation, pathway strategy, market readiness, and stakeholder alignment.Designed to reduce delay, misalignment, and wasted development spend.

Explore the offering

See the pathway

The market reality

Most medical device ideas do not fail because the technology is weak.

They fail because the path from concept to adoption is misunderstood, underfunded, or approached sequentially instead of strategically.

Products & Services

Clients & Engagement

Engagement Team Model

pairs strategic healthcare insight with technical credibility.

Practice Lead

Linda McQuade, MD MBA

15+ years of experience in digital health, quality systems, evaluation analytics, clinical informatics, and medical device strategy. Work spans CMS, FDA, VA, NCQA, IBM, and CAHIR consulting engagements focused on regulatory compliance, workflow optimization, predictive modeling, performance measurement, technology readiness, commercialization strategy, and due diligence across devices, SaMD, wearables, and remote patient monitoring.

MD with MBA in Finance/Data Analytics and PMP certification
FDA pathway knowledge across 510(k), PMA, De Novo, and SaMD frameworks
ISO 13485 quality systems, ISO 14971 risk management, clinical evidence generation, and post-market strategy
EHR/EMR optimization, Tableau, Power BI, SAS, Azure ML, Foundry, and predictive analytics
Experience advising VA, CMS, industry clients, and healthcare innovation stakeholders

Biomedical Engineer | Device Support g

BS/MS Biomedical Engineer

Expertise includes therapeutic ultrasound device development, DHF-oriented design documentation, ISO 14971 risk management, 21 CFR 820.30 design controls, manufacturability optimization, and preclinical-style verification work.

MS in Biomedical Engineering with thesis focused on regulatory compliance and rapid device prototyping with FDA pathway experience across 510(k), PMA, De Novo, and SaMD frameworks
Hands-on prototyping in SolidWorks, 3D printing, injection molding, and GD&T
Bench testing, design verification, protocol development, electrical safety, and biocompatibility screening
Data analysis using JMP, RStudio, GraphPad Prism, MATLAB, Python, and SQL
Experience in upstream development and R&D environments including Johnson & Johnson and J. Craig Venter Institute