Chanalytics is a boutique strategic leadership firm with deep roots in the medical device industry. We bring senior-level program leadership, compliance initiative management, and outcomes-based decision making to organizations that need experienced support without the cost of a large firm.
Our experience spans the full breadth of business operations — from new product development and design controls to manufacturing, distribution, sales and marketing, facilities management, and packaging and sterilization programs.
Whether you need an embedded program leader, a compliance initiative driver, or a strategic partner who knows the spine space inside and out, we're ready to deliver.
We work as part of your team — not at arm's length. Senior-level engagement and accountability from day one.
Every engagement is structured around measurable results — milestones met, programs closed, decisions made with confidence.
From compliance initiatives to commercial strategy, we bring cross-functional experience across the full device business lifecycle.
A broad depth of program leadership experience across the medical device business — from product inception through commercial execution.
End-to-end program management for medical device initiatives. Scope definition, milestone tracking, resource alignment, and stakeholder communication across complex cross-functional teams.
Leadership of compliance-based programs across quality systems, regulatory submissions, and cross-functional compliance activities. Experienced with FDA pathways for Class II and III devices.
Strategic leadership through the full product development lifecycle — from concept and feasibility through design verification, validation, and commercialization. Spine device expertise.
Oversight of design control processes in compliance with 21 CFR Part 820 and ISO 13485. Leadership of change management programs ensuring controlled, documented, and auditable transitions.
Program leadership for medical device packaging design and sterilization process development and validation. Experience with EO, radiation, and sterile barrier systems for Class II/III devices.
Operational strategy and program leadership for manufacturing environments. Process improvement, production readiness, supplier management, and operational efficiency initiatives.
Strategic oversight of distribution programs, supply chain structure, and logistics operations. Experience with domestic and international distribution networks for medical device products.
Program leadership for commercial initiatives including product launches, sales enablement, market development, and go-to-market strategy within the medical device space.
Leadership of facilities-related programs including infrastructure planning, operational readiness, compliance with facility-level regulatory requirements, and capital project oversight.
Not a generalist firm. Over 15 years embedded in the spine sector means faster ramp-up, fewer surprises, and sharper strategic judgment on every engagement.
No bait-and-switch. You work directly with experienced program leaders — not junior staff. Senior accountability from kickoff to close.
We structure every engagement around clear outcomes — not billable hours. Measurable milestones, defined deliverables, and decisions grounded in data and experience.
From design controls and compliance initiatives to distribution, manufacturing, and commercial strategy — we bring program leadership experience across the full business.
Project-based, retainer, or embedded arrangements. We structure engagements around what your team actually needs — without the overhead of a full-time hire.
Built lean by design. Low overhead means we deliver senior-level program leadership at rates that make sense for growing device companies.
Reach out to discuss how Chanalytics can support your team. We respond within one business day.
