Operator-led consulting for life sciences & medtech
Scale operations.
Fix quality. Ship faster.
We help small and mid-size biotech, medtech, and life sciences teams build scalable operating systems — combining hands-on execution with data-driven frameworks to improve throughput, compliance readiness, and margins.
Why teams choose Inflexion
Measurable Outcomes
Quantified results across quality, operations, and margins. Every engagement is tied to specific KPIs and measurable improvements.
Scalable Operating Models
Build the org structure, processes, and rhythms that scale with your growth. Not just advice — execution-ready operating systems.
Digital & Systems Integration
Real systems implementation, not slideware. Tool rationalization, data integration, and automation that your teams actually use.
How we work
Choose Your Starting Point
Pick a starter package for a quick, focused engagement — or reach out to scope a custom project tailored to your needs.
Complete Intake
Fill out a short intake form so we understand your context. We'll reach out if we need additional information before starting.
Receive Deliverables
Track progress in your client portal. Review and accept deliverables when ready — payment is only captured upon acceptance.
Proven outcomes across industries
Anonymized results from engagements spanning biotech, medtech, diagnostics, and life sciences SaaS.
Global Quality Function Rebuild & Scaling
Rebuilt the Quality function after multiple leadership changes, scaling from a small manufacturing-focused team to a ~54...
Data-Driven Quality Metric Standardization
Integrated fragmented complaint data across Zendesk, Salesforce, and Oracle, standardized quality metrics, and drove a 6...
Strategic ISO Certification & QMS Roadmap
Secured executive approval for ISO 13485 certification at 30–50% of previous estimates and launched a certification pr...
AI-Enabled eQMS & IT Infrastructure Modernization
Replaced fragmented legacy quality systems with an AI-enabled eQMS, reduced SaaS costs by ~40% while doubling license co...
Quality Crisis Management & Audit Readiness
Contained a major inventory storage quality issue during a leadership transition and delivered zero findings across ISO...
Nonconformance & CAPA Backlog Reduction
Addressed a backlog of over 200 open nonconformances through eQMS data categorization and cross-functional Kaizen events...
QC Testing Throughput & On-Time Release Improvement
Transformed QC on-time testing from 50% to 95%, improved instrument availability from 50% to over 90%, and saved over $1...
4x Production Scale-Up for Global Demand
Achieved 4x regulated instrument output in 3 months by leading a 20-person cross-functional tiger team to resolve manufa...
Start with a focused engagement
Our starter packages give you defined scope, fixed pricing, and clear deliverables — the fastest way to see what we can do. From there, we can scale into broader engagements as needed.
Explore ServicesReady to transform your operations?
Whether you start with a focused package or a custom engagement, we deliver measurable outcomes — no payment until you accept the work.
Get Started