Medical Imaging: From Market Assessment to FDA Clearance and U.S. Adoption
Client Type
International medical imaging company developing quantitative MRI-based liver diagnostics
Challenge
Pre-FDA clearance, the company lacked a clear, evidence-based U.S. commercialization and reimbursement strategy to support regulatory approval and drive meaningful clinical adoption of its MRI diagnostic technology.
Approach
An innovative imaging company engaged Health Business Group while its lead product was still pre-FDA clearance and seeking broader U.S. clinical adoption.
The company needed to:
Define the highest-value clinical use cases
Quantify the U.S. addressable market
Develop a reimbursement strategy
Position the technology for regulatory and commercial success
Over an eight-week engagement, HBG conducted a comprehensive U.S. market assessment including:
Market sizing and segmentation, analyzing MRI abdomen and liver biopsy volumes to estimate adoption potential
Interviews with leading radiologists, hepatologists, transplant surgeons, and oncologic surgeons to validate clinical demand and refine positioning
Competitive analysis of MRI techniques, elastography platforms, and blood-based diagnostics to sharpen differentiation
Reimbursement pathway development, outlining a strategy toward an add-on CPT code and identifying reimbursement advisors to support execution
Go-to-market strategy evaluation, including SaaS, per-scanner licensing, and OEM partnership models
HBG helped reposition the technology around clearly defined clinical decision points, not just technical accuracy, strengthening regulatory and commercialization readiness.
Impact
The market assessment and strategic roadmap provided a foundation that supported regulatory approval and accelerated early U.S. adoption. Following the engagement:
The company secured FDA clearance for its quantitative MRI technology
Implemented a focused U.S. commercialization strategy
Prioritized high-value surgical, transplant, and hepatology use cases
Advanced a defined reimbursement roadmap
Strengthened clinical credibility through targeted engagement with key opinion leaders
Why It Matters
Achieving FDA clearance is necessary but insufficient for commercial success.
Medical technologies must also demonstrate clear clinical utility, reimbursement viability, and workflow integration. By aligning regulatory strategy with market realities early, the company was positioned to enter the U.S. market with a focused, evidence-based growth plan.
As non-invasive liver diagnostics become increasingly important amid rising metabolic disease, this work helped bridge the gap between innovation and adoption.
