FDA-Regulated Products
Four Product Classes. One Integrated Approach.
Medical Devices
Implantables, capital equipment, and combination products. From 510(k) to PMA — we know the path from clearance to covered procedure.
Drugs & Biologics
Small molecules, large molecules, and autologous therapies. We align clinical, regulatory, and payer strategy from the earliest development stages.
Diagnostics
In vitro diagnostics, point-of-care tests, laboratory assays, and imaging systems. Coverage and coding for diagnostics requires a different playbook — we know it.
SaMD
Software as a Medical Device, digital therapeutics, and AI/ML-enabled clinical tools. The regulatory and reimbursement landscape for SaMD is evolving fast — we help you stay ahead of it.
Insights to Navigate an Evolving Market
The medtech landscape is shifting faster than ever. Payer policies tighten, regulatory pathways evolve, and the window for successful market entry narrows. Walnut Hill Medical brings deep expertise and real-world intelligence to help your organization stay ahead and move forward with confidence.
How We Make an Impact
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Clients Served0+
Years of Combined ExpertiseEnd-to-End
Commercialization Support
The WHM Model
Regulatory. Clinical. Commercial. Reimbursement. Built as one integrated engine.
Most firms address these as separate engagements. We build them as one because a device that can't be billed for, justified by hospitals, or covered by payers will never reach the patients who need it.
Get Cleared
FDA pathway strategy
- 510(k), De Novo, PMA, IDE
- Pre-submission meetings
- QMS & design controls
- Toxicology gap assessment
- CE Mark / EU MDR
02 Clinical Evidence
Get Proven
Trial design & management
- Protocol & IRB submissions
- KOL identification
- IDE execution
- Health Economic integration
- Data & site management
03 Commercial Execution
Get Adopted
Go-to-market strategy
- Sales force design & launch
- Value dossier & messaging
- Distribution & channel strategy
- Board & investor reporting
- Physician & facility training
04 Reimbursement Architecture
Get Paid
CPT/HCPCS coding strategy
- Medicare & payer coverage
- NTAP, TPT, TCET, STEP
- Payer medical director outreach
- Prior auth & appeals
Health Economic Modeling
- Field reimbursement training