Case Study
THE OPPORTUNITY
Launching a Global Device Manufacturer into the U.S. Market
In 2018, a global DEVICE manufacturer of respiratory spacers (attachment for inhalers to allow more medicine to reach the lungs) contracted with USDDR to launch 4 SKUs in the US. The client had no U.S. market presence and limited understanding of the U.S. healthcare ecosystem—including reimbursement, distribution, payer dynamics, and institutional access.
THE SOLUTION
US Drug and Device Register built and executed a full U.S. commercialization strategy across both pharmacy and institutional channels.
Pharmacy Go-To-Market (GTM)
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Reimbursement Strategy - Established a favorable pharmacy reimbursement model within key databanks to drive adoption
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Distribution Build-Out - Secured national drug wholesale distribution to ensure broad access
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Retail Penetration - Targeted top-tier pharmacy chains (80/20 focus) and executed direct supplier agreements
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Market Access - Contracted with PBMs, Medicaid programs, and commercial payers
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Brand Activation - Increased awareness through pharmacy trade shows and targeted industry outreach
Institutional Go-To-Market (GTM)
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Coding & Visibility - Secured HCPCS alignment through CMS and ensured product visibility across databanks
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Channel Expansion - Established distribution across drug wholesale, med-surg, home health/DME, and specialty channels
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Contracting Strategy - Secured GPO contracts spanning hospitals, long-term care, and home health
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Demand Generation - Activated GPO marketing vehicles, trade shows, and direct outreach to top facilities
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Direct Access - Established direct contracts with key healthcare facilities
Where Market Access Meets Measurable Results
At a Glance
Company Type:
Global Device Manufacturer
Market:
Respiratory Medical Device (Spacer Technology)
Challenge:
No US presence and little understanding of the US markets
Results:
51% 6-Year CAGR
Disclaimer of Warranties and Results
The consulting services, strategies, guidance, and information provided by USDDR are designed to support the improvement of your business operations, performance, and overall efficiency. However, every organization is unique, and actual results will vary based on individual circumstances.
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USDDR makes no guarantees, promises, or representations regarding specific financial outcomes, revenue increases, business growth, or performance results that may arise from the use of our services. Your success depends on numerous external factors, including market conditions, industry dynamics, internal resources, and your implementation of recommended strategies.
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By engaging with USDDR, you acknowledge that all business decisions remain your responsibility. USDDR is not liable for any losses, damages, or adverse outcomes resulting from the use or interpretation of our consulting services, recommendations, or materials.
THE RESULT
Achieved 51% CAGR growth post-launch
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Successfully launched and established a U.S. market presence from zero
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Built access across retail, payer, and institutional channels
By simultaneously addressing reimbursement, distribution, contracting, and awareness, USDDR created a fully integrated market entry strategy—transforming a company with no U.S. footprint into a rapidly growing market participant.
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Channels Added
2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | |
|---|---|---|---|---|---|---|---|
Pharmacy | 0 | 1 | 1 | 3 | 7 | 11 | 14 |
GPOs | 0 | 0 | 0 | 2 | 6 | 8 | 10 |
Distributors | 3 | 5 | 6 | 8 | 12 | 15 | 16 |
0
6-Year
CAGR
0
Revenue Increase
Over 6 Years
CASE STUDIES
A global DEVICE manufacturer had no U.S. market presence and limited understanding of the U.S. healthcare ecosystem.
Device
