International Liaison Partner – Navigator of U.S. Hospital Procurement and Distribution Networks

• Distributor Matching: We identify and connect manufacturers with the most suitable distributors based on local market dynamics, regulatory knowledge, and business potential.

• Joint Ventures, Mergers & Acquisitions: We provide strategic support for manufacturers looking to form joint ventures, engage in mergers, or pursue acquisitions. Our team facilitates negotiations, structuring, and execution of partnerships to ensure mutually beneficial outcomes.

• Buyout Services: We assist manufacturers in exploring and executing buyout opportunities, helping them acquire new companies or sell their operations as part of strategic growth or exit plans.

• Trade Intelligence: Leveraging our deep industry insights, we provide trade intelligence services that offer manufacturers data-driven guidance on market entry strategies, competitive positioning, and regulatory landscapes.

• Global Market Expansion: Our expertise enables manufacturers to scale their operations internationally, enhancing distribution channels and unlocking new revenue opportunities in previously untapped markets.

HEDONE USA LLC acts as a healthcare innovation liaison and market access partner primarily for the U.S. healthcare sector, particularly targeting Group Purchasing Organizations (GPOs)

Screening and Selecting Innovative Products

• Search for high-potential innovative products, especially in the medical device and hospital consumables sectors.

• Prioritize products that solve unmet needs, offer better outcomes, or improve hospital efficiency.

 OEM Representation and Trade Service

• Represent innovative manufacturers as their market access consultant or OEM partner.

• Arrange OEM partnerships if necessary to adapt products under private labeling for easier GPO access.

GPO/IDN/RPC Registration and Contract Preparation

• Guide manufacturers through registration processes required by GPO/IDN/RPCs.

• Prepare and manage contractual documents needed for GPO/IDN/RPCs tender submissions, supplier registration, and price setting.

FDA Compliance and Regulatory Support

• Ensure the innovative products meet FDA 510(k), PMAs, or other necessary registrations.

• If a product is not yet FDA-approved, help organize steps for regulatory compliance.

• Arrange partnerships with regulatory consultants if needed.

Clinical Validation and KOL Engagement

• Identify and collaborate with Key Opinion Leaders (KOLs) for clinical feedback and endorsements.

• Arrange pilot studies or hospital trials to generate real-world evidence (RWE).

Building a U.S. Distribution Network

• Match the product with distributors already contracted with GPOs.

• Establish regional distributor networks where necessary to cover geographic requirements.

Value Proposition and Marketing Strategy

• Develop strong value propositions specifically tailored for the GPO decision makers.

• Create marketing materials, presentations, and GPO-specific sales kits.

 Relationship Building with GPOs and IDNs

• Maintain relationships with key contacts inside GPOs and Integrated Delivery Networks (IDNs).

• Attend trade shows (IDN Summit, Medica, Arab Health, FIME) and healthcare networking events to promote products directly to GPO representatives and hospital chains.

Contract Negotiations

• Act as the negotiator between the manufacturer and GPO procurement teams.

• Ensure pricing structures, rebates, and compliance terms are competitive and acceptable.

Post-Contract Support

• Support post-award implementation with training, supply chain management, and customer service planning.

• Monitor sales through the GPO and assist in renewal processes or performance reporting.

CPT & HCPCS Code Support for U.S. Market Entry

Securing CPT (Current Procedural Terminology) and HCPCS (Healthcare Common Procedure Coding System)codes is a critical step for international medical device and software companies seeking reimbursement eligibility in the U.S. healthcare market. These codes are essential for billing insurance providers, including Medicare and Medicaid, and for gaining broader adoption across hospitals and clinics.

HEDONE USA LLC assists global healthcare manufacturers and technology providers in navigating this complex process. Our services include:

• Assessing the eligibility of your product or software for CPT or HCPCS coding

• Guiding you through the AMA (American Medical Association) or CMS (Centers for Medicare & Medicaid Services) application processes

• Supporting documentation preparation, including clinical evidence and product use cases

• Strategic positioning of your solution to match reimbursement frameworks

• Advising on insurance billing alignment and pricing strategy

Whether you're introducing a new medical device, digital health solution, or specialized equipment, HEDONE USA LLC acts as your trusted partner to obtain the procedural codes necessary for reimbursement success and market acceptance in the United States.