Case Study

International Reimbursement Strategy for Orthopaedic Therapy Device

Project Overview

An EU-based early-stage medical technology startup had developed breakthrough technology for orthopaedic trauma therapy and rehabilitation.

The prototype device was in the clinical evaluation phase with a positive outlook to launch the product successfully. To create positive revenue streams on the product launch, the startup sought optimal market entry points within Europe and significant markets outside Europe, which required an effective reimbursement strategy.

Client Needs

The client had become aware of the fact that their national process for reimbursement coverage for novel medical devices could take up to five years after regulatory approval.

As a breakthrough technology, the client’s product could not be directly categorised under the existing reimbursement coverages, and additional requirements were applicable in the initial target market.

The client approached inXso to initiate a reimbursement strategy project to identify optimal countries regarding market introduction and revenue realisation.

Reimbursement strategy

Client Challenges

The reimbursement framework is largely diverse and depends on the country, the country’s national health insurance scheme, and the role of insurance companies and self-insured employers.

The orthopaedic therapy device was designed to be used in both clinical inpatient therapy and outpatient rehabilitation, complicating the reimbursement framework.

The pricing model considering fees for the device and procedure and the price level for manufacturers vary largely between different countries and are subject to price negotiations.

Project Initiation & Key Objectives

The client decided to leverage inXso’s international business expertise in market access and reimbursement framework.

The project scope included:

  • Initial assessment of nine European countries and four globally significant target markets.
  • Market research of the six identified countries for market access.
  • Market access requirements for the six identified target markets.
  • Reimbursement strategies for the six identified target markets.

inXso Approach

inXso assessed the client’s current stage of development and intended business models, as well as analysed gaps in generated clinical data and clinical evidence requirements.

Together with the client, inXso identified six target markets based on the initial assessment by inXso

inXso provided market insights on pricing models and reimbursement frameworks for the identified target markets.

inXso Solution

inXso supported the medical technology startup in the following activities:

  • Identification of potential target markets and exclusion of countries associated with market entry risk factors. 
  • Market research of identified target countries, including pricing levels, optimal reimbursement models and market access requirements.
  • Reimbursement strategy for identified target countries, including pricing calculation models, preparation for price negotiations and clinical evidence requirements.

Project Achievements

inXso supported the medical technology startup in identifying optimal target markets that delivered the shortest time to revenue upon market access.

inXso delivered:

  • Analysis of requirements for market approval and reimbursement process.
  • Assessment of required clinical evidence for market approval and reimbursement process.
  • Recommendations to country-specific pricing strategy.
  • A clear and systematic approach to successfully planning and carrying out market entry activities.

Outcomes for the Client

The client identified six countries for optimal market introduction and revenue realisation.

The client gained an understanding of best practices for reimbursement involving national health insurance coverages, insurance companies and self-insured employers.

The client was prepared for price negotiations and to deliver the necessary data for the reimbursement processes.

The client gained a comprehensive understanding of country-specific pricing levels and calculations for pricing models to strategise and optimise revenue.


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