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International Expansion

Our teams of industry experts continuously monitor and evaluate the Medical Device markets in the U.S. & Internationally to help you expand around the world or penetrate the U.S. Market.


Entering the U.S. market can be both a substantial opportunity and a daunting venture. The U.S. market is large, complex, and a traditional leader in Medical Devices. The rewards of a successful U.S. presence are unparalleled.
In the world of Medical Devices, success in the U.S. will depend on your ability to answer the following questions:

  • Do you have a comprehensive “Market-Entry Strategy”?
  • Do you have the financial capital to launch the initiative?
  • Do you have the necessary human capital?
  • Do you have an importer and/or distribution partner?
  • Do you know how you will set up and manage your distribution?
  • Do you know the requirements for testing according to FDA standards?
  • Do you know who will answer questions from the FDA during the review process?
  • Do you know who will prepare and manage your regulatory submission to the FDA?
  • Do you have a solid Quality System?
  • Do you know what logistical platforms and systems you will use to service your customers?



Today, the United States is the world leader in medical devices, with the majority of the leading medical device companies based here. However, there are multiple threats to U.S. dominance due to:

  • Increasing global competition.
  • FDA approval process that makes innovation a challenge.
  • A legal environment that forces surgeons to practice defensive medicine.
  • An increasing difficulty for new products to obtain reimbursement.
  • A financial community that is uncertain of the future.

So, as the U.S. medical device industry is facing challenges, companies of all sizes and inventors are now looking at ways to leverage foreign markets. The opportunities offer high-growth potential and provide more efficient and effective routes to launch new products cost effectively, and gathering clinical data.

Kapstone cross-border expertise, allows the organization to offer you a comprehensive suite of services that leverage the right network, the right people and proven processes to help you establish an international presence.

European Expansion

While the European Union has greatly simplified the process of doing business in Europe, it still is a mix of 28 countries with different regulations, different cultures, different languages, and different business practices.

With Kapstone’s support, launching your organization or your invention in Europe will be a swift, efficient and timely process designed to help you establish the foundations for sustainable growth.

  • 1. Our suite of services includes:
  • 2. Craft a strategic plan for market-entry.
  • 3. Establish & register your entity.
  • 4. Set-up your quality system.
  • 5. Get your technologies approved (CE-Mark).
  • 6. Maintain your quality system.
  • 7. Offering guidance on pricing & reimbursement strategy.
  • 8. Identifying distribution options.
  • 9. Provide back office support.
  • 10. Conduct staff training.
  • 11. Participate in client visits.


Our goal is simply to enable you to easily and cost effectively establish your European division.

Emerging Markets Expansion

“The U.S., E.U. & Japan comprise nearly 75% of total sales revenues for medical device.”

The developed industrialized markets of the United States, European Union and Japan comprise nearly 75% of total sales revenues for medical device companies. By all estimates these markets will continue to grow due to an aging global population. However, this growth is slowing down thereby pushing companies to look at emerging markets as a new opportunity.

“Emerging markets are growing at rates 2 to 5 times that of the industrialized markets.”

In China, India, Brazil and Russia, for example, the demand for healthcare is increasing rapidly as the standard of living is improving and the growing middle class has the resources to choose between more options.

Here are a few keys to successfully penetrate emerging markets:

  • 1. Planning strategic product mix.
  • 2. Getting timely regulatory approvals.
  • 3. Pricing products for target geographies.
  • 4. Developing distribution partners.
  • 5. Establishing foreign government relations.
  • 6. Establishing local manufacturing in the larger markets.
  • 7. Hiring and developing local talent.

Kapstone Medical can help you every step of the way, leveraging our strategic relationships to help you achieve the above-mentioned objectives.

Call us at (704) 831.5316 or contact us online to discuss how we can be part of your organization and help you grow and expand your international business.


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