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.
ENTER 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:
EXPAND OUTSIDE OF THE U.S.
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:
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.
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.”