The U.S. produces the most medical devices, and also consumes the most medical devices in the world. U.S. medical device companies are well positioned and are highly regarded globally for their innovations and high-technology products.
Why Expand your Exports
• Access to new markets has never been easier
• Demand, 70% of purchasing power is outside the US
• Improved Top Line and Bottom-Line Profitability
• Improved Valuation of your Company
Steady Growth in Mature Markets:
We continue to see steady growth even in the largest and more mature medical device markets in the European Union such as Germany, Belgium, France. Denmark and Sweden, Italy, Austria, and Ireland. There are a couple important issues to consider in marketing in Europe:
MDR
From May 26, 2020 onwards, medical device manufacturers operating and/or selling within the European Union must comply with the Medical Device Regulation (EU 2017/745), or “EU MDR”. This regulation’s objective is to improve patient safety by evaluating existing devices (e.g. through more stringent post-market surveillance and post-market clinical follow-up) and ensuring transparency throughout a device’s lifecycle once it has gone to market. Even countries outside of the EU such as the United Kingdom, Norway and Switzerland will most likely follow along MDR standards.
How to get Paid
Conforming to the MDR is necessary in the EU but is not sufficient for getting paid. While EU regulations under MDR may become more harmonized — the ways to get paid are not and each market must be addressed according to their often idiosyncratic practices. It is critical to do your research and understand how each market decides purchasing decisions. Some markets have started to use Health Technology Assessments, HTA to qualify your technologies for their market. You will need to demonstrate efficacy and cost efficiency.
Strong Opportunities in non-European markets as well as Emerging Markets:
As U.S. exports of medical technology tend to be on the cutting edge of sophistication and advancement. US medical devices compete well in sophisticated mature markets. We see continuing growth in other markets such as Japan, Australia, Canada, Singapore, Korea, and Israel which are more mature and new growth in markets such as Mexico, Saudi Arabia and China.
As emerging markets become more digitally sophisticated there will be real growth opportunities in emerging markets in Southeast Asia and Latin America. Some of these markets are very receptive to FDA Approved Devices.
Global Industry Landscape
U.S. medical device companies remain highly competitive globally and the industry has increasingly embraced globalization. Multinational firms are aggressively pursuing markets around the world. Global demand for medical devices is driven by increasing expenditures and activities on health care by developing markets with the building of new hospitals and clinics, establishment of public health insurance and greater focus on health. The multinational companies are expanding their international sales. You can too.
How can your company take advantage of global opportunities?
Partner with an expert advisor – Mark-Tech International has helped U.S. medical device companies research markets, identify and work with Key Opinion Leaders, evaluate sales channels, develop reimbursement strategies and introduce new products into new markets. With global partnerships of companies on five continents, Mark-Tech International brings broad-based industry experience and product expertise to your enterprise. Our decades of helping companies like yours achieve global export goals means you can effectively navigate the many challenges inherent in a global strategy. Working with Mark-Tech will yield a clearly defined export strategy with insightful market intelligence for your desired locales, with the key relationships and sales channels in place to help you deliver on your strategy.