Getting a new medical device approved by the U.S. Food and Drug Administration is a slow process that can take at least two to four years. Many emerging companies, seeking to gain a market share while they work through the U.S. regulatory process, look to Europe. Other companies may already have a presence in Europe, but may want to expand their distribution overseas. However, breaking into the European medical device market is a complex endeavor that is further complicated by language barriers and time differences.
HealthLink Europe help medical device and pharmaceutical manufacturers enter the European market by offering a full range of distribution-related services. The Raleigh, NC-based company takes care of the details from proof of concept to commercialization, allowing medical device companies to focus on product development. Some of the services offered by HealthLink Europe include customer service; payroll, taxes and other accounting services; order processing, shipping management, inventory, warehousing, financial consulting, clinical trial management, and service repairs for medical devices. With HealthLink Europe’s help, biotechnology companies can set up a dedicated distribution center a continent away. Among the company’s clients are Alveolus, a developer of stent and delivery device technology; and Transoma Medical, a maker of implantable wireless diagnostic systems.
In this video from the 2010 OneMedForum, Rick Hughes, President of HealthLink Europe, talks to us about the services offered by his company.