Over the past few weeks I’ve had several conversations with manufacturers and consultants alike regarding the export of an Unapproved Investigational Device for use in a Clinical investigation to be conducted entirely outside the United States. One of the first comments I get asked: does the FDA have jurisdiction? While the answer is easy, Read More …
Tag: International Strategy
Skip Domestic. Commercialize in a Foreign Market first?
Over he last few months, several companies that had not commercialized their products in their domestic markets asked me about entering one or another foreign market. Normally, I tell them that’s probably not a good idea. The reasons behind my statement are straightforward. Entering a foreign market is more difficult than addressing your Read More …
Assess and Protect against Product Liability Claims when Entering a Foreign Market
When you enter a Foreign Market you will probably face a Product Liability regime different than the one in your home country (Similar But Still Separate and Distinct). Chances are your company is not intimately familiar with the risks in the market you plan to enter. Our experience has shown that “the unknown” can often Read More …
Considering Global Growth? Get Expert Help
A Washington Post article written by UPS, Considering Global Growth? Try domestic expansion first, suggests that companies interested in growth dive deeper into domestic markets first. The article quotes Robert Eberhardt, assistant professor of management at Santa Clara University’s Leavey School of Business, who said “The research is fairly clear that, generally speaking, companies do Read More …
What is International Business Development?
To arrive at the definition of International Business Development, we have to understand what is understood by “Business Development”. If you search for the term, you will find several definitions, and you will find that different people define it in different ways. Similar to that group of blind experts talking about the elephant. Some think Business Development is the same as sales. Others think it Read More …