June 22, 2018

MedTech Manufacturers, EU Distribution: Importer and Distributor Agreements (Part 2).

With the new MDR’s coming closer it becomes urgent for companies present in the EU market to sort all matter of distribution issues. The EU distinguishes several levels of economic actors: the Manufacturer, the Authorized Representative, the Importer and the Distributor, and each of these actors is now referred to in the Regulations. In this

June 18, 2018

MedTech Manufacturers, EU Distribution: Authorized Representative Agreements (Part 1).

With the new MDR’s coming closer it becomes urgent for companies present on the EU market to sort all matter of distribution issues. The EU distinguishes several levels of Economic Operators: Manufacturer, Authorized Representative (AR), Importer and Distributor. In this first article we will review the role of the Authorized Representative.   The Authorized Representative

May 3, 2018

GB5D and SciMed Partners Announce Agreement to Collaborate

GB5D helps Companies Expand beyond Their Domestic Market The World Just Got a Little Bit Smaller   SciMed Partners and GB5D have agreed to cooperate in order to better help foreign life sciences, medtech, and healthcare technology companies with US market entry. With several hundred years of combined biotech, medtech, life sciences, healthcare technology and international business

March 25, 2018

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

March 3, 2018

Milken NTE101: Mentoring Businesses Successful Domestically but New to Export.

The Milken Institute’s California Center recently launched a program called New to Export 101. The Milken NTE101 program aims to help local manufacturers who have a domestic market but are new to export. I volunteer as a Mentor. Any local manufacturer with an established domestic market and New to Export can apply to the program,

January 29, 2018

Should US MedTech companies be concerned about the new EU Medical Device Regulations?

The EU market has always been attractive for US MedTech companies. Obtaining approval to sell into the EU market has in the past always been easier than getting approval to sell in the US. That may soon change in view of the new EU Medical Device Regulations. For a long time, US manufacturers preferred to

December 26, 2017

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

November 25, 2017

Hurdles facing European MedTech companies wanting to enter the US Medical Device market.

Last week I visited the Medica show in Dusseldorf, Germany, the world’s biggest medical devices trade fair. 120,000 professional visitors from over 130 different countries met with more than 5,000 companies. I spend four days meeting with European MedTech companies that didn’t have a presence in the US market. I wanted to know why they

October 22, 2017

Locate HQ on the East or West Coast when entering the US Market? Have one on each Coast?

With Amazon soon making a location decision as to where it should open a second headquarters in the US, foreign companies may ask themselves if they need two headquarters, or at least a Regional HQ on either Coast? Usually, a foreign company entering the US market makes a location decision to erect a HQ on

August 29, 2017

Life Sciences Cluster: What are Your International Expansion Challenges?

International Expansion Challenges The Life Sciences Industry faces some of the same International Expansion Challenges faced by other industries pursuing global expansion: They must ask themselves which geographical markets they want to expand into. They must find out how they will go about market entry. License the technology to a foreign partner? Find a distributor?