April 10, 2019

EU MDR Implementation: a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 1 of 4)

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 1) From MDD to MDR Over the past few years manufacturers paid a lot of attention to the new European Medical Devices Regulations and the challenges and opportunities created by the changeover from the Medical Device Directives to

October 4, 2018

The Southern California Life Sciences Clusters

Life Sciences Clusters Overview:   The Southern California Life Sciences Clusters are created by bringing together world-class academic institutions (UCLA, USC, Caltech, UCSD, UCI,), top-notch research facilities (Scripps Research Institute), a close-knit medical community and Human and financial capital.   1,796 medical device and equipment manufacturing firms, and 1,453 biotechnology and pharmaceutical companies in California

August 13, 2018

Exporting an Unapproved Investigational Device from the US in Support of a Clinical Trial in a Foreign Country.

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,

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