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The Advamed Latin America Compliance Conference and the upcoming Global MedTech Compliance Conference  Sometimes I feel that compliance is like a jigsaw puzzle where every new piece brings us closer to the complete picture: Codes of Ethics. After being heavily involved in the adoption of the MedTech Europe Code of Business Ethical Practice, during my […]

As a medtech lawyer, my focus naturally gravitates to assessing “downstream” relationships and risk; that is, analysis of the legal arrangements between manufacturers, distribution agents, and health care providers that together bring medical technologies to the patient’s bedside. These relationships can be complex, as are the legal issues they raise. But ensuring ethical standards in these relationships […]

As a compliance professional, it’s exciting to witness new Codes of Ethics take root worldwide.  Voluntary industry Codes of Ethics serve several important functions.  A credible Code demonstrates industry’s ability to self-regulate, in turn fostering consumer and governmental trust and confidence.  A Code centers stakeholders on the most meaningful business principles that the entire industry […]

Eight years ago, I was interviewing executives of a prospective Chinese distributor for my employer, a publicly-traded medical device company based in California. “We understand that it is hard to do business in China without paying kickbacks to physicians and hospital administrators” I observed. “How do you handle this?” Without hesitating, one of the executives […]

The discussion over superbugs moved center stage earlier this month when British Prime Minister David Cameron launched a global review of the crisis. “If we fail to act, we are looking at an almost unthinkable scenario where antibiotics no longer work and we are cast back into the dark ages of medicine where treatable infections […]

As AdvaMed and Eucomed prepare for our next Global MedTech Compliance Conference May 20-22, 2014 in Barcelona, Spain, I reflect on the remarkable policy outcomes attributed to our past conference discussions.  Our MedTech association-led compliance conferences offer a platform—not available in a commercial compliance conference—to spur discussion and best practices exchange among compliance leaders on […]

Today, March 24, is World TB Day. We’re examining the link between HIV and tuberculosis (TB) infections and how, by fighting these diseases together, we can create a generation free of HIV and TB!

In 2008 Eucomed published its revised Code of Ethical Business Practice. We’re six years on now and we’re thinking about writing a new one. Why? Because so much has changed in the world of medtech compliance.

Two years ago in our annual report on the medtech sector, Pulse of the industry, we warned that the sector was facing a perfect storm, caused by a general shift toward value-based care, growing regulatory pressure in the US and limited resources as a result of a global downturn. Those events came to pass, with the added complication of tougher new regulatory issues in Europe. It was time, we felt, in this year’s report to see how the sector is weathering the storm.