Clinical Trials in India–Start early

We are beginning to see India considered for clinical trials by US companies.   They require a locally admitted insurer, which isn’t unusual or bad. The slight idiocyncracy is that the insurer won’t issue a certificate of insurance until they have received the premium.  Apparently the banking system is a little slow, and it can take as much as a week before a payment is confirmed to have been received by the insurance company. Usually, once coverage is ordered by the client, a certificate can be issued so that patients can be...

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Special Access Trials in Canada

We are seeing increased interest among device companies to use the Special Access Trial process in Canada.  One such 15 patient trial in Quebec engendered discussion about whether locally admitted insurance was needed.  The consensus seemed to indicate that Gemini paper was acceptable, through Berkley Life Sciences.  Premium is approximately $5,000 for $1M coverage limit, $7,000 for $2M.

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Medical Device Distributors and Liability

This article is a great primer on why medical device distributors should be carrying their own liability insurance, and are not safe in relying on Additional Insured endorsements from the manufacturers they represent.  

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Why Silicon Valley Is Running Scared From Health Care

This article by Allan May in the September Atlantic illuminates some fundamental problems in the medtech investment environment, which has in the past been one of the most robust industry sectors in Silicon Valley. Allan is a founder of Life Science Angels, the largest angel organization in the U.S. focused on early stage medical device and life science start-ups. Since 2005, LSA has invested $30M in 30 early stage companies, attracted in excess of $600M in contemporary or follow-on venture capital, and achieved four favorable exits. In...

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Learned Intermediary Doctrine

This article from Sara Dyson, Esq. discusses the “Learned Intermediary Doctrine” and to what extent it protects prescription drug and medical device manufacturers from liability. Ms. Dyson is the Assistant Vice President, Loss Control for Medmarc Insurance Group. She provides loss control services that are designed to reduce products liability risks to over 1000 drug and medical device...

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Do Distributors Require Professional Liability Insurance?

This article by Francis Stockwell, Sr VP of Underwriting at Medmarc is a great reference for answering the question posed.

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