Publications
Risk Management 360: Contracting, Part II: What Should Be In Your Contract and How to Deal with Adverse Terms from the Other Side
In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing...
Risk Management 360: Contracting, Part I: Why Use Contracts?
In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing...
What You Need to Know About Products Liability Litigation: Key Takeaways
Products liability litigation has several unique facets when life sciences products are involved. Having explored several areas in which this is particularly true—case resolution, crisis...
Products Liability Litigation Challenges for Life Sciences Companies, Part II
In addition to the challenges that were addressed in the previous installment of Litigation 360—negative jury biases and joint and several liability implications—there are a couple of...
Risk Management Checklist for Safety Information for Home-Use Products
Home-use products have been increasingly utilized by patients to improve their quality of life and to allow them greater independence. The increase in demand for home-use devices has been attributed...
Risk Management 360: Risk Management in Clinical Trials
In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing and...
Under the Watchful Eye of the FDA: What do FDA Warning Letters Tell Us?
Kevin L. Ong, Ph.D., P.E.1; Joshua White, Ph.D.2 1 Principal Engineer, Biomedical Engineering practice, Exponent, Inc., Philadelphia, PA 2 Senior Associate, Biomedical Engineering practice,...
What should a medical device sales representative do if she observes a surgeon using a medical device incorrectly during a procedure?
Question: What should a medical device sales representative do if she observes a surgeon using a medical device incorrectly during a procedure? Answer: While in the operating...
Beyond Insurance - Comprehensive Risk Analysis Through Enterprise Risk Management
Enterprise Risk Management (ERM) has the ability to help medical device companies align people, processes and ideas that support corporate objectives, improve cash flow and earnings, capture...
Insurance Considerations for Global Clinical Trials
Excerpted from the Journal for Clinical Studies, September 2009. As the number of trials being conducted in multiple countries continues to increase, sponsors must insure themselves against...