Medical Technology and Life Sciences Publications (8)

Supply Chains, Emerging Growth, Outsourcing, Series: Ask an Expert

The Future of Supply Chain Management

Question:What can the life sciences industry learn from the aerospace industry’s Nadcap program for supply chain management? Answer: Partly as a result of the growing complexity...

3 minute read

FDA, Products Liability, Blood and Tissue (HCT/Ps), Regulatory and Compliance

Human Tissue Products

Products or product components that are composed of human cells and tissues, such as stem cells, are at the forefront of medical technology. They may also receive unique treatment under...

3 minute read

Products Liability, Warnings and Labels, Series: Ask an Expert

Product Labeling Requirements

Question:How do product labeling requirements differ between medical devices and pharmaceuticals? Answer: The FDA has stringent regulations regarding the labeling of medical...

5 minute read

Risk Management, Claims and Litigation

Changing Times: What Buyers of Legal Services Need to Know Now

If you think you know how corporate legal services are purchased, you might want to take a second look, because the relationship between companies and their lawyers is rapidly...

4 minute read

Products Liability, Insurance and Policy Issues, Claims and Litigation

The Perfect Storm: Keys to a Successful Products Liability Defense

Snow in Dallas on Thanksgiving day? The last thing anyone expected for the Dolphins - Cowboys game that afternoon. We had been dealing with it the whole game and as it continued to build...

5 minute read

Claims and Litigation, Series: Litigation 360

Managing Litigation Expenses: Ebbing the Tide

You’re the CEO of a medical device company that manufactures implantable orthopedic devices. Your company has enjoyed years of success with limited FDA involvement. But then the Warning...

7 minute read

Products Liability, Supply Chains, Contract Manufacturing, Distributors, Outsourcing, Series: Products Liability 360

Component Parts and Raw Materials, Successors, and Distributor Liability

Introduction Now that we have discussed the four main theories of liability that can arise when selling a product – manufacturing, design, warnings and instructions, and marketing...

13 minute read

Risk Management, Sales Reps, Warnings and Labels, Series: Ask an Expert, Off Label Promotion

Off-Label Promotion

Question:What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device? Answer: Promoting medical devices and...

4 minute read

Supply Chains, Outsourcing, Series: Ask an Expert, Contracting, Claims and Litigation

Battle of the Forms and Contracts

Question:What is the "battle of the forms" and how can life sciences companies benefit from using contracts? Answer: The “battle of the forms” refers to a method of determining...

1 minute read

FDA, Risk Management, Series: Risk Management 101, Regulatory and Compliance

When is a Drug or Device Misbranded?

The Federal Food, Drug, and Cosmetic Act ("FDCA") is a federal law that is a primary source for many rules that impact the pharmaceutical and medical device industries. The FDCA's intent...

1 minute read

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