Insurance for Life Sciences & Medical Technology.

See how our Life Sciences & Medical Technology Insurance Division helps these types of companies reduce products liability risks, avoid costly litigation, and enhance their FDA-required quality management systems.

Medical Device Manufacturers & Distributors  •  Biotech Research & Development Companies  •  Testing Laboratories

Pharmaceutical Manufacturers & Distributors  •  Medical, Drug & Hospital Equipment Wholesalers  •  Clinical & Contract Research

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Risk Management Solutions.

Partnering with industry leaders helps our clients have access to industry specific resources.

TRAIN

Insurance Force offers access to training courses designed to provide companies with information about how to reduce products liability risks and avoid costly litigation.  Courses are taught by industry professionals and include data collected by the carrier’s 30 plus years of defending products liability claims for the medical technology and life sciences industry.

WORK

We offer access to tailored products liability risk management and FDA compliance consulting services.  We are committed to helping medical technology and life sciences companies reduce products liability risks, avoid costly litigation, and enhance company’s FDA required quality management systems.

EXPLORE

Insurance Force offers access to a variety of publications webinars, and industry specific news designed to help companies enhance their quality management systems, reduce their potential products liability risk exposure, and improve their litigation defense position.

 

Complex Companies Require Complex Coverages.

Knowing the types of coverages that are applicable to the industry makes a big difference to our clients.

Product Recall Expense â€¢ Security Breach Notification & Remediation Expense â€¢  Crisis Management Service Expenses  • Clinical Trial Medical Expense • Protypes, Research Data & Documents • Spoiled or Condemned Stock •  Blanket Clinical Trial

Business Income Coverage. Covers challenges posed by lost grants or unique research expenses related to FDA recertification, extending the period of restoration. It also protects your business from income loss resulting from damage to research animals, prototypes or valuable papers and research records. Covers dependent properties and operating expenses for non-income operations.

Specialized Liability Insurance. Special coverage protects your company from liabilities involving medical devices, whether they are being tested in clinical trials or being sold worldwide. Devices include in vitro diagnostic tools, biotechnologies and pharmaceuticals. This coverage protects test subjects and consumers from bodily injury and adverse reactions to known or foreseeable side effects, regardless of fault.

What’s at Stake.

Even the best, most conscientious companies face claims and lawsuits.  Here are some examples from a variety of medical technology companies.

Product Failure

A patient suffered a stroke while receiving intravenous treatment. The manufacturer of the infusion pump was blamed for failing to provide adequate warnings and training to prevent improper loading of the pump.  In-service training had been conducted, but attendance was poor.  Total cost: Over $1.9 million

Software Incompatability

When a technician entered a lab result in error and then quickly corrected it, the lab software recorded the change.  But the correction never made it into the hospital software, which was a different, incompatible system.  The patient underwent unnecessary surgery, and the software developer was among the parties sued.  The $250,000 cap on pain and suffering awards applied to the other parties, but no to the software developer.  Total cost: Over $2.5 million

Errors & Omissions

A customer claimed a manufacturer of computerized diagnostic equipment delivered a faulty prototype that resulted in the customer’s financial loss.  The customer further alleged that the instruments did not meet their specifications.  Total cost: Over $250,000

We Take a Snapshot of Your Current Program.

Knowing what questions to ask helps up tailor a custom insurance program for our clients

  • Does the coverage for physical assets include building, equipment, furnishings, fixtures, inventory computers valuable papers and records, and research materials, including animals, plants, cell cultures and other media?
  • Does the coverage specify replacement cost, including the value of research or modifications completed by your business?
  • Does the coverage include change in humidity or temperature, spoilage or breakdown of the equipment which might lead to temperature or spoilage loss?
  • Does the coverage include any additional costs for biological hazardous waste or radioactive decontamination clean-up if the laboratories have such materials?
  • Are there extensions of coverage for property of others at your site, transit, off-premise property, or samples in the custody of salespeople?
  • Does coverage extend to lost income as a result of physical damage to research materials and records, prototypes and design plans, or other unique property?
  • Will coverage apply to business income lost from failure to meet milestones or other contractual obligations as part of research grants and project funding?
  • If the laboratory or manufacturing facility requires FDA certification, does the business income period of restoration extend to cover this additional time for lost income?
  • Does your company use or make highly valued products, such as expensive metals, narcotic drugs, or sought-after therapeutic treatments? Are security measures formalized and do these take into consideration the actions of third parties, including transit companies?
  • Does your company have robust post-marketing surveillance formal processes and procedures? Even if not mandated by the FDA, post-marketing surveillance is a key factor in detecting trends in adverse events, off-label use, and consumer variability.
  • Does the company regularly utilize experienced attorneys to craft and review contracts? Purchase orders, agreements, or contracts with unfavorable terms can actively hurt a company should litigation arise.  A contract without conditions for indemnification, provision of coverage limits, and survivability may passively cause financial harm by preventing a company from accessing applicable resources for defense of a claim.
  • Does the coverage adequately protect the landlord for fire damage that may be caused by your operations?
  • If required by your lease, is the landlord an additional insured on your policy?
  • Does the policy offer coverage for injury that results from your business operations, even if you do not have a commercial product in the marketplace?
  • Are injuries allegedly resulting from your website of other communications methods covered?
  • Is vicarious auto liability covered from hired autos or employee non-owned auto liability?
  • Do you have the appropriate excess limits in an Umbrella form?

Experience the Insurance Force difference.

Questions? Call us.

We are here to help. Call us and speak with a team member who will answer any question you may have. 410-268-6868

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Our approach to your business will help you navigate the complex world of insurance.