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Higginbotham’s life sciences insurance specialists know the business of research, product development, clinical trials and commercialization as well as the FDA and other governmental agencies that regulate these processes.
We’ve served life sciences companies in every stage of development—from startups to global operations, including:
This deep experience means we have the know-how to design a custom risk management and insurance solution for your life science company’s unique risks.
Employee-owned and customer powered, we make caring for you our business.
We begin with listening and end with customized solutions. They embody the hefty legal and regulatory challenges you face. And they demonstrate our understanding of your research, product development, clinical trials and commercialization processes and their regulations.
We’re more individual and less institutional. By making policies personal, we help you accomplish more. That’s why life sciences companies in every stage of development have trusted us to deliver insurance products that protect them against the specific risks they encounter.
By committing to transparency while demonstrating authenticity, we’re a place that leads with values so value leads.
Higginbotham’s specialty life science industry expertise is recognized by the major life sciences insurance carriers.
From clinical research labs to medical technology companies, biotechnology companies, contract manufacturers and other life sciences businesses, our tailored insurance solutions are designed with your specific needs in mind.
While your insurance needs will vary based on your location, unique risk exposure and the specifics of your operation, these are some popular life science business coverages.
If you’re a startup operating out of a leased space, you’re probably required to carry general liability coverage. Considering the many ways a life science technology firm can end up liable for bodily injury, property damage and advertising injury, this coverage is important to consider, even if your landlord doesn’t require it.
Directors and officers liability coverage can help protect the directors and officers of your organization from the costs of being sued. D&O can help with legal costs like attorney fees, settlement payments and judgments, safeguarding you from potential financial ruin in the aftermath of a mistake or negligence.
If your company is publicly traded, regulations and public scrutiny can create additional layers of risk. Higginbotham offers several alternative risk financing solutions tailored to public life sciences companies. In some cases, these proprietary alternative solutions can save you money and reduce your risk in comparison to the more traditional coverage options available in the marketplace.
While most startups have little tangible value in their pre-MPV (minimum viable product) stage, it’s still wise to consider carrying enough coverage to cover your liabilities. This coverage is especially important for consideration if you have a life science company renting space from a commercial landlord.
Regardless of your product’s current stage of development, your life science company should consider carrying clinical trial insurance. This specialized coverage can extend protection to the sponsors/organizers of clinical trials for medical devices or drugs, helping with the potential cost of an injury or death.
If you conduct clinical trials overseas, you should carry foreign clinical trial coverage. Whether you need a locally tailored policy to comply with regulations in the country, are conducting a trial or simply looking to extend your domestic coverage, we can help guide you through the process.
Like clinical trial insurance, products liability coverage is designed to protect against the liabilities involved with administering medicines and medical devices to the public. If use of your life science product results in injury or death of a consumer, your product liability insurance can help you with the cost of a lawsuit or settlement.
During the research and development phase, establishing proof of concept in animal models plays a key role in the FDA regulatory approval process. Should an unforeseen event damage or destroy your research, the resulting impact on development can be devastating.
Insurance coverage for research animals should not only replaces the cost to purchase new genetically modified animals, but also account for the costs to recreate the animal model (labor and materials).
As a life science professional, cleanroom integrity is critical to successful product testing and development. Even the slightest level of contamination can confound study results or ruin samples, costing a life science business considerably.
Cleanroom contamination insurance is designed to help with these costs, enabling your business to get back on track in the aftermath of a cleanroom contamination.
Because precision instruments tend to be both sensitive to damage and costly to replace, life science businesses should carry insurance designed to help with the costs of repairing or replacing them should they experience loss or damage.
Spoilage insurance protects against financial loss caused by medicine, vaccine and other product spoilage. From a power outage taking out your refrigeration to inventory outlasting its shelf life, medicine and vaccine spoilage coverage can help pay to replace your spoiled products.
Like the important record and document protection carried by many other businesses, loss of medical and biotechnology record coverage can help you with the cost of losing important records. From a fire at your lab to data theft and more, your loss of medical and biotechnology records insurance can help you get back on track.
Intellectual capital infringement is an unavoidable risk in the life science and technology industries. Intellectual property insurance can help with the costs of litigation should your life science business end up entangled in a lawsuit alleging intellectual capital infringement.
Considering the ever-present threat of your sensitive data getting compromised, it’s wise to carry insurance developed for the risks associated with working with private and confidential information. This coverage can help with the costs of investigating a data breach and assist with data recovery, settlement payments, legal defense and other related expenses.
If your life science operation does any clinical testing or handles the sensitive information of others in any capacity, you should consider adding this coverage to your policy.
Also commonly known as “inland marine insurance” (a more accurate name for the product is “stock throughput)”, inland and ocean transit coverage protects property in transit. Unlike marine insurance, which covers property in transport over water, inland marine can cover products, materials and equipment against loss, damage and theft during transportation over land.
If your life science organization conducts business abroad, you should consider international liability insurance. This coverage can help your business with legal fees and other costs should one of your products, services, activities or employees injure or damage a third party. In most cases, this coverage can also include kidnap and ransom, workers’ compensation and commercial auto coverage.
Latent injuries are defined as “injuries which appear several years or more after initial exposure to a toxic or harmful substance.” If your life science business conducts medical trials or produces products for public use, you can be held legally responsible for an injury or death suffered by a consumer who uses them.
If you face a latent injury lawsuit, latent injury liability insurance can help pay for legal costs, settlements and judgments.
This coverage acts as an extension of a life science organization’s commercial general liability insurance. If you hire contract workers or other third-party medical professionals to work for your business, you can be held legally responsible for their actions. Incidental medical malpractice insurance can help cover legal fees, court costs and settlements if you’re accused of malpractice.
Product recall insurance can assist with the cost of recalling a defective or dangerous product from the market. If you need to recall a medication or medical device your organization produced, this coverage can help pay your customer notification, shipping and disposal costs.
Life science companies often rely on complex supply chain networks to deliver products to customers; therefore, it is crucial to consider the impact a supply chain disruption could have on your operation. From first-party risks like loss of revenue to third- party risks like the threat of a lawsuit, it’s important to take a holistic approach to risk management.
Lawsuits alleging injury from defective or dangerous medical appliances, organ transplants, prosthetic devices, surgical implants, hospital supplies, diagnostic equipment, surgical equipment and hearing and visual aids make loss control a paramount concern for life science companies.
Our risk managers are familiar with the nuances of product liability, statutes of limitation and Food and Drug Administration (FDA) requirements, and we implement safety and loss prevention programs that help avoid lawsuits and noncompliance penalties.
Life science insurance refers to coverages that are designed to address risks faced by companies involved in the research, development, manufacturing or distribution of life science products. These policies may help to address exposures tied to laboratories, clinical trials, products, data, regulatory requirements and professional services.
Life science insurance may be relevant for biotechnology firms, pharmaceutical manufacturers, medical device companies, diagnostic labs, contract research organizations and related startups. Coverage needs will vary widely depending on a company’s operations.
Coverage needs will depend on your operations and risk profile. Common options may include general liability, product liability, professional liability, clinical trial insurance, property insurance and cyber liability. Some businesses may also consider obtaining coverage for regulatory risks, supply chain disruptions and intellectual property (IP) exposures.
When selecting an insurance advisor, it’s important to consider their experience with life science risks, understanding of the industry’s regulatory environments and ability to tailor coverage. It can also help to review carrier financial strength, claims handling approach and flexibility as your operations evolve or scale.
Clinical trial insurance requirements often depend on study location, sponsor agreements and applicable regulations. Coverage commonly addresses participant injury, investigator liability and other trial-related activities. Requirements may vary by country, protocol and trial phase, so policies should be reviewed closely before a study begins.
Some insurance policies, such as business interruption or product liability insurance, may address losses tied to supply chain disruptions like delays from third-party suppliers or transportation issues. Coverage availability and terms will depend on factors like reliance on specific vendors, geographic location and the nature of the materials or components involved.
Biotech startups may benefit from specialized coverage that’s tailored to early-stage operations, funding requirements and regulations. Policies can be structured to align with development milestones and investor expectations while allowing flexibility as research progresses or business activities expand.
A great plan starts with a conversation. Let’s talk about what you need.