Product Damage in the Healthcare, Pharmaceutical, Biotechnology & Medical Device Industries

Insurance companies, pharmaceutical/biotechnology companies, medical device manufacturers, and hospitals engage Exponent to investigate losses in manufacturing operations and healthcare institutions. These losses involve a wide range of product damages resulting from incidents such as fire suppression system leaks, refrigeration/freezer failures, HVAC failures, structural damage associated with weather events, anesthesia and oxygen-enriched fires, warehouse accidents and exposure to temperature excursions during shipping due to extreme weather events or supply-chain issues. A typical loss claim could involve claimed damage for the loss of high value research and development products stored in a defective freezer with minimal back-up and monitoring; or to packaged medical devices that may have been exposed to excess heat or moisture.

A number of questions arise from these types of claims:

  • How did the failure occur?
  • Are the products damaged, salvageable, or adulterated?
  • What is the value of an irreplaceable research product; for example, a compound that is the product of years of research, but has not yet been valued in the marketplace?
  • What can be done to prevent a similar loss in the future?

Exponent can provide clients with proactive scientific services, economic analyses, and engineering support to address these questions and related issues.

Areas of Expertise:

  • Disaster response and preparedness training
    • Education
    • Evaluation of existing plans
  • Economic analyses
    • Complex product valuations
    • Loss assessments
  • Facility cleaning and disinfection practices
    • Evaluation of disinfectant claims, including equipment assessment
    • Materials compatibility assessment
  • Fire safety
    • Facilities
    • Anesthesia gases and oxygen
  • Electrical safety
    • Proper grounding
    • Maintenance of generators
    • Failure analysis
  • Mechanical systems
    • Failure analysis
    • Refrigeration and freezer failures
    • HVAC system failures
    • Back-up power systems evaluations and fault analysis
  • Pharmaceutical product and medical device damage assessments
    • Sterile packaging systems assessments
    • Assessment of container closure integrity
    • Exposure investigations
    • Contamination assessments
    • Mechanical and material property/testing evaluations
    • Assessment of product temperatures as a function of environmental excursions
    • Functional evaluations of medical devices post-exposure
    • Assessment of device material property compatability with the use/storage and distribution temperature and humidity requirements
    • Evaluating failure mode realization probability through modeling for risk management
  • Product Damage Evaluation
    • Biological system damage assessment – prokaryotic and eukaryotic cells, biological tissue
    • Biologic product assessment – vaccines, enzymes
    • Cost evaluation – valuation of loss, regeneration of materials
  • Proactive hazard identification
  • Root-cause investigations
  • System and work process analysis
  • Water leaks
    • Sterile products exposure assessment
    • Damage assessment
  • Weather-related damages
  • Human factors
    • Training / oversight
    • Device labeling / device usability
    • Response to alarms

Lost Prevention Services:

  • Assess suitability of equipment for critical products and processes
  • Assess backup power, monitoring and alarm systems in place
  • Reviews of equipment suitability (qualification) at facility design stage
  • Support drafting of SOP’s/procedures in anticipation of loss
  • Selecting acceptance criteria for damage to medical devices
  • Review medical device manufacturing susceptibility to critical supplier loss
  • Review medical device portfolio risk through quality defects in single suppliers
  • Assess manufacturer’s ability to respond to critical Supplier Notification of Chanhe (SNC) requests
  • PHA/Hazops type systematic risk analyses
  • Review operator workflow and training, labeling of hardware, and/or software usability.



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