COVID-19 Support Services: Market Readiness of New Disinfection/Decontamination Products, Medical Devices and PPE

Exponent’s trusted advisors are actively providing comprehensive product design, safety, and regulatory guidance to clients at all stages of the medical device, PPE, and biocidal product lifecycles.

Our Expertise:

Exponent’s multi-disciplinary team of engineers, health scientists, and regulatory experts has a long history of supporting clients across medical specialties and product sectors. Our infectious disease experts have experience in microbiological contamination detection and mitigation for pharmaceutical, biotechnology, clinical, and industrial applications. Our textiles and materials scientists and engineers have extensive knowledge of fibers and yarns; nonwoven, woven, knit, and braided fabrics; dyes and finishes; fiber- and textile-reinforced composites; and foams, films, coatings, and adhesives.

Our biomedical engineers are well versed in current regulatory guidance and exemptions, as well as the quality processes associated with products for these sectors. Our engineering expertise includes 3D printing, fluid delivery systems, ventilator systems, and more. Our regulatory experts have worked across government and industry to achieve active substance and new product approvals from the U.S. EPA, U.S. FDA, EU REACH, and regulatory authorities across the globe. In a time when every moment counts, our team of experts can help manufacturers efficiently ready new disinfection/decontamination products, medical devices, and PPE for market.

Our Capabilities:

Materials and chemicals selection, characterization, and testing

Exponent’s multi-disciplinary team of engineers and health scientists can help clients characterize and evaluate the performance of medical device, PPE, and biocidal product components against various standards, regulations, and specifications. We offer a range of standard and customized testing services in our cGLP facilities. Our advisory work includes, but is not limited to:

  • Synthesis of global ASTM standards, NIOSH standards, and evolving FDA guidance for PPE
  • Material selection for new component suppliers  
  • Advanced imaging capabilities using electron microscopy and computed tomography (CT)
  • Compatibility assessments, especially when biocidal products are retroactively introduced to product use profiles
  • Characterization of materials subjected to disinfection or decontamination to assess potential degradation or other failure modes
  • Comparative tests of product components for functional characteristics such as permeability and water penetration

Biomedical, mechanical, and electrical design support and evaluation (including 3D printing)

Exponent’s multi-disciplinary team of engineers and health scientists can help clients conduct comprehensive design reviews for new and improved medical devices, PPE, and biocidal products. Our advisory work includes, but is not limited to:

  • Comprehensive design reviews at all stages of the product design cycle
  • Software, component, and system evaluations for newly developed products  
  • Independent audits of vendor components for offshore manufacturers
  • Guidance on 3D printing of critical parts for medical devices or PPE
  • Human factors assessments of usability and function, including for non-traditional users of medical devices and PPE

Product safety and compliance assessment

Exponent’s multi-disciplinary team of engineers, health scientists, and regulatory experts can help clients verify and validate new product safety and performance for regulatory approval. Our advisory work includes, but is not limited to:

  • Finite element, corrosion, fatigue, fretting, and wear testing
  • Fluid dynamics, material property, and fracture mechanics testing and hazard analyses
  • Vulnerability analyses for regulatory, quality control, and business systems
  • Development of SOPs, global regulatory models, and compliance manuals
  • Computational modeling for preclinical testing, numerical modeling, and failure analysis
  • Evaluation of worker exposure to new disinfection/decontamination products  

Impact assessment of temporary regulatory orders and return-to-normal processes

Exponent’s multi-disciplinary team of engineers, health scientists, and regulatory experts can help clients in healthcare and other impacted industries prepare return-to-normal solutions. Our advisory work includes, but is not limited to:

  • Guidance on return-to-normal procedures needed for the expiration of government and regulatory orders
  • Systematic removal of Emergency Use Authorization (EUA-based) items (e.g., reprocessed or alternative forms of PPE)
  • Retroactive assessments to determine whether emergency solutions during the COVID-19 crisis performed as intended
  • Review of temporary supply chain changes
  • Product authenticity evaluations

Regulatory compliance reviews and dossier submittals (U.S. FDA and EU REACH)

Exponent’s multi-disciplinary team of engineers, health scientists, and regulatory experts can help clients plan compliance strategies for market entrance or expansion. Our advisory work includes, but is not limited to:

  • Navigation of U.S. FDA and EU CE mark regulations for new product commercialization
  • Collaboration with the U.S. EPA, EU member states, the Far East, and Codex Alimentarius
  • Compounding facility registration
  • Technical support for pre-market strategy, testing, and submissions
  • Dossier submittals for the U.S. FDA and EU REACH regulatory approval
  • Adverse event reporting
  • CAPA, product recall, FDA inspection, and warning letter response
  • Strategies to apply EUA status to future regulatory position

Requirements associated with Emerging Viral Pathogens Guidance and List N postings


Exponent’s multi-disciplinary team of health scientists and regulatory experts can help clients navigate the Canadian and U.S. EPA Emerging Viral Pathogens Guidance, List N posting, and List N registrant communication to healthcare communities and consumers.

For more information on our services, please contact 888.656.EXPO (within the U.S.), 650.326.9400 (outside the U.S.), or info@exponent.com. Additional information is also available here.