How can IVD and medical device manufacturers ensure their products comply with changing user requirements?
IVD and medical device development are dynamic and complex, accompanied by increasing pressure to develop new tests and protocols quickly under changing user requirements. Because there are often no specific standardized processes available, creating innovative tests and methodologies necessitates designing testing strategies with tailored approaches.
Developing a characterization and verification assay for products like COVID-19 polymerase chain reaction (PCR) tests, determining a product's antimicrobial efficacy, or evaluating potential contamination of a medical device requires extensive knowledge of a wide range of microbiological, molecular, and chemical technologies, as well as in-depth experience with the changing public health and regulatory landscape.
Exponent's Microbiology & Molecular Biology Laboratory team specializes in quickly developing customized testing while adhering to industry quality standards. We have the in-house expertise to perform protocol development, quality control checks, and comprehensive microbiological testing, including antibiotic susceptibility testing, antimicrobial efficacy testing, disinfection and cleaning assessments, and contamination sampling and analysis.
Working with bacteria (e.g., Escherichia coli, Staphylococcus aureus, Burkholderia cepacia), bacteriophages (e.g., MS2), inactivated viruses (e.g., inactivated SARS-CoV-2), and other biosafety level 2 (BSL-2) pathogens, we can design model systems for extensive testing. Our customized approach also entails risk mitigation and failure analysis, as well as assay development and verification.
SERVICES
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• qPCR
• RT-PCR
• Nucleic acid extraction
• Western blotting
• Enzyme assays
• Protein assays
• ELISAs
• Lateral flow immunoassays
• Biological contamination identification
• Microbial identification
• Antibiotic susceptibility assays
Exponent's microbiology and molecular biology experts can help assess and address potential medical device and in vitro diagnostic risks for a range of applications at any point along the total product lifecycle.
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Medical Device Evaluation
Sophisticated medical device evaluations for a vast array of applications.
Regulatory Compliance for Medical Products
Experienced regulatory support for medical devices, pharmaceuticals, and combination products.
Life Sciences Due Diligence
Due diligence technical consulting services to help verify the science and technology behind medical devices and related therapeutics.
Safety and Biocompatibility of Medical Devices & Products
Gain insights into the biocompatibility and regulatory requirements of medical devices and implants.
Materials Used in Medical Devices, Implants & Surgical Tools
Expert evaluation of the materials used in medical devices, implants, and surgical tools.
Emerging Infectious Diseases
Scientific research, strategy, and tactics to support strategic planning related to numerous aspects of emerging infectious diseases.