How can you get ahead of complex biocompatibility challenges in medical device development?
Building on years of development support in a wide range of medical devices, Exponent's biocompatibility and biological risk assessment experts are equipped to assess and test the new generation of implantable and tissue-engineered medical devices that control biological interactions with pharmacological agents, bioactive coatings, and/or nano-enabled materials to improve safety and efficacy.
Many of these combination drug or biologic devices are creating new regulatory challenges as companies pursue Food and Drug Administration and EU Medical Device Regulation compliance when seeking product clearance or approval. With our device and combination products expertise, Exponent is uniquely qualified to perform biocompatibility and biological risk assessments of medical devices and materials for a range of needs and help you address compatibility risks during device development.
Evaluating the biocompatibility of a biomaterial is typically addressed by testing outlined in FDA guidance documents and ISO 10993 biocompatibility standards. We offer customized analytical chemistry testing and subsequent toxicological risk assessments in accordance with ISO 10993, as well as 21 CFR Part 58 good laboratory practices.
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• Assessing the toxicity and biocompatibility of biomaterials, including metals, polymers, ceramics, composites, nanomaterials, and particulates
• Consultation on device-related infection control strategies and associated regulatory support
• Characterization of cells and tissues to the mechanical environment through mechanical testing, assaying for matrix protein accumulation, and RT-PCR
• Real-time physiologic measures using fluorescent intra- and extracellular probes
• Characterization of protein changes in response to the mechanical environment through ELISAs, measuring enzyme activity, and biochemical assays
• Characterization of cellular responses to soluble factor gradients (2D and 3D), cell migration assays, and autocrine/paracrine interactions
• Epifluorescent microscopy techniques, including confocal microscopy
• Corrosion and toxicity assessment
• Quantifying blood damage, such as blood flow through cardiovascular devices or cardiovascular flow dynamics in prosthetic devices
• Intellectual property support for cases involving medical device biocompatibility
Exponent has an extensive background working with medical devices.
Medical device experience
Spinal fixation devices
Stents for cardiovascular, neurovascular, biliary, carotid, tracheal-bronchial, and other applications
Cardiovascular occlusion devices
Vena cava filters
Pacemakers (leads and generators)
Implantable cardioverter-defibrillators (leads and generators)
Drug delivery systems
Allograft implants (vascular, pericardial, dermis, skin, ligaments, etc.)
Implantable electromagnetic transponders
Hernia and pelvic meshes
Urinary and IV catheters
Laparoscopic, endoscopic, and colonoscopic devices
Laparoscopic surgical cutting tools
Radiographic shields during surgery
Electrodes and control units
Medical socks with anti-infective coatings
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.
Life Sciences Due Diligence
Due diligence technical consulting services to help verify the science and technology behind medical devices and related therapeutics.
Medical Device Evaluation
Sophisticated medical device evaluations for a vast array of applications.
Medical Device Design & Development Support
Crucial medical device design and development analyses to empower your decision-making.
Biomedical Expertise for Therapeutic Areas
Multidisciplinary insights for a range of therapeutic product development challenges.
Regulatory Compliance for Medical Products
Experienced regulatory support for medical devices, pharmaceuticals, and combination products.
Biomedical Engineering Laboratories
Expert biomedical laboratory services, delivering evidence-based answers for your most complex challenges.
Biomedical Expertise for Disputes
Support for complex disputes, from intellectual property and patent infringement to hospital fires and product damage.
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.
Group Vice President and Principal Engineer
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Senior Managing Scientist
Senior Managing Scientist