Materials Used in Medical Devices, Implants & Surgical Tools

Thought leadership

Transitioning from FDA's COVID-19 Enforcement Policies

How can Exponent's polymer & materials chemistry experts help you address challenges regarding materials used in medical devices?

Polymeric materials, batteries, hydrogels, textiles, and combination materials play a critical part in transforming what's possible regarding medical devices, implants, and surgical tools — but not without encountering issues on the way to market.

Exponent's polymer and materials chemistry scientists collaborate with multidisciplinary teams composed of mechanical engineers, toxicologists, materials and corrosion experts, and data scientists to evaluate and enhance the biocompatibility, safety, and performance of next-gen medical products.

Applying exacting science and rigorous methods, Exponent assists clients with early-stage feasibility, design, manufacturing, and post-market considerations. We help clients navigate design verification and validation (V&V) in manufacture and launch and develop appropriate regulatory strategies.

We support validation of medical device performance for regulatory approval (e.g., FDA 510(k) or premarket approval (PMA)) as well as conduct finite element, corrosion, fatigue, fretting, wear, fluid dynamics, material property, and fracture mechanics testing and analysis of all types of medical devices.

We also assist clients with full cycle support for issues of intellectual property including patent infringement, patent validity, and trade secret assessments.

Our 50+ years of experience in failure analysis informs our approach to medical device quality, usability, and risk management, and we connect past lessons from all industries to make the future safer and healthier. Together, we bring expertise in polymers, metals, and ceramics — helping you accurately understand your medical device challenge, mitigate it, and move forward.

Capabilities and Services

Effectively evaluating and mitigating potential product exposure risks of extractables and leachables requires unique testing for a variety of product use scenarios and regulatory considerations. Exponent's approach integrates analytical, toxicological, and regulatory expertise with standardized and custom methods to perform comprehensive materials characterization and assess potential health risks from medical devices, to drug delivery systems, to implants.
The analysis of human specimens provides physicians with critical information to properly diagnose, treat, and prevent human disease. To meet this need, industry strives to produce in vitro diagnostics (IVDs) that deliver rapid, sensitive results while minimizing cost and complexity. Whether helping refine the set up and operation of a clinical lab or assisting with the development, manufacturing, or product launch for central lab, at-home, or point-of-care (POC) diagnostics, Exponent can help clients successfully navigate challenges throughout the development and commercialization phases of IVD products.
Textiles are composed of fibers and are often combined with other materials to make composites and combination products, enabling and extending their use in a variety of applications in medicine, implants, and surgery. With expertise in textile, chemical, environmental, electrical, mechanical, and materials engineering, fiber and textile science, and health sciences, Exponent is uniquely qualified to assist you with a range of textile and textile-based products for a range of applications in the life sciences industry.
Biocompatibility testing includes evaluating the negative effects or reactions derived from a medical product as well as the evaluation of how a material promotes natural health and healing. With the emergence of combination products, biocompatibility is becoming a more and more important part of medical device functional requirements. Combination drug or biologic devices result in new regulatory challenges as companies pursue FDA and European Medical Device Regulation (MDR) compliance. Our multidisciplinary team of experts assists clients with the challenges and risks faced during the device development phases, and our clients have access to our state-of-the-art laboratories, which offer biocompatibility testing in compliance with the applicable regulatory standards.
Our teams conduct systematic risk assessments to evaluate the potential health risks associated with exposure to known or potentially toxic agents within all types of medical devices and pharmaceutical products. Our multidisciplinary teams are highly skilled in data evaluation, and conducting exposure assessments, toxicology, dose-response evaluations, and risk characterization as well as offering solutions for remediation.
Medical devices are constructed of materials that are either demonstrably non-toxic or are judged to be satisfactory in a cost-benefit analysis, and Exponent conducts modeling of metal alloy components to show the likely toxicological and carcinogenic outcome after exposure to trace amounts of elements or compounds that leach from medical devices. Exponent offers regulatory, litigation, and product-development support to clients who can benefit from physiological modeling for device assessment, critical evaluation, regulatory submission, or scientific peer-review.
To help clients effectively evaluate and mitigate potential product exposure risks, Exponent offers a range of extractables and leachables (E&L) testing services for a variety of product use scenarios and regulatory considerations. Our approach integrates analytical, toxicological, and regulatory expertise with standardized and custom methods to perform comprehensive materials characterization and assess potential health risks from medical devices, drug delivery systems, food and pharmaceutical packaging, and a variety of other consumer products.
Medical device manufacturing uses a wide variety of adhesives for all types of applications. Whether seeking to select a candidate material, test a new adhesive material, or analyze the failure of an existing adhesive bond, Exponent can help you understand how to ensure your adhesive is "sticking" enough or too much for your medical application. At Exponent, our multidisciplinary teams have extensive experience consulting on adhesives used in a broad range of medical device applications and conduct assessments to evaluate the human and occupational risks associated with these materials regarding the full device lifecycle.
Medical plastics are used in a wide variety of applications, including sutures and mesh medical products used to close wounds, reinforce tissues, and as a surgical option for soft tissue repair. Our multidisciplinary team of scientific researchers and subject matter experts performs tests for new product development, examines failures of existing medical plastic components, and assists clients with laboratory research in our state-of-the-art facilities. We provide strategic consultation throughout all stages of the medical plastic lifecycle. We have studied the leaching effects of plastics and polymer products in biomedical wearable devices as well as the efficacy of medical plastics used for internal applications during surgery.
Hydrogels are used in a variety of pharmaceutical and biomedical products, chosen for their ability to retain large amounts of water and maintain the shape of the intended product use. Exponent's polymer scientists are experienced in hydrogel research and provide critical insights for the advancement and use of hydrogel technologies for various medical applications. Our teams specialize in the design and evaluation of polymeric materials and small molecule additives and assist clients with materials selection, deformulation, and failure analysis of injectable hydrogel materials.
Prolonged exposure to elements within the human body as well as to external elements can affect the performance of medical devices and their battery technologies. Our multidisciplinary teams have extensive experience testing all components used in various medical devices to ensure the material composition is resilient and safe, and able to withstand the daily wear and tear and exposure to all sorts of elements. Exponent's multidisciplinary teams help clients assess weathering and exposure risks to help develop proactive plans to mitigate hazards and develop a clear path moving forward. We use cutting-edge tools to enhance the resilience of medical products and offer guidance for companies that desire to understand and quantify their exposure to extreme environmental risk. We are often called to provide expert research and expert witness testimony in legal disputes and accident investigations involving weather and exposure.
Exponent leads the medical device consulting industry in helping clients make informed decisions regarding lithium-ion batteries. Our capabilities span the entire product lifecycle, including battery design reviews, battery safety and storage, quality safety assessments, risk assessments and corrective actions, battery safety and recall support, battery supply chain services, battery recycling, and product stewardship initiatives. Our experts use Exponent's state-of-the-art testing and disassembly laboratory services for design, testing, and recall assessments of all lithium-ion batteries.
- Failure analysis
- Medical device manufacturing
- Technology acquisition/technology transfer
- Design validation
- Product recall
- Litigation support and expert testimony

Our Capabilities Are Unparalelled

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.