Safety and Biocompatibility of Medical Devices & Products

Thought leadership

Biologic Interactions With Metallic Implants

How does Exponent's multidisciplinary approach provide an accurate understanding of global regulatory challenges for medical devices and surgical implants?

Medical devices such as joint replacements, heart valves, drug delivery systems, battery casing, pacemakers, dental implants, and stents comprise a combination of biomaterials with different biocompatibility characteristics that can affect the human body in various ways.

Medical devices have expanded to include a wide variety of components containing polymeric, biologic, metallic, ceramic, and composite materials. As medical devices continue to advance in their capabilities and include more combinations of materials, regulatory frameworks are requiring biocompatibility as part of the functional requirements of these devices.

Medical Devices, Implants & Surgical Tools [MCE]

What are biomedical materials, and how can they promote healing after surgery?

The concept of biocompatibility has expanded from identifying whether a product is inert, meaning non-toxic, non-antigenic, or non-mutagenic, to classifying materials as bioactive based on their ability to encourage positive healing responses by actively interacting with the tissue.

Finite Element Analysis for Medical Devices & Biomaterials [BES]

Bioactive materials promote the formation of normal healthy tissue, as well as the integration of the device into adjacent tissue.

The new generation of implantable and tissue-engineered medical devices control biological interactions using pharmacological agents, bioactive coatings, or nano-enabled materials to improve safety and efficacy.

Our teams include experts in health sciences, mechanical engineering, materials and corrosion engineering, electrical engineering, biomedical engineering, pharmacology, and data science. Working together, we help you understand the various complexities of medical devices and implants.

Exponent offers biocompatibility testing plans, regulatory strategy advice, and biological safety evaluations customized to your medical device product. Our health scientists regularly conduct toxicological risk to complement ISO 1099318 chemical characterization testing.

Medical Devices, Implants & Surgical Tools [PSMC]

How does Exponent evaluate a medical device's potential performance in real-life simulations?

We can characterize cells and tissues to the mechanical environment through assaying for matrix protein accumulation and real-time quantitative RT-PCR to determine gene expression and can provide real-time physiologic measures using fluorescent intra- and extracellular probes. We can also characterize protein changes in response to the mechanical environment through ELISAs (enzyme-linked immunosorbent assays), measurement of enzyme activity, and biochemical assays.

Our teams use 2D and 3D technology to characterize cellular responses to soluble factor gradients, cell migration assays, and autocrine/paracrine interactions, and can incorporate epifluorescent microscopy techniques, including confocal microscopy.

Exponent provides rigorous assessments for all types of medical devices.

Biocompatibility

Joint replacements

Hip implants

Knee implants

Heart valves

Stents

Dental devices

Cosmetic implants

Surgical tools

Surface devices

Wearable electronic devices

Battery casings

Capabilities

Whether seeking regulatory approval for a new medical device or evaluating the biocompatibility of an existing product with proposed changes, Exponent has the expertise and experience to help medical innovators throughout the entire product lifecycle.

Exponent's toxicologists provide rigorous risk assessments of the toxicity of extractable and leachable substances from products and devices. We also evaluate the biocompatibility of biomaterials, including metals, polymers, ceramics, composites, and biological materials, and we are equipped to evaluate residues on multiple-use units after reprocessing or re-sterilization.
We provide assessments of corrosion (such as general, pitting (ASTM F2129), galvanic (ASTM G71), and fretting), degradation, and toxicity of materials in long-term implants or particulates remaining in situ after surgical procedures; can measure the metal leach rate for long-term implants; and often conduct biokinetic modeling of metal release from metallic implants.
Our multidisciplinary approach helps you understand the various complexities of safety involving medical device and consumer products.
We evaluate the toxicity and biocompatibility of biomaterials, including metals, polymers, ceramics, composites, and biological materials, and are equipped to evaluate residues on multiple-use units after reprocessing or re-sterilization. We also offer control strategies and regulatory support for device-related infection.
Consumer products that are not be classified as medical devices may still need safety and/or biocompatibility assessments to ensure interactions with the consumer do not pose unacceptable risks to human health. Exponent's toxicologists assess products and ingredients or formulations to ensure a safe product is marketed.
To quantify blood damage, we evaluate blood flow through cardiovascular devices for design evaluation to gain an understanding of the complex interaction of cardiovascular flow dynamics with the function and complications of prosthetic devices.
Medical device, pharmaceutical, and biotechnology companies often face challenges when preparing to submit applications for regulatory approval. Nonclinical development for regulatory documents and submissions requires extensive knowledge and expertise for bringing medical products to the market. Exponent scientists provide the highest quality technical, regulatory, and safety assessments to assist our clients with issues related to medical products, with a particular focus on nonclinical development, toxicity testing, and regulatory support.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.