Biocompatibility & Biological Risk Assessment

[MCE] [BES] Medical Device Development Support - a tray of surgical tools

Thought leadership

Is It Safe to Sterilize Your Medical Device?

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.

services

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

Joint replacements

Stents for cardiovascular, neurovascular, biliary, carotid, tracheal-bronchial, and other applications

Annuloplasty rings

Cardiovascular occlusion devices

Heart valves

Vena cava filters

Pacemakers (leads and generators)

Implantable cardioverter-defibrillators (leads and generators)

Drug delivery systems

Allograft implants (vascular, pericardial, dermis, skin, ligaments, etc.)

Combination devices

Implantable electromagnetic transponders

Ocular shunts

Dental implants

Hernia and pelvic meshes

Urogynecological devices

Breast implants

Ocular devices

Urinary and IV catheters

Laparoscopic, endoscopic, and colonoscopic devices

Laparoscopic surgical cutting tools

Radiographic shields during surgery

Battery cases

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.

Exponent biomedical scientists conduct due diligence of medical devices by examining aspects of design and invivo applications on smart screen

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.