Medical Devices and Diagnostics

Medical device and diagnostics companies continue to develop newer technologies to provide better treatments, less discomfort for the patient, and improved patient assessment. Continued advances in technology, chemistry and materials are integral to the future progress of medical devices and diagnostics. In the near future, medical device and diagnostics companies are faced with developing new platforms with aggressive requirements on chemistries, materials and components. The devices and diagnostics of tomorrow will require smaller features, thinner coatings, improved stability while improving effectiveness and safety.

For medical devices and biomaterial companies, EAG Laboratories offers the most diverse and comprehensive suite of testing and engineering support available. EAG Laboratories has established ourselves within the technology and biomedical space by developing scientific expertise in difficult analytical measurements, characterizations of complex materials and systems, and a pioneering approach to problem solving.

How do you drive R&D productivity and at the same time keep pace with evolving regulations?  Turn to EAG. WE KNOW HOW.

HOW WE CAN HELP

Our offering to the medical device and diagnostics industry answers difficult technical questions where a scientific answer is challenging.  Additionally, we align ourselves with our customer’s device and diagnostic development process and have developed efficient service offerings commonly requested by our customers. We offer the following scientific services and studies for a wide variety of biomedical products:

Concept and Research

Medical device and diagnostic companies engaged in research and early design are passionate about their ideas. During this phase, they want answers to their scientific questions quickly so they can continue to push their programs. Companies come to us for medical device analysis to gain competitive product insight, assess chemistries and materials, and perform proof-of-concept studies.

Prototyping Design and Development

The generation of prototypes one can see and feel is exciting during this stage. Materials selection and device engineering are crucial elements to generate promising prototypes. During the design and development phase, engineers are evaluating materials, performing preliminary performance testing, and developing future safety testing strategies.

Design Verification and Validation

Prototypes are challenged during this stage to evaluate preliminary safety and effectiveness.  A significant amount of testing and evaluation is performed to study the device. EAG has broad range of medical device analysis services and capabilities to support companies in this stage with materials characterization, reliability testing, supplier qualification and selection.

Regulatory Submission and Launch

This is the final stage to get the product to market. A successful submission to the FDA is critical for a speedy approval in addition to establishing efficient and effective manufacturing process. A substantial amount of testing is required to evaluate safety of the device and demonstrate control of the manufacturing process.  EAG has years of experience in extractables/leachables, ISO 10993 Part 18 testing, and contamination control.

Post Market Surveillance

Once the device is approved and in the market, continued support is required to evaluate quality issues, control manufacturing and manage supply chain. Unforeseen failures can occur during a products lifetime requiring companies to investigate and determine root cause.  Additionally, availability of critical raw materials for device manufacturing can change requiring new vendors of equivalent materials to be selected. EAG supports customers with failure analysis, raw material benchmarking and comparison, process improvement, and quality control testing of materials and components.

Our customers value the scientific interaction they receive during project scoping and discussion. Please call us at 800-366-3867 to speak with one of our scientists about your medical device analysis challenges.

Medical Device Analysis Services:

Materials and Surface Analysis

Materials & surface analysis: From metal oxide characterization for implants to surface chemistry for contact lenses, EAG has done it all. No scientific services company has more experience with the breadth of techniques used to characterize, test and assure purity of medical devices and their materials, components, products and packaging.

Medical polymer chemistry: From plastic failures to questions of medical device composition, EAG has studies many different types of medical plastics, including coatings, sutures, catheters, patches, dental materials and more.

Diagnostics and Medical Device Morphology and Microstructures: EAG’s advanced microscopy services apply SEM and TEM analysis to understand device features, defects and particles.

 

Electronics Testing

Electronics testing: EAG offers engineering support for FA analysis and electronic troubleshooting, fault localization and root cause determination. Our electrostatic discharge (ESD) testing ensures that medical device chips will withstand electrostatic discharge events that may occur during handling and assembly.

Part 18 Testing

ISO 10993 Part 18 Chemical Characterization of Materials: Our scientists can help you move efficiently through the FDA approval process of evaluating the biological safety of medical devices by providing the qualitative information, material equivalence and quantitative information.

CMC Support

Chemistry, manufacturing & controls (cGMP): Comprehensive analytical support and quality control for devices and combination products under cGMP including analytical method development and validation; raw material and component testing; drug-device compatibility testing, IND-enabling, clinical, registration stability and post-marketing programs; reference standard management; QC release testing; and full extractables and leachables programs for products and product packaging

Nickel Rich Implants

Characterization of nickel rich alloys for biocompatibilityEAG has the full set of capabilities to characterize nickel rich alloys for biocompatibility consistent with FDA Guidance. The overall studies can include a combination of corrosion testing, nickel ion release and oxide layer thickness. We have extensive experience working with nitinol, MP35N and stainless steel alloys in a variety of shapes and geometries.

Failure Analysis

Failure analysisEAG scientists investigate device failures, including adhesion and bonding issues. We also have expertise solving problems of corrosion, oxidation and embrittlement. Our expert metallurgists can determine the location of failure as well as offer the root cause so a solution can be developed quickly.

Consulting and Litigation Support

Consulting & litigation support: EAG maintains a team of scientists and engineers who provide technical consulting, problem solving and litigation support, including expert testimony for product liability and other cases.

Dana Medlin, Ph.D., P.E., FASM: Dr. Medlin has over twenty-five years of experience as a consultant and expert witness in biomedical engineering, metallurgical failure analysis and medical device failures.

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