Medical Devices and Diagnostics
Concept and Research
Medical device and diagnostic companies engaged in device concept, research and early design are passionate about their ideas. During the device concept phase, they want answers to their scientific questions quickly so they can continue to push their programs. Companies come to EAG Laboratories to gain competitive product insight, assess materials and their chemical composition; and perform proof-of-concept studies.
Chemistries, materials and components available to medical device and diagnostic researchers continue to improve. Additional insight and characterization is often needed to provide preliminary results about performance and properties. EAG Laboratories serves as your analytical R&D team or an extension of your R&D department.
We have scientists and engineers with expertise in the following medical device chemical analyses, materials and components:
- Polymer chemistry
- Metallurgical alloys
- Nitinol
- Coatings and Adhesives
- Plastics
- Hydrogels
- Glasses and ceramics
- Surface chemistry
- Electronic components
- Biomolecules
Design Verification and Validation
During medical devices verification stage, prototypes are challenged to evaluate preliminary safety and effectiveness. A significant amount of testing and evaluation is performed to study the device. EAG has broad range of analytical services and capabilities to support companies in the medical devices verification and validation stage with materials characterization, reliability testing, supplier qualification and selection.
Initial production batches are generated during this phase for evaluation. EAG Laboratories has experience in evaluating chemical characteristics of key elements in the device or diagnostic product. Customers have come to our scientists and engineers to understand:
- Surface chemistry
- Microscopic structure morphology
- Polymer properties
- Physical properties
- Electronic component reliability and performance
- Cleanliness and contamination
Prototyping Design and Development
In the diagnostic and medical devices design and development stage, there is excitement to see and feel the generated prototypes. 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.
Initial chemistries, materials and components selected during the device development phase require preliminary testing to evaluate properties and plan safety testing. The prototypes can be variations on existing products to improve performance or can be completely new technologies. EAG Laboratories has experience in testing materials and evaluating prototypes for medical device and diagnostics companies.
Our scientists and engineers have evaluated the following types of medical devices and diagnostics:
Regulatory Submission and Launch
FDA Devices Submission is the final stage to get the medical device 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 Laboratories has years of experience in extractables/leachables, ISO 10993 Part 18 testing, and contamination control.
Final testing programs are performed on multiple manufactured batches of the device to evaluate biocompatibility and validate manufacturing for submission to the regulatory bodies. An appropriate testing program is required factoring in application and end use to provide a realistic evaluation of the device. EAG has developed approaches to extractables/leachables and ISO 10993 Part 18 for evaluating the chemical characteristics of biocompatibility.
Post-Market Surveillance
Once the device is approved and in the market, devices post 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 for devices post market.
Previously developed and validated methods can be used to continue quality control testing programs. EAG Laboratories has partnered with medical device and diagnostic companies to provide highly efficient and cost effective support in raw material quality control.
Medical device failure and performance concerns can occur once introduced to the market. EAG Laboratories has developed an investigative approach to failure analysis and we have expertise in the following materials:
Our Approach to Medical Devices and Diagnostics
An understanding of chemistry, materials and components combined with exceptional materials characterization expertise is required for successful diagnostic and medical devices verification programs. We have extensive experience in:
- Method development/validation
- Surface analysis and depth profiling
- Microscopy down to nanometer scale features
- Trace organic analysis
- Polymer characterization
- Metallurgical engineering
- Elemental analysis
Additionally, our scientists and engineers have access to a wide range of analytical capabilities including:
EAG has laboratories with GMP compliance, ISO 17025 and ISO 9001 certifications depending on the needs of our customers. This level of quality management combined with scientific expertise and capabilities offers a compelling solution to ensuring a successful regulatory devices submission.
We recognize the importance of having a broad range of capabilities combined and have technical experts available for discussion.
Would you like to learn more about using Medical Devices and Diagnostics?
Contact us today for your medical device and diagnostic needs. Please complete the form below to have an EAG expert contact you.