Lab Services & Materials Consulting

Chemical characterization of extractables and leachables (E&L) is a critical part of medical device biocompatibility assessment. Our industry-leading technology ensures accurate and efficient E&L testing. We have more than 40 years of experience with complex polymer systems, which gives us a unique perspective on E&L testing. Today’s medical devices are often very complex and contain a variety of different polymetric materials. Our deep polymer knowledge allows us to make better identifications and avoid unknowns.

We have extensive knowledge of the appropriate testing recommendations and play a lead role in improving standards as members of both the Association for the Advancement of Medical Instrumentation (AAMI) and International Organization for Standardization (ISO) committees. We also have vast FDA experience. We routinely partner with our study sponsors and provide experts to support discussions with FDA and other notified bodies.

Our approach minimizes the effects of response factor variation. Many other laboratories use methodologies that can produce errors in concentrations and identifications.

Leadership in medical device E&L analysis

• Proprietary, multi-detector approach
• Strong publication record with frequent citations by regulators
• Best-in-class identification experience to eliminate unknowns
• More accurate quantitation

Strong polymer expertise

• 40+ years of deep polymer deformulation experience
• Extensive databases

Quality control with well-developed and validated analytical methods

Our biological evaluation team guides you through the complex evaluation process to get devices onto the market. We recommend the best materials for your device based on our biocompatibility expertise and deep understanding of polymer materials.

We also provide all testing outlined by ISO 10993 standards, as well as biological evaluation plans and risk assessments for developed devices. For biological evaluation plans, we use our chemical characterization testing experience to provide study design and justification. Finally, we provide toxicological risk assessments as outlined in the ISO guidance. 

Product development strategy in the material selection and biological evaluation process

Biological evaluations at the pre-clinical evaluation stage

• In vitro and in vivo tests
• Biological evaluation plans and risk assessments for final products
• Chemical characterization study design and justification

Toxicological risk assessments

• Risk assessment of extractables and leachables (E&L)
• Biocompatibility of novel medical devices for PMA, 510(k), and De Novo submissions
• Analytical groundwork for pharmaceutical and biologics product registrations

Regulatory submission support for biological evaluation data

• Pre-submission and submission issue support
• Justification of chemical characterization study approach
  
  

We have more than 40 years of experience performing analysis of polymeric materials – including failure analysis, material and additives identification and molecular weight characterization. We facilitate full product deformulation using quantitative and qualitative analysis. 

Our fully equipped laboratory includes chromatography, microscopy and spectroscopy tools. We have more than 60 analytical techniques at our disposal to solve your most challenging problems. We routinely develop new processes based on the most advanced analytical methods to provide novel solutions.

Polymer analysis expertise

• Polymer identification
• Molecular weight determination
• Additive package analysis
• Cracking and discoloration investigation
• Colorant analysis

Particle and contaminant characterization

• Microscopy and image analysis
• Inorganic and organic particulate

Widest range of analytical capabilities

• More than 60 analytical techniques
• Small and large molecule capabilities
• Method development and validation

Our product deformulation services ensure lot-to-lot product consistency, including compositional assessment and additive levels. We also help evaluate material suppliers to confirm conformity and troubleshoot manufacturing problems. Additionally, we perform market research using deformulation techniques to investigate competitive products. Our data is frequently used to support legal teams handling patent infringement cases. 

Method validation and transfer can be performed for routine analysis as well.

Lot-to-lot consistency

• Confirmation of ingredient identity
• Additive levels
• Polymer composition

Supplier investigations

• Confirmation of batch conformity
• Troubleshooting material failures

Competitive product analysis

• Patent infringement
• Market analysis