Tools and techniques to deepen understanding of your device performance
Identify coating risks early and generate submission-ready data to avoid delays
Reduce global regulatory submission risk with clear, defensible data insights
Avoid costly rework and delays through proactive analytical testing
Traditional Medical Device Testing Labs
Surmodics Analytical Testing for Medical Devices
Risk it Addresses:
Undetected defects that may lead to failures
Objective:
Quantify coating structure, uniformity, and adhesion at microscopic and molecular levels
Capabilities Include:
Field Emission Scanning Electron Microscopy (FE-SEM) with EDX/EDS
Optical and digital microscopy (5x - 2000x)
Confocal Raman microscopy
FTIR microscopy and spectroscopy
What This Enables:
Identification of coating defects, inconsistencies, and contamination
Detection of substrate variation that may impact coating adhesion
Measurement of coating thickness and layer structure
Bringing multiple tools and techniques together to find solutions
Risk it Addresses:
Unexpected performance issues under real world conditions
Objective:
Evaluate device and coating performance under clinically relevant conditions
Capabilities Include:
Simulated use testing for medical devices aligned to clinical applications
Friction and lubricity testing
Durability and device tracking performance evaluation
Particulate testing and quantification
What This Enables:
Assessment of coating performance under representative use conditions
Generation of particulate data to support regulatory submissions
Identification of potential performance risks prior to commercialization
Risk it Addresses:
Unknown material or particulate sources that delay global regulatory approval
Objective:
Understand material composition and its direct impact on coating and device performance
Capabilities Include:
FTIR spectroscopy and microscopy
Nuclear Magnetic Resonance (NMR) spectroscopy
UV-Vis spectroscopy
Viscometry, density, and percent solids analysis
Chromatography (HPLC, GC, GPC/SEC)
Thermal analysis (DSC, TGA)
What This Enables:
Chemical identification of particulates for regulatory submission
Evaluation of coating formulation consistency
Correlation between material properties and coating performance
1H-NMR Spectrum (400 MHz; 300 K) of a Pebax 40D resin in deuterated trifluoracetic acid/deuterated chloroform (TFA-d/CDCl3; 3/1 ratio)
1. Terathane segment (methylenes next to a terminal hydroxyl)
2. Terathane segment (methylenes near the ester/nylon linkage)
3. Terathane segment (methylenes near the ether linkage)
4. Nylon alkyl methylene nearest the amide linkage
5. Nylon alkyl methylene C2 from the amide linkage
6. Nylon alkyl methylenes – identity not confirmed
7. Terathane segment (interior methylenes)
8. Nylon Alkyl Chain
Risk it Addresses:
Variations in the performance and composition of device coatings with active ingredients or biological interactions
Objective:
Addressing composition and performance critical quality attributes related to your device
Capabilities Include:
Drug content, uniformity and morphology testing
Residuals and impurities testing
Elution testing
Thrombin Inhibition Testing
Fibrinogen Binding
What This Enables:
Device characterization for development optimization and regulatory submission
Iterative, cross-functional feedback to reduce cycle-time
Holistic understanding of a device instead of a narrow focus on one aspect of performance
Reduce design and material risk early.
Coating thickness and uniformity analysis
Coating performance testing under controlled conditions
Material compatibility and formulation validation
Reduce regulatory uncertainty.
Simulated use testing for medical devices
Particulate testing for FDA 510k, PMA and global regulatory submissions
Chemical identification of particles
Reduce quality and field performance risk.
Coating adhesion testing and failure analysis
Contamination and substrate evaluation
Root cause identification and corrective direction
Challenge:
Coating failure on a polymer substrate with no visible defects
Risk it Addresses:
FTIR spectroscopy and microscopy used to evaluate surface composition across the device
Outcome:
Identified hidden substrate variation before it caused validation failure
Corrective action defined to restore coating adhesion
Challenge:
Requirement for precise measurement of coating layers
Risk it Addresses:
SEM with preparation for cross-sectional analysis
Outcome:
Coating layer thickness measured and documented
Data used to support design evaluation
Challenge:
Requirement for particulate counts and chemical identification
Risk it Addresses:
Simulated use testing combined with light obscuration and spectroscopic microscopy
Outcome:
Particulate dataset generated including size distribution and composition
Results used to support global regulatory submission documentation
Surmodics provides analytical testing for medical devices supported by experience in coating development, material science and derisking regulatory submissions. The Surmodics facility in Eden Prairie has hosted and trained FDA staff on particulate testing techniques and has supported
a broad range of FDA and global regulatory submissions. This experience allows them to develop testing approaches aligned with regulatory expectations.
This allows our team to:
Investigate coating performance at the material and surface level
Interpret analytical data within the context of coating behavior
Provide technical input to support next steps in development or validation
Defined scope testing for specific performance or material questions
Multi-test studies supporting development and validation
Analytical testing aligned with regulatory requirements, including reporting and documentation
Coating performance issues identified late in development can lead to delays, additional testing, and increased cost. Analytical testing should provide clear insight into coating behavior and performance. Surmodics delivers the data and technical perspective needed to support informed decisions throughout development, validation, and commercialization.
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