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  1. CDRH Research Programs

Material Dynamics


David Saylor, Ph.D.


The goal of this program is to support the regulation of medical devices by advancing our knowledge of the internal dynamics of device materials that dictate their biocompatibility and stability. The research combines experimental measurements and multi-scale computational models to address the many regulatory issues governed by transport and degradation processes, such as corrosion and metal ion release, leaching of additives or manufacturing residuals in polymeric materials, hydrolytic and oxidative degradation, barrier properties, and drug delivery. Because these issues are ubiquitous in device applications, this research impacts a wide range of medical device areas. The current areas of focus include: 1) potential patient exposure to additives and impurities in polymeric device materials, 2) leaching and biokinetics of nickel released from device alloys, 3) degradation of polymeric components in cardiac implants (both intended and unintended), and 4) drug and infusion pump compatibility. These projects are conducted in active collaboration with several researchers both within the FDA and at other government and academic institutions and industry organizations.  

Dynamics of a tetracycline molecule in SIBS polymer

All-atom molecular dynamics simulation of a tetracycline molecule diffusing through poly(styrene-b-isobutylene-b-styrene) (SIBS) polymer.

Image of multi-scale model for nickel exposure

Multi-scale model of patient exposure to nickel released from nitinol (NiTi) cardiovascular devices. The model captures nickel transport at a hierarchy of length scales.

The tools and information derived through this research directly impact the regulation of medical devices. Validated multi-scale mass transport models developed by our group are used in regulatory decision-making and can reduce the testing needed to establish the safety and effectiveness of devices during pre-market evaluation. In addition, our efforts to elucidate and quantify potential degradation mechanisms and unintended interactions inform not only pre-market evaluations, but also potential post-market actions.

Current funding sources

External collaborators


Vaishnavi Chandrasekar, Ph.D.
David Saylor, Ph.D.
David Simon, Ph.D.
Eric Sussman, Ph.D.
Paul Turner, Ph.D.

Resource facilities

  • TA Instruments HP-TGA Sorption Analyzer
  • Q-Sense Quartz Crystal Microbalance System
  • TA Instruments ARG2 Rheometer
  • TA Instruments RSA3 Dynamic Mechanical Analyzer
  • TA Instruments Q200 Differential Scanning Calorimeter
  • TA Instruments Q500 Thermogravimetric Analyzer
  • Waters Alliance V2000 Gel Permeation Chromatography system
  • ThermoFisher Liquid Chromatography Mass Spectrometer
  • Agilent Gas Chromatography Mass Spectrometer
  • Sotax USP4
  • Varian USP7
  • Nicolet Fourier Transform InfraRed Spectrometer
  • White Oak NanoCORE Facility
  • Biovia/Accelrys Materials Studio 

Public domain software

Relevant standards & guidance

 Selected Peer-Review Publications


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