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  1. CDRH Research Programs

Novel Materials and Manufacturing

Contact: Katherine Vorvolakos, PhD ; Irada Isayeva, PhD

Image of schematics that use color and shape to envisage novel materials

These schematics use color and shape to envisage novel materials with unprecedented design freedom in both geometric complexity and chemical properties. These new degrees of freedom present advantages and challenges in the creation of medical devices.

These schematics use color and shape to envisage novel materials with unprecedented design freedom in both geometric complexity and chemical properties. These new degrees of freedom present both advantages and challenges in the creation of medical devices.

Summary

The materials which make up medical devices and combination products undergo many physical and chemical changes during their total product life cycle (TPLC), comprising their comprising their formulation, manufacture, storage, deployment and use. From the selection of raw materials, to the implantation of a device in the clinical setting, to the long-term biological responses they inspire, materials may be subjected to some or all of the following:

  • chemical reactions
  • separation/purification
  • temperature excursions
  • phase and microstructure changes
  • molding/extrusion
  • weaving
  • 3D printing
  • imparting of anisotropy
  • creation of functional interfaces
  • washing
  • surface treatments
  • packaging/sterilization
  • degradation during storage
  • preps in the clinical setting
  • in vivo degradation

The Novel Materials and Manufacturing Research Program elucidates mechanisms that explain:

  • how each step in the TPLC relates to other steps
  • how each and every step relates to the Safety and Effectiveness (S&E) of the medical device or combination product

These complex relationships mean that seemingly minor manufacturing changes can lead to significant changes in S&E. Our research identifies and addresses existing and questions which focus on medical devices and combination products:

  • made from soft polymeric materials (e.g., elastomers and hydrogels), such as tissue bulking agents and surgical sealants;
  • the structure and function of which rely on the creation of interfaces (where interfaces are recognized as new material entities), such as products made via additive manufacturing and held together by voxel interfaces;
  • made from materials which may be used for tissue regeneration;
  • which degrade in vivo, such as degradable stents and tissue scaffolds, onto which cells adhere.
  • the bulk and surface properties of which serve different functions, as in hydrophilic-coated intravascular devices and anti-thrombogenic blood-contacting devices;
     

Relating manufacturing process steps to the physical properties, chemical signature and biological response of the final medical product will yield knowledge that will be incorporated into FDA guidance documents and FDA's interpretation of international standards.

Current funding sources

External collaborators

  • Stony Brook University
  • University of Akron
  • Tufts University
  • Biocoat

Personnel

  • FDA Staff:
    • Katherine Vorvolakos
    • Dianne Godar
    • Irada Isayeva

Resource facilities

  • Seraph Robotics Fab-at-Home Printer
  • Rame-Hart Goniometer
  • AR-G2 Rheometer
  • OSEL Microscopy Suite
  • Gel Permeation Chromatography
  • High Pressure Liquid Chromatography
  • Mass Spectrometry
  • Attenuated Total Reflection-Fourier Transform Infrared Spectroscopy
  • Sotax USP 4 Dissolution Apparatus
  • Varian 400-DS Dissolution Apparatus 7
  • Differential Scanning Calorimetry

Relevant standards & guidances

Selected peer-review publications

  1. Sudhanva R. Govindarajan, et al, A hydrophilic coumarin-based polyester for ambient-temperature initiator-free 3D printing: Chemistry,rheology and interface formationdisclaimer icon, Polymer (2018), doi: 10.1016/j.polymer.2018.06.014 
  2. Dianne E. Godar, 3D Bioprinting: Surviving under Pressure, "Tissue Regeneration," 978-1-78923-261-5, http://dx.doi.org/10.5772/intechopen.73137
  3. Anne Lucas, et al , Solvent or thermal extraction of ethylene oxide from polymeric materials: Medical device considerations J Biomed Mater Res B Appl Biomater. 2017 Dec 11 doi: 10.1002/jbm.b.34052
  4. Liudi Zhang, et al. The influence of surface chemistry on adsorbed fibrinogen conformation, orientation, fiber formation and platelet adhesion Acta Biomater. 2017 May;54:164-174
  5. Katherine Vorvolakos, et al. Dynamic interfacial behavior of viscoelastic aqueous hyaluronic acid: effects of molecular weight, concentration and interfacial velocitydisclaimer icon. Soft Matter, 2014,10, 2304-2312. DOI: 10.1039/C3SM52372A.