The Materials Integrity Program involves characterization and performance testing of medical devices, made primarily of polymeric materials, for which there are unanswered questions regarding safety and effectiveness. The program develops a better understanding of relationships between materials processing and performance, incorporating mechanisms of device function and failure into test methods to provide realistic evaluations of medical devices, reduce the potential for clinical failures, and improve product quality control. The regulatory impact of this work is the development of standards and guidance, simulating actual performance, resulting in a minimum set of regulatory test requirements specific to the clinical behavior of the device.
Currently there are three research projects underway in the materials integrity program. The first project is determining protocols for condom/lubricant testing, reflecting the interactions between over-the-counter (OTC) personal lubricants with latex rubber and polyurethane materials and how these interactions affect permeability of bacteria and virulent disease. The second project is to determine appropriate wear characterization for orthopedic devices to permit establishing minimum requirements for clinically relevant test methods (e.g., pin-on-disc (POD) wear testing, guidance for safety/effectiveness data on pre-market orthopedic device submissions). The third project is to assess the drug delivery of drug coated balloons (DCB) to provide guidance on test methods and standards, evaluation of manufacturing quality as well as assessment of drug elution from these combination devices.
Coating process of a drug-coated balloon.
Male condom before and after exposure to mineral oil, showing material changes.
Current funding sources
Center for Drug Evaluation and Research
Office of Women’s Health
Srilekha Sarkar Das
- Dynamic mechanical analyzer
- Differential scanning calorimetry
- Fourier transform infrared spectroscopy
- Optical microscopy
- Scanning electron microscopy
- Atomic force microscopy
- Mechanical testing
- Pin on Disc wear testing
- Ultrasonic coating
- Electrospray coating
- Air brush spray coating
- High Performance Liquid Chromatography
- Dissolution Apparatus
Relevant standards & guidances
- American Society for Testing and Materials (ASTM) D7661-10: Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
- ASTM D6342-12: Standard Practice for Polyurethane Raw Materials: Determining Hydroxyl Number of Polyols by Near Infrared (NIR) Spectroscopy
- ISO TC 157: Non-systemic contraceptives and STI barrier prophylactics, WG 17
- ASTM round robin testing of UHMWPE crystallinity by DSC
- ASTM Total Disc Replacement Impingement Standard Test Method
- Vascular device drug combination products guidance
- Guidance on joint arthroplasty made of UHMWPE blended with vitamin E
Selected peer-review publications
- S Sarkar Das, et al, Controlled Initial Surge Despite High Drug Fraction and High Solubility, Pharmaceutical Development and Technology, 10837450, 2016
- Martin McDermott et al. Application of Quality by Design (QbD) Approach to Ultrasonic Atomization Spray Coating of Drug-Eluting Stents. AAPS PharmSciTech 2015. doi 10.1208/s12249-014-0266-9