Novel Materials and Manufacturing Research Program
Medical device materials undergo physical and chemical changes during total product life cycle (TPLC). Some examples:
- chemical reactions, separation/purification, temperature excursions
- microstructure changes, molding/extrusion, weaving
- 3D printing
Novel Materials and Manufacturing Research Program elucidates
- TPLC findings
- Relationship to Safety and Effectiveness (S&E) of device
- How seemingly minor manufacturing changes can lead to S&E changes
Image credit: FDA