| Design requirement |
How the medical data module helps |
Design significance |
| Materials selection |
Covers nearly all types of plastic and thermoplastic elastomer used in medical devices today AND those not currently used. |
Rapid evaluation of almost all possible materials options – early in design to avoid requalification costs. |
| What materials are available in medical grades? |
Identifies materials available in ISO 10993 or USP Class VI grades, plus their tradenames. |
Enables faster and more certain regulatory approval of a device (FDA 501(k)) or a drug (NDA) |
| What materials are available in food contact grades? |
Identifies materials available in FDA 22 CFR 177, EEC/EU, NSF 51/61 or BfR food contact grades. |
Indicates the possibility of passing medical biocompatibility testing. |
| Sterilizability |
Sterilizability rankings for: Ethylene oxide (EtO); Steam autoclave; Radiation: gamma or electron-beam.
References and notes on the effect of degradation due to sterilization. |
This is an essential constraint for most medical devices. Disposables must withstand one or two cycles; other equipment repeated sterilization. |
| Transparent materials |
Broad coverage of transparent and translucent plastics. |
The healthcare industry attaches a premium to product transparency. It is essential for drug delivery devices, medical packaging, tubing, and fluid containers. |
| Durability to chemicals and UV light |
Chemical resistance ratings of materials to 190 chemicals; Environmental stress cracking (ESC) resistance index for thermoplastics; UV resistance ratings. |
Reduce recalls, redesign, re-approval. Avoid going down a material route where ESC (a common failure mode in plastic components) or degradation due to fluid environments or sunlight become problems. |
| Low temperatures |
Impact strength @ -30C; Minimum service temperature. |
Some medical devices are stored at deep freeze, dry ice, or even liquid nitrogen temperature. Screen out materials that embrittle at low storage temperatures. |
| Barrier properties or permeability |
Permeability to: Oxygen, water vapor, carbon dioxide (CO2), nitrogen (N2) |
Protect efficacy of packaged drugs and medical supplies in blister packs, bottles, containers, bags, etc. |
| Environmental impact |
Estimates for embodied and processing energy, CO2 footprint, recycling. |
Company environmental policies. Assist compliance with environmental regulation. |
| Mechanical, thermal, and electrical |
The full range of mechanical, thermal, and electrical design properties. |
Nearly all products have mechanical, thermal, or electrical design constraints. |
| Cost |
Relative cost of raw materials and forming processes. |
Cost reduction is an objective of nearly all product design. Cost avoidance early in product design is the most effective means to drive out cost. |