Evaluations completed on the product
| 1. Hydrostatic pressure testing for barrier performance | Barrier performance evaluation for all critical zones within metal and linen components of product, using pressurised testing with simulated blood |
| 2. Biological evaluation | Cytotoxicity testing, chemical composition of constituent materials, effects of manufacturing processes, effects of interaction between materials and contact with patient, material degradation and leachable substances |
| 3. Usability and human factors evaluation | Formal usability and human factors evaluation completed with nurses and surgeons to ensure ease of use while maintaining sterility, as well as validation of labelling and training materials |
| 4. Lifetime testing | Extensive lifetime and durability testing in high-fidelity simulated use environments to ensure linens and other components withstand the demands of in-field use |
| 5. Electrical evaluation | Third-party lab evaluations with QAI Labs to show electromagnetic compatibility, electromagnetic interference and leakage in line with requirements for medical devices |
| 6. Drill in-field use and warranty data | Analysis of warranty claims from Bosch and DeWalt over hundreds of thousands of drill devices in the field confirm electrical risk analysis results and safety |
| 7. Drill performance studies | Evaluations to ensure appropriate drill speed, torque, pull-out strength and overheating performance |
| 8. Bone drilling performance study | Evaluation of surgical drill and Arbutus Drill Cover System drilling into bone models by surgeons showed no statistically significant difference in hole size, accuracy, usability or time |
| 9. Steam sterilisation and cleaning validation | External lab testing with Nelson Laboratories to confirm and validate effectiveness of steam sterilisation protocol and instructions |
| 10. Clinical study | Clinical evaluation focused on usability showed preference over manual hand drills across 95 orthopaedic cases, showing a 30 min reduction time per case over manual drills |
| 11. Packaging performance evaluation | Verifies packaging performance for safety of shipping and storage |
| 12. ISO 13485 certified quality management system | All Arbutus products are designed, manufactured, stored and marketed under a carefully controlled ISO 13485 QMS as certified by the British Standards Institution (BSI) |
| 13. Comprehensive ISO 14971 risk management file | Arbutus Medical follows a rigorous ISO 14971 Risk Management process for ensuring safety and efficacy of all products |