From IV to subcutaneous to oral: is this the natural evolution of a medicine?
Does treatment naturally progress from infusion to injection and finally to a tablet—or can digitally supported subcutaneous delivery be the better destination?
Systems engineering
Define product purpose, architecture, interfaces, performance and traceability across disciplines.
When dose delivery becomes Essential Performance
A practical interpretation of Essential Performance for electronically driven injection systems, and what engineers should specify, trace and verify.
Primary functions, essential performance and safety-related requirements
A practical framework for distinguishing device functions, essential performance, safety-related requirements and supporting quality attributes.