Requirements and architecture
Translate clinical workflow into measurable inputs, then connect them to shaft regions, materials, reinforcement, transitions and interfaces.
Manufacturing methods
Understand reflow, bonding, lamination, tip forming, marker placement, tooling and the sources of process variation.
Testing and transfer
Build a line of sight from design intent to bench methods, risk controls, verification evidence and repeatable production.
A useful next step
Share a non-confidential summary of the application, development stage, current architecture and most important uncertainty. From there, the appropriate review, analysis or training scope can be identified.
This content is educational and is not medical advice or a substitute for applicable quality and regulatory requirements.