Moving from a working prototype to 1,000 medical devices requires careful planning, reliable suppliers, suitable materials, quality testing, and manufacturing decisions that support consistent production. A working prototype is a big step. It shows that your idea can work. But can you make the same device 1,000 times without losing quality? That is a different challenge. This is where many teams get stuck. A part that was easy to 3D print may cost too much to mold. A material