The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.
A T-handle has been designed to be used for minimally invasive implantation of a dynamic hip screw to repair fractures of the proximal femur. It is capable of being used in two actions: (i) push and hold (while using an angle guide) and (ii) application of torque when using the insertion wrench and lag screw tap. The T-handle can be held in a power or… (More)
Pedicle screw (PS) malpositioning rates are high in spine surgery. This has resulted in the use of computed navigational aids to reduce the rate of malposition; but these are often expensive and limited in availability. A simple mechanical device to aid PS insertion might overcome some of these disadvantages. The purpose of this study was to determine the… (More)