Abstract
For patients with moderate-to-severe erectile dysfunction, implantable penile prostheses continue to be a viable treatment. Medical device developers apply design controls during the development cycle to ensure that a product performs as intended in the final use environment. This process relies heavily on the principles of systems engineering and documents every facet of performance, unmet need, and risk. To better understand design philosophy, it is important to frame benchmarked performance outcomes in the context of the ideal state. Careful consideration of erectile anatomy and physiology, including flaccid state, transitional phases, and full tumescence, informs penile prosthesis design philosophy and provides the foundation for product advancement.