Prototype development and performance evaluation for a postoperative knee brace monitoring system
Medical devices are needed in order to provide optimal care for patients and the most accurate and beneficial information for medical professionals. There are many important factors to consider throughout the conception and development of a medical device. There must be a thorough understanding of the problem, followed by an iterative design progression before the product is tested and validated. This paper will explore these processes through the creation and verification of a wearable medical device. The subject device is an attachment to a postoperative knee brace for patients who have undergone total knee replacement surgery and it is intended to measure the range of motion (ROM) and total knee cycles (TKC) of the knee during the patient’s recovery process. The purpose of this paper is to understand the different steps and processes that are necessary in order to create an effective and therapeutically beneficial medical device. Although the discovery of problems and the conception and development of successful devices will be different for each medical device that is created, the general progression is standard. The process starts with traditional research in order to gain a complete understanding of the problem and identify any existing competitive devices. This is followed by a brainstorming process to determine various ways to solve the problem, accompanied by theoretical device designs that can be created and tested through computer software. After the initial design of the device is created, prototypes are made and thoroughly tested. Following pre-clinical testing, redesigns and post clinical testing, the device must be approved by the FDA. Once the device design is finalized, the tests are successful, and the device is approved, it can be commercialized. These steps are all essential in ensuring that the device is most beneficial for the patients and their medical professionals. The knee brace attachment that is the subject of this paper is presently going through design adjustments and testing and is expected to fulfill all of its original goals of providing medical professionals with ROM measurements and additional information to better enhance their patients’ postoperative outcomes.