Regulated industries are regulated with reason. Yes, it may hinder innovation however it is to ensure that the devices created are safe and effective for the general public. The regulations placed in the medical device industry are essential and necessary since anyone could potentially create a harmful device. Without these stringent rules, it would be much easier to get a product out without keeping the patient’s safety in mind. Clinical trials are necessary as well. I believe the FDA should look into optimizing the process which I believe they are trying to so that products can be released much quicker while satisfying the requirements. The trials are able to give valuable information regarding the future success of that product so yes it is costly and tedious but essential if the company truly cares about their patients and wants to produce great science.