The development of a medical device, unlike that of a new drug, typically goes from concept to market in just five years. The process has many regulatory hurdles that must be overcome to ensure that medical devices are safe and provide a benefit to the patient.
Typically, the development process starts in a lab where initial research and development is conducted and a prototype is developed.
After a prototype is first developed it then goes into preclinical testing. Steps 1 and 2 can be repeated a number of times so as to modify and improve the function of the prototype in the laboratory setting.
Only after these initial steps have been completed are new medical devices considered for clinical studies. These studies are held in order to demonstrate the device’s safety and effectiveness and to collect the necessary evidence required for regulatory approval.
Regulatory approval needs to be obtained before a product can be launched for more widespread use. The specific regulatory requirements depend on the complexity of the device and the geographical territory. In the EU the CE Mark is required while in the USA a device requires FDA approval prior to being launched for more widespread use. The UK is in the process of developing its own regulatory process for medical devices post-Brexit.
After the product is launched it can be used more widely in patients. It continues to be rigorously monitored and tracked by both the manufacturer and the regulator in order to ensure the continued effectiveness and safety of the product.