Medical devices and diagnostics enable people to have longer, healthier, and more productive lives. Medical devices are considered different from drugs by many. Though both are used to treat diseases, there are certain differences which make devices a complimentary segment of the healthcare system. Medical devices are regulated, whereas developed countries like US, UK, Australia, Japan, and Canada and developing ones like Brazil, South Korea, Malaysia, Taiwan, Mexico, and Russia are gradually blurring the lines between medical devices and drugs in the best interests of patients.

In fact, the random and arbitrary application of the rules for drugs to medical devices stands as a threat to the development and quality of, and access to, medical devices. Also, the duality of the regulatory framework has restricted the growth of the device industry, thereby blocking access to essential therapies in many countries.

Medical practice cannot thrive without medical devices. There are over 14,000 different product types such as adhesive bandages, drug delivery devices, diagnostics, implanted cardiac, cardiovascular, and neurological devices, stair-walking wheelchairs, robotic surgical systems and magnetic resonance imaging devices falling under this category per Global Medical Device Nomenclature (GMDN).

Recent technical advances in medical devices have transformed healthcare delivery, improving patient care to a great extent globally. For instance, there is an increased interconnectivity between medical devices and other clinical systems. But this makes medical devices vulnerable to security threats, similar to other networked computing systems.