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What are Medical Devices?

What are medical devices?

Medical devices are central to medical practice, although they are often lesser known to the public and policymakers than other products including pharmaceuticals. According to Global Medical Device Nomenclature (GMDN), 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. Medical devices and diagnostics allow people to live longer, healthier and more productive lives. 

The difference between Drugs & Devices

In India, the most common misconception about medical devices is that they are the same as pharmaceuticals. For example, only six percent of survey respondents believe that devices are different from drugs, a misconception that stems from the fact that both are used to treat diseases. However, as the table below highlights, the two are very different:

 

Medical devices

Drugs

Diversity

Extremely diverse group of products involving a number of components.

Single-molecule drugs

Scientific disciplines involved

Active components are generally based on mechanical, electrical, and materials engineering.

Based on pharmacology and chemistry, and increasingly encompass biotechnology and genetic engineering.

Product development

Typically have a short product life cycle (18 to 24 months) and investment recovery period. Even in early stages, market competition is intense.

Typically have a long commercial life-cycle (10-20+ years), during which they do not undergo significant changes.

Patent structures

Due to the wide variety of structures and technologies embodied, many different patents cover a single medical device. Thus, patents are not the basis for competition and do not confer market exclusivity.

There are typically very few patents for individual pharmaceutical products. Patents form the basis of competition.

     

The crucial differences between devices and drugs make the former a distinct and complementary segment of the healthcare system and are fundamental to understanding the other misconceptions.

In India, medical devices are regulated as drugs. This is not just a matter of semantics. Other countries, both developed ones like the US, UK, Australia, Japan and Canada and developing ones like Brazil, South Korea, Malaysia, Taiwan, Mexico and Russia recognise that the blurring of lines between medical devices and drugs is no in the best interests for patients.

The indiscriminate and arbitrary application of the rules for drugs to medical devices is a threat to the development and quality of, and access to, medical devices. Moreover, the ambiguity of the regulatory framework has stunted the growth of the device industry, thereby restricting access to essential therapies.