“Yearning for attention!”

Identified often with pharma rather than as a separate entity, the medical devices industry has been long awaiting its own set of regulations as well as recognition


Meanwhile, catching up latest global trends, the technologies in India too are fast moving from labs to the patient's bedside. BioSpectrum tries to find out the latest in this segment.

Access to quality healthcare in India needs to be expanded, and that is not possible without increasing access to medical technology which is a crucial pillar in the healthcare sector. Broadly categorized into two categories, capital equipment, and implantables or what few may call consumables, India's close to $3 billion strong medical devices market is growing at a rate of 15 percent per annum, promising immense potential. As healthcare is also a top priority for government, the industry has also been making many efforts to better explain the medical devices industry and the value of medical technology to patients and the population in general.

We are different please!

Industry insiders feel that with regards to pricing and reimbursement, there is a need to treat medical devices separately. "Compared to pharmaceuticals, medical devices (that include invitro diagnostics) are an extremely diverse group of products. Some are as simple as adhesive bandages, tongue depressors, and plastic tubing. Others are complex, for example, implanted cardiac, cardiovascular, and neurological devices, stair-walking wheelchairs, robotic surgical systems, and magnetic resonance imaging devices, opinions Ms Abby Pratt, associate vice president, Global Strategy & Analysis, AdvaMed, "In contrast to single-molecule drugs, many complex devices involve a number of components that, together, form a system. Given the diversity and complexity of medical devices as compared to pharmaceuticals, outcomes of the use of medical devices often depend directly on the skill or experience of the user."

Another point that is highlighted by experts is in terms of the industry composition, over 80% of the medical devices industry is comprised of small and medium sized companies (SMEs) whereas the pharmaceutical industry is dominated by a few very large multinationals.
The active components of medical devices are generally based on mechanical, electrical, and materials engineering. Many medical devices incorporate and are driven by software. In contrast, pharmaceuticals are based on pharmacology and chemistry, and increasingly encompass biotechnology and genetic engineering. In recognition of these dramatic differences, pharmaceuticals and medical devices are regulated separately in all major markets across the world.


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