In the world of Indian physicians, the paucity of India-made high quality medical devices is a topic of much discussion. From a bulb in an operation theatre to a high-end biochemistry analyzer (used in tests for cholesterol, blood sugar for example) by a pathological laboratory, the dependence is largely on imported devices. “Studies have shown that 80 per cent of the medical devices across all specializations of medicine used in the country are imported. Most of them either from United States, UK, Germany or Japan and now increasingly also from China,” says R Krishna Kumar, Institute Professor, the department of engineering design at the Indian Institute of Technology (IIT), Madras.
He finds it unfortunate that most of the Indian producers are focused only on making cheaper alternatives where as what matters is really lower cost with greater accuracy and the ability to deal with India -specific problems.
“The problem is of economy, technology and the regulatory maze. We seem unable to produce a product that is as good as, if not better and cheaper, than an imported product. Today, the medical devices industry is in the same space as that of the auto industry in the India of 1970s. What is holding us back is lack of background technology and the manpower.”
Era Of Convergence
To him this a new era of convergence of various sciences. But still, he says, “there is very little linkage between the engineering stream and bio-medical education. We need domain knowledge for say design of implantable devices and for this need expertise armed with the domain knowledge and backed by good, vibrant courses suited for engineers.” Today, he says, “there is little awareness of the way engineering and medicine have aligned. These are times where the work of an allopathic doctor is crucially linked to the developments in the field of engineering. Most, from diabetologists, pathologists to surgeons, all use medical devices or a biomedical product.”
He is trying to do this by his own example and says: “I am teaching a course on anatomy and physiology and they in a sense involve a lot of engineering. My point is heart, that crucial electro-mechanical pump of the human body, is a delight of an engineer and a nightmare for a clinician. I have been working on cardiac mechanics for 25 years. It is important to build the domain knowledge and convert it into knowledge that can be accepted by students.” In this journey, he says, the “mindset for quality should be inbuilt.”
The need for India-made high quality medical devices, is imperative all the more today, the professor says. “In the light of the pandemic, the set of requirements have shifted. Be it around remote care and remote diagnostics and in newer areas where we do not have solutions and need to leverage technology.” The professor who is focused also in the area of “convolutional neural network, which he describes very simply, “as one that forms the basis or the underlying algorithm for all the artificial intelligence tools that are being developed.” All of it, he feels, need to be done while staying mindful of the fact that AI cannot replace doctors.
For The Masses
There are areas where India can carve out a niche, he says, “we need to be that differentiator globally for devices that are diagnostic tools for the masses such as say one that can help predict heart attacks with the help of a device? India made-high quality handheld ECG devices. These he says need to be such that they can pass the US Food and Drug Administration (USFDA) regulations and are not just fad-inspired gadgets or handheld devices.
To him, part of the problem is also the hazy regulatory pathway. “We need to do lot more on regulations for the medical devices industry. These are still regulated under the drug controller. There is need for clear guidelines and understanding and along with a well-established devices division.” This, he says, should be with people who have deep domain knowledge and ensure a dynamic organization or one that is able to keep pace with the changing times and needs. “It should be led by subject expects, who also act as enablers rather than just being an approving authority.”
Today, he says, “we are in an era where even USFDA has categorized even a software is a medical device and this will enable approval tools like AI for diagnostics.” While this may be the new area, he give another example of a coolant that is used in any biomedical device and how that also has to have a stringent standard.
Investment & Volumes Play
Kris Gopalakrishnan, the co-founder of Infosys and a leading name from India investing in research and supporting efforts in many frontier areas of research such as brain research, feels one of the reasons that perhaps is an impediment is that “precision manufacturing is a challenging are from an investment and volume perspective.” It tends to be capital intensive and in the medical field also involves use of proprietary technology. He does not see it as a capability issue but more as a problem of precision manufacturing that caters to high volumes and feel India has been able to achieve that in the automotive industry. All eyes are now on the path ahead on medical devices given the long distance ahead.