It’s usually people who quit regular jobs to follow their passion make news; but here is somebody who moved from a government organisation to the business sector to pursue, quite literally, matters of the heart!
Professor AV Ramani is unusual by any standards. Educated to be a chemical engineer with a wide knowledge of material sciences, he taught metallurgy at IIT, Madras. Also experienced with electrochemical technology, he put in 11 years, from 1968 to 1979, at National Aeronautical Laboratories (NAL), Bangalore, where he became conversant with non-conventional processes like spark erosion.
What would all that knowledge be focused on? One amazing product… a completely indigenous heart-valve, to market which he moved to Bangalore.
What are the origins of this heart valve, and what are Prof. Ramani’s associations with it? How did the process of manufacturing and marketing move to Bangalore? These were the questions I asked Prof. Ramani.
“To begin the story, we must go back to when Dr. Valianathan, an orthopaedic surgeon who trained in the US as a cardiac surgeon, found that in India, 6 out of every 1000 children had rheumatic fever, which resulted in permanent damage to their heart valves,” says Prof. Ramani. “A figure of 6 per 1000 may not sound frightening by itself, unless you realise that with our population, it means millions of children with permanent heart damage.
The imported heart valves that were available were very expensive indeed, costing from $800 to $1100 each; well beyond what the average family in India could afford. So Dr. Valiathan came back to India in the early sixties, and joined IIT, Madras, in the bio-medical activity, where he came into contact with Prof. Ramaseshan. But since, at the time, medicine and engineering were hardly finding a meeting point, the doctor went back to Trivandrum, Kerala, where the Chitra Medical Centre was being set up under the state government. Here he started work on developing the heart valve so that he could accomplish both import substitution and directly help the children from the economically weaker sections of society.
Dr. Valiathan became the first Director of the Advisory Committee to the Chitra Thirunal Institute (CTI) and Prof. S. Ramaseshan was the Chairman of the Committee. Prof. Ramani, at the time, was working in NAL, Bangalore, under Prof. Ramaseshan.
Prof. Ramani had already been working with aerospace materials and machines in NAL. Titanium and aerospace alloys were difficult to machine (yes, it is the correct expression) on conventional machines, and when the question of developing the indigenous heart valve came up, he was a natural choice for the job. Dr Valiathan approached him and Prof. Ramani moved from Bangalore to Trivandrum, quitting his NAL post, rather than try out the job for a year, as was suggested. For 11 years, from 1979 to 1990, he worked at the Chitra Thirunal Institute with his team trying out various materials and designs for the heart valve. “It is not often that one has an opportunity to work on something that will directly alleviate some problems of poor people,” he says. “Children from the poorer section of society are the ones affected by the rheumatic fever and the resultant heart valve damage when they are not treated properly for the fever.”
From the very beginning, Prof Ramani and his colleagues decided that the development of the valve would conform to all international standards. “Yes, this was a much lengthier procedure because of this decision,” he shrugs. It was also, at the time, unknown for a hospital to take on the kind of precision engineering activity invovled in creating a heart valve. The institute, he says, had state-of-the-art facilities set up for this endeavour and for whatever they lacked, he says, “We knocked on every door, and every door opened!” Organisations like the Department of Atomic Energy and Council for Scientific and Industrial Research (CSIR) realised the potential of developing an indigenous, cost-effective heart valve and pitched in.
“This was also possible because of another far-reaching decision we took,” says Professor Ramani. “We decided that the intellectual property of a contribution by any institution helping us would remain their own, and credit would be given always, wherever it was due; where there was joint activity, the intellectual property would be one of joint ownership.” The knowledge that CTI would always credit their contributions made every institution and every scientist keen to contribute, and the synergy built up.
Another important feature was that the valve was designed specifically for the Asian population and not the Western. The heart chambers in Asian people are different from those of the western hemisphere and, hence, valve dimensions would also be different. This meant that acceptance of the valve was likely to be much greater in patients. It was a difficult and an un-trodden path, but Prof. Ramani and his team decided that it was the way to go. Some of the hurdles were truly heart-breaking. To cite one of them; one single-crystal sapphire disc was found to be very biologically-and blood- compatible. It passed all the stringent engineering trials and was implanted in animals. Just before applying it for controlled human trials, two of the sheep died, and it was found that the disc had fractured. So, it was back to the drawing-board at this late stage and another material had to be thought of.
Since Prof. Ramani had already been working with aerospace materials, he says, he thought of using these materials to design the disc in a titanium cage. “The comparisons between inner space and outer space are just astonishing as regards to the materials needed!” he exclaims. For both applications, we need material that has a very long life, is wear-resistant, and does not absorb water.”This similarity in requirements,” he says, “never fails to amaze me.”
The heart-valve cage is made from what is called Haynes’ Alloy; it is a titanium-based metal cage (see picture).
The heart valve disc is now made from something referred to as UHMW HDPE (Ultra High Molecular Weight High Density Poly Ethylene). It is a material which has the properties of wax, so it is blood-friendly and wear-resistant. “It is worth remembering,” points out Prof. Ramani, “that the life of the heart valve IS the life of the patient”. The human heart beats about 80,000 times a day. For even a ten year life-span, the valve would have to function for at least 400 million cycles, which means a very high-precision engineering requirement, and, because the heart valve, typically, would be surgically implanted in younger people, it needs to be something that would last for a ‘normal’ lifetime. “We are talking about a long mechanical life, lasting for about 4000 million beats of the heart,” he says, “that’s about 40 years of life in human terms”.
“Indeed,” adds Prof. Ramani, “we at T. T.Krishnamachari and Co. (now usually called TTK, which he joined in 1990) now have a US patent on use of this material as a heart-valve disc.” Other uses of this material are in very high-wear, long-life situations, for example, as lining for chutes loading iron ores in ships.
The time came, when, after several frustrating setbacks, the heart valve was finally ready. By late 1970, it was marketed by the Technology Proving Centre. TTK was involved in the marketing process, too. However, the technology was fully transferred to Bangalore before Prof. Ramani moved to the city in 1990, to begin marketing it on a commercial scale.
At this point, the Chitra Thirunal Institute had set up a cardiac operating theatre and having gone through stringently controlled human trials, and the valve having passed these tests, it helped that several top teaching colleges in India- JIPMER, AFMC Pune, GKNM Kuppuswamy Naidu Memorial Hospital in Coimbatore, and CTI itself- agreed to substitute the indigenous valve for the imported one. This was entirely because of the fact that international standards had been followed all along in the development of the product. When these went well, more and more hospitals started using the indigenous valve in cardiac surgery, rather than the imported, expensive one.
Prof. Ramani had accomplished half his task now. The indigenously developed heart valve that was suitable for the Asians with a fraction of the cost of the imported valves, and which would alleviate the suffering of many poor patients, was ready. But how to scale up the production to industrial levels and market it across India?
Serendipity once again played a part; two Presidents of India, says Prof. Ramani, were very keen on the work being done for the heart valve; Dr Abdul Kalam and K R Narayanan. The latter was a great personal friend of Dr. Ramaseshan! It also helped that the Chairman of the TTK Group, TT Jagannathan, was once a student of Prof. Ramani at IIT Madras.
So the bond between CTI and the TTK group was sealed. Prof. Ramani moved to Bangalore, which is the corporate headquarters of the TTK group, with the promise of a free hand to develop and market the product as he liked- a promise, he says, that the TTK group has staunchly stood by for 20 years.
The indigenous heart valve, developed at the Chitra Thirunal Institute, Trivandrum, and manufactured and marketed by TTK, consists of a cage made of Haynes’ Alloy, and a disc that is now made from UHMW HDPE (Ultra High Molecular Weight High Density Poly Ethylene), a material which has the properties of wax, and is hence extremely blood-friendly. Both materials are also very wear-resistant.
TTK already had a healthcare company in the group which was involved in the grassroots marketing of products like condoms, latex gloves and so on. The heart valve unit was set up as a separate manufacturing and marketing entity under the TTK umbrella.
Bangalore, a city known for its skills in the aerospace and fine engineering. before it became an information technology hub, was the ideal location for this effort. Today, the indigenous heart valve is marketed across the country and is also exported to Thailand and South Africa. It is a commercially viable product. It is that rare combination of ethical manufacturing and good marketing which makes for good business.
The indigenous heart-valve marks an epochal meeting-point of medicine and precision engineering- one, an intuitive practice, and the other a finely-specified, low-tolerance branch of human endeavour. TTK, Bangalore, with Prof. Ramani and his team having put in gigantic efforts to develop the valve, has taken up the major challenge of making this boon to the Indian cardiac patients not only easily available, but also a commercially-sustainable product. Truly, the story of the heart valve is one of merging several skills and abilities. It is a living proof of how academicians, government officials and business people can work together with great synergy to bring out a product that is both profitable and beneficial.