Are we missing the big picture ?

Now-a-days, making claims of working on development of affordable healthcare devices has become more of a fashion statement and is seen as an easy route to gain visibility in the society. Though it attracts heavy funding from government, it is anybody’s guess how many such devices really translate into commercially viable market ready products and actually deliver in the field.

While not questioning the novel intent of people jumping into the bandwagon of affordable device developers, one won’t be really off the mark in stating that they do not necessarily address the needs of the masses where the word “affordability” actually matters. Take for instance, getting an ultrasound / MRI scan etc done is not cheap unless it is heavily subsidized and as a result, patients seeking to get these scans done in government run setups get wait periods starting from few days to months together.

Though healthcare services are offered by private setups at rates, often beyond the paying capacity of a common man, one cannot overlook the fact that most of the high end medical equipments are imported. Not only are they expensive to procure, their spare parts and related disposable accessories, if any, are sold at premium. And hence, one is at the mercy of the whims of the foreign manufacturer, irrespective of the service provider.

The only way to break the monopoly of the foreign players is by raising the barriers to entry into the Indian market through indigenous development of similar devices with no frills attached and making them mandatory to be picked up by the government run healthcare setups. While it is easier said than done, development of high end medical devices need involvement of good dedicated people both from science and engineering background to work in parallel with the medical fraternity. Though a sophisticated functional medical device cannot be churned out within a short time, with the right intent, a good team should be able to develop the same within a given time frame and a reasonable budget. It is not too unrealistic a target for Indian scientific community to achieve, if it is seen in perspective of the achievements of scientists in Indian Space Research Organization who have proven that there is no dearth of talent in India to deal with complex scientific problems. Another successful story highlighting the Indian talent is that of development of indigenous supercomputer Param when India was denied access to the Cray supercomputers initially by the US government.

Keeping in tune with our present Prime Minister Shri Narendra Modi’s “Make in India” campaign, the government should provide the right eco-system to train students and motivate them to take up research in fields where there is a requirement of certain gestation period in order to get good results. More integrated five year dual degree programs like the one offered by IIT-BHU should be introduced in various institutes. While the primary degree (BSc./BTech/BE) should be in a core field of science or engineering, the secondary degree (MSc./MTech/ME) in Biomedical engineering should constitute some core courses offered in medicine as well. It has been observed that students with a primary degree in Biomedical Engineering do not have strong foundation in any core (engineering / science) field in particular and it is the mishmash of subjects taught in such courses which make the student a jack of all trades and master of none.

While the tuition fees of such dual degree programs should be kept high to ensure the best of facilities, it should be ensured that the students after completion of such programs get immediately absorbed in government institutions for a fixed duration, something similar on the lines of short service commission offered by the forces. This would ensure that students are not left clueless about their future after the completion of the course or end up joining private firms at lucrative salaries and have jobs nothing to do with Biomedical Engineering. Raising the amount of grant in research fellowship is a welcome step in this direction.

While continuing with the present approach of inviting new project proposals, the government on its own should set targets where the specifications of the devices are well defined after consultation with the medical fraternity and subsequently the work delegated to institutes depending on their expertise. 

Facilitating smooth execution in a professional manner of high impact medical device development projects with proper audit at every step and providing the requisite support at any point of time to such projects, without allowing the ego of the people of various institutes to come into play will ensure that tax-payers’ money is well spent to make healthcare “affordable” in true sense.

What drives medical device development ?

There is a popular saying that “Necessity is the mother of invention” but it doesn’t seem to hold water in the “Medical Technology” domain. In a country like India where the healthcare setup is failing, one can easily identify substantial number of “Needs” which can be addressed through technology developed using the currently available infrastructure. Then why is it so that there is a drought of indigenously developed medical devices to address these “Needs”.
The diagram of a funnel is often cited to depict the various steps involved in filtration of “Needs-Identified” in order to successfully launch a medical device in the market. But then there has to be a driving force for the filtration to take place and a closer look will reveal that the driving force is fuelled mainly by the gravity of “Greed” rather than that of “Need”.
It is well known that the so-called filtration process gets influenced by the ability of the device manufacturer to translate the idea into a profitable venture, unless one is into philanthropy. Surely, no identified “Needs” are less important; otherwise it wouldn’t have caught one’s eye at the first place. However, the gravity of the “Need” is determined by the “Return of Investment” involved in addressing the “Need” in question.
Numerous technologies have been developed by the academia through research grants from government but there have been no takers for obvious reasons. The problem is universal as someone has rightly stated about the recently passed US Healthcare Reform Bill that no number of reforms would succeed in improving the healthcare scenario unless people stop being greedy.

Licensing Strategy: A conflict of interest

In the “Healthcare Technology” domain, introspection of the process of “Technology Transfer” from academia to industry would reveal a conflict of interest between the two respective parties. In order to prevent the monopoly of a single player in the market, usually the academia insists on “Non-Exclusive Licensing” of the medical technology developed utilizing government funds. And it quite often happens that due to lack of healthy competition, instead of putting in efforts for further refinement of the technology, the licensee would try to command a price in the market, eventually making it unaffordable for the common man to reap the benefits of technology coming out of government funded research.
Though the government’s policy is clearly aimed at protecting the interests of common man, this is viewed as a losing proposition by the industry because a potential licensee would never like to go for a “Non-Exclusive Licensing” of the medical technology for obvious reasons. No firm would like to have a competitor possessing the same technology in the market. Also, it is quite possible that if the new technology is perceived as a threat to the market of an existing product, then the technology owner of the existing product would try to seek an “Exclusive License” of the technology in question and then kill it by not taking it to the market.
This turf-war between the licensee and the licensor makes the industry go on back-foot while scouting for new technology churned out by the academia and ultimately, it is the tax-payer’s money which gets wasted when the technology developed does not move from the lab to market.

Instead of waiting for the industry to come forward, the government should take pro-active steps in harnessing the benefits of the technology developed. In this regard, the Ministry of Health & Family Welfare (MoHFW) can take a cue from the Ministry of Defence (MoD) where all the critical requirements of the forces are met by public sector undertakings (PSU) like BEL, BDL etc. Something on similar lines should be worked out where medical technology developed by academia through public funding, be taken up for translation into a marketable product by government run bodies. Marketing of these products should not be a problem as it can be made mandatory for the government run hospitals to be equipped with such indigenously developed products. Fortunately, steps in this direction have been initiated as demonstrated in the case of the technology for a “Syringe Infusion Pump” developed recently in All India Institute of Medical Sciences [AIIMS, New Delhi]. The related technology development in AIIMS was funded by the Ministry of Information Technology and later transferred to West Bengal Electronics [WEBEL] for further refinement and commercialization. It is envisaged that such initiatives may also generate new jobs indirectly.

Tackling apathy towards rural healthcare

The government has set up rural healthcare centres but they have failed to deliver because of lack of trained medical personnel and the reluctance of the undergraduate doctors to visit the rural areas as a part of their internship in their MBBS curricula.
To address this issue, the government is planning to award extra credits to the interns for the rural visits or enable them to graduate on a fast track mode. However, this process will not be helpful in long run as not many doctors are really motivated to serve in the rural areas and a job done half-heartedly does not really bring the benefits expected out of this program. Also, it is obvious that people used to city-bred life find it difficult to adjust to the rural setup and that too where there are no accompanied monetary gains.
A more logical step would be to tackle this problem at village level. As a part of the National Rural Health Mission (NRHM), one should visit the schools in rural areas and through lucid lectures / presentation, explain to the students as to how engineers and doctors can work together to provide a proper healthcare setup to their village. Then through a screening process testing their aptitude and academic performance, a few selected students should be groomed to take up medicine / engineering through scholarship in institutes of repute. Of course, proper mechanism needs to be put in place to ensure that the selected students do not drop out from the course mid-way and on completion of their courses / training, should go back to their respective villages to help run the healthcare centres already setup by the government.
It is envisaged that such a program would churn out trained people who would be genuinely concerned about the welfare of their village and hence, address the concerns of their community in a more efficient manner.

Concept of "Virtual Incubator"

It has been often found that people joining the government funded projects on contractual basis are not really motivated to work for the project, for the simple reason that they use it as a stop-gap arrangement to prepare for competitive examinations like IAS etc / to go abroad for higher studies / to use it as a source of income till a job of their choice is found. There is no sense of ownership which can keep the employees engaged for productive output. Also, as the project closure date approaches, being on contractual appointment, the project employees stop taking interest in their work and get busy hunting for new job opportunities.
Keeping in view the above scenario, it is proposed that each project funded by the government, be operated as a micro-enterprise incubated virtually in the “Scientific Establishment” and after the project tenure is over, the contractual employees working in that particular project be allowed to take the project forward as a spin-off, with the “Scientific Establishment” having a stake in that. This will not only make the contractual employees work as a team for the whole project duration but also motivate them to put in their best efforts to successfully commercialize the technology developed in the project.
While the researchers (scientists, engineers, professors) working in the “Scientific Establishments” have been empowered to claim an equity stake in such “Scientific Enterprises” during the course of their professional engagement with their parent organizations, the same may be extended to the contractual staff employed in the projects. This concept of “Virtual Incubator” would provide a better focus to the work done in the projects.

Technology to structure development

In a developing country like India, education, health and agriculture sectors have to work as brothers in arms to make an effective impact on the economy.
From the health point of view, since the majority of the Indian population is based in rural areas, the Government of India has the National Rural Health Mission (NRHM) in place to help increase the outreach of the healthcare delivery systems. Assuming that this mission is a success, one would expect the mortality rate to go down. Consequently, there would be not only an increase in the longevity of the population but also a steady growth of the population. As far as population is concerned, its growth has to be handled in such a manner that there are no deaths due to starvation whereas birth control measures should not lead to a dearth of “young working” population. So the two issues which come into forefront are that of imparting education to the young population and availability of food to feed the population.
There is no point in having a large uneducated population as they cannot be gainfully employed and unemployment is one of the key reasons for civil unrest. Also, not everyone is cut out for every sort of work. To maximize productivity, one needs to impart the right kind of education according to the capability of the person. For minimum level of education, the Government of India has launched the Sarva Shiksha Abhiyan and the National Rural Employment Guarantee Scheme (NREGS) to provide employment which is a not a self-sustainable model in the long run.
Availability of a “balanced diet” for the population is a big challenge for the Government. The National Food Security Mission (NSFM) had been setup but merely, providing food for survival is not sufficient, as it is a “balanced diet” which keeps a man healthy enough to be productive at work. With the existing Public Distribution Systems (PDS) for food and various schemes like mid-day meal for school going children and subsidized food for people living below poverty line (BPL), the government has not been really successful in achieving its goals due to rampant corruption prevailing in the country and lack of proper implementation of these schemes as they had been used as mere rhetoric for garnering votes.
In such a scenario, it is technology which can play a significant role in interweaving all the three sectors to have a synergetic effect. Merely having the latest technology is not the solution as one needs to innovate to make them adaptable for the ground users. But then social acceptance of such technologies is easier said than done in a country like India which has such a diverse population. One of the ways to achieve this is to tie-up technology companies with organizations like National Innovation Foundation (NIF) who scout around for innovative technologies at grass-root level. While business is the main driving force for the technology companies to innovate, the technologies developed at grass-root level are borne more out of necessity and have a local contextual outlook. It is the mating of the two ideologies which can together address the three sectors (health, education & agriculture) effectively as it has been found time and again that it is the user or the ultimate beneficiary who can provide the best solution or inputs to overcome the hurdles to their path of development.

Low cost medical device

It has been observed that often people tend to claim that the medical devices developed by them are cheaper as compared to the imported ones. One needs to look into these claims with a pinch of salt before up-scaling them for commercialization. Development of a genuine low cost medical device is ultimately all about innovation and requires lot of creative and technical thinking.
In India, sufficient technical and infrastructural capability is present to replicate the functionalities of some of the imported machines. But the machines can’t be really claimed to be low cost. Often during comparisons, people forget that the expenses involved in manufacturing and marketing a device requires lot of investment and all these get added up to the cost of the machine in the market and in business, the aim is to earn revenue unless one is into philanthropy.
If one strips down all these additional expenses, then one would find in most of the cases that the cost of the imported machine is controlled by the local market prices of the components. This can be appreciated from a simple example. Suppose, a machine designed in India uses standard UL approved components. If two such machines are built with one set of components bought from the US market and the other set bought from the Chinese market, one would find that though there won’t be any difference in functionality / quality of the two machines, both being built from UL approved components, the one made from the US components would be more expensive, simply because the Chinese components are cheaper. So, technically speaking, the device is not really low cost compared to its imported counterpart on a level playing field.