Innovative MedTech for Brighter Future

Innovation in medical technology is India’s need of the hour says, Sanjay Banerjee, MD, Zimmer, India and throws light on the essential focus points for the same

Sanjay Banerjee

Medical technology is essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. The achievement of all health-related development goals including universal health for all Indians depends upon proper manufacturing, regulation, planning, assessment, acquisition, management and use of medical devices which are of good quality, safe and compatible with the settings in which they are used.

Without medical devices, routine medical procedures from bandaging a wounded limb, to diagnosing malaria or implanting an artificial knee would be impossible.

In studies by National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad and PricewaterhouseCoopers, the medical technology sector in India was valued at $2.75 billion in 2008 and is expected to reach $14 billion in 2020 at a compounded annual growth rate (CAGR) of 15 per cent.

As a crucial component of healthcare, medical technology is most effective when considered in the wider context of the complete healthcare package necessary to address our country’s growing health needs: prevention, clinical care (investigation, diagnosis, treatment and management, follow up, and rehabilitation) and access to appropriate healthcare.

Healthcare Scenario in India

India is the second most populous country in the world with more than 70 per cent of its population residing in the rural areas. 27.5 per cent of India’s population is below the poverty line and consequently, cannot afford the out-of pocket expense required for quality healthcare. While the challenges of communicable diseases remain, the rapid rise in non-communicable diseases has led India to be known as the ‘Diabetes Capital of the World’.

In terms of healthcare infrastructure, more than 80 per cent of doctors, 75 per cent of dispensaries and 60 per cent of hospitals are situated in the urban areas. The number of beds, nurses and doctors per thousand Indians is among the lowest in the world.

In such a scenario, there is an urgent need for medical technology innovation in India. These solutions need to be affordable, reliable, resilient and easy to use and distribute.

The World Health Organization (WHO) defines innovation as a “process cycle of three major phases that feed into each other: discovery, development and delivery.”

Role of Innovation

Medical device innovation refers not only to the invention of new devices but also to adjustments to, or incremental improvements of, existing devices and clinical practices. It also denotes efforts to adapt devices designed for use in one setting, such as a modern high-tech hospital, to be used in another setting, such as a patient’s home.

Innovation of medical devices must demonstrate added value for patient health. Yet, even when clear benefits exist, the technology may be rejected simply because it is new, threatens existing practices, or has costs that outweigh benefits.

The vitality of the medical device industry is reflected in its focus on R&D and innovation. Most medical devices undergo constant ‘incremental’ development based on feedback from users and on advances in technology, thereby producing keen competition among manufacturers.

Studies have been done by the WHO to identify the barriers to innovation in medical devices. These note that, traditionally, it has been the smaller companies that are most active and innovative in R&D. According to a research consultancy commissioned by the US FDA in 2006, in the US small companies play a greater role in R&D of new medical devices, with large firms providing organisational and capital assets that help ensure the commercial success of new products.

Many medical devices initially emerged not from clinical research but from technologies developed in other areas. This phenomenon is referred to as “dual use”. Dual use technologies include lasers, ultrasound, MRI, spectroscopy, and information technology. MRI, for example—a non-invasive technology used to diagnose injury to body organs from trauma, tumours and infarction—grew out of basic research on the structure of atoms.

Other examples of technologies incorporated into healthcare that came from outside the medical research field include internet communication, shock wave technology (now used in lithotripsy), and devices devised by the army for use in difficult field conditions, which can often serve as a model for the design of medical devices to be used in remote low-resource settings.

Need for Frugal Focussed Innovation

These trends need to be replicated in India. Frugal focussed innovation is the need of the hour.

Innovation rests on four pillars – Funding or financial support to sustain the required research and development activities over a long period; relevant talent and experienced skill base for carrying out design and development of innovative products; supportive regulation distinct and simplified, harmonised with global standards and incentivised indigenous manufacturing for supporting the development of low cost products.

Similar to any other industry, medical equipment cannot be viewed in isolation but need to be seen in a broader context. From the very inception of a new piece of equipment, treatment or procedure to complete adoption in clinical practice or decline thereafter, innovation is influenced by multiple interests of the involved stakeholders.

These stakeholders include end-users (medical professionals including general practitioners, specialists; paramedics; students; patients and their care providers) and manufacturers, vendors/ distributors, national and international regulators and governments.

Key Areas of Focus

The government and the medical technology industry in India needs to gear for the challenge of innovation and require focussing on three areas:

Regulation for Medical Devices - The value of regulation is indisputable in terms of providing assurance for safety and quality of care. The government needs to promulgate appropriate unbiased regulations to help innovation prosper. The extent of regulatory scrutiny of medical devices must be comprehensive and based on the risk class attached to their use.

Improving Availability and Accessibility – While the government will focus on the price control part of accessibility, the industry must focus on the appropriateness of the context or setting for which the technology is intended. Context here refers to linking the correct medical device with its corresponding health need to maximise its effectiveness. This is even more importance as all existing technology has been designed keeping the developed world in mind.

Presenting a Common Industry front - As Goethe wrote: “Knowing is not enough; we must apply. Willing is not enough; we must do.” Similarly, the medical technology industry in India has the in-depth knowledge and expertise and needs to put forth broad strategic objectives with clearly identified near to mid-term goals to the Government and work together with all stakeholders for fostering innovation in India.

(The author is Managing Director of Zimmer India, a fully-owned Indian subsidiary of Zimmer. He has been actively associated with professional bodies like ADVAMED, AMCHAM, FICCI and CII and has made important contributions, including in leadership capacity)