Pune-based Sushrut Surgicals Pvt Ltd, with its firm belief in innovation, has developed a megaprosthesis that is just one-fourth the price of an imported one, discovers Huned Contractor

Traditionally, a person who is advised an implant after undergoing a limb surgery is always faced with the daunting prospect of buying a prosthesis made in the US or any European country that can easily cost upwards of Rs 2-3 lakh. This has been so despite the fact that such implants are manufactured in India too at a much lesser cost. "That," explains Mr Ajay Pitre, Managing Director, Sushrut Surgicals Pvt Ltd, "is because of our mindset which believes that anything made outside India has always got to be better than what is available locally." It is precisely this psychological baggage that Pitre has been striving to change through the innovative products offered by his Pune-based company.

A significant producer of implants in the space of spine and reconstructive orthopaedics, the company is driven by its founders' objective of providing the Indian healthcare industry with options that conform to the best of quality standards but can also be affordable for a wider section of people than is presently the case. "We are not talking here about volumes or turnovers. Rather, if the same kind of implant can be made available at a reasonable price, the chances of not losing a limb are very high. Therefore, the focus is on innovating to save limbs," Ajay adds. And this is not just mere talk. The company has developed a megaprosthesis that can save the knee from amputation, which is priced below Rs 1 lakh while an imported product costs four times as much.

The Sushrut-Adler Group was founded in 1973 by Mrs Vimal Pitre, a young woman entrepreneur who was encouraged by orthopaedic surgeon friends to provide fracture treatment devices to fill a need caused by both limited availability and the prohibitive cost of imported devices available at that time. She started trading in these devices manufactured by small machine shops in and around Mumbai. Within a few short months, she realised the critical nature of these products that were implanted into the human body and the inability of these machine shops to provide quality and safety. Therefore, as a first generation entrepreneur, she took the bold step of setting up her own manufacturing facility in the remote village of Devrukh in western Maharashtra, the hometown where she grew up.

As the needs of the business grew, her husband, Vasant Pitre, a career professional with experience of working for corporate giants like the Tatas and L&T decided that encouragement from the sidelines was no longer adequate and took the courageous step of joining the fledgling business full-time. "Bala-saheb", as Pitre senior is fondly known, set about the important task of building the organisation that would be needed to realise the aspirations his wife had. With growing organisational needs, both husband and wife set about convincing their 'cricketer' son, Ajay, that the needs of serving the growing needs of patients with high-quality affordable devices was a worthwhile cause to work for.

To his credit, Ajay Pitre embraced his parents' vision with whole-hearted commitment and dedication. Through the 1990s, he set about the task of introducing sophisticated technologies and setting and achieving qualitative goals that were unheard of in the industry. Under his leadership, the group became the first Indian company in the industry to achieve a series of quality recognitions, starting with ISO 9001 in 1999, the coveted European CE certification in 2003 and the highly recognised ISO 13485 certification in 2006. At the turn of the century, with over two decades of experience gained in this critical field, a chance event provided the group with an opportunity to make a significant contribution to healthcare in India.

Tata Memorial Hospital, widely recognised as one of the most prestigious cancer treatment centres in the country, saw the inclusion of two new young members, Dr Ajay Puri and Dr Manish Agarwal, to their team of surgeons to treat bone tumours. Dr Puri and Dr Agarwal, with their exposure to emerging international trends in the treatment of bone tumours, were keen to start applying these advanced techniques for the benefit of Indian patients. Bone tumours typically affect regions of the body close to the joints such as the knee, the hip, the shoulder and the elbow. A large proportion of these tumours affect areas around the knee. Till not too long ago, the only way to save the patient's life was to amputate the limb, a true Hobson's choice in a tragic way. However, pioneering work done in a number of European centres over the last few decades has paved the way to achieve what was considered impossible earlier, to save both the patient's life as well as the limb and provide the patient with near normal limb function after successfully eradicating the disease. The surgery required to achieve this objective came to be known as 'limb salvage' surgery. Specialist surgeons would determine the extent of the disease, carefully remove only the affected bone and soft tissue and then replace the removed bone with an implant called a 'megaprosthesis' or giant prosthesis, a device manufactured from sophisticated materials to very exacting standards considering that it needs to serve as a lifelong functional replacement.

Dr Puri and Dr Agarwal were extremely keen to start applying these evolving techniques for the benefits of their patients at Tata Memorial. Their efforts were however frustrated by the prohibitively high cost of between Rs 4 to Rs 12 lakhs for these sophisticated devices from foreign suppliers. Combined with the very high associated costs of treating cancers, limb salvage surgery was proving to be unaffordable to nearly 99 per cent of the needy patients. The two doctors then decided to approach the Sushrut-Adler Group with a strong argument in favour of developing these sophisticated implants indigenously. Ajay Pitre carefully looked at this request and after analysis realised that the endeavour would require years of effort, uncertain business outcomes and almost no possibility of ever being profitable considering the very small numbers involved. Incidence estimates indicate that less than 4,000 new patients every year are afflicted with this dreaded disease in our country. "However, the development of a megaprosthesis had outcomes that perhaps could not be measured in financial terms. The opportunity to make a difference and to put a smile on the face of a saved patient overrode financial considerations," he states.

Ajay therefore decided that this was an important way in which the capabilities developed by the Sushrut-Adler Group could be put to use in the service of Indian healthcare. With over 250 patients implanted with this prosthesis, the team of Tata Memorial surgeons and Sushrut-Adler engineers were able to work out sizes and dimensions suited to the Indian anatomy while retaining functional characteristics. The pioneering effort led to the introduction of the ResTOR modular resection prosthesis, an off-the-shelf solution to enable limb salvage surgery in the year 2006. Specialised instruments were developed to enable installation of the prosthesis in patients. The development of the ResTOR system has also been a landmark achievement in providing Indian surgeons and device engineers with the confidence and self-belief to develop homegrown solutions that match up with the world's best.

Now the ResTOR system has been successfully adopted for the care of patients in countries like Thailand, Malaysia, Nigeria, Vietnam and various other emerging nations. As Ajay puts it, "The high cost model of medical device development and delivery practiced by the western world faces serious challenges in reaching nearly 85 per cent of the global population who reside outside the so-called 'affluent' world, apart from recent cost pressures even at home.

Companies like the Sushrut-Adler Group have an increasingly influential role to play in providing cost-effective and relevant local solutions that meet the highest standards of quality and performance." What Ajay is now hoping for is a change in the government's policies that favour import of such products rather than encouraging local production. "It will happen once healthcare becomes a priority issue in the country," he says. (Contact: Sushrut Surgicals Private Limited, Pune . Tel: 020-66520700. Fax: 91-20-66520800. Email: info@sushrut.com)