Shira Medtech which has designed and developed Shira Clamp, a microvascular surgical instrument which stalls limb amputations, is now scouting for funds to pursue its manufacture and marketing forays.
Shira Clamp is clinically used in several hospitals in Delhi, Mumbai, Gurgaon, Pune, Coimbatore and Chennai. The Ganga Hospital in Coimbatore, one of the largest microsurgery centers in India, has supported Shira MedTech through the animal tissue experiments and its first use in patient. The product was also demonstrated during the Free Flap Live 2018 conference at Government Stanley Hospital and Medical College, Chennai. It underwent trials at Medanta Medcity, Gurgaon. Pilot studies are underway at AIIMS, New Delhi and Ruby Hall Clinic, Pune.
The Ahmedabad-based company, a finalist for the Design: Impact Awards by Titan in collaboration with Tata Trusts has been funded by BIRAC through the Biotechnology Ignition Grant (BIG) program where it was able to develop the proof of concept. The tenure of BIG will come to an end in July 2018.
In order to sustain our R&D, manufacturing, marketing, we are exploring various grant programs. Follow-on funding is of key importance at this stage, Anand Parikh, innovator and director, Shira Medtech told Pharmabiz.
In India 1,00,000 preventable amputations happen annually due to lack of access to a microvascular surgeons. These amputations result in loss of limbs, employability and livelihood. Many of the amputees are manual workers and factory employees who are sole breadwinners. Microsurgery can be made popular as a general surgery technique if the learning curve for acquiring skills can be reduced. With Shira Clamp, we want to enable surgeons perform microsurgery, which is presently restricted only to specialists. Generalization of skill will reduce the operation cost by 15-20% and eliminate overheads of patient travel. In fact, the device is also used for cancer-tumor removal, aneurysmectomy, AV fistula, etc, he added.
Positive response from surgeons came in as Shira Clamp reduces chances of error. Even the head and neck surgeons have recognised its advantages as it eliminates the need to flip the clamps during surgery. Several Indian surgeons have already invested and encouragement has forth from the international microsurgery community. We would present the device at the World Society of Reconstructive Microsurgery conference in Italy in 2019, stated Parikh.
Although the product development spanned 3.5 years, Shira Clamp has already established its credibility. The purchase from AIIMS-New Delhi makes it easier for us to approach other government hospitals. Currently independent pilot studies will help generate publication in peer-reviewed journals. Marketing will take place through pilot studies, publications and relevant training of medical personnel. Manufacturing process control, reliability testing and electronic calibration of each device will ensures consistent product quality. As per the notified medical devices list by CDSCO, Shira Clamp does not need marketing approval. However, best practices will be adhered to meet global quality standards, he said.
The med-tech start-up was confronted with the challenge to access reliable vendors for precision manufacture besides identify suppliers for Titanium alloys and special steel grades.
Going forward, while the company works to consolidate its position with its Shira Clamp, it is developing a high quality, low weight, ergonomic surgical instruments for micro and general surgery. Besides portable magnification and vision instruments, point of care health monitoring devices are also on the cards.