Import substitution of hot operation theater – Patient positioning devices

Patient positioning system is either a repositioning aid or a device for patient care. Such devices are required for disabled, post-surgical recovery aid; rehabilitative care for elderly/comatose patients, as well as children with birth defects, or who are mentally challenged. An estimate revealed nearly 3646 surgeries are conducted per lakh Indian personnel on annual basis. The increased likelihood of surgical site infections (SSI) is 13 percent, 17 percent, and 37 percent for every 15, 30, and 60 min of surgery, respectively. During such surgeries, patient positioners provide pressure relief to the patient’s boney part by equalized pressure dispersion, as illustrated. This is being tried by using multiple compositions. Earlier attempt of use of silicone mixtures and non-hollow plastic beads and air cushioning was limited due to either increased X-ray level or requirement of ancillary equipment, respectively.

A dual-layered urethane chamber, with deformable and pressure compensating radiolucent fluid, is able to minimize the interface pressure and shear force between the pad and the patient, when comes under pressure (Gabel & Hicks, 2003). The pressure ulcers showed a decreasing trend when such systems were used in conjunction with training programs, as compared to standard foam (Sewchuk & co-workers, 2006). However, this bi-phase system, with encapsulated urethane layer and jelly-like material filled inside, is subjected to risk of getting leaked due to accidental damage caused by sharp edges of the operation theater equipment. International Agency for Research on Cancer described urethane, byproduct of fermentation of alcoholic beverages, as a possible human carcinogen (Chan, 1966). However, the polyurethane foam (polymer) is not considered as carcinogenic by OSHA (US) being inert. Its constituents like isocyanates were reported to be skin and respiratory sensitizers (Demehl 1966). Recent study for prevention of occipital pressure, comparison of viscoelastic-based biphasic fluidic technology with medical foam, exhibited higher immersion, faster rate of relaxation compression cycle as compared to elastic recoil of medical foam.

According to CAGR (2022–2030), the market size of medical devices is expected to reach USD 964.90 bn by 2030 at 6.99-percent CAGR with 0.24 percent for patient positioning system growing at the rate of 4.41 percent (2021–2029), i.e. USD 1.43 bn by 2026 (with Asia Pacific – USD 291.42 million). The analysis of CAGR of medical devices technology market in 153 countries of the world (statista.com) revealed that revenue difference (in USD bn) lies between 0.02–0.09; 0.1–0.9; 1–9; 10–20; 20–50 for 75; 53; 22; 2; and one country (USA) respectively. It indicated that nearly USD 0.298 bn is available as targeted business opportunity (grandviewresearch.com). Pandemic and emerging war scenarios have indicated the need for hot operation theaters to surgically treat contaminated/infected patient(s). Indian medical devices technology is growing at CAGR of 6.78 percent and will reach USD billion 10.57 by 2027. Indian industry had developed non-film patient positioners, using viscoelastic gel (otcare.co.in) with specialized anti-microbial coating (with 90-day protection), extensively used as part of DRDO’s ultraswachh technology (ultraswachh.in) too. However, such devices are not being exported out yet due to the absence of encapsulated film. The maximum market share is managed by film (jelly filled)-based imported patient positioners due to ease of wiping it out in spite of possibility of accidental leakage, if pricked. This gap indicated the need for indigenous film-encapsulated OT positioning devices that do not leak, as well as even when film is broken remained clinically bio-compatible. Such a novel device would be of dual use, doubly coated with anti-microbial composition and hot-operation compatible (Chawla& Singh 2017). These futuristic cost-effective high-quality patient positioning devices possess immense export potential. The Japanese, leaders of medical devices (USD 10.67 bn) and with free trade agreement signed with Australia should be the first priority. Twenty-two countries (USD 1–9 bn) are targets for priority export, while rest of the 75 countries (with USD 0.09 bn) are important manufacturing bases for future partnerships. Transformative R&D approach should be taken in this direction to develop such technology within India.

The authors are Pooja Yadav, Department of Medical Elementology & Toxicology, Jamia Hamdard; Raman Chawla, Institute of Nuclear Medicine & Allied Sciences; Navneet Sharma, Amity Institute of Pharmacy, Amity University; and Rajesh Arora, Defence Institute of Physiology & Allied Sciences, Views are personal.