The role of the medtech industry in the healthcare value-chain is paramount. At the heart of the healthcare delivery system, diagnostics has been arming clinicians with critical information to chalk out the treatment plan. So it’s no surprise that the Indian government has put the medtech sector in the limelight by recognising it as a sunrise sector in the ‘Make in India’ initiative. Growing at a CAGR of 15 per cent, the medtech industry is looking to touch $9.6 billion by 2022 from the current $5.2 billion.

The past few years have seen concerted governmentindustry efforts focused on driving home innovation in product development, expanding reach and streamlining the regulatory processes. 

Focus on R&D 

The government’s decision to include the medtech industry in the Make in India 2.0 programme has been heartening for manufacturers. The setting up of dedicated medtech parks, like the Andhra Pradesh Medtech Zone (AMTZ), has been a positive move. With two more zones planned in Maharashtra and Gujarat, the government is encouraging small entrepreneurs to gain access to quality control units, import and export facilitation centres, regulatory offices and engineering services. By offering low cost rentals and simplifying end-to-end operations, a medtech park would help manufacturers reduce production costs by 40-50 per cent. Further, the parks are being planned to bridge the gap between academia and industry through tie-ups with medical colleges to help entrepreneurs in their R&D efforts. If all goes as planned, a medtech zone could increase domestic production up to Rs 10,000 crore. 

Quality paves the way 

While we speak of developing a robust manufacturing ecosystem, it is also critical to address gaps in regulatory framework. Sadly, many nations don’t have their own frameworks, and depend on regulators in the country of manufacture, like the USFDA.  Indian Certification for Medical Devices (ICMED) is a good initiative, now available to Indian companies as a homegrown certification. ICMED will definitely reduce costs and lead time for getting certifications. However, there is still a long way to go in developing India’s regulatory framework.  Having said that, the onus is on manufacturers to formulate their own quality standards. At Transasia, we facilitate training and have implemented measures to improve the performance quality. Structured systems are in place to identify, monitor and improve supplier systems and performance. Another important aspect is the procurement process. With its network of medical colleges, primary and secondary care hospitals, the government is a large purchaser of medical devices. 

Coming together of minds 

It is good to note that the government-industry collaboration has extended beyond medical device rule to include initiatives linked to standardization. The Government e-marketplace (GeM), is an effort to simplify the public procurement process and support Make in India. However, certain gaps need to be filled to make the process transparent, inclusive and efficient. Unauthorized vendor registration, dynamic pricing, and lax in stringent eligibility criteria such as a mandatory ISO/ICMED/NABL certification for vendor registration, need to be addressed. Nevertheless, it will be noteworthy to say that we now have a ‘GeM’ in the medtech crown and it can serve as a good platform to ensure last mile delivery of affordable diagnostic equipment.  

Ayushman Bharat a game changer 

The health ministry has indicated its intention of promoting healthcare to the remotest areas through ambitious projects such as Ayushman Bharat. A well-timed, historical landmark, it can be a game changer as it is slated to provide health cover to more than 40 per cent of our population. Under Ayushman Bharat, free diagnostics and drug facilities will be provided to the beneficiaries in secondary and tertiary healthcare sector. However, in India where only 30 per cent of population has ever got its blood tested, providing affordable diagnostics, leave alone free diagnostics, poses a big challenge. To ensure healthcare at an annual rate of Rs 1,200 for a family of five, we cannot depend on importing medical devices from developed countries where the average labour cost is Rs 1,200 per hour. That’s the lacuna we need to address to make Ayushman Bharat truly sustainable and beneficial. The world has its eyes set on the success of the scheme. If in the next five years, if we can Make in India our medical devices, we will be in a position to drive this scheme to four billion. 

WHO’s Essential Diagnostics List Another effort to ensure early diagnosis is the adoption of WHO’s Essential Diagnostic List (EDL). It’s a proud feeling that India is the first country to adopt the EDL and India’s EDL is being devised to focus on not just HIV or other communicable diseases but much more. It will help in diagnosis to reduce the entire disease burden, rather than focusing on just episodic or disease profile analysis. Though a welcoming move, we need to develop our own systems tremendously well and in a very short span of time to make them truly effective.

Remote diagnostic technology Recent technological advances have made devices less expensive and easier to use. 

The emergence of Internet of Things (IoT) is touted to be the next level of technological innovation. IoT refers to the network of devices embedded with software, sensors and connectivity that enables them to collect and exchange data. Experts estimate that by 2019, 87 per cent of global healthcare organisations will have adopted IoT. The entire ecosystem — caregivers, patients, and manufacturers — is experiencing a new level of engagement that arises from the need to increase operational efficiency (through predictive maintenance and remote access), and to enhance patient outcomes (through predictive healthcare ). IoT is making strong inroads in the medical device industry that is seriously exploring its short and longterm benefits. India’s leading IVD Company, Transasia BioMedicals is at the forefront of this wave of change by integrating IoT sensors to its fully automated systems. With its remote diagnosis technology, Transasia is able to provide an altogether different level of service to its customers and partner with them in improving lab efficiencies and benefitting the patients at large.