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Make in India holds the key to ensuring affordable diagnostic services

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India’s diagnostics business scenario is changing tremendously. This change is driven by government intervention, digital transformations and increased business collaborations. In an freewheeling chat, Suresh Vazirani, MD and CEO, Transasia Bio-Medicals shares his perspective on the ever-changing business environment in Indian diagnostics with Raelene Kambli

How do you see the Indian diagnostic sector shaping?

Diagnostics as we all know is at the core of any medical treatment. The industry is expected to steadily grow at a CAGR of 15-16 per cent accounting to approximately $12.3 bn in 2020. The pathology segment is expected to contribute approximately 58 per cent to the total market, by revenue. If we consider the medical device market as a whole, India ranks 4th largest in Asia and among the top 20 globally. So you see, the medical device industry is on a growth trajectory. With regards to manufacturing, India has about 750-800 medical device manufacturers in the country, with an average turnover of Rs 450-500 million.

Over the years, the industry has seen a transformational shift. Manufacturers and service providers are adopting automation and digital technologies, in order to serve their customers better. In fact, there is a growing trend in the use of digitisation and Artificial Intelligence in clinical labs whereby manufacturers are providing instruments with remote services for seamless operations. On the other hand, service providers are adopting the use of web-based platforms for electronic records.

Secondly, there is a rising focus on preventive healthcare, as a result of high literacy levels and growing awareness. An increasing number of citizens are opting for proactive health check-ups with a comprehensive number of tests. This is further driven by customised packages offered by diagnostic chain labs that include improvement in collection logistics and affordability of testing.
Another interesting trend is the emphasis on quality accreditations. It is good to see how the industry has woken up to quality compliance in manufacturing. Likewise, accreditation of laboratories ensures standardised services.

Having said that, access to affordable diagnostics still remains the pain point of 70 per cent of our population, who have never had their blood tested. Providing cost-effective solutions is still a big challenge and as a country, we are still dependent on imported medical devices. I reiterate that ‘Make in India’ holds the key to ensuring that affordable diagnostic services reach even the remotest areas.

What is your opinion on the fragmented nature of diagnostics business in India?

What about the increased number of illegal labs? A known fact is that the Indian medical device manufacturing sector is fragmented, both in its scale and geography. The various device manufacturing clusters in the country, along with medical device parks and medtech parks in the vicinity of these clusters, have the potential to create a large ecosystem of manufacturers, suppliers and developers. As a manufacturer we are implementing a niche differentiation strategy by focussing on customisation of products, commitment to after-sales services and quality. The fragmented nature of diagnostics, has led to the mushrooming of a large number of small labs, especially in remote areas. Moreover, setting up a pathology laboratory doesn’t require a skilled pathologist, as licenses can be easily obtained. Unfortunately, the number of diagnostic labs outnumber certified pathologists in the country. In such a scenario, misdiagnosis is not uncommon and most of the medical errors are triggered due to lack of skills and proper training. As a direct result of this skill gap, most laboratories are functioning illegally and are the ones responsible for the misdiagnosis and wrong treatment.

Another important point to note is that less than five per cent of the laboratories in India are authorised by the National Accreditation Board for Testing and Calibration Laboratories (NABL), which is a very insignificant percentage of the total percentage of labs in India. Most labs rely on their internal processes to monitor quality. Only having a pathologist associated with the lab will not ensure reliable results.

The Government needs to devise stringent policies to prohibit path labs managed by unqualified professionals and non-calibrated or non-validated equipment.

What opportunities should diagnostic companies tap in the digital era?

Internet of Things (IoT) has brought in a new wave of digital transformation. IoT refers to the network of devices embedded with software, sensors and connectivity that enables them to collect and exchange data. IoT offers a host of solutions for a win-win scenario for both the lab and the manufacturer. With an increasing focus on offering value-added services, manufacturers can now adopt IoT to resolve problems faster and effectively. Healthcare organisations are moving more towards cloud-based IT infrastructure, to better automate processes. In fact, IoT enabled medical devices can now be remotely monitored to predict possible problems and proactively resolve them thereby improving the uptime.

IoT is most critical to the medical device industry as a precursor to enhanced patient care. 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), to enhance patient outcomes (through predictive healthcare).
Transasia has integrated 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.

What are the core values that diagnostic companies need to imbibe in order to build sustainable business models?

Build you business model on quality. Strive for excellence and continue innovating your strategies, products and services. It is important to have a customer-centric approach for long-term business relations.

What are the values that Transasia follows and how it contributed to the company’s success?

We believe in honest business. We believe in giving the customer their due- in terms of quality and value of products and the after-sales services that we provide. We also believe in paying taxes on time.

Transasia Bio-Medicals recently recieved the ZED Diamond Quality rating. What is its significance? And how important is this rating to medical device manufacturers?

The ZED Quality Certification is an initiative by the Government to encourage ‘Make in India’ and export of Indian products, through manufacturing practices, aligned towards providing products aimed at Zero Defect (for customers) and Zero Effect (on the environment). The initiative is meant to raise quality levels in the manufacturing sector and is seen as the cornerstone of the Make in India programme.

The diagnostic sector in India, is still highly dependent on imports of medical devices. Manufacturing our medical devices indigenously holds the key to meet India’s need for quality, accessible and affordable diagnostic services. The ZED certification further puts the spotlight on quality compliance for Indian device manufacturers. A pathology laboratory can be assured of standardised products and services from a ZED qualified manufacturer thereby ensuring standardised test results for the patients.

What does this achievement mean to Transasia?

For over four decades Transasia has been at the forefront of ensuring equitable diagnostic solutions across the length and breadth of the country. Early on, we recognised the huge gap in the demand and supply of the medical devices in the country and started manufacturing in India in the 1990s. Our focus has always been on quality, affordability and accessibility.

Last year, Transasia became the first IVD Company in India to receive ICMED 13485 certification, the country’s first indigenous quality assurance system for India manufactured medical devices. And this year, Transasia has become the first IVD Company in India to be awarded ZED Diamond Quality rating. This milestone is a testimony that we employ GMP, Kaizen, Lean and other innovative processes to develop technologically advanced products that are also environmentally sustainable. It gives the doctors the confidence of quality and our focus on customer-centric approach.

What were the quality measures taken by your company to achieve this certification?

We follow stringent manufacturing processes and protocols to ensure that our instruments are in the same league as the international products. All our manufacturing sites are subjected to regular, periodical inspections for maintaining quality standards and to ensure compliance to local manufacturing guidelines and environment safety. We encourage improvisation in our systems by implementing feedback from our customers. Not to forget, we lay equal emphasis on the safety of our employees at the workplace.

How does one go about getting this certification for medical device manufacturing? What are the pre-requisites?

The pre-requisites for the medical device sector are no different from the other manufacturing sectors. An MSME applying to be evaluated on the ZED Maturity Assessment Model shall demonstrate and will be assessed and rated on the following parameters at the operational level:

Enablers for Product Quality
Enablers For Emission, Effluent and Waste Disposal Activities
Enablers For Resource Management
Outcomes
The process flow encompasses the following steps:
Online registration and self assessment
Desktop assessment
Site Assessment
ZED rating and certification

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