“For medtech companies, Asia is a primary source of growth”

CHAT WITH Caroline Freeman, Principal Consultant, Consulting Services, IQVIA

Please share your experiences from EU’s medical devices regulatory policy? How would one compare it with Indian one? Are there any measures which could be implemented here?

The EU medical device regulations have made great progress in the last 30 years, putting in place one regulatory system for 30+ countries in Europe, to replace the fragmented patchwork of regulations that existed before. The recent publication of the Medical Devices Regulation and IVD Regulation in May 2017 illustrated that the original harmonization was not flawless, but we hope to have learnt lessons and plugged a few regulatory gaps to ensure higher levels of device safety and patient protection.

The new Indian medical device rules seem to have taken a close look at the European system and adopted some key elements, such as a classification system similar to the EU system. Other similarities include the requirement for compliance with ISO 13485 quality management system; the reference to technical standards and the use of third party conformity assessment bodies (Notified Bodies). I believe that in the Indian system, in the case of the higher risk classes of device (Classes C and D), the use of Notified Bodies is supplemented by a review by the regulatory authority. It is interesting that both the Indian and EU systems are new and it will be important to see how both systems bed in.

Going forward, what outlook do you predict for the medical device regulations globally?

There will be continued convergence of regulatory systems, using the work of the IMDRF and the Asia Harmonisation Working Party. This is already in evidence with the US recently announcing that they will consider the use of third party conformity assessment bodies, and with India adopting a new classification system, similar to the EU system. It is anticipated that there will be more sharing of information by regulatory authorities, for example in the area of vigilance which can enhance safety of devices.

The adoption of UDI systems, although based on the same principles, will not be universal, and there are likely to be different UDI databases in e.g. US, Europe, Japan, China etc. The Medical Device Single Audit Programme is a good example of convergence with regulatory authorities of 5+ jurisdictions sharing an auditing programme. This will take a step forward when the EU joins the MDSAP, in the future.

CHAT WITH Sundeep Shrivastava, Senior Director, Clinical Operations, Asia Pacific Medical Devices, IQVIA

How do you look at the dynamics of medical device regulations in India?

The development of a regulatory framework for medical devices is a major step in recognizing the unique requirements of this sector in India. It is a first step towards harmonizing local regulations which will give a fillip to domestic manufacturing and exports and make Make in India a reality for medical devices. It will set the stage for Indian players to enter global markets and compete with global players. We are likely to see a lot more innovation from India – with more complex, hi-end devices at top of the pyramid and mass, innovative low-cost devices at the bottom of the pyramid.

Has the new ‘Medical Devices Policy 2017’ addressed the challenges that stand before the sector?

The new regulations in place are a first step towards harmonizing local regulations with global standards and will provide a level playing field for domestic manufacturers. As with any regulation, there will always be areas that need to be improved upon but we are pleased that the regulators are taking a very open and collaborative approach in understanding and responding to the needs of all stakeholders in the medical devices industry.

Please tell us about the focus of medical technology business of IQVIA in APAC?

Asia Pacific is a hotspot for medical devices. Advancing technologies, aging populations, growing economies and increasing health care spending by individuals and governments, offer vast growth potential for multinational and local medical device companies.

The region is diverse, and each country presents a complex and challenging regulatory landscape. Gaining market access to Asia Pacific requires a deep understanding of the regulatory environment, culture and payer expectations. Development and commercialization strategies must be aligned with regulatory and market demands, coupled with collaborative relationships with payers, providers and vendors.

IQVIA offers an integrated solution for medical device and diagnostics companies – combining best practices in regulatory, clinical, information and analytics – to transform their growth aspirations to reality.

What are the top priorities for the company in the Indian context?

The fillip being given to the medical devices sector in India is likely to generate interest in both Indian and global devices players. This high potential of Asia Pacific, including India – given the favorable economic, demographic and healthcare trends – is attracting attention from medical device manufacturers looking for investment and expansion. Global players will seek to increase their presence in India in a more predictable regulatory environment while Indian players will seek to consolidate their presence in the country and seek new opportunities overseas. With the expertise and experience we have in the medical devices industry, we look forward to partnering with India device players in support of their local and global aspirations, and with global players in their development and commercialization strategies in the country.

How are the technological trends for MedTech sector shaping up? How will it affect the healthcare?

Asia is on the rise in medical technology development and sales. Having lagged the region’s biopharmaceutical sector, where both R&D spending and outsourced development have increased significantly over the last 20 years, we now see strong medtech growth in the regions.

The factors propelling this are:

 Rapidly changing regulatory environments, with some countries streamlining medtech approval processes as part of the overall support for the life-science industry

 Increasing local companies providing high-quality products that meet local needs; many of these companies also have global ambitions

 Multinationals seeking faster, lower cost development and expansion in a fast-growing region

 Increased demand, fueled by rising incomes, rapidly aging populations and greater government healthcare spending

 And recent developments in other regulatory markets that make Asia an even more compelling and attractive market to develop and launch products.

What are the long-term opportunities for the medical devices sector in India? What do you make out of ‘Make in India’?

Combined with growing economies and more spending by individuals and governments on health care, the Asia Pac medtech market is forecast to grow at 8 percent CAGR for the next several years, reaching USD$133 billion in 2023 (up from $88 billion in 2015), surpassing the EU and second only to the United States. For medtech companies, Asia is a primary source of future growth and countries like India and China are positioned to take the leading pole.

Demographics, economics and unmet health needs are powering the growth of medtech in India. With the implementation of the Medical Device Rules and other incentives given to the medical devices industry in India, Make in India will hopefully become a reality for this sector too, not just in manufacturing but in R&D as well.

Why is the streamlining of medical technology regulations so messy? Can’t all the stakeholders arrive at a consensus to create a win-win situation?

I do not agree that it is messy. The Indian medical device industry in its nascence and we are seeing a very consultative and collaborative approach by the Government of India to nurture and strengthen the medical devices ecosystem.