Kerala makes its MedTech intentions clear at DIA-KMTC Conference 2026

On May 21 and 22, 2026, Thiruvananthapuram became the meeting point for India’s medical technology community. The DIAKMTC MedTech Conference 2026 organised by DIA (Drug Information Association) in partnership with the Kerala Medical Technology Consortium (KMTC) brought together regulators, entrepreneurs, clinicians, and quality professionals under a single theme: Concept to Care-Safe, Smart, and Scalable MedTech. 

The timing made sense. India accounts for just about one per cent of the global medical device market-a striking gap given the country’s large population, strong research institutions, and fast-growing healthcare system. That number was never far from the conversations across both days. 

The event began with welcome remarks from Dr Ashok Swain, General Manager and Executive Director of DIA India, who set a warm and collaborative tone for the two days ahead, emphasising that in today’s evolving healthcare ecosystem, collaboration is essential, not optional.

Padmakumar, Special Officer of KMTC, followed with remarks that were direct and honest. He pointed to a simple but important fact: India had no medical device regulations until 2017, and that gap had held the sector back more than most people acknowledged. Without regulations, most Indian MedTech companies did not meet international standards, leaving the market heavily dependent on imports. His message was clear, “KMTC’s work with DIA was built on the belief that meeting global quality standards is not a hurdle to growth, but the very foundation of it.”

Balagopal Chandrasekhar, Chairman of the Kerala State Industrial Development Corporation (KSIDC) and Programme Chair for the conference, built on that point in his opening address. He spoke about the need for real trust-not just in products, but in how companies work and how the system is run. He made a distinction that stayed with many in the room: following a process is not the same as having a quality culture. Without that deeper commitment, neither domestic credibility nor export success would be possible. 

The opening keynote came from Gregory Smith, Country Director of the US FDA India Office. He brought a valuable outside perspective. India, he noted, already supplies approximately 40 per cent of generic and over-the-counter (OTC) drugs used in the United States and its share of the US medical device market is growing too. Since 2019, the FDA has carried out over 1,900 inspections across India, covering food, drugs, and medical devices. One of the most common issues found during inspections, he said, is a weak quality unit and building a strong quality culture is not just a regulatory need, it is what keeps patients safe. He also pointed to India’s recent affiliate membership of the International Medical Device Regulators Forum (IMDRF) as an important step toward global alignment, and directed attendees to FDA’s free CDRH Learn website that features over 100 mobile-friendly modules available for companies working toward US market access.

The keynote address by Dr B.V.R. Mohan Reddy, Founder Chairman of Cyient Group, Chairman of the Board of Governors at IIT Hyderabad, and Founding Director of THub, focused on the insightful topic, “Empowering Doctors, Expanding Access, Enhancing Care: AI and Engineering Transforming Healthcare.” He opened with a contrast he called “A Tale of Two Realities”-a child born in a Hyderabad corporate hospital with AI-assisted diagnostics and a full digital health record from birth, versus a child born the same day in a rural Mahbubnagar PHC where the nearest doctor is 40 kilometres away and pregnancy is tracked on paper. Same country. Same day. A world apart. He backed it with numbers: India has 1.3 doctors per 1,000 people, just 0.5 hospital beds per 1,000 in rural areas, and roughly 11 specialist doctors per one lakh rural population compared to 67 in cities. The gap is a scale problem and AI is the tool that can fix it. 

He highlighted that India’s national telemedicine platform has logged over 200 million consultations since 2019, proving that patients in remote areas will use digital health if it is easy, trusted, and free. He closed with five recommendations for government and industry: a National HealthTech Innovation Fund, MedTech incubators at every AIIMS, a 90-day CDSCO fasttrack for Made-in-India AI diagnostics, mandatory ABDM compliance in public facilities, and government procurement tied to clinical outcomes-not spec sheets. 

The first session, on quality leadership, moved the conversation away from “audit preparation” toward something more fundamental-quality as a way of running a business. Chaired by Manoj A, a former VP at Terumo Penpol, the session featured Rupam Chaudhury of L&T Technology Services on FDA’s alignment with ISO 13485, and Sreejith Viswam of Stryker’s Global Technology Center, who made a strong case that quality culture, when done right, actually speeds up the path to market. A panel discussion moderated by Manoj A brought together Sarada Jayakrishnan, General Manager-Quality at Terumo Penpol, Dr P.S. Chandranand, WHO Prequalification Consultant and Director at Iqzyme Medtech, and Srihariraju Manthena, Service Delivery Manager at BSI India Regulatory Services, to dig into the specifics-supplier controls, data integrity, CAPA systems, and design controls. 

Adding a strong state-level perspective to the discussions on innovation and ecosystem development, P. Vishnuraj, IAS, Managing Director of KSIDC addressed the conference on the theme “Bio Connect 4.0: Strengthening Kerala’s Innovation & Life Sciences Ecosystem” 

Session two focused on clinical evidence and performancea topic that many Indian MedTech companies find difficult to navigate. Chaired by Dr B. Satheesan, Director of the Malabar Cancer Centre, the session asked a basic but important question: what does good evidence actually look like, and how do you generate it without wasting resources? Dr Anju Gopan of IQVIA looked at how clinical trial approaches are changing, while Atonu Dutta of Neujin Solutions spoke to the real challenges of device validation in India. The panel that followed brought in Dr Vivek Ahuja, EVP at Eversana; Dr E. Sreekumar, Director of the Institute of Advanced Virology, Kerala; Dr Vijayakumar Manavalan, Pro Chancellor of Yenepoya University and former Director of KIDWAI Memorial Institute of Oncology; and Dr Deepa Arora, CEO of Clinexel. Together they spoke frankly about where companies get stuck and how to avoid it.

The afternoon session on AI in MedTech was one of the most closely watched of the conference. Chaired by Dr Sridevi Nagarajan, Founder of AyusArogya Ltd and DIA’s Communities Chair for AI in Healthcare, it covered a lot of ground from how Software as a Medical Device (SaMD) is classified under the EU AI Act and FDA guidance, to cybersecurity requirements and postmarket monitoring for AI systems. Adarsh Srivastava of Roche presented on AI in diagnostics and drug development, while Dr Vivek Ahuja of Eversana covered validation and lifecycle control for AI systems. A panel that included Mr Aseem Sahu, Deputy Drug Controller at CDSCO, Rohit Philip of KMTC, Dr MiRa Jacobs of the UK’s MHRA, and Dr Alberto Gañán Jiménez, Head of Committees and Quality Assurance at the European Medicines Agency, gave the discussion a genuinely international feel. 

Day One closed with a session on regulatory pathwayshow to actually navigate the approval routes to the Indian, US, and EU markets. Chaired by Sinto Poulose of IQZYME MEDTECH, it featured a virtual presentation from Dr Pooja Jani Medical Officer, Diagnostic Data Program at CDRH, US FDA, and Mr Aseem Sahu’s overview of India’s framework for medical device software. A panel moderated by Dr P.S. Chandranand that included Sreejith Viswam of Stryker’s Global Technology Center, and virtual participants Wil Vargas and Stephanie Shedd, both International Regulatory Policy Analysts at CDRH, US FDA, rounded things off with practical lessons from real market entry journeys. 

Day two opened with keynotes that stepped back from regulation and looked at the bigger picture. Reflecting how the “D” in DIA today extends beyond drugs to encompass devices, diagnostics, and digital health, Dr C. Palani Palaniappan, CEO of Aridica Corporation and DIA Global Board Member, spoke about the growing convergence of these domains and what that means for how companies need to think about product development. Mohammed Y. Safirulla K., IAS, Director of the IndiaAI Mission at MeitY, addressed India’s national ambitions in AI-driven healthcare, drawing particular interest from start-ups and digital health companies in the audience. 

Session five looked at leadership, talent, and business ecosystems. Chaired by Chetan Makam, MD and Board Chair of Terumo Penpol, it asked how companies build teams and systems capable of scaling MedTech in regulated global markets. Dr Susheela Branham, CEO of the Bio Valley Incubation Council, AMTZ, opened with a presentation on ecosystem building, before a panel with Dr Vibhav Garg, President of Global Government Affairs at Meril, Dr Mrutyunjay Suar, CEO of KIITTBI, Director General Industry-Institute-Innovation- Interface at KIIT University and Chairman of BCKIC (an initiative of the Office of PSA to GoI), and Dr. Vijayakumar Manavalan, Pro Chancellor of Yenepoya University who played a key role in establishing Yenepoya Technology Incubator, took on the harder questions around talent, supply chain resilience, and competitive positioning.

Session Six tried something different. Rather than another panel discussion, the World Café format chaired by Rohit Philip, Senior Program Consultant at KMTC, put delegates into small, facilitated groups to surface the real obstacles: in regulation, clinical evidence, quality systems, digital trust, and export readiness. Each group then presented back to the room. It was one of the more energetic sessions of the conference, and the outputs are expected to feed into KMTC’s policy work going forward. 

Session seven brought the focus to manufacturing. Himanshu Baid, Managing Director of Poly Medicure Ltd, gave a frank talk on what it genuinely takes to compete at a global level-process validation, supplier qualification, traceability, and the discipline of scaling up without losing quality. A panel moderated by C. Padmakumar, Special Officer of KMTC, and joined by B. Harikrishnan, General Manager at Terumo Penpol Anilraj Radhakrishnan, General Manager at SFO Technologies, Thomas John, Managing Director of Agappe Diagnostics along with a virtual address by CDR Neil Bonzagni of the FDA India Office on device imports and common issues, added useful regulatory and on-theground manufacturing context. 

Reflecting the shared emphasis on collaboration and collective industry engagement to advance healthcare innovation, day two also featured the formal launch of the Kerala Medical Device Industry Association (KMDIA)-a new body that will represent Kerala’s medical device and diagnostics companies. Thomas John, Managing Director of Agappe Diagnostics, took charge as inaugural President, with Jayashankar delivering the welcome address as Secretary, and Binu Augustine, Treasurer of KMDIA, offering closing remarks. The formal launch was marked by remarks from DIA’s Palaniappan and KMTC’s Padmakumar. 

The conference also formally introduced the KMTC Hearing Aid Development Project-an effort to build an affordable, high-quality digital hearing aid from Kerala, bringing together engineering expertise, clinical institutions, and public sector support to address a large and underserved need in hearing healthcare. This session was chaired by Dr Rejeesh GR, General Manager -Marketing at KMTC. 

The DIA-KMTC MedTech Conference 2026 showed that the right people are in the room, the conversations are getting more specific, and the structures like KMDIA are beginning to take shape. The work ahead is not simple, but the direction is clear. 

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