Pavithra Kumar B: A Pioneering Engineer Aspiring To Have A Positive Impact On The Medical Devices Industry | CEOInsights Vendor
Pavithra Kumar B: A Pioneering Engineer Aspiring To Have A Positive Impact On The Medical Devices Industry

Pavithra Kumar B: A Pioneering Engineer Aspiring To Have A Positive Impact On The Medical Devices Industry

Pavithra Kumar B,Quality Head

Pavithra Kumar B

Quality Head

The Indian medical devices industry is a booming market segment and according to the Minister of Health and Family Welfare, Mansukh Mandaviya, the domain has the potential to grow at 28 per cent each year to reach USD 50 billion by 2030. Heka Medicals India is a startup company focusing on developing and manufacturing innovative next generation medical device technologies and products in the medical industry. The company has developed an indigenous medical device ‘HEKAFLO’ for High Flow Nasal Oxygen therapy. The HekaFlo is an IoT enabled High Flow nasal Oxygen Therapy machine with remote monitoring capabilities. Heka Medicals is also India's first company to develop an HFNC machine. HekaFlo is the world's first IoT-enabled machine capable of remote patient monitoring. HekaFlo blends, warms up and humidifies air & oxygen to be administered to the patients for treating hypoxemia in spontaneously breathing patients with warmed and humidified oxygen up to 60L/M.

Heka Medicals are committed to offering innovative medical devices that comply with relevant regulatory requirements and improving customer expectations. Pavithra Kumar B is the Head of Quality at Heka Medicals India and under his guidance, the quality department focuses on aligning the department's objectives and performance with their quality policy which give major emphasis on ensuring customer satisfaction.

In an exclusive interview with CEO INSIGHTS, Pavithra Kumar talks more about his professional journey and the unique operations of Heka Medicals India.

Could you give a brief account of your professional background and experiences?
After graduating in Electronics and Biomedical Engineering from Govt. Model Engineering College, Kochi, I got campus placement by Cohere Med Solutions, a healthcare company in Bangalore. Here, I worked on software development for IoT devices and gained experience working in a team of brilliant engineers. Then, I was offered a position as a software developer at Heka Medicals. I joined Heka Medicals where initially I was involved with the project for design
and development of a non-invasive respiratory device. For Indian medical device manufacturers, it was necessary to establish a quality management system for medical devices. So later I began my role as Head of Quality, and we implemented QMS in accordance with the ISO 13485: 2016 standard.

Leveraging his strong technical expertise and industry experience, Pavithra Kumar aspires to offer the best quality medical devices which offers the best user experience. He is a passionate learner who aspires to constantly learn and reinvent himself.

What are the value additions that customers can expect from your offerings?
We at Heka Medicals are committed to offering innovative medical devices that comply with relevant regulatory requirements and improving customer expectations. Establishing a quality management system is a structured approach for managing quality that can help our company to ensure that the devices we design and manufacture meet regulatory requirements and are safe & effective. In order to maintain longterm relationships with customers we maintain the effectiveness of the quality management system, continuously improve the products, services and also take account of affordability for the Indian market.

During the design and development phase, design controls was a systematic approach that can help in identifying and addressing potential hazards and risks. As part of the usability engineering process, we also take into account the devices' ease of use, easy maintenance, and potential for improved patient and healthcare provider convenience. We improve the quality and safety of the devices by implementing robust manufacturing processes that minimize the risk of defects and errors. Regular testing and inspections help in identifying and addressing issues with the products before they reach the market.

Could you reflect on some of the toughest challenges you have encountered in your journey so far? How did you overcome them and what did you learn from them?
Being new to corporate culture was a challenge when I started my first job. The most difficult challenge for a regulatory and quality professional is adapting to new regulations and its documentation. For me, we had
to build a quality management system from the ground up. Although I had a basic understanding of the ISO:13485: 2016 standard, it was very challenging to perform a gap analysis and document SOPs, manuals, and records for the first stage of certification with less experience.

One common challenge in medical device QA is ensuring that products meet regulatory requirements & standards. This can involve navigating complex and evolving regulatory frameworks, such as those established by the Food and Drug Administration(FDA) in the US or the European Medicines Agency (EMA) in the European Union.

The most essential lessons that I learned during my professional journey are that the obstacles faced by individuals and organizations in the medical device sector vary widely, and it is critical to take a proactive and adaptable approach to confront & overcome them. The standards and regulatory requirements must all be followed for the system to operate efficiently.

Going forward, what are the changes in market behavior that you anticipate and what are the opportunities that you foresee?
There are several changes in the medical device regulations that I anticipate in the coming years including-

To ensure the safety and effectiveness of medical devices, increasingly stringent regulations such as US FDA, MDR 2017, and others are in place. This may result in increased regulatory scrutiny of medical device manufacturers and distributors, as well as increased scrutiny of clinical data used to support the safety and efficacy of these devices.

Medical devices have become more connected and data-reliant in recent years. The security of this data and the protection of patient privacy are becoming increasingly important. This will likely lead to increased regulatory requirements for data and cybersecurity in the medical device market.

Though these regulations are challenges for manufacturers, it can also drive innovation and the development of new technologies. The changing regulatory environment for medical devices and the healthcare sector suggests that the future of care giving will be critical and should be safe and effective. As a result, the roles of professionals who work to make society healthier by regulating drugs, food, medical devices, and cosmetics may become critical in private and government sectors. We have the ability to strengthen the regulatory sector of the nation, and I believe engineers can play a significant role in that.

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