Medical Devices, unlike other products, need to be safe and effective before they can be used on real patients to deliver positive outcomes.

Abishamala Kingsly, our next pathbreaker, Senior Regulatory Manager – Clinical Informatics at Philips, designs regulatory pathways for both hardware and software medical devices, focused on Pathology and Precision Diagnostics.

Abishamala talks to Shyam Krishnamurthy from The Interview Portal about moving from the field of Epidemiological research to the corporate world at the intersection of healthcare, technology and product design !

For students, keep a personal set of non-negotiable values that guide both your life and career. These are different for everyone, but having them gives you mental clarity, especially when you face tough choices.

Abishamala, Your background?

I grew up in Chennai. As a child, I was an avid reader — especially anything related to science and science fiction. My parents were wonderfully supportive of a creative life, so I also trained in Piano under Trinity College of London. That experience taught me something important early on: you can be methodical & rigorous and creative at the same time.

I also had some fantastic English teachers in school who pushed me toward public speaking and writing. Throughout my school years, I participated in creative writing and oratorical competitions. Looking back, trying my hand at so many different things — science, music, writing, speaking — gave me a well-rounded foundation: discipline, creativity, and the ability to communicate. These turned out to be exactly the skills I needed to chase my dreams.

It was during my teenage years that I decided I wanted to enter the world of Biotechnology — specifically, I had my eyes set on genetic engineering, basically I loved biology and did not want to be a doctor but wanted to do research.

What did you do for graduation/post graduation?

I studied B.Tech in Biotechnology. At the time, there was a lot of negativity around this course — people said it had “no job prospects.” But honestly, I wasn’t even thinking about jobs. My goal was research, and I had already decided I wanted a PhD before I even finished my first year.

After my B.Tech, I pursued a Master’s in Biotech/Bioengineering. After that, I did a PhD in Epidemiology/Global Health Sciences from Deakin University

What made you choose this career?

While doing my BTech, I rediscovered my love for reading — but now I was reading about statistics. Biostatistics was part of our curriculum, but I felt it didn’t go deep enough, so I self-taught many concepts and did additional courses at CMC Vellore.

That’s when something clicked. I realised I was more excited about applying statistics to understand health at a population level — like, instead of studying one person’s genes, I wanted to understand health patterns across thousands of people. This became my turning point — shifting from genetic engineering toward public health research and clinical trials.

The next challenge was: how do you enter public health/epidemiology with a biotechnology background? I was also determined to do my PhD abroad. So, in my second year of my Master’s, I began reaching out to professors and universities internationally. After multiple conversations and applications and few cleared interviews, I chose the fully funded international scholarship at Deakin University, Australia called the Deakin India Research Initiative (DIRI) Fellowship.

Tell us about your career path

My PhD was, in many ways, the experience that shaped everything that followed. The research explored how neighbourhood environments — mapped through GPS — affected the physical activity and metabolic health of adolescents, with physical activity captured through accelerometers. It was part of a broader international study looking at the same questions across multiple countries, and I was responsible for the Indian arm of it, partnering with the Madras Diabetes Research Foundation. The work sat right at the intersection of technology and public health, and my engineering background made me a natural fit. Though my university was in Australia, the research brought me back to India, and the scholarship gave me something truly rare — the chance to work across both countries, collaborating with researchers, urban planners and policy makers from around the world and seeing firsthand how data and science could speak to some of public health’s most pressing questions.

Outside of my research, my professors shaped something even more valuable in me — the habit of thinking critically, being detail-oriented, and always practising ethical research.

My PhD supervisors at Deakin University were genuinely transformative figures in my life. Growing up in academia, I had seen some discouraging things — disputes over research credits, ethical misconduct, slow timelines, and very little collaboration across fields. My supervisors helped me see past all of that. They showed me what research could look like when done with integrity and passion.

More importantly, they helped me think clearly about what I really wanted from my career. Through their mentorship and my experience working with international research teams, I realised I didn’t want to stay within academia — I wanted to take my research skills into the corporate world, where I could see my work reach patients and make a real difference.

How did you get your first break?

Breaking into the corporate world was harder than I expected. For a long time, I thought my PhD topic was my only skill. It was only after I landed my first role — at National Institute for Research in Tuberculosis — that I had a lightbulb moment. I realised that what I had actually built during my PhD were transferable skills: attention to detail, research methodology, scientific writing, statistical analysis, and the ability to communicate complex research clearly. Once I started speaking about these confidently in interviews, doors began to open.

From there, I joined Johnson & Johnson (Ethicon)’s regulatory team through HCL, working across medical devices in Surgery, Orthopaedics, and Energy. Focused primarily on the European market, I drew on the research foundation built during my education to construct strong clinical evidence and evaluations that spoke to the safety and efficacy of each product. Where evidence gaps emerged, my reports made sure they were addressed — advocating for clinical trials or additional literature to fill those gaps responsibly.

This gave me a broad view of the industry and the different paths available for someone with my background.

I then moved to Qure.ai, which was one of the most exciting experiences of my career. Here, I got to combine my clinical trial expertise with something completely new — building ethical, safety-focused regulatory pathways for AI-based and software medical devices seeking FDA clearance (the FDA is the authority in the USA that approves medical devices and products). I worked on a Software based Medical Device that analysed CT images to detect and measure cancer nodules — helping clinicians catch what matters, sooner. My day-to-day involved collaborating closely with R&D, engineering and medical teams to understand the product deeply and then mapping out regulatory and clinical pathways. Think of regulatory pathways as the rulebook a company must follow to prove their medical device is safe and effective before it can be used on real patients.

Seeing research translate directly into something a doctor could use, something that could genuinely change a patient’s outcome, gave me a sense of purpose.

I continue to work in this space today, now with an even broader scope — exploring regulatory pathways across multiple countries and working with both software and hardware medical devices.

What were some of the challenges you faced? How did you address them?

Breaking into the corporate world required me to look beyond my research topic and recognise the broader skills I had built. Through honest self-reflection and carefully studying job descriptions online, I identified what I was truly experienced at and how those skills could be applied in a corporate setting.

Where do you work now?  What problems do you solve?

I currently work at Philips, as part of their regulatory team in clinical informatics. My role involves designing regulatory pathways for both hardware and software medical devices. Currently, I work in new product development, focused on Pathology and Precision Diagnostics.

Sound knowledge on technology, regulatory pathways specific for the country in plan, market understanding of competitors but the base for all this starts at interest in technology, research skills and upskilling regularly regarding the regulations.

Whats a typical day like?

On a typical day, I work with R&D scientists to understand the product and technology in detail and assess the possible regulatory possibilities and bottle necks, in case of bottlenecks I consult with the US FDA authorities (if working on US clearance) and design the clearance plan along with clinical doctors and risk team for maintaining patient safety.

I work with a highly experienced and collaborative team from around the globe, which means every day involves rich knowledge sharing. This environment keeps me constantly learning — both deepening my expertise in regulatory strategy and exposing me to cutting-edge technologies that are shaping the future of medicine.

How does your work benefit society? 

My work directly influences which medical technologies become available in the market. The clearance pathways I help build along with our cross functional teams (like R&D, Engineering, etc.,) allow companies to get approval from bodies like the FDA (USA) or European Notified Bodies, ensuring that only safe, well-tested devices reach patients.

Tell us an example of a specific memorable work you did that is very close to you!

I had the opportunity to work on the regulatory clearance of a technology designed to detect cancer earlier through CT scans. This project was deeply meaningful to me — I had recently lost a loved one to cancer. Contributing to this work felt like a small but significant way of giving back, and it reminded me exactly why I chose this path.

Your advice to students based on your experience?

  • Develop a habit of reading. Reading widely helps you discover what’s out there — the fields, the careers, the possibilities you didn’t even know existed. If sitting down with a non-fiction book feels daunting, start with fiction. Let it pull you in, and slowly branch out into general reading from there.
  • Know your principles — and don’t let go of them. I keep a personal set of non-negotiable values that guide both my life and my career. These are different for everyone, but having them gives you mental clarity, especially when you face tough choices. For me, ethical practice comes first, I continue to explore these principles at a philosophical level. Having this anchor has helped me build a career I’m genuinely proud of — and maintain a rich personal life alongside it.

Future   Plans?

I now have deep, well-rounded experience in regulatory research. Going forward, I want to continue to combine this with my clinical trial expertise and research skills to move into product design and, eventually, health policy shaping — where decisions I contribute to could influence entire healthcare systems.