Healthcare Regulations directly contribute to ensuring the safety and efficacy of cutting-edge medical technologies, ultimately benefiting patients and healthcare as a whole.

Medha Sateesh Bharadwaj, our next pathbreaker, Senior Regulatory Affairs Specialist at Intuitive Surgical (Seattle), works on a range of challenges centered around ensuring that the devices developed for robotic-assisted surgery meet rigorous regulatory requirements and international standards.

Medha talks to Shyam Krishnamurthy from The Interview Portal about the satisfaction of being closely involved with medical product development while keeping an eye on patient centricity.

For students, the medical field is vast, and the more you explore through internships and projects, the more your career will evolve based on your chosen field !

Medha  Your background?

I was born and raised in Bengaluru, popularly known as the ‘Silicon Valley of India’. All my formative years were spent in this beautiful city. My father is a professor of structural engineering, and my mother is a software engineer. They are hardworking individuals who have built their careers from scratch and remain grounded.

Education held significant importance in my family. My sister and I grew up with the belief that knowledge is the greatest asset one could acquire in life. Our family has consistently upheld women’s equality and celebrated the birth of girl children. Throughout generations, the women in my family have been equally educated and accomplished as the men.

My personality and interests were significantly influenced by my family, especially my parents and grandparents, who instilled in me a sense of morality, purpose, and passion. I consider myself fortunate to have spent a lot of time with my grandparents. 

My paternal grandmother who was initially educated only up to the 10th standard, pursued further education with my grandfather’s encouragement. She went on to obtain a master’s degree in literature and history. She was a gifted poet, earning appreciation from notable Kannada authors such as Kuvempu and D. R. Bendre. My maternal grandmother is equally inspiring, becoming one of the first working women of her generation. She is a retired teacher who deeply cared for her students who came from economically disadvantaged backgrounds. The saying, ‘Educate a woman to educate the country,’ truly resonates. My bedtime stories were frequently sourced from world history and famous literary works ranging from Shakespeare to Kalidasa. 

When my parents married, my mother held a bachelor’s degree in engineering. Encouraged by my father and his parents, she pursued a master’s degree in engineering, completing it when I was around 2 or 3 years old. When I was around 8 or 9 years old, my father pursued his PhD. My parents encouraged a reading-friendly environment at home where my sister and I learned to appreciate the pursuit of gaining knowledge. 

Despite my parents’ deep involvement in engineering, they never tried to steer my interests. I had diverse passions growing up, from abacus and literature to psychology, debates, Indian classical music, and spirituality. I was an ardent fan of literature and read most of the books available in the local library. 

I always performed well academically even though my parents did not place a lot of importance on ranks or marks. I didn’t even know I was the topper for my school in the 10th standard board exams until someone pointed it out to me. 

Early on, I had a strong desire to make some form of meaningful contribution to society. As cliché as it may sound, I discovered that if I were to have a successful career, I had to truly be passionate about it. 

During my pre-university years, I started to develop an interest in engineering, but none of the traditional branches appealed to me. I wanted to pursue a career that is close to technology and at the same time contributes to the field of medicine. This blend of influences ultimately led me to develop an interest in utilizing technology to solve complex medical problems, prompting my decision to pursue a bachelor’s degree in medical electronics engineering.

What did you do for graduation/post graduation?

I earned a bachelor’s degree in engineering with a specialization in Medical Electronics from BMS College of Engineering (BMSCE), Bangalore and a master’s degree in biomedical engineering from the State University of New York, Stony Brook, USA. 

The four years that I spent at BMSCE played a big part in shaping my career and interests. I was passionate about this field and pursued my education with genuine interest. I received five scholarships in recognition of my academic performance which covered a portion of my fees. I was awarded a Gold Medal for graduating with the highest marks (known as Grade Point Average) for my batch. My primary focus during engineering was to work hard and deliver my best consistently, rather than aim to be the top-ranking student. The gold medal proved to me that I made the correct decision by pursuing the branch of engineering that I loved. 

When I was in my third year of engineering, I started to develop an interest in pursuing a master’s degree. I researched different options and learned that the US has the most innovation happening in my field. I was worried about the immense financial burden that comes with pursuing a master’s degree in the US. I spent many months researching and shortlisting a few universities and decided to take a loan with my parents’ support. 

I applied to a few state universities in the US that were renowned and aligned well with my interests. One such university is the State University of New York (SUNY) at Stony Brook, which is very well known for its biomedical engineering program. I wanted to gain research experience alongside my degree, and this university had some of the top researchers in the field. However, I knew that getting admitted here was very competitive as the department accepted only about 10 students per year, so I kept my expectations low. 

I was excited to receive an acceptance letter from the Department Chair saying that I was among the top 0.05% of the students who had applied that year, as they had received over 200 applications for only 10 positions in the master’s program. 

Pursuing my master’s degree was one of the best career decisions I ever made.  Moving to a new country all by myself at 21 taught me a lot about independence and maturity. It also steeply sharpened my technical and critical thinking skills.  

Who were your key influencers and mentors? 

My key influencers are my parents, grandparents and the countless books that I have read during my formative years.

We had a huge collection of books at home covering various topics ranging from engineering and technology to philosophy and arts. My grandmother would always tell me to appreciate the influence of arts and literature on our lives. This steered me towards reading, which opened my mind to multiple new worlds.

 I truly feel that reading a wide variety of books is one of the easiest and most overlooked ways of understanding how to carve our path. As said by the French philosopher and mathematician Rene Descartes, reading good books is like having a conversation with the finest minds of past centuries. 

I’ve been fortunate to have had several mentors and managers who’ve provided me with invaluable support throughout my journey. I hold a special gratitude for the teachers and professors who have guided me through the years.

The ongoing support from my husband and his parents has played a pivotal role in my recent career milestones. 

What were some key turning points?

I developed an interest towards STEM (science, technology, engineering and mathematics) at an early age, probably because of frequent exposure to this field at home. I grew up witnessing how passionate my parents were about their professions.

Around the age of 10, I accompanied my mother to the Indian Institute of Technology (IIT) Kharagpur, where she presented her technical paper at a conference. At that young age, I didn’t fully comprehend the content of the seminars, so I occupied myself by reading books and observing the attendees. During this time, I befriended a group of young doctoral students and spent a lot of time going around the town with them. I closely observed the enthusiasm and dedication that everyone exhibited for their respective fields of study, and this left a lasting impression on me. 

What made you choose such an offbeat, unconventional and uncommon career?

My father initially wanted me to become a doctor. He took a lot of time to inspire me about the field of medicine, taking me to various medical colleges and introducing me to medical students and doctors. I am so glad he did that; it allowed me to discover how passionate I was about healthcare. This helped me decide that I wanted to pursue something related to medicine, but I was equally interested in engineering and wanted to stay close to technology. So, I wanted to pursue a field where the two converge. 

Initially, I felt my interests were conflicting, and I believed I had to choose between the two. This perspective changed when I learned about the possibility of working in the field of medical technology. It felt like the best of both worlds, and today, it truly is for me.

During my third year of engineering, I was selected for an internship at a medical technology startup called InnAccel. During my stint here, my teammate and I assisted with the MedTech product development process and learned about the stages of medical device development and the role of regulatory affairs in ensuring the development of safe and effective devices. This was my first introduction to the world of product development and regulatory affairs. 

How did you plan the steps to get into the career you wanted? Or how did you make a transition to a new career? Tell us about your career path

Subsequently, my second internship was in collaboration with Narayana Nethralaya, where I was part of the team that developed an algorithm to assist in the automated classification and detection of Retinopathy of Prematurity, a deadly eye disease that occurs in premature infants. This was also my final project thesis for engineering and our team won the Best Project Award that year. 

Both opportunities came my way through the Department of Medical Electronics at BMS College of Engineering and these provided a strong foundation for my career. 

After moving to the US for my master’s, I worked as a graduate student researcher in computational neurodiagnostics at my university. I assisted with developing algorithms to compute data acquired from different modalities such as Magnetic Resonance Imaging and Near Infrared Spectroscopy. This was a great opportunity as I learned a lot by working closely with some highly accomplished professors and doctoral students. 

Neuroimaging data was acquired from modalities such as fMRI (functional magnetic resonance imaging) and NIRS (near-infrared spectroscopy). Statistical analysis of the time series was conducted to gather insights on certain neurological and psychiatric disorders. I was able to learn more about statistical analysis and pattern recognition.   

During my master’s degree, I landed an internship at LivaNova in Houston, Texas. LivaNova is well-known in the industry for developing implantable devices to treat drug-resistant epilepsy. 

This was a medical device/medical technology company. Drug-resistant epilepsy occurs when a patient does not successfully respond to anti-seizure medications. For such cases, vagus nerve stimulation therapy can be very useful. A small device is implanted in the chest and connected to the left vagus nerve in the neck. The system sends mild electrical pulses to the brain through the vagus nerve to help prevent seizures before they start and can also help stop them once they start. The system includes an implantable pulse generator and falls under the most stringent regulatory requirements in most countries. For example, this is a Class III medical device as per the US FDA regulations, which is the highest risk classification for a medical device in the United States. I was part of the regulatory team and also worked on clinical engineering projects. My work here was both challenging and exciting, and I gained a deeper understanding of regulatory affairs and product development processes. My manager showed genuine interest in my career development, assigning me some amazing projects that significantly contributed to my skill set. This helped me land my full-time job soon after graduating. 

Soon after I completed my graduation, I started a full-time job at Fujifilm Sonosite in Seattle, Washington. Fujifilm is known for its reputation in the field of diagnostic imaging. I was part of many exciting projects there. I was given great opportunities where I functioned as a regulatory lead for new product development and authored submissions to regulatory authorities across the globe. This job helped me develop expertise in regulatory affairs, especially in product development and design control processes. 

I received incredible support and guidance from my immediate managers and higher-level managers at Fujifilm. My time there is something I value greatly. 

While Fujifilm is popularly known for its cameras, it has also achieved remarkable advancements in the field of diagnostic imaging. Fujifilm Sonosite is one of the industry leaders in portable ultrasound technology. Ultrasound imaging systems are complex medical devices used in multiple specialties such as cardiology, emergency medicine, anesthesiology etc. My work was focused on regulatory affairs for diagnostic ultrasound imaging systems and transducers. 

I currently work at Intuitive Surgical, renowned for its products in the robotic-assisted surgery space. My previous work experience played a big part in getting me here. 

How did you get your first break?

I got my first break at Fujifilm. My previous experience helped me land this job. I applied online for the role, had successful interviews, and was subsequently hired.

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

Challenge 1:

While many think medical technology is a narrow field, it’s actually very vast. At first, I didn’t know what to focus on. Doing internships and research during my studies helped me figure out what I liked the most. My advice for others is to find what you enjoy, and get really good at it as you move forward in your career. Depth is important as you progress. 

Challenge 2: 

Academic knowledge does not always translate into industry skills. If you’re looking for a job as a student, it’s vital to know what skills companies want and then work on developing those skills. What worked for me was looking at job listings to see what skills they wanted and talking to people who already work in the field. 

Challenge 3

If you’re an international student in the US, it’s crucial to understand how to get a work permit and find a company that will sponsor your visa. Many companies will sponsor work visas, but they want certain skills which you might not have right after graduating. So, it’s important to build those skills during your degree program, which connects to what I mentioned in my previous response.

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

I currently work at Intuitive Surgical. 

In my role, I tackle a range of challenges centered around ensuring that the devices developed for robotic-assisted surgery meet rigorous regulatory requirements and international standards. To ensure this, I am closely involved throughout product development and beyond.  

What skills are required for your role? How did you acquire the skills?

The skills needed for my job involve a blend of technical expertise and regulatory knowledge. I’ve developed proficiency in interpreting medical device regulations, navigating complex requirements, and interpreting international standards. Given that there are many countries with distinct regulatory requirements, adaptability and the ability to tailor strategies to different regions are essential. Additionally, strong communication, attention to detail, and problem-solving abilities are crucial in my role.

Breaking into the regulatory field can be challenging due to its specialized nature, but I acquired these skills through a combination of formal education, hands-on experience, and continuous learning. Engaging with industry professionals, attending workshops, and staying updated on evolving regulations have all contributed to honing my skills and developing my expertise in the field. 

What’s a typical day like?

A typical day in my job involves a lot of cross-functional collaboration, problem-solving and working closely with product development teams to ensure that every step of product development adheres to regulatory requirements. Additionally, I review and sign off on various technical plans and reports, attesting that they meet regulatory requirements and standards. It also includes developing and refining regulatory strategies for upcoming product launches or changes, considering the most appropriate regulatory pathways and potential challenges.  

What is it you love about this job? 

I enjoy being closely involved with product development through the eyes of regulatory. The dynamic nature of this job ensures that there’s always something new to explore, making it almost impossible to get bored. This keeps me motivated and intellectually stimulated. In my current role, I enjoy working with robotic-assisted surgery. I find it exciting to delve deep into regulatory matters while simultaneously staying attuned to the rapid advancements in medical technology. 

How does your work benefit society? 

I have a sense of fulfillment from the knowledge that my work directly contributes to ensuring the safety and efficacy of cutting-edge medical technologies, ultimately benefiting patients and healthcare as a whole.

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

I’ve been fortunate to witness some of the medical devices that I worked on being used in real-life situations, particularly in emergency rooms within one of the busiest hospitals in the US. It was a truly rewarding experience and gave me a sense of purpose. I’m grateful to my employer for giving me the opportunity to experience that firsthand. 

I’ve had the privilege of working on several impactful projects throughout my career. All my employers have provided me with great opportunities to advance my career. While I can’t delve into the specifics due to confidentiality agreements, each project has taught me valuable lessons and allowed me to grow in my role. 

Your advice to students based on your experience?

My advice to students based on my experience would be to focus on building a strong foundation of knowledge in your chosen field. Stay curious and open to learning, as industries and technologies evolve over time. Seek internships or opportunities to gain practical experience alongside your academic studies – hands-on experience can be invaluable. Develop strong communication and teamwork skills, as collaboration is often key in professional settings. And finally, be adaptable and embrace change, as the working world is dynamic and being flexible will serve you well as you embark on your career journey.

Future Plans?

When considering my future career plans, I envision developing further expertise within the medical devices industry. I anticipate that my work will become progressively more complex due to the innovation happening in medical technology. I aim to take on progressively challenging roles that allow me to contribute to advancing the field of medical technology.