Medical Devices play an integral role in healthcare delivery, through life-saving products that are designed and engineered from applications of different disciplines of science such as mechanics, computer science and electrical engineering.
Rachel Pranitha Wood, our next pathbreaker, Device Engineer at AstraZeneca, works on combination products that have a drug and a device within the same medical product.
Rachel talks to Shyam Krishnamurthy from The Interview Portal about being fixated on the field of medicine, but taking a different route through biomedical engineering to develop medical technologies and devices to improve lives.
For students, always remember that there are multiple paths to achieve your goals. Keep the “Big Picture” in mind and recalibrate yourself based on your progress.
Rachel, a little bit about your background?
I was born in Hyderabad. I grew up with my parents all my life until I had to make this big move to the US. My dad took up businesses in several private sectors while my mom still serves the government as a Woman and Child Welfare Officer. I was into a lot of extracurricular activities and had decent grades in high school. Since both my parents were working, I was on my own for most of the time and the biggest achievement at that time was trying to do everything on my own and not get into trouble. Until my 10th grade, I wouldn’t say I was really determined or had great ambitions. It was only when I joined my 11th grade that I had an ambition and started working towards my career.
What did you do for graduation/post graduation?
I chose Biomedical Engineering as a major for both Bachelors and Master’s degree.
What made you choose such an offbeat, unconventional and unique career?
Growing up in a country like India, where you either want to be a doctor or an engineer, I wanted to be a doctor as well. Somehow, I realized it takes an enormous amount of sacrifices to be a doctor and I wasn’t really ready for that kind of life. So, I chose a happy medium of being an engineer in a medical field, thanks to my dear friend who introduced me to this field and explained a few details about this degree.
I was determined to take this as an option as I was fixated to be in the field of medicine which could help save lives.
I always wondered how we could see the images inside of the body without having to cut open the body, how undergoing a certain surgery could fix a problem. In the degree program, we initially learnt about our body and associated diseases, and in parallel, learnt about the different kinds of technologies available to treat ailments. The field of Biomedical Engineering allows us to learn about different sciences such as mechanics, computer science, electrical engineering and apply them in the final product which could eventually help save a life. This innate curiosity and passion within me to learn how a technology could save a person from dying pushed me towards Biomedical Engineering.
I would say my parents and my grandmother primarily influenced me. My grandmother and mom were both working women and I was inspired by how they balanced their work with family.
At every stage of my life I had beautiful and inspirational people who guided me. They were my school teachers, my family and friends, my managers and mentors at work. They all played a significant role in me becoming the person I am today. I would like to say that networking plays a huge role in your life as you can learn from someone who has already faced your problem.
How did you plan the steps to get into the career you wanted?
Through my under graduation, I realized that there aren’t many opportunities in India in the field of Biomedical Engineering. We don’t have research and development within India since we source medical devices and drugs from the US or rest of the world. This led to my next decision to pursue Masters in the USA.
After moving to the US, I learnt about various kinds of opportunities within Biomedical Engineering. I was initially star-struck by medical imaging – A CT Scan or an MRI machine. I wondered what is inside those machines that could help build an image of what is going on deep down inside my body. This led me to pursue Medical Imaging during my Masters and I wanted to focus on MRI. However, life always has different plans, so I was chosen by my professor Dr. Ciprian Ionita who does both prototyping of devices and medical imaging. Under his supervision, I learnt about prototyping a product, using different imaging technologies, and at the same time reading the images of the prototypes we used to build in our lab.
After I graduated, I was determined to work on medical devices as I thoroughly enjoyed my time at the lab building prototypes.
During my Masters, we are given an opportunity to work as a research assistant and publish a thesis on our research. As I mentioned, I chose prototyping using a 3D printer and validating the device we built. It was an exciting opportunity as I got to work with renowned neurosurgeons and accomplished scientists. We worked on designing a tool to validate a software where blood volume, blood flow and transit time of the blood is measured for people affected with stroke. These parameters help identify the stroke affected site. My role was to build varying prototypes of this tool which could be used as standard to validate the software.
How did you get your first break?
After graduating with M.S in Biomedical Engineering, I was applying for various job opportunities. Living in a different country and attaining jobs in the US with a temporary visa is a feat in itself. As I mentioned earlier, I was determined to work on medical devices. I applied to every role to land a job in the medical device industry. After several attempts, I was able to secure a job in the medical device industry.
What were some of the challenges you faced? How did you address them?
Challenge 1: The first challenge was when I moved to the US. I grew up very happily and comfortably with my parents until I made my move to the US. I did not realize the importance of many things while living at home. It is not easy when you move to a new country – as the culture, ways of working, food, people, conversations, friends, and family have changed within a flight’s time. It was a rude awakening for me, and especially when you are a student and you had to spend in dollars while you were not earning teaches you life all over again and appreciation for the little things in life.
Challenge 2: To secure a job while you are a visa holder is extremely difficult, you have no choice but to apply every day and follow up a zillion times. At times, the good grades or hard work doesn’t pay off since you are at the mercy of an immigration policy. This experience humbles you and teaches you to never stop trying in life.
Challenge 3: The most difficult challenge I had to face was when I lost my dad to kidney failure because of his history with diabetes. I graduated and just started to work while he fell extremely ill. Living thousands of miles away, trying to fathom that your most loved person is at the edge and being able to excel at your work was extremely challenging. I cannot thank my manager at that time for his support, my friends and most importantly, my family who stood by me during the difficult times. Through all these challenges, I have learnt that I should never take any day for granted.
Can you tell us about your work in the medical devices industry?
I am currently working as a Senior Device Engineer at AstraZeneca. As I said earlier, I was inclined and was determined to work on medical devices. I previously worked exclusively in the medical device industry. I currently work on combination products. When I was offered this job opportunity I was excited since the combination products I support have a drug and a device within the same product.
As a device responsible person, I am primarily responsible for the device and the part where the device interacts with the drug. We are responsible to make sure we follow the design controls and continuously review that our product is safe and effective for the patient. I can provide an example on applying design controls to a product: Suppose if we are designing a pen – the length, tip, breadth, ink color will be considered as design inputs. The actual drawing of the pen or the pen itself is a design output. I need to make sure the actual pen length is the same as what we documented during the input by measuring the dimensions, this part is design verification. I would then conduct a study with a set of people who might be using this pen and get feedback on their experience. From this user experience, such as grip of the pen, flow and the ink color satisfaction, and many other factors, we validate our design, also considered as design validation. These are the main elements of design controls and we need to document every step of the product development and maintenance even after it is released into the market. If I would like to make a change to the pen ink color, I need to go through the design documentation and assess if this change would impact the user interface and if it is still safe to use at a high level.
Prior to joining AstraZeneca, I worked at Zimmer Biomet which is an orthopedic implant company. My role here was similar to my current role, to maintain the Design History File documentation following the design controls.
Prior to my role at Zimmer, I was a Quality Engineer and was responsible for Risk Management activities of a medical device. The Design Controls and Risk Controls are applied throughout the lifecycle of product. At every design stage, the risks are reviewed and the overall medical benefit should outweigh the risk. I can provide an example – Consider the pen example again. Now, suppose the pen’s cap has not been replaced and the tip is exposed. In this setup, the tip presents a hazard. If anyone picks up the pen, then we are presented with a hazardous situation. If they now hurt themselves due to the sharp tip, then we have a risk of harm”
Similarly every medical device will have risks, we need to identify the risks (sharp tip), and mitigate (making it rounded/ blunt) through the design. After applying all the risk controls to the product and minimizing the risk factors, any residual risk should be informed to the patient.
How does your work benefit society?
Aviation and healthcare are highly regulated industries due to the risks they pose for their kind of application. Working in the healthcare industry, and understanding that whatever we do will directly impact the life of a patient and save their life provides utmost satisfaction for me. It takes anywhere between 4-10 years for a product to be launched into the market since its inception. The amount of documentation, design reviews and validation to launch a product into the market is heavy lifting work done by thousands of people which is ultimately used to save lives.
Tell us an example of a specific memorable work you did that is very close to you!
I cannot give one particular example, but the whole journey is very exciting for me as I get to learn about various technologies that could help save lives. As I said earlier, I lost my dad due to diabetes and my mother had a near death experience due to COVID. I currently support the Diabetes product portfolio and I know how important these drugs are to a patient and the difference it makes in their life.
Your advice to students based on your experience?
None from my school chose Biomedical Engineering, since it was considered a niche career choice. If we are willing to believe in ourselves, take a step forward and put in our hard work, the opportunities will be more conspicuous to us.
I read this book where I learnt that being insightful is one aspect which is the big picture, and the continuous development of an idea is another aspect and is the smaller picture. The trick is to sustain both the aspects of being insightful and work towards the development of your goal. Failure is not about failing in a course / situation, it is to stop trying and making progress.
I would like to excel in my field and may be part of an amazing invention during my lifetime.
I need to discuss Medical Device design with Rachel Pranitha Wood.