How did I end up working for medical devices?

When I reflect on my career so far, I realize that it is multifaceted and diverse in ways more than one. If you’d asked me three years ago when I was working on protein structure in research labs, I would never have thought that I would be working in the world of quality a few years later!

Transitioning from research to industry was challenging. I had started a path of a PhD in India, as I thought that it was the only way I could use my degree in biology. While coming back to my hostel, I came across a medical device startup incubator. A lucky introduction with the director there turned my life around in a few months. I found myself focusing more on medical device development, standards and market strategy. Soon, I decided to pursue the path of quality and regulatory. After a few introductory courses, I decided to pursue a master’s in regulatory affairs and off I went to the U.S.! Since then, I have worked in regulatory and quality teams for surgical eye implants, virtual reality based devices and wearables for remote patient monitoring, along with providing thought leadership on artificial intelligence regulation.

How do you navigate a career in a foreign country?

I feel that most immigrants have several identities, and as an early-career Indian woman, I have realized that you must make opportunities happen to you. Boston gave me a ton of opportunities to network as a student: some of my most memorable ones revolved around International Society of Pharmaceutical Engineering (ISPE), Society of Quality Assurance (SQA), American Society for Quality (ASQ) and others. Many of these organizations offer scholarships as well. As a student, involving oneself in networking events is another way to build connections and relationships, especially if you are far from home.

If I could rewind and go back three years, here is the advice I’d give myself to break into quality roles for medical devices:

1. Be (read: be genuinely) curious: If you really want to break into a field, know everything about it. Interview experts, read the latest research and don’t be shy about asking questions!
2. Have an eye for detail: Quality is so much about having an eye for detail—whether it is for documents, or for potential risks.
3. Be passionate about the truth: It might come as a surprise, but a lot of work in quality is about finding the ‘root cause’ to problems. Searching for root causes can feel a lot like investigating a crime scene where you want to search for the truth. You may get obstacles but keep pushing through!
4. Read the room: A lot about working in quality is reading the room and understanding how people perceive you—as someone who works with the police or is a facilitator?
5. Your job depends on others: While many parts of the job are about improving processes, understand that nothing can move forward without collaboration. Understanding when people are overwhelmed by other work is important, and giving people time to rest and get back to you is critical to maintaining positive relationships.

How do you cultivate different passions to find your work identity?

Learn fast and adapt: this is a common saying applicable to almost all industries. In my experience, school has been the best time to understand what I am truly interested in and to keep building on those ideas. I have been passionate about artificial intelligence (AI) and the regulatory landscape in the healthcare space, and although my degree did not have an official thesis, I was able to publish a paper in this field, which opened opportunities to talk at 8+ conferences and present my work. I feel that having this domain expertise has aligned well with my long-term career goals as well!

While working on the job is important, it is equally important to re-evaluate one’s long-term career goals. It might not always be possible to get your dream job right after school, but having defined career objectives would help you to understand your current standing and areas of improvement. Identifying my passions early on in my career—an intersection of quality, AI and regulatory—has enabled me to identify my career ikigai.

How important is it to get involved?

While working in a cross-collaborative role such as in quality, it is important to understand that inclusion and getting a seat at the table is a step forward to contributing your ideas. In my career, I have worked with startups, pre-seed startups and larger companies—and I have realized that speaking up contributes a lot to being able to influence decision-making while working in quality and regulatory.

When I started off, I would often consider my work in quality to be the most critical task on projects—but as I understood business timelines and project deliverables, I realized that I would have to establish the criticality of my work in language which is understandable to those outside of quality in order to get work dependencies cleared out. Breaking down barriers between departments by adapting to language styles has led to efficient communication. Some examples I have seen working out in my favor are talking in terms of deadlines, criticality, and business risk to project managers and higher management.

What challenges can you face when explaining quality to those working outside quality?

I enjoy explaining the importance of quality to engineers and business alike and have learned that informal lunches, talks and coffee meetups go a long way in establishing quality culture. As a student or early-career professional, I have felt that explaining quality terminologies in a relaxed environment helps to get the message across much more effectively than setting up official meetings. After all, quality is a duty of every individual!

How do you navigate diversity and belonging in the workplace?

Regardless of the role, feeling a sense of belonging to the workplace is important for all employees. I have faced situations where I am the only woman on the team—and developing leadership skills is crucial to communicate your value to the workplace. I have found value in professional network groups which provide advice on navigating corporate waters as an early-career woman. Embracing one’s diversity is important for assimilating in new teams, understanding their self-worth and assessing their strengths and weaknesses. Speaking up never hurts!

Any final words?

Quality is a lot about grit and determination, along with the ability to influence teams and guide organizations to the path of success. I realized the stakes are high when people—and maybe even my loved ones—may be using a device I have been working on. My grandmother passed away due to heart failure when she was 62 years of age. Looking back, I feel that maybe wearables—if they had been as popular now compared to ten years ago—may have been able to give indications of the problem before it escalated to such a critical point. Now that I am working on medical devices related to cardiovascular problems, it almost feels as if working on this product category was predestined.

Working in quality in the medical device industry gives me a sense of purpose every day. As a quality professional, knowing that my efforts contribute directly to the safety and well-being of patients worldwide is a huge responsibility. Every task I undertake, from ensuring compliance with stringent regulations to meticulously reviewing product designs, reinforces my commitment to excellence and passion to contribute to the best of my ability.