Dhwani's journey into healthcare began at a young age, fueled by a deep-seated interest in biology, medicine, and human health. Her undergraduate years were spent in the lab, where she immersed herself in biomedical research. This foundation laid the groundwork for her future endeavors in the field of regulatory affairs.
It was during her master's internship working in consumer healthcare products that she first encountered the world of regulatory affairs. She quickly realized the significant role compliance plays in bringing life-changing products to those in need. This realization sparked her interest in regulatory affairs, leading her to delve deeper into the subject.
"I started with my undergrad in biomedical research, where I was in the lab for a lot of my undergrad years. Then, during my master's in life sciences, I worked in healthcare with consumer healthcare products. It was during this time that I got introduced to regulatory affairs, finding it very interesting. The realization that research and product development are impactful only when aligned with compliance requirements triggered my exploration into regulatory affairs."
Relocating from the UK to the US, Dhwani found herself in the heart of the medical device industry in Minnesota. This move provided the perfect opportunity to apply her knowledge and skills to ensure that cutting-edge research reaches the individuals who need it most. She then pursued a Master's in Regulatory Affairs to solidify her expertise.
Since 2015, Dhwani has been an integral part of the medical device and IVD industry. For over two years, she has served as an independent consultant, aiding manufacturers in obtaining clearances for their devices, primarily with a focus on FDA approvals, and is now expanding her expertise into Health Canada.
Dhwani reflected on the unconventional route she took to become a regulatory professional. Unlike many in the field, she did not transition from another sector but instead found her calling in healthcare early on.
One of the challenges she highlights is the delicate balance between ensuring a device is both safe for patients and financially viable for manufacturers. This dynamic underscores the complexity of regulatory affairs, as decisions must consider both the business and health aspects.
For Dhwani, the most gratifying aspect of her role is the tangible impact she can make on patients' lives. Her background in research and development and her close connection to patient needs give her a unique perspective on the vital role of regulatory affairs in healthcare.
"As a kid, I always wanted to be a doctor. And then while growing up, I realized that maybe research is a better fit for me because I can bring newer drugs, medicines, or cures to people rather than just treating them. And then when I saw that medical devices are not always made correctly I wanted to help so I could benefit people to the maximum potential. [...] I had a manager who used to always say something that stuck with me. If you can use a medical device on your parents and your grandparents, if you can use it on your family and loved ones, then that device is good enough."
Looking ahead, she emphasizes the importance of improved communication between regulatory professionals and governing bodies. She envisions a more accessible and collaborative environment, where information flows freely, leading to better-informed decisions: "If we can speak openly, learn more, and have honest conversations, I think that will help."
Dhwani acknowledges the potential for AI to revolutionize regulatory processes, particularly in streamlining submissions and enhancing standardization. However, she underscores the irreplaceable role of human oversight in ensuring the right application of regulations.
When asked about an alternative career path, her commitment to healthcare shines through. Whether in research or application, her goal remains the same: to bridge the gap between innovative technologies and the people who need them most.
She leaves us with two valuable pieces of advice. First, she encourages newcomers to the field to never shy away from asking questions. Second, she emphasizes the need to embrace the nuances of regulatory affairs, recognizing that it often operates in "shades of gray rather than black and white."
Dhwani Thakkar's journey through the world of healthcare and regulatory affairs is a testament to the diverse pathways one can take in this RA. Her unique blend of scientific expertise, patient-centric focus, and business acumen exemplify the qualities that make her a Regulatory Rockstar. We look forward to witnessing her continued impact on the industry and patients worldwide.
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