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Q: What initially attracted you to apply for this internship at our company?
At the time, I was hoping to contribute to medicine as a future researcher, and this opportunity aligned closely with that goal. Cardio Flow Design bridges engineering and clinical practice by applying CFD analysis in the cardiovascular field to surgical planning in real medical settings, and I was strongly drawn to an environment where I could put my background in biomedical engineering to work in the form of actual medical devices. What ultimately decided it for me was seeing my own research goals line up with the direction the company was heading.
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Q: How did this internship contribute to your professional development and career growth?
Spending about six months on usability and risk management for regulatory approval taught me firsthand that building good technology alone isn't enough to bring a medical device to market—proving its safety and efficacy through documentation matters just as much. As someone aiming to become a researcher at the time, coming to understand that a regulatory perspective is essential to actually implementing your work in society became a real foundation for how I think about my career going forward. I feel like my understanding of both academic research and the practical work of turning it into a real product became much sharper.
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Q: What specific skills or knowledge did you gain during your internship?
Knowledge of regulatory affairs was by far the biggest takeaway. Specifically, I learned the practical side of usability engineering and risk management, along with what regulatory frameworks like the FDA, EU MDR, and PMDA actually require of medical device software. On top of that, I picked up the skill of evaluating and improving package inserts and user manuals (IFUs) against regulatory requirements, as well as the ability to write documentation that communicates technical content clearly and accurately.
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Q:How would you describe the company culture and work environment for interns?
It's a small team of highly specialized people, and perspectives from engineering, medicine, and regulatory affairs intersect constantly in day-to-day work. Even as an intern, I was trusted with work tied directly to regulatory approval—something core to the product—so it felt like a culture built on real ownership and responsibility. Whenever I had questions, people were happy to walk me through the specialized background behind them, which made it an environment where I could contribute to real work while still learning.
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Q: What were some of the most challenging aspects of your internship, and how did you overcome them?
The hardest part was making sure I precisely met the requirements demanded by regulations and submission documents. The FDA, MDR, and PMDA each call for different content and levels of detail, so aligning a single document with multiple regulatory frameworks meant carefully working through each set of guidance. At first I struggled to judge what would even count as "sufficient," but by going back to the original guidance documents and related standards for each regulation and breaking the requirements down item by item into a checklist, I was able to make sure nothing fell through the cracks.
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Q:In what ways did the internship meet or exceed your expectations?
What went well beyond my expectations was getting to deeply engage, over six months, with regulatory approval work I'd assumed I'd have no access to as a student. Understanding the company's mission of bridging technology and clinical practice from the inside—through the concrete work of regulatory compliance—turned out to be far more rewarding than I imagined.
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Q:Can you share an example of a project or task you worked on that had a significant impact on the company?
I evaluated iTSurgery's user manual (IFU) against the FDA, EU MDR, and PMDA regulatory frameworks and compiled a report on areas for improvement. I identified the gaps against regulatory requirements and made concrete proposals on how to strengthen the descriptions of safety and usage instructions. Since this became foundational material for getting the product compliant across different countries' regulations, I feel I was able to contribute to raising the product's quality from a regulatory standpoint.
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Q: What advice would you give to someone considering applying for this internship?
I think you'll get a lot more out of it if you go in thinking not just about the technology itself, but about how that technology actually reaches society. In the medical device field especially, understanding regulatory affairs is essential—you come to realize that even the paperwork that looks mundane at first is actually what underpins the product's safety. If you're not afraid to ask questions when you don't understand something and you're willing to dive into areas outside your own specialty, this is an environment where you can gain far deeper experience than you'd expect.
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Q: What surprised you the most about working here as an intern?
I was surprised to find that bringing a medical device to market takes just as much—if not more—effort in "proving safety and efficacy through documentation" as it does in the actual technology development. I really came to understand the reality that even with a great analytical method or product, it won't reach patients unless it's properly recorded and explained in line with regulations.
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Q: How did the internship impact your understanding of the industry or field?
I came away with a new perspective—thinking of medical devices as products that actually get implemented in society. I now understand the full journey a piece of new software goes through, from development, through regulatory compliance, to becoming a medical device actually used in surgical planning, and I can now see my own field within that broader context that includes clinical practice and regulation.
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Q: Did you have a chance to participate in company events or social activities as an intern?
I got to attend the company's 10th anniversary party. It really stands out in my memory, since it let me connect with people I don't normally get to interact with in day-to-day work.
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Q:What do you think sets this internship apart from others in the industry?
I think the biggest difference is that, despite being an intern, I was trusted with work tied directly to regulatory approval—something core to the product—for a full six months. While many internships keep you in a supporting role, this let me take on real responsibility at the intersection of engineering, clinical practice, and regulation, and learn the full picture of how a medical device actually reaches society. That's an experience that's genuinely hard to come by elsewhere.
