Katie Anderson on Designing for People, Not Just Devices
Introduction
In this installment of Coffee with Clinical Engineers, I sat down with Katie Anderson outside Farley’s Coffee in San Francisco. Fueled by coffees and empanadas, we talked about her career in medtech innovation, from her early days in biomechanics to her work in surgical robotics. Katie’s story highlights how clinical engineering bridges medicine and technology to shift an innovator’s perspective from designing the device to designing for people.
Interviewee Profile
Katie Anderson is a clinical engineering expert with nearly two decades of experience in medtech innovation. She has worked at Smith & Nephew, Intuitive Surgical, and Verb Surgical [acquired by J&J], contributing to advancements in orthopedics, surgical robotics, and digital platforms. Today, she runs her consulting firm, K2A2 Consulting, advising companies on user-centered design strategies across diverse clinical areas, such as orthopedics, thoracic surgery, gynecology, and urology.
Here’s what Katie had to say about her career journey and the lessons she’s learned along the way.
Q&A: Katie Anderson on Clinical Engineering
Q: How did you first get interested in medtech innovation?
A: “I’ve always been fascinated by how the human body moves and heals. Growing up in Tennessee, I was the kid who loved biology class dissection days and was the friend everyone came to if they got hurt. In college, I focused on biomedical engineering and biomechanics and realized it combined what I loved: understanding how the body works mechanically and applying that knowledge to solve real-world problems. That foundation eventually led me to developing implantable medical devices at Smith & Nephew and later working in clinical engineering at Intuitive Surgical and Verb Surgical.”
Q: How did these experiences shape your perspective as a clinical engineer?
A: "Working at Smith & Nephew was pivotal for me. I joined an all-male team of mechanical engineers focused on designing knee and shoulder implants. At the time, we were trying to make knee implants and instrumentation smaller because they required large incisions - about eight inches - just to fit alignment jigs into the knee. The team kept coming back with smaller implants, but the instruments to place them were still the same size.” She explains this is an example of a common gap that many medtech companies face between the device design engineering and the clinical context of a surgical procedure.
She goes on to say, "my biomedical training gave me a very different point of view. I started thinking, ‘What’s the curvature of the knee? How can we tuck this in? How do we avoid disrupting soft tissues?’ It wasn’t just about making smaller knee implants—it was about rethinking how everything worked together to make surgeries less invasive for patients. That perspective set me apart and reinforced my belief that clinical engineering is about more than just the device - it’s about designing for people.”
Q: What does clinical engineering really mean?
A: “Clinical engineering is, in the simplest form, the intersection of everything in the clinical setting—whether that’s surgery, labs, or diagnostics—and engineering expertise. It’s about bridging these two domains to create devices that not only work but also fit seamlessly into real-world clinical environments.”
She recalled her first exposure to the field while applying for a job at Intuitive Surgical: “The title was clinical engineer, and when I read the description—working side by side with surgeons, observing procedures, collaborating with engineers—it just clicked. There was no other job I wanted.”
Q: Intuitive Surgical is credited with really establishing how clinical engineering can help product development. Where do you see the field headed next?
A: “Surgical robotics is really where clinical engineering became essential—it’s such a complex environment that you need someone who understands both the technology and how it fits into procedures. We didn’t have this function in orthopedics because those devices were simpler; mechanical engineers handled both design and user-focused aspects. But as products become more complex—like surgical robotics—you need dedicated clinical engineers embedded in R&D or marketing teams.”
She added that new fields are embracing clinical engineering due to regulatory shifts: “With FDA pushing human factors studies as part of device approval processes, companies are starting to recognize the value of user feedback in addition to traditional human factors methods. Clinical engineers complement human factors teams by diving deeper into the technology—for example, studying how much force is applied during procedures or understanding tissue interactions to help with design decisions. It’s exciting to see companies centralizing this function as they realize its importance to delivering value.”
Q: Where does clinical engineering fit within an organization?
A: “It really depends on the company and product. I’ve seen clinical engineering teams succeed in both marketing and R&D. If your focus is on commercialization, it might make sense to place them closer to marketing. But if you’re developing something highly technical—like surgical robotics—you might want them embedded in R&D.”
Q: When should companies engage in clinical engineering?
A: “Clinical engineering should be involved at all phases, but if you’re a startup just trying to get off the ground, you’re probably not going to have funding for full-time expertise right away. That’s where consulting comes into play—it allows you to bring in experts early without overextending your budget. You can start small by having a consultant help you make sure you’re on the right path or serve as an advisor while you develop your product.”
“Where you’re going to really need them again is when you start heading toward a true product—you’ll need their expertise during customer testing and validation phases. Is it valuable to have them in between to look at other applications and keep you on track? Absolutely. But do you need to build up a full team? When you have limited resources that’s really hard, so I would advise going with a consulting group.”
Katie explained that larger companies may take a different approach. “If you’re looking to scale up and manufacture, start building your in-house team early because it takes time to train and invest in their expertise.”
Q: What makes a clinical engineering team effective?
A: “The best teams are cross-functional and collaborative. One of my favorite teams included clinical engineers, human factors experts, industrial designers, and preclinical researchers. Everyone brought their expertise to the table without working in silos. When you have that kind of alignment across disciplines—where everyone is looking at the user from different angles—things just fly.”
Q: What advice would you give to an aspiring clinical engineer?
A: “Be curious, energetic, and willing to learn from others. This isn’t your typical quiet engineer role—you need to talk to people, study them meticulously, and really understand their needs.”
She also emphasized resilience: “Don’t take no as an answer! If someone says something can’t be done, let that fuel your determination to make it happen.”
“It wasn’t just about making smaller knee implants—it was about rethinking how everything worked together to make surgeries less invasive for patients. That perspective set me apart and reinforced my belief that clinical engineering is about more than just the device - it’s about designing for people.”
Key Takeaways
Start Early: Engage clinical engineers from day one to align technical capabilities with user needs.
Consider Consulting: For startups or smaller organizations, hiring consultants can provide critical expertise without requiring a full-time hire.
Build Cross-Functional Teams: Collaboration between clinical engineers, human factors experts, industrial designers, and preclinical researchers accelerates innovation. It provides complementary views of the user.
Focus on User Feedback: Observing how users interact with devices should guide every stage of development.
Invest in Training: Building a high-performing clinical engineering team takes time but delivers long-term benefits.
Connecting Innovation with Clinical Engineering Expertise
Katie’s insights underscore why clinical engineering is essential for medtech success—it ensures that innovative technology is also clinically practical and user-centered.
At Clinical Product Insights, we specialize in helping companies integrate these principles into their product development processes. Whether you’re just starting out or scaling up, our consulting services can help you bridge the gap from technical innovation to clinical application.
Reach out for a consultation on how you can leverage the power of clinical engineering to accelerate your path to market.
