Victoria Wu on the Power of “Why” in Clinical Engineering
Introduction
In the fast-paced world of medical device innovation, clinical engineering stands as a critical bridge, connecting cutting-edge research and development with the practical realities of clinical use. In this first installment of our series, "Coffee Chats with Clinical Engineers," we sit down with Victoria to explore this evolving field and its role in medtech innovation. Victoria is a seasoned clinical engineering professional who has worked with both established medical device companies and innovative startups. While sipping coffee at the Groovy Goose in Menlo Park, Victoria shared her unique insights into how clinical engineering drives medical device innovation, procedural development, and successful product implementation. Her journey highlights the importance of understanding not just how a device works, but why it's needed. Armed with the power of “why,” design decisions can be made that improve the entire clinical workflow.
Interviewee Profile
Victoria's background is a blend of materials engineering and industrial design that gives her a unique perspective. She started her career at Edwards Lifesciences as an R&D engineer, working on structural heart valve repair and replacement devices. Driven by a desire to understand the "why" behind the designs, she transitioned to a brand-new clinical engineering team in the transcatheter mitral and tricuspid technologies division. Today, she leads clinical engineering efforts at Moon Surgical, focusing on their Maestro system, a robotic first assistant for laparoscopy.
Q&A: Victoria Wu on Clinical Engineering
Q: What sparked your interest in clinical engineering, and what does your current role involve?
A: "I started in R&D at Edwards Lifesciences, diving deep into nitinol implantable devices," Victoria explains. "But I became increasingly curious about why we were building specific products and addressing particular needs. I kept asking questions about why the anchor needed to hold a certain amount of force, or why we chose a specific location in the heart. I wanted to reverse engineer what the customer really needed. That's what drew me to clinical engineering."
Now, at Moon Surgical, Victoria focuses on defining customer needs, linking them to system-level requirements, and testing whether those needs are met through design validation and usability studies.
Q: How do you define clinical engineering?
A: "For me, clinical engineering is everything at the interface of R&D and clinical users," Victoria says. "That includes procedural development, simulator development, clinical training, customer needs, gathering requirements, and the initial phases of product development. It also means understanding disease states, patient selection, and clinical trial design, with connections to human factors and usability engineering. In essence, clinical engineers act as translators, ensuring that the technical capabilities of a device align with the practical needs of clinicians and the realities of the clinical environment."
Q: Can you share an example of a project where you saw the impact of clinical engineering firsthand?
A: "Absolutely," Victoria replies. "When I transitioned roles from a design engineer to a clinical engineer, I joined a team that was being built from the ground up to work on a pre-commercial device within Edwards Transcatheter Mitral and Tricuspid Technologies business unit. It may seem surprising, but it’s not uncommon that you can get to a point where a prototype is developed, you’ve demonstrated the implant is feasible, but you don’t yet have the delivery procedure defined. Our team was responsible for determining what the first users of the product should be trained to do in order to deploy the heart valve and how to use the catheter. So, in order to do that, the first step was to develop a simulation of the physiology and anatomy that would be interacting with the device."
Victoria continues, "I was definitely building on the shoulders of giants because it’s Edwards. We had incredible pulsatile flow models, but we didn't have a way to recreate the exact angles and locations of key anatomy to represent a case to test our recommendations. We needed to orient the model exactly the way it would be in the patient, simulate the imaging that would be used intraoperatively, and recreate the team that would be present in the lab. We used a simulated cath lab, complete with a C-arm and echocardiography machines, to develop the communication between all the members of the team, specifically the interventional cardiologist, their first assistant, and the echocardiographer."
"It was such a collaboration; we had engineers there helping understand the limits of all the knobs to control the catheter, clinical specialists there who were sonographers by background, junior clinical engineers preparing the animal specimen to make it repeatable. There were a lot of problems that needed to be solved cross-functionally. This eventually led to successful first-in-human procedures and was my first real experience with how clinical engineering can accelerate medical device innovation."
Q: When is the best time to bring in clinical engineering during product development?
A: "I'm biased, but I believe clinical engineering should be involved from the very beginning," Victoria asserts. "While an R&D engineer or product person with clinical knowledge might cover the role initially, a deep understanding of the clinical environment and needs is crucial for proper design from the outset."
Q: What does the "clinical environment" encompass in your experience?
A: According to Victoria, the clinical environment includes, "everything from the physical setting where the device will be used, to all personnel involved in the workflow for that product, and whether there are other technologies or other devices that get used along with it in the workflow.” Victoria stresses the importance of understanding the roles of each person in the workflow. "In structural heart procedures, for example, it's crucial to understand how different team members, such as echocardiographers, perceive the device and what they need to see during deployment."
Q: What are the characteristics of effective clinical engineering teams?
A: "Effective clinical engineering teams need to be extremely organized given their cross-functional nature. This is even more crucial depending on where clinical engineering sits within the organization. For example, I have seen clinical report in different ways, like either to clinical affairs and marketing or to R&D, but that really changes the culture and the motivation behind clinical."
Victoria continues, "Regardless of the reporting structure, it's important to cultivate expertise within the team in different areas, with members focusing on specific subspecialties, from procedural development to biostatistics and data analysis. You can't expect everyone to be cross-trained in everything."
Q: How has your background in engineering and industrial design shaped your career?
A: "My combined background has helped me bridge the gap between humanities and STEM in healthcare innovation," Victoria reflects. "Industrial design experience, in particular, helped me understand human factors, usability, and how to apply design thinking to medical device innovation. It ensures that products are not just safe and effective, but also user-friendly and efficient."
Q: We've discussed how clinical engineering spans from early design to later stage commercialization. Can you elaborate on how clinical engineering connects with marketing and commercialization strategies?
A: "The initial clinical engineering research ends up being where marketing starts. The upstream marketing person will take that data and expand on it," Victoria notes. "For example, defining those top indications for the product really sets the stage for your market access and commercialization strategy. That early clinical work becomes the foundation."
Q: You've worked with both established companies and startups. How does the approach to clinical engineering differ in those environments, and what are the key challenges in each?
A: "In startups, you're often making the argument for clinical engineering's value, demonstrating how it can impact everything from product development to market access," Victoria explains. "The challenge is often prioritizing clinical amidst the urgency of R&D and product strategy. In established companies, the challenge is more about navigating established processes and ensuring clinical insights are integrated effectively across different departments."
Q: What advice would you give to a new clinical engineer or to a company considering adding a clinical engineering function?
A: "For new clinical engineers, I'd say don't be afraid to ask 'why' and to explore the 'whys' behind every aspect of a product and its use," Victoria advises. "For companies, recognize that clinical engineering is an investment that pays off in more user-friendly, efficient, and ultimately successful medical devices. It's not just about meeting regulatory requirements; it's about creating better solutions for patients and clinicians."
“I’ve found that a lot of people, like me, need fulfillment from understanding the ‘whys’. Clinical engineering ends up being such a rich discipline because the ‘whys’ lead to understanding the many parts and users of a device’s workflow. For example, sometimes we get asked, ‘what’s going to be the impact if we change this part of the product on sterilization?.’ You end up talking to hospitals and sterilization managers and it leads you down a lot of super interesting paths that you wouldn’t have anticipated.
I think ultimately what happens as a clinical engineer is you get a holistic understanding of the product. You can speak intelligently on pretty much every design decision that’s been made because it touches a user in some way. So, that’s what I love about clinical engineering. That’s amazing.”
Key Takeaways
Clinical engineering is a vital link between R&D and clinical users, ensuring that medical devices meet real-world needs.
Early involvement of clinical engineering in product development is essential for success.
The role requires a deep understanding of clinical workflows, environments, and team dynamics.
Effective clinical engineering teams are cross-functional, organized, and possess diverse expertise.
The field is growing, particularly in robotic surgery and medical devices, driven by increasing regulatory requirements and the need for user-friendly designs.
Human factors and usability engineering are increasingly important aspects of medical device development.
Clinical engineering provides a holistic understanding of product development and implementation.
The approach to clinical engineering can differ in established medical device companies versus entrepreneurial start-ups.
Is Clinical Engineering Right for Your Project?
Is your startup struggling to build a bridge between innovative ideas and the practical realities of the clinical environment? Or is your established company finding it difficult to maintain a holistic view of the clinical workflow amidst siloed departments? As Victoria Wu emphasizes, clinical engineering is about understanding the "why" behind every design decision, ensuring that your device not only works, but is readily adopted by clinicians.
Clinical Product Insights, LLC specializes in helping medical device companies, both startups and established players, achieve seamless clinical adoption. We provide tailored solutions, including:
For Startups: Defining initial customer needs and translating them into clear system-level requirements, ensuring your device is clinically relevant from day one.
For Established Companies: Workflow analysis to identify integration challenges, optimize existing processes for seamless adoption into clinical environments, and build your clinical evidence generation strategy.
At Clinical Product Insights, we de-risk your product-market fit and build a clear strategy to clinical adoption. Reach out for a consultation on how you can leverage the power of clinical engineering to accelerate your path to market.
