Human-centered design in medtech – what to consider early

When you design a new medical device, it is tempting to start with the technology: new materials, smarter electronics, tighter tolerances. But as one of the afternoon sessions at the MedTech Congress 2025 in the canton of Jura underlined, the real question is simpler and harder at the same time: how will real people actually use this in the real world?

For Original Equipment Manufacturers (OEMs) and suppliers in the Basel Area – a region built on precision, reliability and trust – human-centered design is not a “nice to have”. It is a strategic capability that can unlock adoption, reduce risk, and keep you competitive in global medtech value chains. 

This article unpacks the core ideas shared in a session involving Peter Hess, CEO at HKT Design and Gwenael Hannema, CEO at OrthoSens, and presents them here as practical guidance for owners and managing directors who want to build better medical devices, faster: 

 

Why human-centered design matters in medtech 

In medtech, you rarely design for a single user. A typical product touches surgeons, nurses, technicians, procurement, maintenance teams and, increasingly, patients and their families. 

If you focus only on the “typical” expert user – or only on engineering constraints – you risk creating products that look impressive on paper but never become part of everyday clinical practice. 

Human-centered design shifts the focus: 

  • From “What can we build?” to “What problem are we solving, for whom exactly, in which context?” 
  • From “Can it be manufactured?” to “Can it be safely and intuitively used at 06:30 on a busy Monday?” 
  • From “What does our key opinion leader want?” to “What do the 80% of everyday users need?” 

This is particularly important in regions like the Basel Area, where many OEMs and suppliers are moving from watchmaking, precision mechanics or general engineering into regulated health markets. The technical bar is high, but the usability bar is even higher. 

“Many companies work only with key opinion leaders and complex cases. But when you cross the chasm to the 80% of everyday users, they say: ‘This is too complicated. This is too expensive. We don’t want it.’ Companies need to ask: what do those 80% really need?”

Start in the operating room, not in the meeting room 

The human-centered design process does not start at your CAD workstation. It starts in the clinical environment where your product will live. 

A robust early phase often includes: 

  • Contextual inquiry: Going into hospitals and clinics, watching real procedures, taking notes, asking open questions. Mapping who does what, when, with which tools and under which constraints. 
  • Workflow mapping: Turning these observations into visual journey maps: from preparation and set-up, through use, to cleaning, maintenance and storage. This reveals hidden steps, handovers and failure points. 
  • Simple mock-ups in the real space: Before you invest in polished prototypes, you use cardboard, wood, 3D prints and tape to model devices and interactions around real operating tables and real staff. What matters is speed and learning, not aesthetics. 

“We built a mimicked surgery room with very simple means – just wood and cardboard – and invited nurses to show us the ‘dance’ between the sterile and unsterile fields. We were fast, early and we co-created with users.”

For companies used to highly controlled workshop environments, this step can feel messy. But it is exactly here that you discover: 

  • how devices are actually lifted, moved, plugged, cleaned 
  • how many times someone must bend, twist, confirm, re-enter data 
  • where the risk of error and frustration is hidden in the workflow. 

Design for the whole team, not just the star user 

Many medtech companies design based on input from expert surgeons and key opinion leaders. They are important partners – but they are not your only users. 

In reality, most cases are performed by “standard” surgeons and nursing teams working under time pressure, on mixed lists, in very different hospital cultures across Europe, the US and beyond. If your device works only for the top 5% of users, adoption will stall. 

A human-centered approach therefore asks: 

  • Who sets up and tears down the system? 
  • Who cleans, sterilizes and maintains it? 
  • Who moves it between rooms or wards? 
  • Who needs to understand basic alarms, messages and modes? 
  • How do these answers change between Switzerland, Germany, Italy or the US?
“Working only with expert users can hide real adoption risks. I’ve experienced it firsthand. When broader users got involved, complexity and workflow misalignment surfaced quickly. That’s why diverse user testing and listening to critical voices is really essential.”

This is where the Basel Area’s international footprint is a strength. Many local suppliers already work with global OEMs and have networks in different markets. Human-centered design helps you leverage that network more systematically: 

  • Test early prototypes in different hospitals, not just your favorite reference center 
  • Include circulating nurses, radiographers and biomedical engineers in your feedback loops 
  • Bring “negative” feedback into the core of your design process instead of filtering it away 

Bring design and engineering to the same table early 

Human-centered design is not “fluffy” work you add on top of engineering. It is a way of structuring collaboration between disciplines so that usability, manufacturability and regulatory needs evolve together. 

In practice, that means: 

  • Design and engineering start together: Designers lead early exploration of user needs and concepts. Engineers in mechanics, electronics and software develop technical options in parallel, not afterwards. 
  • Shared models instead of silos: Design CAD and engineering CAD are merged, not rebuilt from scratch. Human factors constraints and manufacturing constraints are visible on the same drawings. 
  • Manufacturing is in the room from day one: If something delights users but cannot be produced reliably at a viable cost, it is not a good solution. Likewise, if something is easy to make but confusing to use, it is not a good solution either.
We start holistically, with everyone at the table. We co-create with users and make things tangible and testable as quickly as possible. If we invent something that is good for users but cannot be manufactured, our work is basically useless.”

Treat human-centered design as an investment, not a delay 

From the outside, human-centered design can look like “extra work,” involving things like travel to hospitals, time away from machines and customer projects, and building mock-ups that will never be sold. 

But the cost of not doing it is almost always higher, for example due to: 

  • Having to redesign user interfaces just before regulatory submission 
  • Discovering integration issues during final validation in a foreign market 
  • Seeing low adoption because the device does not fit standard workflows 

Investors and sophisticated medtech partners increasingly recognize this. They now expect to see robust user research and usability data, not just elegant technology. 

“Some people still see field research as a cost that is not worth it. But the more sophisticated medtech investors know it is critical to involve end users at the beginning, otherwise it becomes too expensive later on.”

Five practical steps for aspiring medtech OEMs and suppliers 

If you want to bring human-centered design into your next medtech project, you do not need a big internal design team to start. You can begin with five practical moves: 

  • Choose one pilot project: Pick a product or subsystem that is important but manageable in scope. Commit to applying human-centered design principles from the start. 
  • Map the real workflow: Visit at least three clinical environments where your product will be used. Observe, document and visualize the full workflow, including set-up and tear-down. 
  • Prototype with simple materials: Build low-fidelity mock-ups in cardboard, wood or basic 3D prints. Test them in the real environment with real staff. Capture what confuses, slows down or frustrates them. 
  • Expand your user pool: Involve not only key opinion leaders but also more typical users, nurses and technicians. Pay special attention to critical feedback and patterns that repeat. 
  • Align design, engineering and manufacturing: Set up regular joint reviews where all disciplines share their perspectives, challenge assumptions, and work together to find the best possible solution for users. This helps to make explicit decisions when a usability improvement conflicts with a manufacturing constraint, and vice versa. 

The Basel Area’s dense medtech and life sciences ecosystem, combined with the Jura’s industrial know-how, is an ideal place to experiment with this approach. You can access world-class hospitals in Basel, and international OEMs and highly skilled suppliers within a short driving distance. 

Level up your medtech manufacturing approach 

Human-centered design does not replace your engineering excellence. It builds on it and makes it visible where it matters most: in the hands of real users, in real hospitals, solving real problems. 

If you want to build your team’s skills in innovation and usability, access the right clinical or industrial partners for early testing, and structure your next medtech project around human-centered design, you do not have to do it alone. 

Learn more about our Level Up services and explore how we can support your next medtech innovation. 

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