The Secret To Medical Device Development Success: A Mindset For Continuous Learning

By Chris Danek, Bessel LLC

We all want our development teams to get better. But when will we make time to learn and improve? Is learning something we save for after hours? Weekends? Maybe we’ll learn in that professional development course or even an advanced degree we’re considering.

I’m here to tell you that learning is much simpler and more available than you think. You don’t need to sign up for a course or order a book to learn about your craft. You can learn from the work you’re already doing on development teams.

The key is a mindset shift: Instead of thinking about learning as something that happens outside of work, flip the script. Look for the many opportunities to learn and grow as a part of your work.

In my experience leading medical device development teams, I’ve seen that innovation happens when teams dedicate themselves to continuous learning. Design-build-test isn’t enough. Learning during each development sprint makes a team stronger, more insightful, and ready to innovate faster the next time.

Make Learning Explicit

When people talk about design-build-test cycles as their framework for innovation, they’re brushing off learning as an understood, implicit part of the process.

That’s a mistake. Instead, make learning an active, explicit part of your innovation process. Here’s how to get started. Set aside time as a team to reflect after each sprint or design-build-test cycle. Ask: “How can we get better as a team?” By making this a regular practice, you’ll become aware of learning moments as they happen, prompting a shift toward continuous learning and improvement.

One team I work with recently decided to dedicate 10% of their effort to improving their capabilities. Their focus: streamlining their testing to free up time to learn. They used ChatGPT to help them automate their data analysis, which cut hours of manual number-crunching and allowed them to visualize results immediately. They used that newfound time to improve the design further.

Get The Most From Your Prototyping

Prototypes are another area full of opportunities to learn. To pull as much learning as possible into each prototyping cycle, isolate one critical design feature to develop. Prototype parametrically with 3D printing. Send many design candidates to be printed in the same run. This is a great use case for additive manufacturing. Make the feature or component you fabricate as small as possible to minimize build time. You should be able to converge on the design of that feature in less time than it takes to make a full prototype. By focusing on a single feature and quickly innovating to get it right, teams I’ve worked with have fine-tuned the design of catheter handle mechanisms, fluidic channel configurations, and plastic snap-fit designs.

Here’s another approach for prototyping. When making serial iterations, create a modular design or “test bed” for rapid innovation. For example, design a basic catheter handle shell that you can use to test different mechanisms, so you don't have to fabricate the handle shell in every iteration.

When you approach prototyping with an eye on constant learning, you’ll be amazed at how much faster you can reach your goals.

Embrace Simulation-Driven Design

Simulation-driven design is transforming the medical device design and development process, unlocking new possibilities for teams.

Here are three ways you can put simulation-driven design to work to learn and innovate faster.

• Optimize designs with real-time results: 3D product simulation software like Ansys Discovery react in real-time to model geometry changes. I’ve used such software in applications like electronics cooling inside an instrument enclosure. These powerful tools offer finite element analysis for flow, heat transfer, and mechanics. Once you’ve selected a design configuration, you can refine it and carry forward in your design and development process as usual.
• Try low-code software development: Software like Simulink from MathWorks lets designers simulate their system in a graphical user interface, as well as “prototype” control algorithms. The underlying code can be directly exported as firmware to the microcontroller or microprocessor of your choice.
• Simulate performance: Many typical CAD programs like Fusion 360 or SolidWorks include built-in simulation tools for stress, flow, and more.

Here’s an example of how I used simulation to learn and innovate. During the pandemic, I was part of a team that developed a lifesaving device – with a heavy assist from simulation. The Texas Breather is an automated resuscitation bag-squeezing device developed for hands-free ventilation of patients awaiting a ventilator. During early life testing, the initial device designs failed within days at precisely the location predicted by static stress analysis. Armed with this confidence in the simulation results, the team then iterated the mechanical design to address stress concentrations. The second round of prototypes all survived continuous operation for more than 30 days. The value here was magnified because in life testing to failure, the time on test increases with every iterative improvement of the device!

Push yourself to get the most learning out of each iteration and take another look at what simulation can bring to your rapid innovation process. This mindset of active, continuous learning accelerates projects and puts them on target.

When teams make learning explicit, explore new ways of prototyping, and discover the possibilities of simulation, they learn faster, improve together, and get better results. Here’s to more learning!

About The Author:

Chris Danek is the CEO of Bessel LLC. He is a serial entrepreneur and veteran of the life sciences industry. At Bessel, he works with entrepreneurs, startups, and established company teams to develop breakthrough medical device technologies. In prior roles, he was co-founder and CEO of AtheroMed (now Philips AtheroMed) and VP of R&D at Asthmatx (acquired by Boston Scientific). He is a visiting professor at the W.M. Keck Center for 3D Innovation at the University of Texas at El Paso, an advisor to the Santa Clara University Healthcare Innovation and Design Lab, and an inventor of more than 85 U.S. patents.