4 tips for successful medical device design


By Tom KraMer, Kablooe Design

We all look forward to what the New Year will bring us, with the hope of improvements, successful efforts and positive results. I have found that when developing a forward-looking vision, it is always helpful to look back and see what we have learned in the past. Sometimes we learn things the hard way, and sometimes it is easier, but these lessons can help us take positive steps forward.

This season, I thought it would be nice to take a look at some of the more “hands-on” type activities in design and development and brainstorm some lessons that will help future innovation projects this year. Using a surgical device project as a metaphorical springboard, here are some things worth considering:

1. Building things in 3D CAD is not the same as building them in real life.

For example, when you’re working on something really tiny – like an end effector for a robotic surgical device that’s going to fit into a small space in human tissue – you absolutely have to make a comparison to the real world. If you rely too much on a CAD design, it may seem like everything moves, clicks, and spins just fine, but in reality the movement and actions will put too much force on the part, causing parts of the device to fail. . When we get too much tunnel vision in our CAD parts, it becomes easy to lose sight of all the physical factors that play into the success of a functioning mechanism. Friction, wear, shear, torsional force, overhang, lever arms, etc. can easily be bypassed while we are eager to build a new idea. Considering these elements and entering the empirical world of practical prototypes is a great way to see things that will trigger the right side of your brain to start creating more “what if” scenarios. This leads to more ideas and more innovation, so don’t be afraid to start prototyping the quick, simple, and easy way ASAP to bring your noblest ideas to life.

2. Imitating the robustness of the human body is not a simple task.

If the surgical standard is a doctor holding a scalpel, then your design certainly has an uphill battle. Human fingers can do a lot of things: they are padded, they rotate easily, they are durable, they can be moved in a wide variety of unique positions, and they can give the user immediate feedback on how hard they are pressing. and on the characteristics of the surfaces they touch. If you’re designing a tiny end effector for a robotic arm, every tolerance along the way needs to be equally small, nimble, and durable, which can be a daunting task. Try to think about the feedback that the active parts of the human body give to the brain during associated device tasks and start to think about what the brain should do without this feedback and how your device can give similar or alternate feedback to the brain. . This will put you in the shoes of the user and lead to innovative solutions.

3. Giving the user a good design is not the same as designing a device that performs well.

Surgeons need to be empowered to do their jobs better. We certainly don’t want the tools we design for them to take away their decision-making capacity, their autonomy to change their minds and adapt on the fly. Rather, you have to find a way to to improve these capabilities. Enabling a user to do their job better starts with understanding their needs in doing that job. If your device is there to help them do this job, then we need in-depth knowledge of user needs. It doesn’t just come from the standard, fast voice of customer data; it also comes from rich empathetic information that only results from observations, ethnographies, and stories straight from users’ experiences that give us insight into their world in relation to the device we are focused on changing. Try spending time with users and instead of bombarding them with questions, have them tell stories about their user experiences and find out what they think. This information can be boiled down to design requirements that will stimulate your team’s creativity to solve the problems your device is trying to solve.

4. Inspiration can come from outside the industry.

There is only a certain amount of information to be gleaned from studying other medical devices, so why limit yourself to one pool of knowledge? Expand your search to include other less related industries such as agriculture, manufacturing, and the military. You would be surprised how much you can learn just by watching warehouse fulfillment robots run for an hour or two. I am always in awe of how many unique product solutions can come from the toys we designed so many years ago or the agricultural implements we developed ideas for.

We take inspiration not only from analog devices, but also from nature. Nature provides a vast pool of complex working systems with wonderful little parts that work in fantastically amazing ways. What better way to be inspired to innovate?

On your next project, try to step away from the specific industry your device is intended for and spend some time thinking about other unique devices and systems. Then come back to your project with fresh eyes and a flexed right brain, and see what the innate innovator in you can come up with.


Taking a proactive approach to these lessons by incorporating the learnings into your innovation and development process will hopefully bring new perspectives and colors to your endeavors this year. If you take steps to understand the user, their needs, and the problem at hand, all you have to do next is make sure that your design is manufacturable, durable, and can perform as intended. Keep learning and you’ll be well on your way to creative innovation in the design of surgical robotics!

About the Author:

To MTom KraMer, President and CEO of Kablooe Design, has been a product innovator for over 30 years. He holds a master’s certificate in product development from Northwestern University and a bachelor’s degree in industrial design from Minneapolis College of Art and Design (MCAD), as well as a certificate from the Cardiovascular System in Health and Disease program at Stanford University. . KraMer has generated revenue for countless customers by delivering innovative product solutions to their portfolios. He led the D3 (Design Driven Development) process, a vehicle for delivering these results to clients, and he teaches this process by traveling as a speaker and talking about innovation and development processes.

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