ARTICLES

Designing a research study for a medical technology device can be an incredibly intimidating process. As one of the first steps in your device design process, it effectively sets the stage for the success of the entire project. That’s not to mention that looming voice in the back of your head reminding you of all the things you need to do to make the FDA happy.

When it comes to designing medical technology devices, making the Food & Drug Administration (FDA) happy is key. That’s because, if you plan to bring your product to market someday—and I’m sure you do—they’re the final troll under the bridge you’ll need to get past.

For product designers, 2021 was a year of supply chain nightmares. Many electronic parts suppliers were completely unable to keep up with demand, leading to significant shortages of multiple components—not just microchips as many news outlets have been quick to report. While these supply chain issues may gradually correct themselves over the next few months or years, as product designers, we don’t exactly have the luxury of sitting around and waiting. We NEED to get our clients’ products into the marketplace as soon as possible!

As we start fresh on a new calendar once again, it’s only natural to want to look ahead to see what the new year has in store. Particularly in the wake of the COVID-19 pandemic, it’s more important than ever to keep your finger on the pulse, as it could be the difference between life and death for your medical device business—and the patients that rely on it.

In the world of surgical device development, identifying needs first and testing concepts second is the key to user adoption and gaining a competitive advantage. This approach serves as the foundation to innovating smartly, along with quick, efficient, and robust methods of concepting. At Kablooe Design, we include Design thinking early on in the process, which minimizes rework and aids in hitting cost and schedule targets.

We live in a world of specialists. Nobody sings the same note, right? Our corporations are filled with the special engineer of this or that. In the world of product development we might have human factors specialists, user experience specialists, manufacturing engineering specialists, and so on. We apparently have everyone singing a different note.