MindFlow Design

In your quest to design a user-friendly, software-driven medical device, you likely plan to spend the lion’s share of your time and attention on, well, the software. Make no mistake, the quality of your software and user interface (UI) are critically important. But they aren’t the only factors that determine the success of #medicalproductdesign

Getting ready to develop a next-gen version of your legacy medical device? Don’t assume it’ll get the FDA’s seal of approval just because your previous version did. The FDA’s standards change rapidly especially in the past several years. Here’s what’s new with the FDA, and how your updated product can forge its own regulatory path.... https://www.mindflowdesign.com//fda-changes-next-generati/

Mindflow Design has not renewed ISO 9001 certification and continues to be certified through ISO 13485. As we at MindFlow Design were investigating whether to pursue ISO certification, we were surprised at the antagonism toward ISO that was on display in some quarters of the product design industry.... Critics were #medicalproductdesign

[vc_row][vc_column][vc_column_text css=".vc_custom_1621633944440{margin-bottom: 0px !important;}"]Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason. All that to say, as you’re developing a next-generation version of your existing #designstrategy

[vc_row][vc_column][vc_column_text css=".vc_custom_1621633860567{margin-bottom: 0px !important;}"]Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason. All that to say, as you’re developing a next-generation version of your existing #designstrategy

The most successful medical devices make their end users’ lives easier. Unfortunately, though, designing an excellent user experience (UX) is far from inevitable. Yet the key to creating a best-in-class experience isn’t some deeply held secret. It’s simple: You must get to know your users and listen to their feedback about your product as you design and develop it. In short, you need to understand and leverage formative evaluations. So what exactly is a formative evaluation...? How does it work? And when should you employ it? We have answers: https://www.mindflowdesign.com//formative-usability-evalu/

Watch this short time-lapse video of a creative exercise we conducted at our product design studio. We are inspired by the vision and accomplishments of Steve Jobs, as illustrated here! #medicalproductdesign

Human factors and usability activities play a vital role in medical product development. Not only do they help provide insight for development, they are also closely tied to risk management and regulatory requirements. Whether you need a better understanding of usability requirements, the usability tools and processes to get your project back on track, or to valuably integrate usability into your development process early on - you must evaluate where your project is today and define where it should be at its successful conclusion. We can help. https://www.mindflowdesign.com//human-factors-usability-d/

Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a catalyst for deep collaboration and clear communication. It can be overwhelming, however trying to keep track of the variety #humanfactorsusabilitytesting

From toys and automotive parts to cell phones and mechanical components, injection molded parts can be found in many of the objects we interact with each day. And the same goes for medical devices, which are frequently designed with injection molded parts in mind. Which means that if you are developing a new medical product, you need to have a smart strategy for producing injection molded parts. Start here: https://www.mindflowdesign.com//injection-molded-parts-me/