Patient imaging data is a powerful and robust source for developing anatomically accurate and functional 3D models. Having an accurate representation of anatomy available to engineers and designers during product brainstorming and design is an invaluable resource. This blog outlines the process of creating 3D models, and innovative methods to use them throughout medical device […]
Posts categorized as“Industrial Design”
One of the goals of good medical device design is to turn a lot of complicated science and engineering into a simple package that’s easy to use and understand. To help achieve this goal, remember that less is more when designing user interfaces, device enclosures, and instructions.
Improve your medical device innovation process Everyone has a mental toolkit of innovation – a series of patterns that innovative people find. They take something and they break it into pieces or they take pieces and put them together or they put things upside down or they hollow them out or they turn them inside […]
There are so many methods available to prototype that I’d like to expand upon an earlier blog. In this article I share the low-cost tips and methods on how to prototype a medical device on a budget that I use in my New Product Introduction (NPI) work. Just as importantly, I explain when I use […]
As part of our 20th anniversary celebrations, we asked our experts to share the biggest lesson they have learned in medical device commercialization. Several themes emerged: budgets, production readiness, usability, and what to tackle first. Here are their top 13 lessons learned in no particular order.
It goes without saying that women are anatomically different from men. Health conditions affect women differently and women have different health concerns than men. Because of this, more companies and start-ups are focusing on addressing medical conditions specific to women.
Alarm fatigue is a multifaceted problem, and its presence is influenced by a variety of factors. Preliminary investigation into the intended use environment of a medical device is a crucial step in identifying key desirable, and undesirable features – including auditory cues and warnings.
Observation can be a powerful tool. It allows industrial designers to better understand how a product will be used by different users in different environments. Setting up an observation session can be quite time consuming. Finding the right participants and holding sessions is a lot of work. Here are three tips to make the most […]
Observations are an integral part of summative evaluations, the final validation that a device’s user interfaces are safe to use. During a summative evaluation, the manufacturer sets up a set of scenarios that capture all of the tasks that the device is expected to perform. The manufacturer creates environments that mimic the real use, capturing […]
I was recently asked if I knew USP class VI is another standard that’s often quoted – the two standards are similar in some respects, but are not equivalent.
If I was to describe design control for consumer vs medical design in sports terms, medical design would be cricket and consumer design would be ice hockey. That is to say medical devices use a slow, carefully considered and accountable design methodology while consumer goods are bunch of aggressive speedsters shooting the puck around hoping […]
There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team of medical device designers, developers, QA/RA, and manufacturing professionals recently brainstormed 11 medical device development mistakes that have surfaced multiple […]