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 […]
Posts categorized as“Industrial Design”
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 […]
The New Year brings reflection and desire to improve. We asked our designers, engineers, manufacturing, supply chain and regulatory experts to consider projects finished in 2017 and think about things they could have done better or wish they had considered. Here is their list of 2018 resolutions and smart things to do that would speed […]
The top 10 StarFish Medical blogs of 2017 feature a heady mix of regulatory, engineering, and practical information and advice. Seven of the blogs are perennial favorites with high ranking on Google and other search engines. The remaining three are from new writers and hint of new evergreen standards in the works. New or tried […]