Getting Past “No” with Engineers
I often find myself playing both sides of the field as a project manager and an engineer. This lends an interesting insight into the mechanics of both. Project management certainly has its...
View Article5 Things designing medical devices and coats for canines have in common
With 15 years of experience as an Industrial Designer I recently accepted a position at StarFish Medical. I hadn’t worked in the medical field before, so the last 3 months have been full of amazing...
View ArticleWhat is your medical device communicating and what is the value?
The Internet of Things (IOT), Digital Health and your Medical Device: Understanding the value of your medical device communicating when IOT and Digital Health become commonplace The Internet of Things...
View ArticleDigital health roadmap for your medical device
If you are managing medical device products, there is little doubt that you have a digital health roadmap. For years the investment community has been funneling dollars into anything that spits out...
View Article6 Digital Health communication technology options for medical devices
Increasingly medical devices include Digital Health connectivity. StarFish engineers Sal Sanci, Dean Addison, Mike Sanders and Nigel Syrotuck explore the pros and cons of popular communication...
View ArticleDigital Health communication technologies and considerations for medical devices
As a medical device design and development service provider, we help entrepreneurs and innovators make technology decisions for diagnostic, therapeutic, and rehabilitative applications. Increasingly...
View ArticleFDA “hit list” of highest priority medical devices for human factors guidance
Did you know that this year FDA’s Human Factors Premarket Evaluation Team have a priority review hit-list for medical devices? Are you on it, are you ready, and what does it mean? This blog will help...
View ArticleBranding is storytelling – even in medical device design
Branding is storytelling. Every product has a story, and like most good stories it is a summary of not how it grew, but how it overcame failure. Good Industrial Design tells the story of both the...
View ArticleThe user experience (UX) design process for medical devices: research
The UX design process for medical devices places emphasis on safety and documentation. Designers are provided standards such as IEC 62366-1 and IEC 62366-2 to guide us in the application of usability...
View ArticleDelivering great medical usability and emotional design
Medical device designers and developers have a responsibility to deliver a positive medical experience through the device. We cannot focus solely on fixing the problem efficiently. We need to address...
View ArticleThe power of an image – initial concept design sketches
I once had an argument over a design given to me by an industrial designer. The design was difficult to manufacture, and I knew would cause some significant manufacturing challenges. There was one...
View ArticleFDA “hit list” of highest priority medical devices for human factors guidance
Did you know that this year FDA’s Human Factors Premarket Evaluation Team have a priority review hit-list for medical devices? Are you on it, are you ready, and what does it mean? This blog will help...
View ArticleBranding is storytelling – even in medical device design
Branding is storytelling. Every product has a story, and like most good stories it is a summary of not how it grew, but how it overcame failure. Good Industrial Design tells the story of both the...
View ArticleThe user experience (UX) design process for medical devices: research
The UX design process for medical devices places emphasis on safety and documentation. Designers are provided standards such as IEC 62366-1 and IEC 62366-2 to guide us in the application of usability...
View ArticleDelivering great medical usability and emotional design
Medical device designers and developers have a responsibility to deliver a positive medical experience through the device. We cannot focus solely on fixing the problem efficiently. We need to address...
View ArticleThe power of an image – initial concept design sketches
I once had an argument over a design given to me by an industrial designer. The design was difficult to manufacture, and I knew would cause some significant manufacturing challenges. There was one...
View Article62366-1:2015 vs Applying Human Factors and Usability Engineering
The application of usability engineering to the design of medical devices is defined by IEC-62366-1. The FDA recognizes this standard but has also published a guidance document describing the process...
View Article3 real–world approaches to an FDA inspection
This is the first blog in series of 3 that will cover StarFish Medical’s recent experience with the FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to...
View ArticleHow ISO 13485:2016 changes will impact your QMS (sections 4-6)
With the March 1, 2016 release of ISO 13485:2016, medical device developers and manufacturers have been given a three year grace period to implement changes from the previous 2003 version. During those...
View ArticleWill new FDA final rule on symbols for device labels make devices cheaper?
In June, FDA finally dropped their requirement for symbols for device labels to be explained with adjacent text and now allows the use of standalone symbols on medical device and In Vitro Diagnostic...
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