Point-of-care optics design for testing infectious diseases
Optical imaging techniques offer a number of important advantages when developing medical devices for diagnosis at the point of care. Optical imaging can provide real-time and high-resolution...
View ArticleMedical Device Coverage & Reimbursement Tips and Trends
Expert Advice from the 16th Annual Medical Device Coverage & Reimbursement Conference A medical device sponsor must feel like they have successfully climbed Mount Everest when they receive their...
View ArticleSubmitting a medical device application under the Health Canada Interim Order
Our experience submitting under the Health Canada Interim Order Prime Minister Trudeau announced StarFish Medical’s participation in the NGEN Canadian Emergency Ventilators project on March 31, 2020,...
View ArticleCOVID-19 Testing Authorizations in the US and Canada
This blog provides an overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada. In the world of regulated health care products these tests...
View ArticleFDA Breakthrough Devices Program Update and Advantages
The FDA Breakthrough Devices Program provides several advantages for novel devices that meet the inclusion criteria and can significantly reduce a product’s time to market. The Breakthrough Devices...
View ArticleScience Fiction Medical Devices
Real medical devices from the imagination of science fiction Many shows, movies, books and videogames feature science fiction medical devices and technologies that seem otherworldly and far beyond our...
View ArticleTools and tips for holding COVID-19 friendly brainstorming meetings
Brainstorm Better with COVID-19 friendly brainstorming meetings Just because your team is working from home due to COVID-19, doesn’t mean your ability to work collaboratively has to suffer. Our design...
View ArticleFormative Evaluations and Tests, and When to Use Them
A critical component of Human Factors input during product design is evidence – based, user-centered feedback, gathered from conducting formative usability activities. We use two main approaches to...
View ArticleCOVID-19 Ventilator Design lessons
Our design team discuss their top insights from time constrained, critical ventilator project in Canada’s Response to COVID-19 Paul Charlebois, Industrial Design and Human Factors Manager, asks team...
View ArticleAddressing ingress protection for home healthcare medical devices
What the standard says and what you should know. Increasingly medical device technology is filtering down from hospitals and into patients’ homes. Designers need to understand and address the impact...
View ArticleUsing the Jupyter Notebook for product prototyping
In this post, I’d like to share with you a toolkit that I’ve found works quite well with both my creative process and my workflow: the Jupyter notebook, and the Python/Numpy/Scipy stack. The initial...
View ArticleTop 10 COVID-19 Medical innovations
Rapid technological advancement is often triggered by external events such as international conflicts, political pressure, economic downturn, competitions or disease. The COVID-19 pandemic has...
View ArticleWhat’s the worst mistake you can make when developing a medical device?
How many have you made? We posed the question, “What’s the worst mistake you can make when developing a medical device?” to our team of engineering, design, quality, regulatory and manufacturing...
View ArticleManufacturing safety and efficiency during COVID-19
Our manufacturing leaders recently convened on Zoom to identify changes we’ve made for manufacturing safety and efficiency during COVID-19 and offer tips for delivering a healthy, productive...
View ArticleSupply Chain Reports that keep your eye on the ball
Having overcome the challenges of transferring a product design into manufacturing, it is time to enter a new process cycle. At this stage, Supply Chain Reports are essential to assess and monitor...
View Article5 LEAN Manufacturing Techniques for Medical Device NPI
Waste in manufacturing drives up product costs affecting both short term profitability and the long-term adoption curve. LEAN Principles that reduce waste are widely adopted to improve high volume...
View Article5 Basic principles to avoid typical manufacturing pitfalls
Congratulations! You’ve conceptualized and prototyped a functional medical device that will improve the lives of countless others! So now what? Market approval? Sales? Praise and adulation??? Let’s...
View ArticleWhy qualitative research for medical device design?
The value of qualitative research in a highly regulated industry When designing medical devices, it is important to remember that, just like consumer products, the devices we are creating interact with...
View ArticleBattery safety for medical devices
As medical devices and instruments become more portable and ultimately wireless, the need for a reliable power source has become a major design element. The demand for ever smaller, higher density...
View ArticleOur 10 most read medical device development blogs of 2020
Three new medical device development blogs and two new authors joined our 2020 “most read” list. Regulatory edged out electrical engineering articles as the most popular topic. Many thanks to our...
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