If you are interested in learning how Human Factors / Usability Engineering is changing the landscape for medical device development, this report from BSI is a must read. It outlines the basic activities in the HF/UE process, how it aligns with the overall device risk management process, and the biggest challenges for device manufacturers.
“Fail Early!” “Fail Fast!” “Fail Cheap!” These are the latest, fashionable mantras of the business world, but in the design world these mantras simply restate the long held tradition of the iterative design process. Designers of all types have been “failing fast” since the dawn of man, from the first failed spear to the latest smart phone app. Designers know that a key part of product development is iteratively developing prototypes and testing them out - in other words “failing” throughout the design process.
The Washington Biotechnology & Biomedical Association recently hosted an event titled “Succeeding in Today's Medical Device Environment” to discuss the medical device sector in Washington state and the challenges it faces. The topics included the federal medical device tax, the lapsing R&D tax credits in the state, and the Affordable Care Act.
I recently attended MD&M West, which bills itself as “America’s Largest Medtech Event.” It includes an enormous exhibition and extensive educational opportnities, so as a mechanical engineer at an innovative product development company, I decided to focus my attention on emerging trends.
It doesn’t start with leaping forward, a battle-cry and weapon in hand. It starts with stepping back.
The qualities of an effective product development team are derived from mastering the basics first, not immediately running into battle with all weapons drawn. When approached with opposition, strength can be drawn by first stepping back - drawing the momentum in reverse to create a powerful drive forward. It’s strategic technique, providing the opportunity to observe and plan before recouping strength for the attack. In product development, application of this core principle throughout the project enables the team to skillfully navigate obstacles and execute the approach with finesse.
Join Stratos President, Sean MacLeod on Thursday, February 26th at 5:00 for an update on the medical device industry. He and several other industry experts will be participating in a panel discussion on the medical device sector in Washington state and the challenges it is facing from the federal medical device tax, lapsing R&D tax credits in our state, and the Affordable Care Act.
It wouldn’t be too much of a stretch to characterize Seattle’s Juno Therapeutics as the biotech company of the year for 2014. And depending on how the company progresses, by 2020, we might well be calling it the biotech of the decade.
Product Designer Spotlight is a monthly feature on our blog that highlights our talented engineers and designers. The month's spotlight is on Will Brown from our Quality Engineering team. WillI ensures project designs comply with government regulatory guidance and helps design the testing of the products we develop.
Attending CES is an exercise in sensory overload, but it’s also a fantastic place to take the pulse of the rapidly changing landscape of Digital Health. We saw some great innovations this year and we saw some tepid trends as well. Here’s our roundup of the Digital Health Expo show floor:
As I wrote last time, over the Holiday break my family took a road trip from Seattle, WA to Orange County, CA in our Tesla Model S Sedan. Needless to say, a new-ish car with a new-ish charging network that could get us the 1200 miles to our destination was an unforgettable experience. However, it was also an experience that led me to think about some Product Development truths that are sometimes forgotten. Read about three more that I learned.