Medical Product Design
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Summative Usability Testing: Why and How to Do It
by Chris Ross Posted Jun 29, 2018 In Human Factors & Usability Testing, Medical Product Design
The business of introducing new medical devices requires us to address enormous technical challenges that require plenty of hard work. As we strive to meet these challenges, the FDA reminds us not to lose sight of
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Patients are taking healthcare advancement into their own hands
by Chris Ross Posted Apr 18, 2018 In Medical Product Design
For patients who are diagnosed with serious, sometimes fatal, diseases, waiting for future medical technology to fill the needs of immediate problems may not be an option. Knowing that solutions could be available now, but haven't been developed due to lack [...]
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Robots: The future of home healthcare?
by Chris Ross Posted Apr 10, 2018 In Medical Product Design
Technology has completely transformed the way medical professionals deliver care over the last few decades. Electronic health records, 3D printing, nanotechnology and artificial intelligence are among some of the digital devices advancing the healthcare sector, [...]
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Medical Device Workflow Is Not The Same As User Experience
by Chris Ross Posted Mar 13, 2018 In Medical Product Design, User Insights & Design Research
People use your medical device differently than you think they do. It doesn’t matter what you say during training, or write in a manual or formal “instructions for use” document. Personal experiences influence our expectations and how we will approach interacting with your product. This [...]
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2018 will be a big year for EVV in home health care
by Chris Ross Posted Feb 20, 2018 In Medical Product Design
With new advances in technology regularly emerging among various industries, it's no surprise that 2018 will be a big year for transformative medical device solutions. According to Home Health Care News, this year in particular will be substantial for elect [...]
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Document organization tips for medical device designers
by Chris Ross Posted Jan 24, 2018 In Medical Product Design
No matter what industry your line of work falls under, keeping documentation in order is vital. For medical device designers, organizing specific details in regard to design, development and manufacturing, as well as the information on FDA compliance and regula [...]
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Key takeaways from the 2018 CES Digital Health Summit
by Chris Ross Posted Jan 24, 2018 In Medical Product Design
This year, modern medicine, healthcare and wellness professionals gathered in Las Vegas between Jan. 9 and 12 for the Consumer Technology Association Digita [...]
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How to use the FDA Process to Deliver a User-Friendly Medical Device
by Chris Ross Posted Jan 24, 2018 In Design Strategy, Medical Product Design, User Insights & Design Research
Seasoned medical device developers know that the FDA cares about safety and effectiveness, and nothing more. And because of the intense focus required to meet stated FDA expectations, it’s easy to put on blinders regarding issues outside the immediate frame of refer [...]
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Why MindFlow Design’s ISO 13485:2016 certification matters
by Chris Ross Posted Nov 28, 2017 In Medical Product Design
In September, MindFlow Design received ISO 13485/2016 certification for its work in medical device design and development. Based on a third-p [...]
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What is a quality system?
by Chris Ross Posted Nov 06, 2017 In Medical Product Design
Makers of medical devices must balance their pursuit of technology development and user needs with a strong focus on safety and regulatory compliance. Constant attention to the [...]
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New studies point to biomedical innovations ahead for devices
by Chris Ross Posted Oct 19, 2017 In Medical Product Design
Manufacturers of medical devices are always looking for fresh opportunities to advance product design and development. Technological advances c [...]
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How do patient preferences influence medical device regulations?
by Chris Ross Posted Sep 29, 2017 In Medical Product Design
Federal regulations for medical devices are designed to minimize risks, requiring manufacturers to provide evidence of a product's safety and effectiveness before bringing it to market. In some cases, however, the people who actually rely on those devices c [...]
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How to Break the Curse of Habit
by Chris Ross Posted Sep 29, 2017 In Human Factors & Usability Testing, Medical Product Design
Our brains are like a GPS mapping app, automatically adapting to a constant stream of information and only occasionally asking us to choose an alternative route. That automatic decision-making process driven by our subconscious is both a blessing and a curse for medical product companies. The [...]
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How new regulations are changing the market for medical devices in Europe
by Chris Ross Posted Sep 27, 2017 In Medical Product Design
For firms engaged in medical technology development that do business in Europe, 2017 brought important changes in the laws governing how [...]
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What can medical device firms learn from a pacemaker recall?
by Chris Ross Posted Sep 19, 2017 In Medical Product Design
On Monday, August 28, Abbott Laboratories announced a voluntary recall of pacemakers so the devices could undergo a firmware update. Impacting about 465,000 units, the recall demonstrates how pressing cybersecurity issues have become in
ISO 13485:2016-Certified
ISO 9001:2015- Compliant
MindFlow Design is a leading medical product development firm for Medical, Life Sciences, and Consumer Health Companies and is based in Carlsbad, CA. We aspire to introduce powerful, intuitive healthcare technologies to the world.
