News & Insights from Engenious Design

Discover how we bring your ideas to life, stay up-to-date on the latest industry news and insights, and hear from our team experts on the innovations that hold promise for the future of medical device design.

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FDA Device Recalls: A Primer for Medical Device Research & Development Leaders

When medical device Research & Development groups face the potential for a recall, it’s an all-hands-on-deck situation. Smart R&D leaders must equip themselves ahead of time in order to lead effectively during recalls.

FDA Emergency Use Authorizations: What Happens to Products After the Emergency Is Over?

How do medical device R&D leaders get a product to market quickly in emergency situations like the COVID-19 pandemic, with a 90+ day 510(k) approval timeline to consider?

Are Bag Valve Mask drive systems the COVID-19 emergency ventilation solution? A designer’s review.

Like many with engineering history in ventilator development, I was excited to see globe-spanning work to quickly create or adapt emergency ventilators to address the mounting COVID-19 pandemic. I read the MIT paper with their BVM system and came away thinking the system isn’t the simple answer we all want.

COVID-19 Respiratory Distress Workflow Hypothesis

When Engenious got the call from a government organization to help brainstorm ways to avoid a ventilator crisis, we jumped into action. It was obvious that there were a thousand ways to design a ventilator, but we were particularly interested in designing something that meets the core needs of doctors and nurses on the front [...]

N95 respirators are medical devices; learn how FDA treats these devices that are critical to our nation’s COVID-19 response.

Protective masks like the N95 are in the news with shortages, stockpiles and new legislation around this important personal protective equipment. In this article we summarize how the FDA regulates these products, who makes them and what’s in place to make sure that they work!

Industrial Design Trends: What Medical Device R&D Leaders Need to Know

Medical devices have particular industrial design needs that set them apart from consumer products. In this article, we explore what makes medical devices unique, and provide a summary of recent industrial design trends: aesthetic, style, color, material and finishes applicable to the needs of medical devices.

Clinical Insights Program: Involving Healthcare Providers In Device Design

At Engenious Design, we create medical devices on behalf of our clients. We are a group of designers and engineers, and we invest a lot of time thinking about how these devices will be used.

Ideo’s farm team: why med device R&D leaders need one too

Savvy medical device research & development leaders benefit from cultivating medical device design consultants as a way to get innovative systems to market quickly, especially when local job markets are tight for technology experts with specialized skills.

Expertise in Electrosurgery

In 1920 an eccentric inventor named William T. Bovie developed an innovative electrosurgical unit that passes high frequency current into the body allowing the current to cut or coagulate. Harvey Cushing, the founder of modern neurosurgery, introduced this technology to clinical practice.

Our Mothers Would Be Proud

At Engenious, we design products that help your loved ones! Our mothers’ would be proud!

Research has long shown the correlation between the use of urinary catheters and morbidity and mortality among elderly patients.

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