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Closing the quality health care gap through disruptive design

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By Vinesh Narayan

In May 2015, I got an unexpected message from our manufacturing partner in China that our product, the ReMotion Knee, had failed the cyclic testing of its ISO certification. I was surprised as our own rigorous internal tests gave us confidence that we would pass the official lab’s intense protocols. Given this failure, we had to redesign the product quickly, with a micro-budget, and get our product approved ASAP. Plus, we had the added pressure that Krista Donaldson, our CEO, was telling a TED audience that same day that we were nearly ready to deliver our product to market. It was not a good morning.

Some context: I am part of the team at D-Rev, a non-profit product development company that exists to close the quality healthcare gap for under-served populations  by designing and delivering medical technologies. The ReMotion Knee is our fourth product to go to market and the first formobility. The affordable – at just $80 – and high performance prosthetic knee joint is designed for clinics serving amputees in low-income countries.

Our prosthetic knee was designed with a laser focus on durability, efficiency and affordability to address the unique needs of underserved markets. Like other prosthetic knee joints, it is built to last 3-5 years, has a universal adapter design for mass implementation and is built for maximum stability. Unlike other options, it works very well in hot, humid and dirty conditions, such as construction and farming, where many amputees in developing countries work. Its high range of motion (160 degrees) gives amputees the flexibility to move freely, including kneeling, squatting, and riding a bicycle. Critically, it is also much more accessible, at approximately one-fifth the cost of equivalent devices.

Failing that first ISO test required us to make quick decisions to stay on track to bring this critical new technology to market and start helping people live fuller lives. Our roadmap committed us to delivering the ReMotion Knee by the end of 2015. We did not want to miss our target and disappoint customers, funders and our team at D-Rev.

While our internal D-Rev team is small and budgets are limited, collaboration has helped extend our impact and agility. Autodesk Foundation, one of D-Rev’s key backers, connected us to Dell, which donated powerful hardware including Dell Precision workstations optimized for Autodesk software. Our engineering team was up-and-running quickly, using the new equipment to accelerate internal testing, specifically, finite element analysis (FEA) and failure analysis. We affectionately named the new products Superman, Batman and Robin – as they gave the team “super powers.”

“Our team saved hours and hours of time by completing almost everything in a virtual environment, rather than relying on prototyping and testing sequentially.”

The Dell equipment and Autodesk’s software allowed us to use FEA to rapidly evaluate hundreds of design changes to address the specific issues that led to test failure. Our team saved hours and hours of time by completing almost everything in a virtual environment, rather than relying on prototyping and testing sequentially. After selecting the best options from the simulations, we could then test just the most promising designs, eliminating the need to invest time and resources in creating and physically testing each iteration. In ten weeks, we went from cause analysis on our failed product to starting testing on an improved version – by far the fastest process ever for us for critical design changes.

Prior to the use of Dell Precision workstations, our computers crashed or required multiple hours to run simulations. As a result, we had to outsource all of our FEA analysis. By bringing these tools and process in house, we were able to focus our trusted vendor partner on design support and the vetting of our recommended prototype changes.

In early December 2015, the ReMotion Knee was officially released to the world, having passed third-party certification testing, including ISO 10:328 standards. The knee is now registered with FDA and CE marks and we are moving quickly to fulfill more than 700 pre-orders from customers in 17 countries.

We’re grateful to Autodesk Foundation and Dell for making our final design work possible.

 

About Dell

The Dell sustainability team supports D-Rev in partnership with the Autodesk Foundation, which donates money and design software suites to non-profit organizations doing good through design. Dell believes technology has a powerful role in helping others to benefit the world. We’re committed to achieving 21 goals by 2020 that bring social and environmental objectives together with our business objectives to create value for our customers as well as our people and the planet. Explore more here.

About Vinesh Narayan | ReMotion Product Manager, D-Rev

Vin joined D-Rev’s ReMotion project after co-designing a low-cost elbow prosthetic in a Stanford University course on medical device design. While a graduate student, Vin gravitated toward the medical device arena because of its direct human impact, and this same passion led him to continue his work at D-Rev. Vin believes that solutions with the highest capacity for positive impact combine organizational sustainability with human benefit. Consequently, he is focused on finding sustainable ways to bring ReMotion prosthetic devices to more people outside of India, where it is currently being fit through clinical trials with the JaipurFoot Organization.

Vin holds a Master’s degree in Management Science & Engineering from Stanford University with a concentration in Entrepreneurial Design, focusing on the design of products and services in startup environments that have a high degree of ambiguity. Prior to Stanford, he studied restorative tendon-transfer surgeries at the Rehabilitation Institute of Chicago and earned his Bachelor’s degree in Mechanical Engineering from the University of Illinois.

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