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How the riches of Industry 4.0 are helping small medical device makers go beyond expectations

Amar Hanspal CEO Bright Machines
By Amar Hanspal CEO, Bright Machines

FIELD INTELLIGENCE: Smart Processes, Solutions & Strategies

Today, it’s tremendously difficult to get products made. To turn an idea into a tangible object requires a list of difficult-to-obtain resources, including expensive machinery and capital, and a lot of time to program and configure machines. For this reason, the business of building things has long been reserved for the giants of the manufacturing world.

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A doctor in Zimbabwe uses HIV-testing cartridges that DRW assembles with a Bright Machines Microfactory.

This presents a dangerous problem: Great ideas—no matter how innovative or novel—never make it to shelves without an abundance of resources behind them. Consider the COVID-19 pandemic: Just months ago, countries around the world were scrambling to source important medical devices that could save the lives of at-risk patients. When the world’s manufacturing sits in the hands of giants, it means vital products like ventilators and surgical masks are unable to scale when we need them most.

Fortunately, technology is accelerating a transformation in the sector. While manufacturing as an industry has historically been slow to embrace change, advancements—from 3D printers to computer vision to intelligent software—are entering factories and permanently changing the way physical products are made. Intelligent automation, driven by software, is making manufacturing simpler, more transparent and more affordable than ever, and in doing so democratizing the process of making things for companies and individuals alike.

Now, smaller companies and entrepreneurs have access to capabilities previously available only to companies with large capital expenditure budgets.

Diagnostics for the Real World (DRW) is a 50-person organization that develops advanced diagnostics devices for the world’s most infectious diseases. Initially conceived as a passion project for Dr. Helen Lee of the Diagnostics Development Unit at the University of Cambridge, the firm brings disease testing and management to resource-poor parts of the world where medical testing is limited and expensive. DRW’s toaster-sized SAMBA (Simple AMplification Based Assay) testing device has been a game changer for patients—particularly those in rural communities of Africa.

Typically, nucleic acid-based tests for HIV diagnosis are offered in centralized settings in city hospitals, requiring patient blood samples to be shipped on dry ice for testing. For patients living in remote areas, it can take as long as two to three months to receive results. SAMBA, however, provides these results at the point of care in less than two hours, allowing critical treatment to begin much faster. To date, more than 200,000 patients have received same-day test results from SAMBA.

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A patient in Zimbabwe provides a blood sample for rapid infectious disease diagnosis via DRW’s Simple AMplification Based Assay testing device.

While their products have already impacted the lives of thousands, DRW’s leaders knew that in order to reach hundreds of thousands, and one day millions, they would have to change the economics of the production of their tests. The assembly process for the SAMBA’s nucleic acid test is inherently complex, requiring human hands with a precise touch to ensure quality and accuracy of these important devices, severely limiting the device’s scalability. DRW’s executives were desperate for an affordable way to scale up production quickly so they could bring this important technology to more of the developing world.

Enter, smart automation. DRW implemented an adaptive robotic system called a microfactory to handle the assembly of these complex testing units. Leveraging intelligent software, computer vision and machine learning, the microfactory changes the economics of manufacturing by not requiring expensive hardware or a team of system integrators to achieve smart automation. Most importantly, it means DRW is able to scale up production without scaling up costs.

The company has been able to save on labor costs by decreasing its assembly headcount by more than 15 percent per unit. The microfactory accelerated production to just 20 seconds from two minutes per unit. Most notably, after a full year in deployment, DRW expects to increase production output to one million units a year from today’s rate of 100,000 units per year. Thanks to smart automation, providing millions of patients with affordable access to DRW’s care-critical tests is a milestone within reach.

With COVID-19 taking our world by storm this year, and infectious diseases continuing to threaten entire populations, the ability to quickly make and scale medical products is of paramount importance.

Armed with intelligent automation, this small and mighty company based in San Jose, Calif., is taking on other urgent challenges.

DRW recently rolled out a rapid diagnostic test for COVID-19 across England—a test that healthcare providers can complete at the point of care in less than 90 minutes.

Ultimately, intelligent software in manufacturing is about so much more than increasing run rates. It’s about transforming manufacturing from a mysterious, dark art into a capability that anyone can tap into. And in a time when our health and safety quite literally depend on access to critical products, that is something worth celebrating.

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