Building Reliable Products Begins with Data, Testing, and Regulation

Alisha Gallagher

It happens to every team in the manufacturing industry: a new program is running smoothly when units start failing reliability tests. A laptop hinge fails, a video game controller stops working, the speakers start buzzing, and no matter how you look at the data, you can’t find the root cause. It’s a stressful moment for any engineer — especially for those building life-saving products.

That’s why companies like Insulet Corporation, L3 Harris and Intuitive Surgical have embraced the need to create rigorous reliability testing programs. They engineer products that have to function in high-pressure, life-altering situations, no matter the time of day or environment, and finding failures faster helps them better support their customers. David Nazzaro of Insulet Corporation, Michael Sternowski of L3 Harris, and Matt Ohline of Intuitive Surgical joined Sam Weiss, CTO and co-founder of Instrumental, on the virtual stage at Build Better 2022 to discuss what it takes to build some of the world’s most reliable products.

Data is the missing piece for better builds

For Matt Ohline, senior director of process engineering at Intuitive Surgical, the ability to build better products like their Da Vinci robotic surgical system, depends on data. This concept hit home for him while his team was attempting to solve a common challenge in manufacturing: unit anomalies due to operator error. One of their manufacturing systems was designed to interact with technicians and operators, yet despite the automated nature of the system, some technicians found a way around a particular performance test.

But Matt and his team were prepared. They had data that allowed them to bracket the units affected by the operator error, which helped them avoid a recall that could have led to financial and customer risk. “Our devices need to function as designed every time,” he said, and data-backed systems help his team make it happen.

There’s no cutting corners in reliability testing

Michael Sternowski is interim director of quality at L3 Harris, a company that develops tactical radio systems for deployed troops. His team is charged with building a product that allows customers to establish secure communication with their peers under the rigor of any environmental situation, which makes reliability testing mission-critical to the function of their product.

Just how much testing do they do? “For every 45 minutes of assembly time, we’re probably doing six times that in parametric testing to ensure every channel across the board is performing properly.” Design verification testing and extensive field testing is also a critical component of their manufacturing process and product success.

Regulatory standards are your friend

While some may complain about the strict engineering regulations imposed on medical and emergency services products, Dave Nazzaro, vice president of hardware engineering and advanced technologies at Insulet Corporation, embraces them. Insulet makes the Omnipod, a small patch pump that enables insulin management for those with diabetes. In fact, he recommends all companies follow Insulet’s lead: encourage team members to learn all they can from the governing bodies that develop industry standards.

The panelists agreed that viewing regulatory standards as a support can actually help companies raise the bar on their design standards and use them as a template for a resilient product. “[Getting involved with regulatory boards] helps us learn about the standards before they’re released and network with people who are trying to solve the same problems as we are.”

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