Building the World's Most Reliable Products: Insights from Medical and Defense Leaders

It happens to us all: reliability tests are failing, 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 designing life-saving products.

That’s why companies like Insulet Corporation, L3 Harris and Intuitive Surgical have embraced the need to combine rigorous reliability testing programs with quality management systems. 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, to discuss building some of the world’s most reliable products.

Proactive data is critical to identifying unexpected issues

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 attempted to solve a common challenge in manufacturing: operator errors. One of their manufacturing systems was designed to interact with operators, yet despite careful design, some operators skipped an important performance test.

Matt's team had data from quality control systems that alerted them to the issue in the first place. Thanks to track and trace manufacturing, they were able to identify the units affected by the operator error and quarantined them for retest. This enabled them avoid a recall. “Our devices need to function as designed every time,” he said, and ensuring you have data with proactive alerting ensures that happens.

No shortcuts to functional and 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 withstands many rigorous environmental conditions -- so reliability testing is an absolute requirement. Design verification testing and extensive field testing is a critical part of their manufacturing process and product success.

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 performs properly.” While he wasn't able to share how many units got through destructive tests at L3, it's common for mission-critical electronics manufacturers to send more than 50% of their development allocation to destructive tests.

Regulatory standards are your friend

While some may complain about the strict engineering regulations imposed on medical and defense 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. He recommends that all companies follow Insulet’s lead: encourage team members to learn from the governing bodies that develop industry standards.

The panelists agreed that viewing regulatory standards as support can help companies raise the bar on their design and quality 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 trying to solve the same problems as we are.”