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Build Better Handbook: Table of Contents
  •   

    Start Here

    • Introduction to the Build Better Handbook

    • Manufacturing Term Glossary

  •   

    Getting Culture Right

    • Jeff Lutz: Team Culture Drives Product Performance

    • Scrappy Ways to Execute Like Apple

    • Building a Culture of Quality

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

    NPI: A How To Guide for Engineers & Their Leaders

    • Leading from the Front

      • Building the Team
      • Quality is Set in Development & Maintained in Production
      • 3 Lessons from Tesla’s Former NPI Leader
      • Reject Fake NPI Schedules to Ship on Time
      • Leadership Guidance for Failure to Meet Exit Criteria
    • Screws & Glue: Getting Stuff Done

      • Choosing the best CAD software for product design
      • Screws vs Glues in Design, Assembly, & Repair
      • Best Practices for Glue in Electronics
      • A Practical Guide to Magnets
      • Inspection 101: Measurements
      • A Primer on Color Matching
      • OK2Fly Checklists
      • Developing Your Reliability Test Suite
      • Guide to DOEs (Design of Experiments)
      • Ten Chinese phrases for your next build
    • NPI Processes & Workflows

      • EVT, DVT, PVT Stage Gate Definitions
      • Hardware Schedules are Driven by Iteration
      • The Shedletsky Test: 12 Requirements for NPI Programs
  •   

    Production: A Primer for Operations, Quality, & Their Leaders

    • Leading for Scale

      • Greg Reichow’s Manufacturing Process Performance Quadrants
      • 8D Problem Solving: Sam Bowen Describes the Power of Stopping
      • Oracle Supply Chain Leader Mitigates Risk with Better Relationships
      • Brendan Green on Working with Manufacturers
    • Ship It!

      • Serialization for Electronics Manufacturing
      • Tactics to Derisk Ramp
      • E-Commerce Ratings Make Product Quality a Competitive Edge
    • Production Processes & Workflows

  •   

    Thinking Ahead: How to Evaluate New Technologies

    • Saw through the Buzzwords

      • Automation Tipping Points
      • CTO of ASUS: Systems Integrators for Manufacturing Automation Don't Scale
    • Opportunity Analysis and Realizing Value

    • Building a Buying Committee

    • How to Buy Software (for Those Who Don't Usually)

  1. Build Better Handbook
  2. Getting Culture Right
  3. Building the World's Most Reliable Products: Insights from Medical and Defense Leaders

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

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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 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, to discuss building some of the world’s most reliable products.

David Nazarro, Michael Sternowski, and Matt Ohline

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 that alerted them to the issue in the first place. They then identified 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.”

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