Intellectual Frontiers

Eleven Builder Tools Take a Device From Evidence Inventory to Release

These are the builder tools, in the order a design team uses them: from listing the evidence the device produces to the release gate for its interfaces. The chapters work each tool on one of the book’s recurring devices, but every tool applies to any institutional device class: a magnetic resonance imaging system, a blood gas analyzer, an electrosurgical unit, an extracorporeal membrane oxygenation console, an intravenous compounding robot, a fetal monitor, or a low-temperature sterilizer. Copy them for your own design reviews and release gates. Fill in one copy per product or release. Keep each copy with the design records it informed.

  1. List Every Kind of Evidence a Device Produces

  2. Review the Architecture for Any Dependence on the Network

  3. Give Each Dependency Failure a Row and Four Questions

  4. Record Where Each of the Twelve Identities Comes From

  5. Write Down What the Device Means Before Choosing a Protocol

  6. Start the Threat Model With Every System Element

  7. Write Fleet Capability Into the Product Requirements

  8. Check Update and Rollback Before Every Field Release

  9. Test Disconnection as a Normal Operating Condition

  10. Pass an Evidence Item Only When Normal Operation Produces It

  11. An Interface Is Done When the Customer Can Use It Without You