%20-%20Tint%20100.png?width=811&height=811&name=Logo%20-%20Favicon%20Square%20-%20Green%20(810%20x%20810)%20-%20Tint%20100.png){kind=logo}
%20-%20Tint%20100.png?width=664&height=226&name=Logo%20-%20Design%20by%20Boyd%20-%20Green%20(689%20x%20250)%20-%20Tint%20100.png){kind=logo}
© 2026 Boyd Biomedical, Inc.
Design & Development
We turn a proven concept into a specified device. Through detailed design, prototyping, and testing, we complete and freeze the specifications your device needs to be verified, validated, and manufactured.
Please feel out the form below and someone from our team will contact you shortly.
Phase Overview
Design & Development is where the device takes its final form. Design inputs become detailed designs, prototypes progress from alpha to beta, and testing drives iteration until product and subsystem specifications can be frozen. The output is a complete, testable, and traceable design package optimized for manufacturability, with the bill of materials locked and the device ready for formal verification and validation.
What Happens in This Phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that complete the design and freeze the specifications your device will be built to.
Detailed Design
Concepts developed into complete designs with defined geometry, materials, tolerances, and interfaces.
Engineering Analysis
Structural, fluidic, thermal, and mechanical performance modeled and analyzed before committing to build.
Prototyping
Beta prototypes built to production-representative intent to evaluate the design as it will actually be made.
Design Verification Testing
Bench testing against design inputs to confirm the design performs as specified and to drive iteration.
Design for Manufacturability
The design optimized for repeatable production, with process implications resolved before specifications freeze.
Material Sourcing
Materials and components qualified and specified, with the bill of materials locked for the frozen design.
Risk Management
Hazard analysis and risk controls updated as the design matures, with mitigations traced to design outputs.
Regulatory Strategy
The regulatory pathway confirmed and design outputs documented to support the submission that follows.
What You Walk Away With
A frozen, manufacturable design: complete product and subsystem specifications that are testable and traceable, beta prototypes built to production intent, a locked bill of materials, design verification test results, an updated risk file, and a design history file ready to support formal verification and validation.
Why This Phase Matters
A device that can't be specified can't be manufactured, and a specification that can't be tested can't be verified. This is where those two things get resolved together. Freezing a design that was optimized for manufacturability means the phases ahead confirm what you built rather than uncover what you missed, and it means the cost of the device is understood before you commit to producing it.
Verification & Validation
With specifications frozen and the design package complete, the device is ready to enter Verification & Validation, where formal testing confirms it meets its design inputs and performs for its intended users.
Please feel out the form below and someone from our team will contact you shortly.
.webp)
.png?width=401&height=401&name=Logo%20-%20Just%20Mighty%20-%20White%20Logo%20(400%20x%20400).png){kind=logo}