Concept Development

Boyd Biomedical, Inc.

Home
Knowledge Center
Careers
Newsroom

Home
Services

Design by Boyd

Build by Boyd

Launch by Boyd
Knowledge Center

Articles

Reports

Videos

Case Studies

Newsletter
Careers
Newsroom

Commercial Phases

We integrate with every phase of your medical device development.

Engage us when you need us, from Concept Generation through Design Transfer.

Learn More

Concept Generation

Translate your clinical ideas into device concepts with a clear product vision and detailed development plan.

Concept Development

Refine and select device concepts, assess feasibility, and gather feedback to understand the user experience.

Design & Development

Freeze your device specifications with designs optimized for manufacturability, traceability, and regulatory compliance.

Verification & Validation

Ensure that your device meets requirements for functionality, reliability, usability, and safety through rigorous testing.

Design Transfer

Transfer your validated devices into commercial manufacturing with tooling, process validation, and risk management support.
Disciplines

We provide the development rigor your device demands.

Our disciplines span ideation, design, engineering, prototyping, quality and regulatory support, testing, and material sourcing.

Learn More

Ideation

Explore the clinical need, select the strongest concepts, and protect the IP created along the way.

Design

Create safe, effective devices that integrate user needs, ergonomics, and aesthetics.

Engineering

Mechanical, electrical, systems, software, and process engineering for complex devices.

Prototyping

Build and test prototypes from early feasibility through verification and validation.

Quality & Regulatory

Maintain design controls, risk management, and regulatory compliance throughout development.

Testing

Biocompatibility, feasibility, verification, and validation testing.

Material Sourcing

Source and manage equipment, tooling, components, and third-party services.
Our Work

Home
Services

Design by Boyd

Build by Boyd

Launch by Boyd
Knowledge Center

Articles

Reports

Videos

Case Studies

Newsletter
Careers
Newsroom

Commercial Phases

We integrate with every phase of your medical device development.

Engage us when you need us, from Concept Generation through Design Transfer.

Learn More

Concept Generation

Translate your clinical ideas into device concepts with a clear product vision and detailed development plan.

Concept Development

Refine and select device concepts, assess feasibility, and gather feedback to understand the user experience.

Design & Development

Freeze your device specifications with designs optimized for manufacturability, traceability, and regulatory compliance.

Verification & Validation

Ensure that your device meets requirements for functionality, reliability, usability, and safety through rigorous testing.

Design Transfer

Transfer your validated devices into commercial manufacturing with tooling, process validation, and risk management support.
Disciplines

We provide the development rigor your device demands.

Our disciplines span ideation, design, engineering, prototyping, quality and regulatory support, testing, and material sourcing.

Learn More

Ideation

Explore the clinical need, select the strongest concepts, and protect the IP created along the way.

Design

Create safe, effective devices that integrate user needs, ergonomics, and aesthetics.

Engineering

Mechanical, electrical, systems, software, and process engineering for complex devices.

Prototyping

Build and test prototypes from early feasibility through verification and validation.

Quality & Regulatory

Maintain design controls, risk management, and regulatory compliance throughout development.

Testing

Biocompatibility, feasibility, verification, and validation testing.

Material Sourcing

Source and manage equipment, tooling, components, and third-party services.
Our Work

Phase 1

We refine and select device concepts before formal development begins. We test feasibility, build alpha prototypes, and gather early user feedback so the concept entering design and development is the right one.

Please fill out the form below and someone from our team will contact you shortly.

Home / Services / Design by Boyd / Commercial Phases / Concept Development

Phase overview

Concept Development is where a concept is tested against reality. Feasibility studies, breadboard and alpha prototypes, and early user feedback establish whether the concept can be built and how it needs to change. The output is a refined, down-selected concept with documented user needs and design control documentation started, ready for formal design and development.

What happens in this phase

Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that prove a concept can be built and prepare it for controlled development.

Concept Refinement & Selection

Leading concepts refined, assessed for feasibility, and down-selected against a clear success statement.

Feasibility Prototypes

Alpha prototypes built and iterated to evaluate form, function, and usability.

Feasibility Testing

Informal testing and analysis of technical performance, manufacturability, and cost.

Human Factors

Early feedback from clinicians and end users to validate assumptions and identify requirements.

Design Inputs

User needs and intended use documented as design inputs to support the design history file.

Risk Management

An initial hazard analysis and risk assessment maintained as the concept evolves.

IP Support

Invention disclosures and patent support for refined concepts.

Development Plan

Scope, milestones, and cost refined for formal design and development.

What you walk away with

A validated concept ready for formal development: a down-selected design supported by alpha prototypes, documented user needs and design inputs, invention disclosures for refined concepts, an initial risk assessment, and an updated development plan and estimate for the next scope of work.

Why this phase matters

This is the last phase where changing direction is inexpensive. Feasibility problems caught here cost a prototype iteration. Caught after design controls tighten, they cost redesign, retesting, and schedule. Proving the concept now, against real users and real physics, is what makes the phases that follow predictable.

NEXT PHASE

Design & Development

With feasibility proven and user needs documented, the concept is ready to enter Design & Development, where the design is completed, specified, and frozen for manufacturing.

Continue