Design Transfer

We transfer validated products into commercial manufacturing

 

We transfer validated products into their commercial manufacturing setting and support process verification and validation. During Design Transfer tooling, process verification and validation, and risk management are completed. We set up products for ongoing commercial production and quality control with the manufacturing partner.

Documentation

Our program management team controls all documentation in a project file or a design history file, depending on the quality system we use to control development. We conduct a phase-end design review to review all tasks against the development plan and ultimately release all documentation into the quality system.

Device Master Record (DMR)

We will complete a Device Master Record (DMR) during the Verification & Validation phase, including specifications, formulations, production processes, and quality controls used to produce the device and transfer it to the selected manufacturing partner.

Process Engineering

We optimize device designs for manufacturability to facilitate manufacturing processes that are scalable, reliable, and efficient.

Manufacturing Coordination

We will coordinate with the selected manufacturing partner, whether that is our team at Build by Boyd or an external partner. If our team at Build by Boyd is selected, they will lead trials, including EOF, DOE, IQ, OQ, and PQ. Once the process validation is complete, the team at Build by Boyd will transfer the device to commercial production. 

If the device is transferred to a non-Boyd manufacturing location, we will support the Design Transfer program as necessary to align with the capabilities of the external partner and meet the client's needs. 

What's the ROI on Better Product Development?

 

Better design and development drive measurable outcomes. Organizations that achieve improved product development enhance quality through better device usability and functionality, reduce the cost of product development and cost of goods sold, accelerate time to market for product launches and future product iterations, and increase innovation with more protectable intellectual property.

Our Approach

We simplify complex design and development challenges 

 

We help biomedical innovators understand complex challenges and create simply effective solutions. From concept generation and product brand strategy, industrial design and product development to verification and validation, we help commercialize biomedical innovations with our design and development services. 

Discovery

 

We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings.

APPROXIMATE TIMING: 1-2 DAYS

 

Assessment

 

We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.

 

Approximate Timing: 1 week

 

Statement of Work

 

We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, cost, and key milestones.

 

Approximate Timing: 1-2 weeks

 

Content Card - Just Mighty - Design - Two Color - Full (1920 x 1080)
Logo - Just Mighty - White Logo (400 x 400)

Your innovation Just Might change the world. But is your design up to the task? We help you turn Just Might into Just Mighty.