We provide medical device design and development services to biomedical innovators.

Biomedical innovators often struggle to develop devices effectively and meet their objectives. They are faced with increasing technical complexity, challenging requirements, and high costs. We provide the expertise and resources to help them overcome these challenges and meet their goals.

At Design by Boyd, we partner with biomedical innovators to develop complex devices with superior functionality and intuitive user experiences—ultimately, providing them with a more successful design.

We help you turn Just Might into Just Mighty. 

Concept Generation

Concept Development

Design & Development

Verification & Validation

Design Transfer

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We work with clients to translate clinical ideas into device concepts. We will outline a compelling and executable business strategy, create a clear product concept with a detailed development plan, and appropriately identify risks. Many projects begin with Concept Generation; however, in some cases, if an idea is sufficiently defined, a project may proceed directly to Concept Development. 

  • Concept Generation
  • Concept Evaluation
  • Project Plan

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We work with clients to refine and select device concepts to assess feasibility and gather feedback to understand the user experience. We will design, build, and adjust alpha prototypes while conducting informal testing and analysis. Concept Development is conducted without design controls in place, but will begin to establish design control documentation to support the design history file and subsequent design and development phases.

  • Concept Refinement & Selection
  • Prototypes & Feasibility
  • Documentation

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We will complete the design, prototyping, and testing process such that the product and subsystem specifications can be frozen and are testable and traceable. We will optimize the design for manufacturability (DFM) and freeze the bill of materials. Our work during Design & Development will be completed under engineering-level design controls. 

  • Design Review
  • Development Plan
  • Device Design
  • Design Prototypes
  • Device Manufacturing
  • Risk Management
  • Documentation

 

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We will confirm that the product works as designed and meets the user's needs through objective evidence during Verification & Validation. We will ensure that the product meets requirements for functionality, reliability, usability, and safety through rigorous verification and validation testing. We will complete engineering builds, packaging design, labeling, human factors testing, manufacturing tooling and equipment, and pilot production builds. 

  • Verification Prototypes
  • Verification Testing
  • Validation Prototypes
  • Validation Testing
  • Documentation & Reporting

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We will 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 will be completed. Products are set up appropriately for ongoing commercial production and quality control with the manufacturing partner. 

  • Device Master Record (DMR)
  • Manufacturing Co-ordination

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EPA
ISO 13485
FDA
Made in USA

Case Studies

Trusted medical device development

 

Design by Boyd is a team of design and development engineers with deep medical device expertise. Our objective is to partner with biomedical companies to design and develop biomedical innovations. To each client partnership, we bring a wealth of industrial design, biomedical engineering, mechanical engineering, and technical skills from within the biomedical industry. Here’s a quick glimpse at some of our work.

Glacial® Skin

SILS™ Hand Instruments

ZipThaw®

Erbi Breez™

Your medical device Just Might change the world. But is your design up to the task?

 

Investing in medical device design and development drives measurable outcomes.

 

We help you turn Just Might, into Just Mighty.

The usability and functionality of medical devices require extensive expertise in industrial design and human factors studies.

Medical devices must have a competitive cost of goods sold, achieved through bill of materials selection, process automation, and effective quality procedures.

Time to market requires accurate development timelines, strong program execution, and the reduction of unnecessary iteration or rework.

Biomedical innovation requires more than a great idea; design and development work should capture invention disclosures and patentable intellectual property. 

Trusted Partners

We help the best biomedical innovators in the world design, build, and launch medical devices. We're proud of our strong partnerships which lead to greater innovation and better health. 

FREE ASSESSMENT

Build a Better Device

Schedule a free device assessment to help you understand where you are in the design and development process, what gaps you need to fill, and the critical next steps in your process.

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What's Involved?

 

Assessment

Schedule a call with us. We'll gather all the information you have today and complete a device assessment for you.    

 

Recommendations

Receive a written evaluation from us outlining future work and the proposed next steps for you.

 

Consultation

Schedule a consultation with our team to discuss the initial scope of work for your project and outline the next steps. 

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