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Design by Boyd

We design novel biomedical devices with superior functionality, uncompromising aesthetics, and unmatched user experiences.

We design best to market.

Services

We provide design services for biomedical devices across all phases of product commercialization, from concept generation to manufacturing transfer. 

Design Phases

Concept Generation
Concept Development
Design & Development
Verification & Validation
Manufacturing Transfer
  • Concept Generation

    This phase aims to translate a clinical idea into a device concept. We work with clients to develop the initial idea. The idea may be as early as a napkin sketch or as advanced as a patent. Many projects begin in this phase, but we may recommend starting in the next phase if an idea is sufficiently advanced. 

    Features
    Way of Working

    Program Management
    Concept Generation
    Design and Development
    Process Engineering
    Quality & Regulatory Support
    Material Sourcing
    Testing
    Proposal Support

  • Concept Development

    This phase aims to refine the device concept and assess feasibility. We work with clients to refine the initial concepts and identify the most important device functions to address the clinical problem. Prototype designs will be generated with enough detail to assess function. We will identify key metrics to be used as objective measures for feasibility testing, which could be done through a combination of bench testing, animal testing, and analysis.

    Features
    Way of Working

    Program Management
    Design Engineering
    Prototype Engineering
    Process Engineering
    Quality & Regulatory Support
    Material Sourcing
    Testing
    Intellectual Property Development and Support

  • Design & Development

    This phase aims to translate the device concept into a design that can be verified and manufactured. This phase represents the transition from research to development. Typically, the phase will begin with a design review to review all work done to date. Boyd will control documentation in a project file or a design history file as appropriate for the client, depending on whose quality system will be used to control development. We will create a development plan with detailed tasks, the development schedule with key milestones, and a proposed allocation of necessary resources. We will perform the work to develop a practical and successful device design. 
    Features
    Way of Working

    Program Management
    Design Engineering
    Prototype Engineering
    Process Engineering
    Quality & Regulatory Support
    Material Sourcing
    Testing

  • Verification & Validation

    This phase aims to show that your design outputs meet all your design inputs. We will produce final design verification prototypes using released procedures and full material traceability. At a minimum, build procedures and processes will be representative of commercial production. Design validation prototypes will be produced using fully validated processes. Devices will be packaged, sterilized, and conditioned. Testing will be performed by qualified clinical personnel to released protocols. Boyd will assist CROs or other external organizations as needed.

    Features
    Way of Working

    Program Management
    Design Engineering
    Prototype Engineering
    Process Engineering
    Quality & Regulatory Support
    Material Sourcing

  • Manufacturing Transfer

    This phase aims to complete process verification and validation and transfer devices into their commercial manufacturing setting. Production tooling, process trials including EOF, DOE, IQ, OQ, and PQ, risk management, and necessary documentation will be completed. We will then transfer devices into commercial production. If products are transferred to a non-Boyd manufacturing location, programs are customized to align with that production environment.  
    Features
    Way of Working

    Program Management
    Design Engineering
    Prototype Engineering
    Process Engineering
    Quality & Regulatory Support
    Material Sourcing
    Testing


The Value of Our Growth Platform

Technology is advancing faster than ever before. The opportunity to develop new devices and therapies that improve patients' lives, or even cure disease, is better than any time in human history.

But, biomedical innovators are under enormous pressure from fragmented markets, shorter product lifecycles, and soaring costs. To succeed, innovators must adapt to these changes by commercializing products more effectively. How products are designed, built, and launched matters more than ever before.

We bring together the essential commercialization skillsets - the technique of designing, the craft of producing, and the art of marketing. Our combined expertise informs and improves the value we provide in each domain. Whether we deploy one or all of our services, our work always delivers the insight and expertise of the whole.

Design

We design novel biomedical devices and work across all phases of design. 

Build

We manufacture complex biomedical devices and liquid media. 

Launch

We create world-class brands and compelling content for biomedical innovators. 

Phased

Our phased approach to work allows our clients to fill gaps in their commercialization process exactly when and where they are needed. 

Customized

Our engagements follow a customized scope of work precisely aligned to our client's timeline and resources.

Adaptable

Our services are adaptable unlike the fixed costs necessary for our clients to build captive operations.

Scalable

We have decades of experience integrating and scaling our services appropriately to meet the needs of start-ups and market leaders alike.  

Integrated

We help our clients repeatedly and consistently maximize the value they capture from our services by engaging in long-term integrated partnerships. 

Aligned

We extend our integrated relationships across business functions to align and optimize in everything we do.  


Qualifications


GROWTH PLATFORM

Design Services

We provide design services for biomedical devices across all phases of product commercialization, from concept generation to manufacturing transfer.