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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.
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Design Phases
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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 SupportConcept generation services are performed under master services agreements between Boyd Biomedical and our partners. Our master services agreements cover all our design and development services and include a detailed scope of work for each program phase. At the end of this phase, we typically deliver a concept summary, recommendations for the next steps, and an estimate and project plan for a mutually agreed-upon scope of work.
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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 SupportConcept development services are performed under master services agreements between Boyd Biomedical and our partners. Our master services agreements cover all our design and development services and include a detailed scope of work for each program phase. At the end of this phase, we typically deliver functional prototypes, preliminary user needs documentation, engineering-level documentation, summary reports, and memos. -
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
TestingDesign and development services are performed under master services agreements between Boyd Biomedical and our partners. Our master services agreements cover all our design and development services and include a detailed scope of work for each program phase. At the end of this phase, we typically deliver plans for development, risk, sterilization, and manufacturing, a trace matrix listing design inputs, design files, including solid computer models, electronics design package, and code, prototypes at all stages through pre-verification, protocols for design verification and design validation, initial manufacturing documentation, risk management documentation, design review documentation, and an updated development plan. -
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 SourcingVerification and validation services are performed under master services agreements between Boyd Biomedical and our partners. Our master services agreements cover all our design and development services and include a detailed scope of work for each program phase. We typically deliver commercially representative devices that can be used for design verification testing and fully released devices for validation and clinical testing, necessary reports, design review documentation, and an updated development plan during this phase. If work is performed within Boyd's quality system, a design history file will be provided. Otherwise, a project file that can be incorporated into the client's design history file will be provided. A device history record and a device master record will also be provided. -
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
TestingManufacturing Transfer services are performed under master services agreements between Boyd Biomedical and our partners. Our master services agreements cover all our design and development services and include a detailed scope of work for each program phase. We deliver a validated manufacturing process and initial commercial products at the end of this phase.
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.
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Comprehensive
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Flexible
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Responsive
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
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Design Services
We provide design services for biomedical devices across all phases of product commercialization, from concept generation to manufacturing transfer.