We refine and select device concepts to assess feasibility and gather feedback to understand the user experience. We design, build, and adjust alpha prototypes while conducting informal testing and analysis. We conduct Concept Development without design controls in place, but begin to establish design control documentation to support the design history file and subsequent design and development phases.
Concept Refinement & Support
We refine selected concepts and use them to assess feasibility and make a final selection. We generate a clear and simple statement based on the clinical problem to define concept success (e.g., the device should be able to grab and hold the walls of a femoral artery). We translate the selected and refined concepts into solid computer models.
IP Development & Support
We support the development and protection of intellectual property. During our work, we describe device concepts in a memo with sufficient detail to serve as an invention disclosure, and we support patent applications. When necessary, we conduct or support a freedom-to-operate analysis to help determine limits on device concepts.
Human Factors
We specialize in understanding how users interact with medical devices to create designs that are safe, effective, and easy to use. We utilize external partners to complete usability tests, formative and summative studies, and focus groups to gather feedback when necessary.
Industrial Design
We create safe and effective medical device designs that successfully integrate user needs, ergonomics, aesthetics, and functionality. We may create and refine several design iterations before we reduce them to practice.
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.
Material Sourcing
We provide complete sourcing support for design and development programs. This includes sourcing, selecting, and managing suppliers for equipment and tooling, components and raw materials, and necessary third-party services.
Feasibility Prototypes
We build feasibility prototypes to explore and refine the device's design. We focus feasibility prototypes on the device's form, function, and usability. We test and iterate the design through informal testing and analysis. We conduct these builds without design controls in place, but we begin to establish design control documentation to support the design history file.
Feasibility Testing
We test concepts for feasibility to assess the technical performance, manufacturability, and costs, and determine if the concept is practical and viable before proceeding to more advanced stages of development.
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.
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
Your innovationJust Mightchange the world. But is your design up to the task? We help you turnJust MightintoJust Mighty.
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