We complete the design, prototyping, and testing process so that the product and subsystem specifications can be frozen and are testable and traceable. We optimize the design for manufacturability (DFM) and freeze the bill of materials. We complete Design & Development work under engineering-level design controls.
Engineering
We bring together the engineering concentrations necessary to design and develop medical devices successfully. This includes mechanical engineering, electrical engineering, systems engineering, software engineering, and process engineering to support Design for Manufacturability (DFM).
Packaging & Labeling Design
We support the development, sourcing, and validation of primary, secondary, and tertiary packaging, labeling, and instructions for use according to quality and regulatory requirements for pre-clinical, clinical, and commercial stages.
Design Prototypes
We build design prototypes to assess function, gather user feedback, and begin developing preliminary manufacturing processes. We produce design prototypes using rapid prototyping techniques and test them using preliminary test methods. In some cases, we may create tooling, such as short-run aluminum molds, to produce these prototypes. We fabricate final design prototypes using the preliminary manufacturing processes. We perform pre-verification testing on the design prototypes to the draft protocols to assess the design and identify any issues with the protocols. We summarize the testing results in one or more reports, and we can adjust the design and the protocols as needed.
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.
Sterilization Development
We support the development, sourcing, and validation of sterilization services. We work with external partners to develop new sterilization cycles or adopt existing cycles into our programs.
Quality & Regulatory Support
We support the quality and regulatory needs of each program under design controls per our quality management system. We conduct formal design review meetings throughout each program, complete risk management activities, and control all documentation in a project file or a design history file, depending on the quality system used.
Risk Management
We complete risk management activities throughout each program, which involve identifying, assessing, and mitigating potential risks associated with a device throughout its lifecycle. We ensure that devices are safe and effective for users through risk analysis, risk evaluation, risk control, and monitoring residual risks.
Design Review
We conduct formal, documented evaluations of each medical device's design at various stages of development in design review meetings. We ensure that the design meets specified requirements, identify potential issues, and confirm readiness to proceed to the next phase.
Project Plan
After we complete the Concept Generation phase, our program management team creates a detailed project plan and estimates for further work. We leverage our experience to create a customized plan defining clear and relevant milestones for each program. We outline further development work on the device and provide a roadmap for commercialization.
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.
%20-%20Tint%20100.png?width=811&height=811&name=Logo%20-%20Favicon%20Square%20-%20Green%20(810%20x%20810)%20-%20Tint%20100.png){kind=logo}
%20-%20Tint%20100.png?width=664&height=226&name=Logo%20-%20Design%20by%20Boyd%20-%20Green%20(689%20x%20250)%20-%20Tint%20100.png){kind=logo}
.webp)
.png?width=401&height=401&name=Logo%20-%20Just%20Mighty%20-%20White%20Logo%20(400%20x%20400).png){kind=logo}