Prototyping

We design, build, and test prototypes

 

We design, build, and test prototypes to support our design and development work. This includes prototype builds for feasibility, design, verification, validation, and appropriate testing.

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.

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.

Verification & Validation Prototypes

We build verification and validation prototypes using released procedures, manufacturing processes representative of the commercial production process, and full material traceability. We may build verification prototypes using final procedures and tooling, but this depends on the device's complexity and the prototype volumes necessary. In some cases, we may need to assemble these prototypes manually with fixtures representative of automated machinery, in which case, we validate those assembly processes. We may package and sterilize prototypes for animal or clinical testing to support design validation activities. Prototypes may also undergo age testing, packaging and shipping testing, biocompatibility testing, or agency testing for certification to appropriate standards. 

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

 

Content Card - Just Mighty - Design - Two Color - Full (1920 x 1080)
Logo - Just Mighty - White Logo (400 x 400)

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