Our Approach

Ximedica’s development process aligns 30+ years of best practices

Our nimble product development process has the discipline required by the FDA. Our vertically-integrated process delivers greater efficiencies in how products are designed, engineered, manufactured, and ultimately delivered. We stay flexible and accountable to create products that are innovative and commercially viable.

Research, Product Strategy, Concept Generation

00 Research, Strategy, & Concept Generation

 

Informing and inspiring solutions that make lives better.

In the early stages of the product development cycle the objective is simple – to inspire innovation and create a compelling and executable product vision. This phase unearths the opportunities and identifies the risks. By asking the right questions at the start, we can provide a comprehensive commercialization strategy.

 

Key activities

Contextual Inquiry, User Needs Identification, Business and Design Strategy, Concept Generation, Competitive and Comparative Landscape Research, and Technology Research and Assessment

Research, Product Strategy, Concept Generation

01 Concept & Requirements Development

 

Iterating towards a compelling, deployable solution.

Our teams create and iterate prototypes, prove technical feasibility and gather feedback to understand the user experience. We leverage human-centered industrial design, digital product design, and human factors expertise to translate insights from research into product solutions and experiences. We do this all with a focus on building a solid design history file with clinically relevant requirements, risk management and regulatory strategy. This phase finishes with careful planning around budget and timing needs for the entire program — reducing investment risk.

 

Key activities

Requirements Gathering, Physical and Digital Prototyping, Concept Development, UI Story Mapping, Risk Management, Regulatory Strategy, Anthropometric Research, Participatory Design and User Feedback Sessions

Research, Product Strategy, Concept Generation

02 Detailed Design Development

 

Arriving at a final engineered design.

Its time to translate early concepts into focused, detailed, engineered solutions completed under design controls. To achieve this, we integrate human factors engineering and human-centered industrial and digital design into fully functional, single systems suitable for usability and engineering evaluation. This phase also encompasses risk management activities, like FMEAs, engineering verification testing and design verification planning – all leading to design freeze.

 

Key activities

Functional and Manufacturable Engineered Design Development, Risk Management Activities, Engineering Verification Prototyping, Functional Testing, Human Factors/Usability Evaluations

Research, Product Strategy, Concept Generation

03 Design Verification

 

Demonstrating that the design is proven.

Ximedica’s teams ensure the product meets requirements for functionality, reliability, usability and safety through rigorous verification and validation testing. Our work is conducted using a statistically and clinically relevant verification process, suitable for regulatory submission. Production equivalent devices are built with detailed manufacturing procedures, quality requirements and a qualified supply chain. We demonstrate that the device designed meets the design input specification.

 

Key activities

Production Equivalent Builds, Design Verification Testing, Human Factors Validation Testing

Research, Product Strategy, Concept Generation

04 Process Validation, Manufacturing Transfer & Design Validation

 

Ensuring the design is commercializable.

Our project, manufacturing, and quality engineers oversee production tooling development and configuring manufacturing lines, conduct process validation and complete risk management activities, including the Process FMEA. In this phase, numerous activities drive towards product launch: Pilot units are built and tested, manufacturing procedure and quality requirements are refined to ensure they are appropriate for commercialization, market-ready products are assembled, clinical trials and design validation studies are completed, and all necessary components of the design history file are compiled for regulatory submission to the FDA.

 

Key activities

Process Validation, Production-Ready Lines, Risk Management Activities, Design Validation Testing, Regulatory Submission

Research, Product Strategy, Concept Generation

05 Production & Commercial Support

 

It’s production time!

From sustaining engineering, to supply chain management, to packaging and sterilization, we continue to support our client's commercial needs. Our proven and FDA-audited quality system together with our highly experienced team ensures that the shipped devices and their Device History Record are complete and fully reviewed. As production volumes grow, continuous improvement utilizing lean processes drives cost reduction, reliability and rapid, response-to-market demands. Post-market and user feedback support play critical role in on-going efforts.

 

Key activities

Delivering Product, Sustaining Engineering, Post-Market Evaluations, Cost Reductions

Your bold ideas. Our visionary team.
Iconic results that change the world.

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