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.
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.
Contextual Inquiry, User Needs Identification, Business and Design Strategy, Concept Generation, Competitive and Comparative Landscape Research, and Technology Research and Assessment
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.
Requirements Gathering, Physical and Digital Prototyping, Concept Development, UI Story Mapping, Risk Management, Regulatory Strategy, Anthropometric Research, Participatory Design and User Feedback Sessions
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.
Functional and Manufacturable Engineered Design Development, Risk Management Activities, Engineering Verification Prototyping, Functional Testing, Human Factors/Usability Evaluations
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.
Production Equivalent Builds, Design Verification Testing, Human Factors Validation Testing
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.
Process Validation, Production-Ready Lines, Risk Management Activities, Design Validation Testing, Regulatory Submission
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.
Delivering Product, Sustaining Engineering, Post-Market Evaluations, Cost Reductions