Great development processes are not born overnight or prescribed out of a box. Our proprietary development process aligns 30 years of best practices for nimble product development with the discipline required by the FDA. The result is an efficient and risk mitigated path to commercialization.
Flexible & rigorous to streamline development activities
In developing any product, Ximedica utilizes a human-centered, vertically integrated process that delivers greater efficiencies in how products are designed, approved, manufactured and ultimately delivered.
Research & Innovation
An Empathic Understanding of the User that Results in Successful Product Introduction
Outcomes of Research & Innovation
- Preliminary user needs
- Research insights
- Preliminary SDS
- User risk assessment
- Proof of concept
- Risk management
- Early industrial design concepts
At Ximedica we work to develop value-driven MedTech and Diagnostics products that solve real problems. Solutions are driven by the needs of the users, the environments in which they will work and the technology that will enable them. From the outset we answer questions like-
- What does the user need to be able to do?
- What value does this have?
- What is the commercial strategy?
- What technologies apply?
- What are the development risks?
- What is the regulatory strategy?
Technology, Risk & IP Planning
The best innovations understand the opportunities, alongside the risk. A key advantage Ximedica offers is our ability to pull in experts from our different disciplines early in the process. We ask the tough questions at the start to provide a comprehensive commercialization strategy.
Design & Development
Minimizing risk in the design effort is required by ISO 14971 & adopted practice at Ximedica
Core to the design development effort, user needs are translated into measurable, finite specifications that result in a product that is safe and efficacious. We take a human-centered design approach that ensures products maintain a user-friendly nature while conforming to strict regulatory guidelines. A risk evaluation and mitigation strategy applied early and throughout product development provides assurances that the design effort will minimize design, process and use-errors.
Robust test methods reaffirm design decisions
During verification a product undergoes rigorous testing to verify that function, reliability, usability, and safety meet specifications. Core to this activity are statistical techniques to determine proper sample sizes based on risk and measurement system analysis. Utilizing these techniques along with independent reviewers ensures test methods are robust and validated.
Design & development outcomes
- SDS, Risk Management, UFMEA
- Tooling purchase & debug
- Pilot build
- Traceability matrix
- Final Master verification plan
Validation & Launch
Launch-ready medical devices
Validation is complete when established objective evidence confirms that device specifications conform with user needs and intended use(s). A critical component to validation is proving quality, safety and efficacy are designed into the product.
Ximedica employs the following validation methods:
- Simulated use
- Clinical use
- Ergonomic evaluation
Fully integrated disciplines support product realization
Starting with design validation builds and testing through to the coordination of all required production activities from manufacturing and quality procedures to the proper structuring of BOM’s and Routers and IQ/OQ/PQ efforts draws heavily upon a variety of resources.
Validation & launch outcomes
- Process validation master plan
- Process FMEA
- Installation qualification
- Operation qualification builds
- Performance qualification builds