Collaboration Drives Innovation
We deliver a collaborative approach to project management, based on a proven design control system that is ISO 13485 certified. Facilitated by state-of-the-art communication tools and the latest technology, our process is agile and keeps us far ahead of the curve.
A Streamlined Process
Our guidewires are developed to optimize clinical performance. We focus on an in-depth understanding of your design and clinical requirements to streamline the development process and minimize time to market.
Core Principles of Project Management
- We utilize an approach that emphasizes dynamic, open communication coupled with engineering skill.
- The products we design and deliver directly influence the overall clinician experience. We focus on an in-depth understanding of your requirements to enhance the performance of your medical device.
NeoMetrics Project Lifecycle
1. Gather requirements
2. Risk analysis
3. Project plan management
4. Manufacturing technologies
- Refine specifications
- Evaluate manufacturability
- Analyze competitive product
- Define and correlate test methods
- Analyze device interactions
- Leverage post-market surveillance information
- Understand procedural complications
- Proactive posture in project execution
- Joint planning with customer's project plan
- Customized reporting for easy integration into customer's systems
- Rapid response and progress reporting toward key project milestones
- Seamless design-to-production transition
- Conduct Manufacturing Readiness Reviews with customers
- Vertical integration of key technologies offers more predictable manufacturing outcomes
State-of-the-Art Testing
At NeoMetrics, we conduct extensive device testing to ensure ease of use, reliable clinical performance, and risk mitigation. Defining test methodologies that are relevant to clinical performance improves confidence in the device design and functionality.
Enhanced Guidewire and Interventional Device Test Methods
- Flexible tensile testing and fixturing
- Clinically based path-model testing with devices
- Lubricity testing: coaxial and friction
- Tip Load test capabilities - industry protocol
- Torque test capabilities
- Grind Profile inspection capabilities (Laser Profilometry)
- ISO 11070