Product Development Lifecycle Consulting for Medical Devices
We focus all aspects of the development process with the single goal of turning your medical advance into a successful brand.
Complete lifecycle support
Full lifecycle support for design of medical devices
Many of our people come from device manufacturers themselves, so they know what to ask up front. What indication provides the best return on investment? What claims make sense? How can you ensure that your device will qualify for separate reimbursement? What kind of pricing should you plan on?
Our full-service support for medical devices includes:
- Strategic and tactical study design
- Clinical trial setup and operation
- Project management
- Clinical monitoring
- Study nurse and technical site support services
- Medical affairs and strategic consulting
- Interactive randomization technologies
- Predictive, proactive risk prevention planning
- Up-to-date intelligence on changing EU/FDA regulations
- Data Safety Monitoring Board and Clinical Events committee services
- Risk-based monitoring
- Rapid identification and assessment of potential risks
- Customized safety and vigilance management
- Electronic data capture
- Data management
CLICK HERE to learn more about our Product Development Consulting capability.
Special safety considerations for device trials
Medical devices are ubiquitous, and to ensure the safety and efficacy of these devices, regulators expect device manufacturers to provide data that accurately reflects the device’s risk profile.
Planning for quality
Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional to risk-based monitoring requires collaboration and careful planning.