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.

PREMIER PERSPECTIVE

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.

Related Services

Product development lifecycle consulting is part of a wide range of service offerings that include clinical trial design for medical devices, drug/device combination studies, and quality management through our ePremier technology platform. Follow the links below to learn more about how clients gain from our specialized expertise.