Apps, devices and cloud services
Product development involving one or more of these elements
FDA regulatory compliance
Planning, pilot and clinical studies, agency meetings and submissions
Consulting and project management
Architecting and integrating best-of-breed solutions. Managing projects and coordinating suppliers.
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PROJECT PLANNING AND EXECUTION
Our approach to project planning is based on phases. A phase has prescribed objectives, deliverables, milestones, timetable and pricing—enabling go/no-go decisions. The go/no-go decision points are designed to manage risks inherent to an innovation project.
Projects may range from having been defined well to not so well defined. The latter arises when our customer does not have all the answers to the solution requirements. We can usually help our customers develop the solution requirements with an initial project definition phase, which also creates a project plan, including deliverables, timetable and budget.
Projects may range from simple to complex. Our approach to complex projects is systems thinking to tease out non-obvious interdependencies. Complex problems by their nature often require development and application of new ideas and concepts, introducing opportunity and risk. Additionally, unanticipated opportunities and risks often arise in complex projects. We strive to communicate and address these opportunities and risks promptly.