Common use of Concept Development Clause in Contracts

Concept Development. The goal of Phase 1 is to provide LipoScience with a clear system design concept for moving into detailed design activities. Phase 1 tasks and durations are shown in the attached ▇▇▇▇▇ chart. It is envisioned that a joint team kick-off meeting will occur in early April. This will include LipoScience, [***], [***], and the Varian. The program plan will be revised as needed and roles and responsibilities will be clarified. Initial results of LipoScience’s MRD interviews will be reviewed, as well as updates to the Top Level Requirements Document. Program priorities and metrics for design trade-off analyses will be established. Team members will then accompany LipoScience staff to meet with selected clinical partners and/or major hospitals to better understand the clinical drivers for the Magnus System. This “immersion” will give the design team first-hand insight into the needs of the clinical operators and administrators. A meeting is also proposed at the Varian to understand its existing technology, specific development timeframes, and design challenges and constraints. A review will also be made of its existing software code and procedures. System concepts will be generated by the joint team, as well as through internal [***] brainstorming sessions. Industrial design sketches of key concepts will be created, focusing on user interaction and overall layout of the various subsystems. A brief theory of operation will be created. The overall system architecture—both hardware and software domains—will be developed and initial subsystem partitioning will be defined. An updated Functional Requirements and draft Hazard Analysis will be created. Based on the initial concepts, preliminary mechanical design layouts will be generated to evaluate volumetric sizing and subsystem placement. Overall power distribution and subsystem control layout will be drafted. Finally, based on initial system assumptions, a preliminary unit manufacturing cost estimate will be generated. Software, development will be an integral part of the overall system design. Battelle will coordinate software activities at LipoScience and the Varian. A Software Quality Assurance Plan (SQAP) will be developed in Phase 1 to establish ground rules for all software development. As LipoScience and the Varian currently do not have procedures for developing software under the FDA’s QSR, [***] will help educate the team members and define procedures as necessary. Software development tools, version tracking procedures, and problem reporting tools will be established for collaborative development. To ▇▇▇▇▇▇ open communication and real-time information sharing, an e-Room (a secure web-based, electronic file sharing tool) will be established on [***] servers to allow team members access to appropriate procedures, documents, test results, and deliverables for the project. Interactive “real-time” design reviews will be held with all development partners using web-based tools, such as MS Placeware. Weekly project conference calls or videoconferences will be held to review project status, action items, and issues. Monthly project metric reviews will be held to review costs, schedules, and deliverable status.