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At HEI, we use a highly evolved, phased product development process. The seven phases of design, development and manufacturing include:

Phase 0: Feasibility
Subsystem conceptualization and feasibility demonstration-design concepts are explored, and various technologies are demonstrated with principle models.

Phase I: Requirements
Expansion and refinement of existing specifications:

  • Conduct baseline planning for engineering design
  • Develop project documents (Product Requirements, Product Development and Quality Plan (PDQP), System Risk Analysis)

Phase II: Design
Detailed design and documentation are completed and include electrical, software, systems and mechanical design.

Phase III: Pre-Production Prototypes
All testing is performed in accordance with verification protocols.

  • Prototype units are produced
  • Printed circuit boards are assembled
  • Prototype mechanical components are fabricated
  • Software for device control and user interface is developed

Phase IV: Early-Production
Early-production initiates the transition into manufacturing. This process ensures each unit meets clinical testing requirements.

  • Design is finalized
  • Units are produced in a cGMP environment with final tooling and procedures
  • A Manufacturing Quality Plan (MQP) is created along with manufacturing assembly, inspection and test procedures. Completed systems are tested to verification testing plans
  • A Device History Record (DHR) is completed, along with any manufacturing documentation required for regulatory requirements

Phase V: Pilot Production
The pilot production of a statistically significant number of devices is built in a cGMP environment. The performance and quality of the units are verified according to the MQP, DHR’s while manufacturing documentation is developed and completed. After the manufacturing process is validated, a full production schedule is then developed.

Phase VI: Full Production
Full-scale production of cGMP compliant units along with verifying standard cost, delivering units for service and identifying and resolving out-of-the-box and field issues.