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How We Work
Aubrey Group works with investors and entrepreneurs, incubators and emerging companies, and large corporations. We can function as a complete “ready made” engineering group or as an adjunct to a client’s existing engineering group. We offer fast development speed, thorough documentation, complete engineering and testing services, and turnkey manufacturing capability
We provide support for the full product lifecycle, from product concept to commercialization.
Along with full systems development, we provide design, consulting and analysis services in specific areas of expertise. These are:
- Design for electromagnetic compatibility
- Regulatory compliance design
- Circuits and subsystem performance analysis, testing, and verification
- Disposables design, development, and manufacturing
- Peristaltic pump mechanisms and controls
- Motor and motion controls systems
- Power conversion and control
- Thermal analysis
Our project teams are carefully chosen for each project providing the technical expertise needed for the project completion. A project manager is also assigned to the project based on their area of technical strength.
For smaller projects, the project manager typically functions as the technical leader and as the systems engineer for the project, He/she ensures that the product requirements, budgets, and schedules are met. The project manager is the main interface between the client and the Aubrey Group. In addition, the project manager develops and maintains the Design History File (DHF) for the device and ensures that regulatory and quality requirements for the project are met. For larger projects, we assign both a project manager assuming all the functions described above and a technical project manager in addition, who functions as the systems engineer and the technical leader of the team.
Our clients come to the Aubrey Group at different stages of the product concept. We have several clients that come to us with well defined product specifications, and others who come to us with a concept on a napkin. We provide input on the technical feasibility, manufacturability, cost and other aspects to help the client define the product concept and solidify product features.
Phase 1 – Design Input and Planning
The project begins with a parallel effort to develop the project plan, risk management plan, requirements and any early prototypes, if required to prove feasibility. Working in concert with the client, we develop the product specification, system design, systems risk analysis, and detailed requirement specifications for software, hardware and mechanical components that are essential to cGMP and FDA mandated Design Controls. In particular, we work closely with the client in the early stages of the project to refine the GUI requirements and support the System Hazard Analysis with the goal of ensuring that the design satisfies the critical requirements of patient and operator safety.
Phase 2 – Product Design and Development
With the hardware and software requirements in place, we begin with the detailed design of the system. We start the development of the printed circuit board assemblies (PCBA) and begin the mechanical layout of the system. If the client has existing prototypes of the design, we leverage of the existing components that allow us to satisfy the product requirements.
If applicable, a thermal analysis of the system is made as soon as the initial layout has been completed.
Hardware verification and software V&V would begin after the client and Aubrey Group agree to freeze the design, which usually occurs after completing the prototype testing at the client and Aubrey Group facilities. Software V&V includes unit testing, code inspections, integration testing, design reviews, code walkthroughs, and validation testing. The extent of this effort is dependent on the Software Hazard Analysis which assigns low, medium, and high levels of concern to the various software modules.
We use several prototypes to run the tests for safety, EMC, and shipping, in parallel. A traceability report, made using a requirements tracking tool, provides the requirement-to-test traceability to complete the Design History File (DHF).
Phase 3 – Product Design Evaluation and Release
Manufacturing tooling is developed as subsystem designs are frozen during the development process. Design documentation and the Device Master Record (DMR) are updated to the final configuration. Manufacturing procedures and assembly instructions, begun in Phase 2, would be finalized and used for the Pilot Build. A Manufacturing Readiness Review is conducted. The documentation output of this phase is suitable for manufacturing transfer to our manufacturing facility or a third party manufacturer.
Our Design Controls process ensures that regulatory and quality requirements for the project are met. We provide assistance with the DHF, DMR and other information required for FDA submissions.