Our Capabilities

Aubrey Group’s services and capabilities are broad and encompass the entire spectrum of product development, from concept to commercialization.

System Engineering

Our systems engineers work very closely with the clients to develop system concepts, design the system architecture, analyze and simulate system operation, contribute to the hazard analyses, develop user requirements, write product specifications and lower-level requirements specifications, and participate in system performance evaluation.

Analysis & Simulation

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Our staff has a command of a wide array of analytical and simulation skills and tools. We use MATLAB for system simulation and analysis, various forms of SPICE for circuit analysis, specialized tools for simulating FPGAs and measuring timing of digital circuits.

In the mechanical world, we use powerful ANSYS software for finite element analysis, computation of fluid dynamics, thermal system design and modeling, structural analysis, and acoustic and vibration analyses.

Using these tools, we are able to optimize our products in ways that would not be practical using only cut-build-test techniques.

Electronics Engineering

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Our electronics engineers deliver robust designs that address not only the functional design requirements but those of safety, electromagnetic compatibility, reliability, serviceability, and reproducibility. Our engineers draw on not only their experience in developing medical products but also their previous experience in systems engineering, aerospace engineering, test equipment design, high-speed communications, analog and digital television, RF transmitters and receivers, high-speed digital design, and electronics packaging design.

We develop systems, subsystems, and circuits in the following categories:
Computer and Digital Systems and Circuits Design, Digital Circuit Design

Microprocessors, microcontrollers, and DSPs
Programmable logic design (FPGA/CPLD)
User interface devices, such as LCDs, touch screens
All types of memory devices, SRAMs, SDRAMs, Flash
Communications interfaces, such as Ethernet, USB, etc.

Analog Circuit Design

RF power generators for surgery and therapy
Accurate and stable digital RF power control
Signal conditioning of low-level signals from transducers
Electrochemistry support circuits
Thermometric circuits
Video and audio circuits
Power supplies and battery charging and management systems
Motor and motion control
MEMS accelerometer and inertial measurement system
Pneumatic control
PCB design

Specific areas of expertise include:

High-power generators for high-intensity focused ultrasound ablation systems
Surgical (cutting) and ablative RF generators
Control of fluidics
Design and control of blood pumps
MRI-compatible instrumentation

Software Engineering

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We have a seasoned software development team that brings experience in several areas of software including: software system architecture and design, object oriented programming, embedded programming, UML, control algorithms and systems, USB, TCP/IP software, Web development, GUI development, signal processing, real time operating systems, and software verification and validation.

We develop software using our Software Development Standard Operating Procedure. This procedure specifies details on activities performed during each phase of software development and is in compliance with FDA and ISO requirements for software development processes.

Aubrey Group has developed software for over 60 medical devices including Class III medical devices.

Specific areas of expertise include:
Embedded Software Development

Microcontrollers and DSPs
Real-time operating systems
Graphical user interfaces

Algorithm Development

Numerical signal processing
Temperature control
Control systems

Windows Application Software Development

.NET, Java, C#
Graphical user interfaces

Mechanical Engineering

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Our mechanical engineers are experienced in conceptual design, structural design, mechanism design, fluidics design, sheet metal design, disposables design, injection-molded plastic part design, thermal and stress analysis, cooling system design, system dynamics, fluid and solid modeling, design for manufacturing, and prototyping. We maintain a dedicated in-house machine and prototype shop. We also have a selection of pre-approved shops and facilities to provide capabilities such as anodizing, injection molding, rapid prototyping, Coordinate Measurement Machine inspection, painting, and welding.

Industrial Design

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The role of an industrial designer is to create and execute design solutions to solve problems of form, function, usability, user ergonomics, marketing, brand development, and sales. An industrial designer works closely with the client’s marketing and engineering staff to ensure that the instrument meets the needs of the user and the marketplace.. Our mechanical and electrical engineers work closely with the industrial designer to ensure that provisions for cooling, maintenance, space, operation, fluid ingress, electromagnetic shielding and such are not compromised.

Test Engineering

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During the development process, our test and manufacturing engineering provides inputs to the designs regarding manufacturability and testability. Test engineering contributions range from simple test fixtures, to be used only sporadically, to complex production-ready test systems for large volume manufacturing.

Specific areas of expertise include:

Design for testability
Development of automatic & manual test fixtures
Development of software for production testing
Electro-mechanical life test systems
Data acquisition and analysis using National Instruments LabVIEW

Rapid Prototyping

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During the development of detailed requirements and specifications, we have the ability to initiate breadboard work to verify assumptions in the areas of electronics, mechanisms, and industrial design. This parallel effort shortens the development schedule and reduces development risks.
We use rapid prototyping techniques wherever possible to expedite development. These include stereo lithography (SLAs), using our in-house machine and model shop for quick turn parts, and using OEM evaluation kits to construct breadboard electronics.

Manufacturing and Manufacturing Transfer

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We offer full-service contract manufacturing services for your medical devices.

We have the capability to manufacture products, including the ones we design, from clinical builds to full production runs. Our design and manufacturing engineers work closely together to help ensure design for manufacturability and serviceability. We use existing Aubrey Group qualified suppliers, or choose and qualify new suppliers, as required.

Specific areas of expertise include:

Custom manufacturing test equipment
Prototypes
Clinical test units
Pilot builds
Process verification and validation
Full-scale manufacturing of systems and disposables

Depending on the needs of the client, we support any of the following production scenarios:

Manufacture the product turnkey, with material and workmanship warranty
Manufacture the product with workmanship warranty only, with the client procuring all material
Manufacture at our facility for an initial period to minimize time to market, and then support the client in transferring the manufacturing to another facility
Establish the entire production line at the client facilities for the first pilot build

Clean Room

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We have a Class 100,000 (ISO Class 8) clean room available for building product, especially single-time use disposable devices. Our clean room is fully maintained and certified as required by ISO 13485, 14694, and 14698. All clean room certification and maintenance records are available to our clients for their review.

Along with device manufacturing in our clean room, other capabilities include:

Sterile packaging
Pouch or blister/tray package and sealing capability
Packaging validation services
Sterilization validation services using outside sourcing of either Ethylene Oxide, Gamma, or e-beam sterilization methods.

The clean room is set up modularly to accommodate a variety of circumstances, including light pilot production to substantial commercialized product builds, all in compliance with GMP, proper line clearance, lot history traceability and sterilization protocol. All of our procedures and specifications are released under our Quality System Document Control.

With the sterilized disposable device development and manufacturing capability, we are able to ensure comprehensive integration of sterilized disposables with a complete system as both are developed at the same time in the same place.

Verification and Validation

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We have extensive experience in Software Verification and Validation having performed V&V on over 50 medical devices, including several Class III medical devices. Types of activities performed for V&V include: code inspections, code walkthroughs, unit (module) testing, integration testing, requirements testing, and traceability. Aubrey Group also uses the expertise of Noblitt and Rueland, a consulting company specializing in technical FDA & international regulatory issues, including software V&V, to provide independent validation services.

We have developed a rigorous process for software V&V and have completed software V&V on more than 50 medical devices. Many of these medical devices perform critical procedures on patients. FDA has found our software and software V&V to be acceptable for all our products that have been submitted so far.

Safety & Regulatory Compliance

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We are registered with the FDA as a Medical Device Establishment and are licensed by the California Food and Drug Branch for the design and manufacturing of medical devices. Our Quality System complies with the ISO 13485-2003 standard.

We can help you setup your quality and compliance policies, procedures and systems.