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Turning your medical device innovation into reality

Arterex design engineers have extensive experience in the development and manufacture of Class II and III medical devices. It’s our passion. We leverage our product realization process, technological innovation, know-how and project management skills to efficiently develop detailed designs that ensure products perform to specification and validation is executed according to plan.  We draw upon on our vast engineering and regulatory experience to help you bring your product to market, whether it be for an individual component or a complete turnkey design and development for your Class III device, we have the expertise to support you through validation and 510(k) submission. A sampling of the tools and capabilities we utilize are as follows:

  • PFMEA and DFMEA – Process and Design Failure Modes & Effects Analysis
  • DfX, or Design for Excellence – This encompasses DfM, DfA, DfC, or Design for Manufacturing, Assembly, Cost, etc.
  • Software  – SolidWorks, OrCAD, Moldflow Analysis, Finite Element Analysis (FEA), Weibull Analysis
  • 3D models & 2D part print generation
  • Reverse engineering
  • Development of test protocols and sampling plans
  • Drafting Validation Master Plans (VMP)

Product realization process

The first step is understanding the inspiration for your device, whether it’s an improvement of an established device or a novel device. Once we identify user needs and define how the device will be used, we can establish the foundation for the design.

Research and discovery

The research and discovery phase of medical device design focuses on determining the requirements that provide the parameters for the design. Client needs and desired device functionality provide the starting point for conceptualization. A customer’s need assessment involves the direct participation of the client. Factors that need to be considered include whether the device will come into contact with patients, the operational environment of the instrument, and the lifecycle of the apparatus. Even at this initial stage, questions of manufacturing methods and materials must be taken into account in order to control costs. Risks associated with the process must also be assessed at this point and communicated to the client. Overall cost and time-to-market estimates are established. Feasibility studies are also included in this stage.

Another facet of this stage involves designing in accordance with the design control requirements specified in the FDA Quality System Regulation (21 CFR 820) for U.S. based products, and ISO 13485 (EU Medical Device Regulations) for EU markets. Any new device used with patients in the U.S. must have pre-market authorization by FDA through the pre-market notification process, also known as the 510(k) process (e.g., Class II devices) or have marketing approval by the FDA through the PMA process (e.g., Class III devices) . Considering FDA requirements during the discovery stage avoids issues that could hamper FDA approval later. Planning for quality control necessitates knowledge of the international standards covering areas such as biocompatibility (ISO 10993) and electrical safety (IEC 60601). The experienced team of engineers at Arterex knows the applicable regulations and stays current on emerging standards covering new technology.

Specification development

Once the research and discovery phase is completed, engineers formulate specifications for the device. These specifications cover the mechanical, electrical, and software parameters of the project. They cover issues such as device functionality, material requirements and restrictions, operational tolerances, and safety features. Systems engineers create a definition for the device, including functional and structural relationships between components. Precision in the specification process is key to avoiding the need for potentially costly late-stage modifications to the project.

A knowledgeable medical device design team can anticipate the interplay between the various competing factors. For example, specifications stipulating a high tensile strength combined with biocompatibility will have implications for the choice of materials. Well-defined specifications allow design engineers to anticipate possible problems before they occur, saving both time and money.

Engineering – Detail Design

With the specifications in place, engineers can begin developing the actual medical device design. Mechanical engineers are responsible for formulating all physical aspects of the device. They use both traditional design tools and modern 3D-CAD software to analyze and design the mechanical systems, components and tooling; and identify material properties required to meet design specifications. Raw materials are selected to meet the specifications, and the instrument design is separated into its constituent components. Throughout this stage, the engineers remain aware of the impact their design decisions will have on the manufacturing process and the project cost.

The mechanical engineering aspect of medical device design includes decisions about the manufacturing process. The appropriate means of forming components must be selected. The choice of injection molding, extrusion, or other processes will be dictated by factors in the specifications and the choice of material. The proper methods of joining parts will also need to be selected from options such as the use of a bonding agent or a process like ultrasonic welding, tungsten inert gas welding, or resistance welding. The assignment of manufacturing steps to separate cells is part of this stage.

Electrical engineering is the second discipline of medical device design. After determining the electrical system architecture of the product, schematic capture is used to create the detail design of the circuitry. The power supply is determined, addressing questions like alternating or direct current, battery or external power, and voltage and amperage. These issues will be constrained by the size of the device, its portability, and its function. CAD tools are used to design the physical configuration of the electrical system, whether it is a few wires or a complex printed circuit board. Any connectors will also need to be discussed with the mechanical engineers to determine whether standard connectors can be used or proprietary connectors need to be created. More complex devices may require the design of application-specific integrated circuits (ASICs) to control various aspects of device operation. Digital and analog simulation in the design stage ensure that device specifications are being met.

Modern active devices require the development of dedicated software to operate the system. Software engineers determine the appropriate operating system (whether commercial, open source, or custom). That, along with the needs of the project, determine the programming language to be used. Arterex software engineers work with Windows, Linux, QNX, and other real-time operating systems, and they program in most major languages, including C, C++, C#, Visual Basic, and assembly languages. In addition to large systems, the Arterex team designs firmware for embedded microprocessors and digital communication systems within the device. Software design decisions are made in consultation with the electrical engineers.

Medical grade software development must be compliant with the IEC 62304 Medical Device Lifecycle Model. The FDA also has software-specific guidelines for the design of instruments to be used with patients. Cybersecurity risks are required to be addressed, as digital attacks on medical devices are becoming more common. Software validation is carried out via testing protocols that ensure the software performs according to specification. Software planning also needs to include methods for updating and patching software over the lifecycle of the instrument.

Prototyping

Once the detail design phase of the medical device design process has been completed, the next step involves the creation of a prototype. A prototype is a full-scale, working version of the design that is produced in limited quantities. It is generally produced through one-off manufacturing processes rather than through cell manufacturing. 3D printing capability makes it possible to produce prototypes more quickly and cost-effectively.

The prototype allows for the verification and validation of the device. Verification is the process of determining whether the specifications of the device have been met by the design process. Each aspect of the design – mechanical, electrical, and software – is tested. Validation, on the other hand, looks at the overall function of the instrument to ensure that its functions meet the needs of the client while conforming to all applicable international standards and FDA regulations. Documentation for each step is produced for the client and to be used in the FDA approval process.

Validation and verification require comprehensive testing. Risk assessment is done in compliance with ISO 14971. Fault tree modeling, failure modes and effects criticality analysis, and other models allow engineers to track any errors to their source components. Electrical safety is validated per IEC 60601, while biocompatibility verification is done to the specifications in ISO 10993. Environmental testing ensures that the device functions under all likely use conditions. Finally, sterility validation is carried out in accordance with ISO 11607 and packaging transit requirements are verified per ASTM and ISTA standards.

Iteration

Any problems or difficulties identified through prototype testing require parts of the design process to be revisited. The design is returned to the mechanical, electrical, and software design teams to be refined. Once the design issues have been addressed, another round of prototyping and testing begins. This process is repeated until the medical device meets all specifications and passes validation and verification. This iterative modification of the design allows problems to be corrected before full-scale production begins.

Manufacturing process design

When the design and testing of the device are completed and the client has approved the final iteration, the last stage of medical device design requires the development of the manufacturing process. Arterex uses a cell manufacturing model with specialized production stations. Each cell performs one function, such as the production or refinement of an individual component or the fitting and bonding of multiple components. This method of production allows for small changes to be made to the process in a cost-efficient way without having to take the entire production line out of service. Many of the decisions that are implemented in this stage will have been developed in the engineering phase, but the final form of the manufacturing process will need to be set at this time. Once this is completed, the move to the production stage can be made.

Multidisciplinary engineering capabilities

Arterex has developed a strong, team-oriented, multidisciplinary engineering group. Our engineers average more than a dozen years of experience in the medical device development and manufacturing arena. 

Our engineering capabilities include:

Mechanical engineering

  • Advanced use of SolidWorks for design and Finite Element Analysis
  • Mechanical / Electromechanical Mechanisms
  • Molded and Extruded Components & Devices
  • Macro and Micro Fluidics Components
  • Pneumatics
  • Biocompatible Materials Selection
  • Finite Element Analysis
  • Computational Fluid Dynamics Analysis
  • Sterile and Non-Sterile Packaging
  • Rapid Prototyping

Electrical & electronic engineering

  • Advanced use of OrCad, Altium, and PADS for PCBA design, schematic editing, and BOM management and PSpice for simulation of circuit analysis
  • IEC 60601 Medical Grade Electronics
  • Physiological Data Acquisition
  • Embedded Microprocessor Devices
  • Application Specific Integrated Circuits
    (ASIC, FPGA, Gate Array, etc.)
  • Wireless Communication Including Inductive, MICS, Bluetooth, and 802.11
  • Digital Signal Processing (DSP) Solutions
  • Printed Circuit Board Design
  • Battery Operated and Low Power Devices
  • Motor and Motion Control
  • Analog and Digital Design and Simulation

Electrical & electronic engineering

  • Advanced use of OrCad, Altium, and PADS for PCBA design, schematic editing, and BOM management and PSpice for simulation of circuit analysis
  • IEC 60601 Medical Grade Electronics
  • Physiological Data Acquisition
  • Embedded Microprocessor Devices
  • Application Specific Integrated Circuits
    (ASIC, FPGA, Gate Array, etc.)
  • Wireless Communication Including Inductive, MICS, Bluetooth, and 802.11
  • Digital Signal Processing (DSP) Solutions
  • Printed Circuit Board Design
  • Battery Operated and Low Power Devices
  • Motor and Motion Control
  • Analog and Digital Design and Simulation

Software development

  • Medical Grade Software Development using ANSI / IEC 62304 Lifecycle
  • Compliant with FDA Guidance’s and International Standards
  • Major Languages Include C, C++, C#, Python, and Visual Basic
  • Software for Windows, Android, Linux, QNX and Other Major RTOS
  • Embedded Microprocessor Software / Firmware
  • Digital Signal Processor Software
  • Automated Test Equipment Software
  • Independent Software V&V

Human factors engineering

  • User needs analysis & creation 
  • Formative & summative studies
  • User flow & task maps
  • User research
  • Interface design
  • Usability testing
  • Prototyping and simulations
  • Usability studies

Human factors engineering

  • User needs analysis & creation 
  • Formative & summative studies
  • Use flow & task maps
  • User research
  • Interface design
  • Usability testing
  • Prototyping and simulations
  • Usability studies
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