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Medical Device Mechanical & Electrical Engineering

Engineering a Medical Device

Simbex approaches Mechanical and Electrical Hardware Design from a systems integration viewpoint. Our process starts by defining functional requirements and specifications of the design that take into consideration every step of the product life cycle.

The outcome allows the final product to not only seamlessly integrate together to meet functional needs, but also allows the product to integrate with external systems to meet manufacturing, distribution, packaging, and maintenance needs.

Multidisciplinary team working on NXT

3d Modeling and Simulation for Medical Devices

Our research and development teams need to analyze exactly how your design will perform to produce a properly functioning medical device and minimize the chances of there being any unforeseen hazards.  Before a device can be released on the market, it first has to undergo extensive testing. It can be unethical and impractical to perform these tests with humans, as there is potential for both harm to the patient and inaccurate data collection. 

To ensure the initial quality of the device, our engineers use 3D modeling and Simulation software to develop and map out how a product will function in its formative stages. This saves valuable time from being wasted on faulty trialing and minimizes the potential for human error, as well as removing the possibility of injury to a human test subject early on.

Injection Molding

Medical devices and components often require FDA-approved medical grade materials. The same injection-molding processes used to meet demands in tight-tolerance applications and large volume production can also be used in medical device prototypes designed for FDA approval, and provide an exact proof-of-concept device for clinical and laboratory testing.

The medical field has increasingly utilized polymers in recent years, since they offer higher adaptability and can be paired with other materials like metals and fabrics, to create comfortable, affordable, and effective products. Due to the lower manufacturing costs of injection molded devices, healthcare costs have steadily reduced, along with providing a higher capability for medical departments. The use of medical plastic injection molding increases the safety of patients and the capabilities of medical workers.

Prototyping Applications

Effective medical device prototype development requires creating fully functioning components for use in testing for FDA approval processes. Utilizing the same advanced polymers used to create better medical prosthetics and sterile medical devices in the prototype development process ensures your device is adequately prepared to meet FDA regulations. 

The ability to iterate and create prototypes of your medical device design is crucial to ensuring your product ultimately achieves the best product-market-fit. The prototyping process provides a perfect sample of your end device for use in the early stages of development, such as product presentation and testing. This allows developers to determine necessary changes in the design and plan for manufacturing demands before producing high volumes for use in the medical field. Using Computer Assisted Design (CAD) software, our engineers can apply rapid prototyping techniques for needs such as sheet metal design, injection molding, and 3D printing.

A frequent application of rapid prototyping is the fabrication of medical device enclosures, which house your electronic device and turn it from an idea to a consumer-accessible product. Some of the advantages offered by a carefully designed medical device enclosure include: 

      • Improved ergonomics
      • An overall lighter device
      • Increased functionality and user friendliness
      • More cost-effective to manufacture
      • Easier sterilization and maintenance

Electrical Engineering

Ultra-Low Power Digital Circuits

Some devices require the use of ultra-low power digital circuits. Our engineers can incorporate ultra-low power circuit technology into your device, meeting both your specifications and the FDA’s device requirements.

Sensor Interfaces and Signal Conditioning

Signal conditioning processes the signal from a sensor so that a data acquisition board can read it. When the signal from a sensor requires amplification or a format transfer, a sensor interface device can convert it to a compatible form.

Using a signal conditioner can provide a more exact reading, which is necessary for precise data collection. A signal conditioning device can also perform other functions, such as:

  • Signal Conversion
  • Linearizing signals for accuracy
  • Amplification of incompatible signals
  • Filtering a signal to only include valid data
  • Signal Evaluation and Smart-functions
Electric Engineering

Wireless Networks and Power Supply Design

Ensuring the safety of patients, both in healthcare facilities and at home, is essential to the medical device design process. Medical device manufacturers have to implement rigorous standards in order for their product to meet the regulations necessary to guarantee a patient’s wellbeing. Our engineers keep those standards in mind as we work to produce your design, making sure the electronic equipment we develop is fully in line with the requirements of the healthcare industry.

So, what are our standards in terms of a medical device’s power supply? How can we balance meeting the needs of a manufacturer with the wellbeing of the patient? How can we guarantee compliance with the FDA’s regulations? The foremost concern is that the medical device is frequently connected to the patient by way of electronics, such as the conductive pads of an electrocardiograph. As these components come in direct contact with the patient, it’s important for us to focus on minimizing risk as much as possible.

In order to ensure that both the patient and the operator are safe from the risk of an electric shock, there has to be a means of protection (MOP) applied to your medical device. When developing your designs, our engineers make sure that the power supply incorporates the necessary MOP to minimize the chances of user electrocution. This precaution ensures that the end product adheres to regulations set in place by the International Electrotechnical Commision, and can be manufactured for distribution.

Sensor Interfaces and Signal Conditioning

Signal conditioning processes the signal from a sensor so that a data acquisition board can read it. When the signal from a sensor requires amplification or a format transfer, a sensor interface device can convert it to a compatible form.

Using a signal conditioner can provide a more exact reading, which is necessary for precise data collection. A signal conditioning device can also perform other functions, such as:

  • Signal Conversion
  • Linearizing signals for accuracy
  • Amplification of incompatible signals
  • Filtering a signal to only include valid data
  • Signal Evaluation and Smart-functions

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