Important Considerations for the Design and Development of Biomedical Devices

The human body is an impressive machine. The ability of our bodies to adapt to adverse conditions is remarkable and one of the primary reasons we have been able to populate virtually the entire earth. Whether confronted with seemingly unbearable cold and depleted oxygen levels or nearly intolerable heat and stifling humidity, we humans find a way to not only survive but thrive. Of course, all of the credit for this cannot be given to our physiology, as we have always been aided by technology in some form.

Although we have not yet settled some areas of the earth, our civilization’s plans (like the colonization of Mars) show that the next great test of our ability to adapt to unfavorable conditions will be space. Conquering the extreme environmental conditions of space will be based almost entirely on our use of technology. Specifically, developing biomedical devices that enable us to explore the boundaries of our ability to live in vastly different conditions will be paramount. This involves important considerations for the design and manufacture of these devices, but before discussing these, let’s clearly define what is meant by biomedical devices.

What are Biomedical Devices?

The term “medical devices” refers to a broad group of equipment that is typically used to directly or indirectly examine, diagnose, analyze or treat the human body. These devices are classified with testing regimens established based on whether or not there is direct patient contact. These devices are also heavily regulated and require familiarity with many standards that may apply to your device. Adherence to regulatory requirements is one of the essential keys to establishing a good medical devices development plan.

Biomedical devices comprise a subset of medical devices and have a clear focus. These devices include probes, electrodes and electronics that are not uncommon in commercial products. However, there are function and use attributes that distinguish them from most commercial devices, as listed below.

Biomedical and Commercial Devices Attribute Comparison

May be implanted in the body Yes No
May attach to bodily organs Yes No
May interact with bodily fluids Yes No
Require high degree of precision Yes In some cases
Require uninterrupted operation Typically Not typically

Although it is desirable for all electronics products to be reliable and durable, the potential consequences of not meeting this objective are usually much more severe for biomedical devices (and medical devices, in general) than their commercial counterparts.

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Design and Development Considerations for Biomedical Devices

When designing PCBs and electronics for medical devices, you should follow a well-defined paradigm to ensure that standards and requirements are followed throughout the development process. The same is true for the design and development of biomedical devices.

👴 Implement and follow a monitorable quality management strategy

It is critical that a detailed, comprehensive and documented quality management system (QMS) be in place for the guidance and monitorability of your biomedical device development. Minimally, your QMS must meet the requirements of ISO 13485.

👴 Manage and minimize development risks

Although it may be impossible to eliminate all risk, you should continually strive to reduce any risks associated with your device development by applying the rules and suggestions of ISO 14971.

👴 Institute a verifiable supply chain

An important aspect of ensuring that your biomedical device meets its performance objectives is managing the components it utilizes. This can be best achieved by ensuring all suppliers are registered with the FDA and optimizing your component selection process.

👴 Institute an exhaustive testing regimen

The need for thorough testing of your device cannot be overstated. The critical nature of biomedical device operation demands that functionality and operation be checked (and rechecked), as failure is not an acceptable option.

The development of biomedical devices requires that the above considerations are not just included but pervasive throughout the process. This includes designing for PCB manufacturing optimization.

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When designing critical systems such as biomedical devices, it is essential that you can cycle through designing, building, and testing as quickly as possible to ensure the quality of your final design. At Tempo Automation, the industry leader in fast, high-quality PCB prototyping and low volume production, we will work with you to optimize prototype iteration speed.

And to help you get started on the best path, we furnish information for your DFM and enable you to easily view and download DRC files. If you’re an Altium user, you can simply add these files to your PCB design software.

If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you want more information on biomedical devices or important considerations for their design and development, contact us.

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