PCBA Development Essentials for Invasive Medical Devices

Can you imagine being wheeled into an operating room to have a major surgery performed and there are no doctors, nurses, or anesthesiologists present? Instead, there are only robots and other medical devices. Would this be an appropriate time to enter panic mode? Or would you feel reassured, knowing you’re in the hands of machines specifically designed to perform the tasks necessary to address your health situation? It’s reasonable to feel a bit apprehensive, at least initially. However, when you consider how many people depend on implants or other medical devices on a daily basis, robotic surgery seems like it should be almost routine.

The fact is that medical robots are already being used all over the world to perform or assist with surgical procedures, and there is every indication that robots will assume more and more responsibility in the future. This, coupled with our increasing utilization of other invasive medical devices to maintain or improve our health, indicates that we should welcome and not fear robotics. Let’s take a look at some of these devices and their benefits, before discussing what is required to develop the PCBAs that comprise them.

Types of Invasive Medical Devices

What makes a medical device invasive? Well, we can define these devices as follows:

An invasive medical device is an instrument or device that is either inserted into the patient’s body temporarily (for example, to perform a surgical procedure) or permanently (to provide monitoring or control of an organ or bodily function).

There is a bit of vagueness as to whether an invasive device must pierce the skin or can simply be inserted through an existing orifice. However, the important consideration is apparently whether the device must interact with an internal body part to perform its function. If yes, it can be considered an invasive medical device.

Invasive medical devices may be used for a number of specific functions; however, they can usually be classified as either used to:

(i) monitor internal activity,

(ii) interact with or aid internal organs, or

(iii) replace the functionality of an internal organ.

Common types of invasive medical devices include insulin pumps, pacemakers, ear implants, neurostimulators, gastric stimulators, and implants for the leg or foot, as shown in the figure below.

Types of common invasive medical devices

Types of invasive medical devices

Many invasive medical devices not only aid or replace a bodily function, but also perform data acquisition, processing, analysis, and transmission, which requires electronics and PCBAs. Let’s take a look at how to best develop these drivers of the devices to ensure safe, reliable operation.

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Optimizing Invasive Medical Device PCBA Development

Invasive medical devices are likely to be class 2 or class 3, which means that they pose some risk to the patient. Therefore, the most important factor when developing invasive medical devices is safety and each stage of the development process should be guided by minimizing the potential threat to patients that use them. This objective can be achieved by following guidelines; such as those below.

Invasive Medical Devices PCBA Development Essentials

  • Use low power devices and power sources

It is critical to minimize the level of power (voltage and current) that patients are exposed to. Therefore, using the lowest acceptable levels for components and supplies that ensure requirements are met is preferable.

  • Include protection against electrical discharge

One of the most significant threats to patients is exposure to currents and voltages from electronics and boards. Therefore, you should ensure that your design includes protection against electrical discharges that could come in contact with patients.

  • Use biocompatible communication method

It is also imperative that the data communication method not harm the patient’s living tissue or be biocompatible. With the trend towards wireless communications, the requirement takes on more significance.

  • Make sure that boards are protected against the environment

Another safety concern is the leakage of chemicals from the boards into the body, as well as the potential for bodily fluids to come in contact with the board. These issues can be avoided by using conformal coating or some other type of sealant for the board.

  • Optimize space

Although these medical devices are invasive, they should be made as less so as possible. That means, in addition to biocompatibility they should be made as physically small as possible.

  • Incorporate testing and other methods to assure reliability

Board or device failure within a patient’s body can be catastrophic! Therefore, reliability must be a prevailing design and manufacturing concern. To ensure this, adequate testing should be instituted, when necessary.

The above guidelines are safety measures that should be taken for invasive medical devices in addition to the regulatory, quality, and reliability requirements that are standard for medical devices development.

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  • Works with 4 of the top 10 medical devices manufacturing companies.
  • ISO-9001, IPC-600 and IPC-610 commitment to quality certifications.
  • Accurate quote in less than a day.
  • DFM support from Day 1 of design.
  • Fastest turnkey PCB manufacturing in the industry.
  • Rigid, rigid-flex and flex board capabilities for wearables and embedded biosystems.
  • Custom automated BOM verification tool.
  • Sources components from the most reputable suppliers in the industry.
  • Software-driven robotics assembly.
  • Standard quality testing, including X-ray and inline AOI.
  • Superior open, transparent PCB manufacturing experience.

Invasive medical devices are a special group of devices that typically come into contact with the internal organs of the human body. As such, they pose the greatest threat to patients and require safety to be at utmost concern throughout the development process. At Tempo Automation, we are experienced in building medical PCBAs that meet the stringent requirements of the industry. Additionally, we will work with you to institute any safeguards to minimize the risks for patients.

And to help you get started on the best path, we furnish information for your DFM checks and enable you to easily view and download DRC files. If you’re an Altium Designer or Cadence Allegro user, you can simply add these files to your PCB design software. For Mentor Pads or other design packages, we furnish DRC information in other CAD formats and Excel.

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 invasive medical devices or want to learn how to optimize your PCBA development for them, contact us.

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