Developing Circuit Boards for Innovative Medical Devices

July 12, 2019 , in Blog, Medical

We are living in what often seems like indefinable times. For some, this is still the computer age where the ever-expanding network of computers, more commonly referred to as the Internet, is the driving force of our lives. For others, we are living in the information age where the most important commodity is not a product, but access to and utilization of data and information. Still, others would say we are at, or entering, the crux of the fourth Industrial Revolution, or Industry 4.0, in which product manufacturing embraces a number of new technologies to improve return on investment (ROI) for companies through increased production efficiency. All of these would be correct and point to the impact of innovation and its pervasiveness throughout society.

Arguably, the medical industry has benefited the most from innovation over the past few decades. And with the new innovative medical devices being researched or entering the market, the horizon looks extremely bright, especially for devices comprised of PCBs and electronics. Obvious trends are toward smaller devices with greater complexity and the utilization of wireless communications to transfer data remotely for analyses and monitoring. Building these advanced devices places specific demands on board design and manufacturing to improve process methods and efficiency. Let’s take a look at some of the most promising of these innovative medical devices and then examine the requirements placed on the PCB development process.

Review of Innovative Medical Devices

Over the last couple of years, a number of innovative medical devices have been introduced to the market to aid medical practitioners in performing testing that was traditionally limited to large medical facilities. Another area that has benefited from development focus is patient or user devices, such as monitors for vital statistics and glucose level. Below is a list of some of these innovations, along with others that are in the research and development stages.

💡 Glasses for posture, improvement

  • Medical benefits: reduce neck pain and potential for skeletal problems.
  • PCB requirements: very small and complex

💡 Non-invasive glucose scanning

  • Medical benefits: bloodless glucose monitoring
  • PCB requirements: small, complex and highly functional

💡 Wireless vital signs monitoring

  • Medical benefits: wireless BPM, movement monitoring and EMS request
  • PCB requirements: complex and highly functional

💡 Ingestible sensor

  • Medical benefits: gastrointestinal monitoring and diagnoses
  • PCB requirements: small, complex and highly functional

💡 Handheld non-invasive head injury assessment

  • Medical benefits: neurocognition analyses
  • PCB requirements: small, complex and highly functional

💡 Wearable insomnia aid

  • Medical benefits: biorhythm synchronization and sleep process activation
  • PCB requirements: small, complex and highly functional

Although the list above crosses many areas of medical monitoring, analysis, and treatment, the requirements for circuit boards that drive these devices are similar. This commonality allows us to put forth a single set of requirements for PCB development.

Developing PCBs for Innovative Medical Devices

As illustrated above, boards that will satisfy the requirements for the innovative medical devices listed are typically of small size, contain complex routing, and a high degree of functionality. Many of these devices involve data processing and wireless communications, which necessitates advanced PCB development, such as for high density interconnects (HDI) and high-speed signal propagation. PCB development actions that should receive special consideration to meet these demands of innovative medical devices are listed in the table below.

PCB Development Requirements for Innovative Medical Devices

PCB Development Activity

Significance

Institute supply chain monitoring for components.

Medical devices require reliable operation to achieve precision measurements that determine diagnoses and treatments.

Utilize SMD components.

SMD components allow you to design smaller footprint multilayer boards.
Choose materials for high speed signal propagation.

Many devices use high-frequency signals for communications to remote devices.

Ensure boards meet bendability requirements.

For wearables, flexibility is often a necessity.
Make liberal use of device testing.

Accuracy and reliability are of supreme importance for medical devices as imprecision may have catastrophic consequences.

Follow a well-defined quality management (QMS) plan.

A QMS plan that meets ISO 13485 standards is required for all medical devices.
Monitor and continually improve your development process.

ISO 14971 stipulates the requirements to mitigate risks associated with your medical device development.

Innovation in medical device development is guided by functionality and capabilities; however, cost-effectiveness is also a consideration. Therefore, developing the highest quality boards possible that will result in high production yield rates should also be a priority for your design and manufacturing process.

Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
  • 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.

The creation of Innovative medical devices is at the heart of our continual improvement in quality of life and longevity. Many of these devices are comprised of PCBs and electronics that enable complex functionality in very small packages. Tempo Automation not only leads the PCB manufacturing industry in fast, high-quality prototyping and low-volume production, but is also experienced in building boards for some of the most innovative companies in medical device research and development.

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 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 innovative medical devices and how to overcome PCB development challenges, contact us.

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