Shortly after its discovery a little over three decades ago, Turritopsis dohrnii or more commonly the “immortal jellyfish” has been the subject of a great deal of attention from scientists and medical researchers. The reason for all the concentrated effort has been to understand how this simple animal is able to reverse its aging and seemingly extend its life for eternity. The answer seems to be that these unique jellyfish can turn cells off which causes them to essentially go back to an earlier stage of the growing process. The implications for this type of adaptability to treat medical disease is enormous. For example, cancer which is uncontrolled growth of certain unwanted cells could be expunged from the body by rewinding the cells and converting them into a different beneficial type.
The epitome of adaptability
Adaptable cells may be in our future, but adaptability is a present need in medical device development. The design and manufacturing of medical devices are more heavily regulated than any other industry. This is due to the fact that medical devices in one way or another impact the health and welfare of people. And for certain products, such as clinical medical devices, the potential for loss of life is a real possibility. Therefore, there is a complex approval process before a medical device can be used by a patient, medical professional or other end-user. Throughout this process, it may be necessary to make changes to the device. This means that your design and manufacturing process must be adaptable. Let’s define what is meant by adaptable PCB design, which will help us understand why it is so important for medical device development.
What is Adaptable PCB Design?
Similar to what the immortal jellyfish does, adaptable PCB design can be broadly defined as follows:
Adaptable PCB design is the ability to make design changes to a circuit board at any stage of development. To be implementable design adaptability has to be coupled with an agile PCBA manufacturing process.
For most circuit boards or electronic devices and systems that are composed of them, it is typical to make changes to the design and layout of your board during prototyping or the iteration cycle. During this cycle, the design, fabrication, and assembly are consistently improved until the highest quality result is achieved. Although some degree of adaptability is necessary to institute whatever changes are required, this process is normal for PCBA development.
More challenging is when change requests originate post-development or after the board or device has been delivered. This could be due to a number of factors but typically is due to unacceptable production yield rates, component shortage(s) or client requests. When faced with these PCB design adaptations it is best if your contract manufacturer (CM) employs an agile manufacturing process to minimize turnaround time and lost revenue. If you are developing a medical device PCBA then it is essential that you have adaptable PCB design and agile manufacturing processes.
Why is Adaptable PCB Design Important for Medical Device Development?
The medical devices market is highly competitive. Additionally, most entities, like hospitals, research facilities, and medical professionals, for example, are networked and typically make purchases, including for medical devices, for all units or locations from a single source. Thus, it is imperative that you develop your board or device and meet all regulatory requirements as quickly as possible. Getting your medical device to market is the initial phase. Once in the field, it is quite possible that changes to your medical device may still be necessary. The source for these changes includes the following.
Reasons for Adapting PCB Design of Medical Devices
In addition to engineering-change order (ECO) requests that may be identified during production your design may need to be adapted due to one or more of the reasons listed below.
- Changes in device usage
Although the device may be originally intended to be used for one identified purpose, it may be discovered that it is effective for something else. This may require a board redesign and build or reclassification with the FDA.
- Technology advances
If your device is on the market for a long time, it is susceptible to technological advances, such as component upgrades or expanded functionality.
- Correction of identified risk
In response to the mandated risk management plan of ISO 14971, a risk may be identified that falls outside of the acceptable threshold that requires a design change.
- Regulatory change
The possibility always exists that a new regulation or standard may be introduced and your board may no longer be in compliance. In this case, it may be easier to do a redesign than develop a completely new device.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
The likelihood of medical device changes over lifetime is sufficiently high that you should plan for it. This means ensuring that you have an adaptable PCB design and agile manufacturing process to respond to the change irrespective of its source. Tempo Automation, the industry leader for fast, high-quality PCB manufacturing of medical devices, utilizes a software-driven smart factory to provide agile manufacturing to help you compete in the medical devices industry.
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.