According to Greek “dark philosopher” Heraclitus, the world can be described by panta rhei, which means “everything flows.” In other words, the world is in flux or everything changes. It is quite difficult to dispute this claim, as we now know that all physical matter does indeed change over time; although some subtle modifications can be hard to detect. What can also be put forth is that in most cases there will come a time when a change should be initiated. For example, when a product design should be improved. Even so, change can be fiercely resisted which means that instituting change typically must be done as efficiently as possible if it is to breach this resistance and be instituted.
In today’s world, changes in technology are expected, if not anticipated to occur regularly to improve capabilities, performance, and usability. One industry that has put in place guidelines to manage them is medical devices. In fact, the consideration of medical changes over the lifetime of devices is required by regulation. However, doing so necessitates that a strategy for medical device control process efficiency is employed. Before putting forth a method for accomplishing this objective, let’s first define what is meant by medical device change control.
What is Medical Device Change Control?
Medical devices, perhaps more so than for other commercial products, are subject to change over their lifetime. The reasons for this include the requirement by standards, specifically ISO 13485 and ISO 14971, that these devices continually undergo monitoring and risk assessment. This means that device performance is constantly scrutinized and board failures must be documented and corrected if warranted. Simply acknowledging a failure and replacing the board or device is not sufficient to meet these requirements.
To adhere to ISO 13485, the entire development process; including the quality management plan, the steps to ensure quality, the selection of personnel to oversee process stages and the management of design, manufacturing, and production must be documented and reviewed. For ISO 14971 compliance, a risk management plan that includes identification of risks, development of controls to mitigate the risks, application of the controls in the presence of risks and evaluation of the effectiveness of the controls must be performed.
The implementation of these regulatory controls are mandated; however, they do not represent all of the cases when medical device change control is necessary. Other sources that may dictate design or manufacturing modifications; include component changes, which may be due to shortages or obsolescence, technology changes or significant changes in safety requirements or usage of the device. And in some cases, executing a medical device change may be a long process requiring administrative approval from the FDA before the device can be delivered to end-users.
Making the Medical Device Change Control Process the Most Efficient
Irrespective of the source or cause for a medical device change, it is always desirable that the change be instituted as quickly as possible. And doing so is most efficient when your medical device change control process has the following attributes:
- Utilizes components that are traceable and in good supply
The lack of components is one of the most severe changes that can befall your medical device production. Not planning for this possibility can result in extended downtime and the inability to meet end-user volume demands.
- Employs a white-box approach to development
The ability to identify and communicate needed changes quickly is essential to an efficient medical device control process. For best results, the development process needs to exhibit transparency, as opposed to isolation, which can hamper your ability to change quickly.
- Ensures that all aspects of development meet regulatory standards
Failing to meet regulatory requirements; including premarket approval authorization for modified or new products will prevent you from marketing or delivering your medical device.
- Includes risk assessment of the process, as well as the device itself
Not only should you continually seek to improve the performance of your device, but also the process of developing and producing it. By doing so, you may identify potential problem areas in advance of failures and forego unplanned downtimes.
- Includes an agile manufacturing process
When it is necessary to make design changes, it is critical that your contract manufacturer (CM) can incorporate these quickly, without the need for additional equipment and with minimal additional costs.
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The medical device change control process may involve many aspects of development and production. To be efficient, the need for changes must be identified and acted upon as quickly as possible. Ensuring that your process has the attributes above will go a long way towards minimizing the impact when changes are necessary. Tempo Automation, is not only the industry leader in fast, precise and high-quality PCBA prototyping and low-volume production, which most medical devices fall under but also employs an agile manufacturing process such that design changes can be instituted as fast as possible.
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.
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