Is time linear or cyclical? As virtually every facet of our lives is in some way related to time, this question has received quite a bit of attention from scientists, mathematicians, historians, philosophers, and many others. For most of our history, it has been assumed that time is linear and unidirectional. However, ideas such as the Big Bang Theory and the Space-Time Continuum indicate that time, which is fundamentally set by physical movement or change, may be cyclical and allows for bidirectional movement. In contrast to these ideas, our lifetimes do indeed seem to be short and linear; however, when expanded, it is also obvious that our lives are affected by events that exhibit cyclical patterns. These include not only our physical abilities that clearly increase to a peak and then decline but also the physical devices and systems that we build.
Medical Device Lifecycle Management
Understanding the changes that affect the lifetime of electronic devices and PCBAs is essential to optimizing their utilization and the resources required to design, build and maintain them. Although most products can be analyzed from a macro lifecycle perspective, especially electronic components, it is imperative that this is done for medical devices. Before answering the questions of why this is true and how it is best achieved, let’s first define lifecycle management for PCBAs and electronic devices in general. Then, we can incorporate the peculiarities that medical device changes over lifetime necessitate.
Lifecycle Management of PCBAs and Electronic Devices
Before delving into our focus area here, which is lifecycle management of devices, specifically electronic devices and PCBAs, it is helpful to provide some definitions:
- Product development - is the complete process of bringing a product to the state at which it can be sold or distributed to end-users.
- Product lifetime - is the actual time that a product is usable which extends from purchase or acquisition to when the product is removed from usability. NOTE: This is different from the service lifetime, which is the time that the product is actually in use as opposed to available to be used.
- Product lifecycle - consists of a series of stages that a product goes through from its introduction until its removal from usability.
For PCBAs and electronic devices, product development itself includes a cyclical process often referred to as prototyping. Prototyping is the iterative cycle that includes design, build and test or DBT with the objective of arriving as the highest quality design for production. Once, this is achieved and production is begun the product itself usually will not undergo any significant changes unless dictated by component issues; such as obsolescence or other shortage cause.
Lifecycle management, in these cases, is concerned with determining the best number of products to produce, the best price margin, how to best advertise or inform end-users about the product or other marketing issues as the product grows from introduction to maturity. The management cycle ends as the production numbers decline from maturity and until ultimately it is no longer produced. For medical devices, the dividing line between development and production is not as well-defined and effective lifecycle management must include both.
Management of Medical Device Changes Over Lifetime
The development and production stages for medical devices are not distinct and separate. In fact, standards and regulations; such as ISO 13485 and ISO 14971, which provide requirements for medical device quality and risk management, respectively, view development and production as integrated processes. From this perspective, changes that occur after the device has been in production may well cause developmental modifications. In addition to adhering to these standards, all medical devices must be classified with the FDA based upon the risk they pose to patients and users. For more information on classifying your medical device see How to Classify Your Medical Device.
Managing medical device changes over lifetime is best accomplished by identifying changes that may require reclassification and those that do not, as listed below.
Types of Medical Device Changes
Change in type of device*
|Change in operation|
Change in usage
Change in component(s)
|Change in risk (to patients or users)|
Change in packaging
* Type here refers to one or more of the FDA Speciality Panel types.
In addition to the changes listed above that may lead to a change in classification, reclassification is also typically required for a new device type. That is, the device no longer can be classified under a previous or existing device type. However, all new devices, including those that include significant changes in operation, usage, and potential risk must go through the classification procedure, which includes a determination of the need for premarket approval (PMA). This is done by submitting a 510(k) for evaluation to determine whether pre-market approval is required. done when a device. The general criteria for when a new 510(k) is necessary is as follows:
1. When a significant change in design, manufacturing process, energy source, chemical composition or material that could impact device safety or performance.
2. A change in what the device is used for.
For help in determining when medical device changes over lifetime may require that a new approval process be initiated see Deciding When to Submit a 510(k) for a Change to an Existing Device.
Product lifetime management for medical devices differs from most commercial products in that both development and production must be included. This is in part due to regulatory requirements that device performance be incorporated into further production, which in many cases requires development changes. In these cases, it must be determined whether the needed changes also impact the device’s classification status. If so, then a PMA determination is required. This approval process may also be necessary if the device is not to be changed in classification, yet there are significant changes in development or usage.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development|
Incorporating needed modifications to your medical device with minimal manufacturing changes requires that you work with a contract manufacturer that employs an agile board production process; such as Tempo Automation.
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 how to best develop your boards for medical device changes over lifetime with minimal development process change, contact us.