I suppose you could say that people in my area are fortunate. We live in an area where there are a few well-known research medical schools. Both my wife and daughter were born at one of these and it was common to have a room full of students accompanying the doctor. In addition to bringing babies into the world, these institutions also are regularly seeking volunteers for clinical studies and trials. Although I am usually too busy to participate, I am grateful to those persons that do as they pave the way for new medicines and medical products that preserve health and save lives.
Participating in a clinical trial
Clinical trials are not only required for medications or substantially invasive medical devices, such as biomedical devices. In fact, most new products categorized as class 2 or class 3 by the FDA require some type of testing. And 10-15% require clinical testing. Let’s take a look at the process of testing these clinical medical devices and how it impacts your PCBA development.
For more information on the FDA classifications for medical devices, see the articles below.
Testing Process for Clinical Medical Devices
If your medical device is class 3, it will likely need pre-market approval (PMA) before it can be used by medical professionals or other end-users. The same is true for many class 2 devices. Obtaining PMA is not a simple exercise and can take years to acquire. The reason for this sometimes lengthy process is such that reasonable assurance that the device is not only effective for its intended purpose but is also safe to use. A primary means of showing that a medical device should be granted market approval is by testing.
There are three types of medical device testing. These are:
1. Bench testing
The testing of devices during design and manufacturing to ensure acceptable operation and reliability. For this testing, no human or animal subjects are used.
2. Animal testing
The testing of animals is declining; however, when it is done the FDA requires that 21 CFR 58 Good Laboratory Practice For Nonclinical Laboratory Studies be followed. Animals testing of medical devices evaluates biocompatibility or whether the device can function without harming human tissue.
3. Clinical trials
Clinical trials are research studies involving people. In contrast to clinical trials for pharmaceuticals that may consist of many stages where the number of participants gets progressively larger, for medical devices there may only be one or two stages.
Testing of clinical medical devices or medical devices that undergo clinical trials may have the following attributes:
Attributes of Clinical Medical Device Testing
- Fewer participants than for drug studies
- Used to support a marketing application to the FDA
- Typically include feasibility stage(s) and pivotal stage
- Intended to show a “reasonable assurance of safety and effectiveness.”
- May be doctor technique-specific
- Diverse endpoints
As indicated by the list of attributes above, clinical trials vary from device to device. However, all clinical trials must be approved before they can be initiated and the results approved prior to the granting of a PMA.
Developing PCBAs for Clinical Medical Devices
Before a medical device will be allowed to be used for its intended purpose generally, it must go through a two-step approval process. The first step is to obtain FDA approval for clinical testing, which requires the submission of an investigational device exemption (IDE) application. For the second step, a 501(k) application for PMA must be approved by the FDA, which depends upon the clinical results. In order to make the best case for your clinical medical device’s approval, you must ensure that the device, its electronics, and circuit boards meet all functional objectives and do not pose an unreasonable risk to the intended patients or end-users. This can be accomplished by following good PCBA development process guidelines. The following articles can be helpful.
- PCB Standards for Medical Electronics Device Design.
- PCB Manufacturing Regulations and Standards.
- PCB Safety Requirements for Implantable Devices.
All medical devices are heavily scrutinized to prevent injury to patients and end-users. Clinical medical devices are even more so as they are implanted, worn or in some way are in contact with people. The process of having these devices approved can be long and complex; however, the best way to ensure your devices reach the intended benefactors is to make sure the boards that drive these systems meet the highest standards for quality and safety. At Tempo Automation, we are committed to building the highest quality, safest PCBAs in the most efficient manner, including helping you to meet all medical device industry requirements.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems 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 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 clinical medical devices or developing PCBAs for them, contact us.