The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so that you get a safe and effective device at the end of the process.
One of the important steps of this long process is clinical evaluation. Clinical evaluation allows medical manufacturers to determine how their devices work in clinical settings. Since we are dealing with medical devices, knowing the devices work well is kind of a big deal. That is why clinical evaluation and all its methods are pretty important, too.
Formally, the process of gathering clinical data from the usage of a medical device in order to verify its efficacy and safety is known as clinical evaluation. As this is a significant process, most regulatory bodies have some sort of legal requirements regarding clinical evaluation.
In this article, we will discuss one of the most crucial aspects of clinical evaluation: the timing. We’ll also go over the several elements that can affect the clinical evaluation process and how you should consider them.
Why do we do clinical evaluation?
Before you can think about when you need to do a clinical evaluation, you need to know why you do a clinical evaluation. The cause should justify the timing and the extent of the process. The primary reason to do a clinical evaluation is the obvious one. The regulatory requirements make it impossible to launch a device without doing a clinical evaluation first.
According to the MDR, clinical evaluation starts along with the start of medical device development. The MDR document mentions that manufacturers do clinical evaluation during the device development process to:
- Gain more info regarding the device’s clinical performance and safety.
- Find more data in case of clinical equivalency to another device.
- Do a gap analysis. A gap analysis provides info regarding the clinical data that the device still needs. It allows the manufacturer to see if clinical investigations are required and, if so, define the research design.
Apart from these, a clinical evaluation is also important for assessing the performance of a device. A manufacturer needs to know what the device can do and how well it does. Clinical evaluation studies are also great for combining any unwanted clinical effects. A new medical device can have a variety of reactions that are hard to predict without verification tests.
A thorough clinical evaluation process can also be invaluable during design control. The idea is simple: the more supporting evidence you have on your device’s efficacy, the safer your device is.
What does clinical evaluation consist of?
The clinical evaluation process has five stages:
- Defining the scope and planning.
- Identifying data.
- Assessment of data sets.
- Analyzing the data.
- Writing the clinical evaluation report.
The data is collected through several methods, including clinical trials, pre-clinical studies/clinical investigations, post-market surveillance, risk management activities, literature searches, user reports, etc.
When should you do a clinical evaluation?
Clinical evaluation is an ongoing process. You have to start at the very beginning during the development of the device and keep doing it even after the device is on the market. In fact, the clinical evaluation report will have to be updated every few years and when new information is available. That being said, during these stages, you should review the data you collected and ensure you are actively collecting clinical data.
- During the medical device development process: Clinical investigations should be done during the initial phase of medical device design and development. Earlier detection of any possible safety or performance defects helps make the necessary changes to the device before it goes to the market.
- Before device launch: Before a device hits the market, it should undergo a full clinical evaluation. Usually, the results of the clinical investigations are submitted in the CER document. These will also help draw the PMS, risk management, and other documents required for regulatory approval.
- Post-Market Surveillance: Clinical evaluation doesn’t stop after device launch. Regular clinical studies and data collection should be done after it has been placed in the market as part of post-market surveillance. This helps keep an eye on how the device works in the real world and find any long-term safety issues or other problems that might not have been clear during initial testing.
- Before Making Big Changes: If any significant changes are being made to a current device, like how it’s designed or what it’s meant to be used for a new clinical evaluation should be done to see how these changes affect the device’s safety and performance.
What factors affect the timing of the clinical evaluation?
While medical device companies are suggested to do thorough clinical evaluations as frequently as possible, sometimes it’s not feasible. A lot of factors are at play here.
For example, deciding to conduct clinical trials can depend on the developmental stage a device is in. Manufacturers can conduct bench tests, computer simulations, and animal experiments early in development. When the device is ready for human use, proper clinical investigations are done.
The time also depends on the device’s complexity. Clinical investigations might not be necessary if the device is a simple class I device with plenty of equivalent devices in the market. However, clinical trials are required if the device is sophisticated, has a high-risk profile, and is of relatively new technology.
The availability of funding also matters. Clinical trials and investigations can be an expensive and time-consuming process. Manufacturers often have to assess the timing and money for clinical evaluation carefully. If a medical device requires substantial clinical testing, the product launch could be delayed, causing losses.
Given the complex process, it depends on individual manufacturers and teams to decide when it’s best to conduct a clinical evaluation. However, starting early does have more benefits!