Medical device development studies take place over specific phases, each intended to accomplish specific goals. Let’s take an in-depth look at the purpose and function of these phases and their different names throughout the entire medical device development process.
Reasons for Phases
There are a few reasons why studies are divided into phases. Perhaps the most obvious is that problems can be spotted and addressed before full testing. To discover how effective or safe a device is, study designers generally divide it into three stages to ensure the medical device is properly designed.
It is because of how expensive it is to develop new technology. In order to get their product on retail shelves, they need to ensure that it is safe and effective for its intended use. If no issues are found during phase one testing, they can move on to phase two. If not, further research may be needed before further testing begins. Completing thorough testing in multiple phases ensures that devices are as safe as possible when put out on the market. There are also other factors, such as cost and manufacturing capabilities.
Stage 1: Pilot Stage
The initial stage is the pilot stage, which is essential to see if the device works. The goal of this phase is to gather all necessary information.
- Product Viability – This answers the question regarding if the medical device is feasible and “Is the medical device financially viable and feasible?”
- Prototyping and Research – This phase will answer if the device works.
- Testing and Development – This phase evaluates to ensure the device can move through the approval process.
These phases will ensure a device works as expected. A lot of data is being analyzed during this phase as it looks into a plethora of information. Once a product is found to be working properly, it then moves on to the next phase, known as the Pivotal Stage.
Stage 2: Pivotal Stage
The pivotal stage is the next stage that’s still considered pre-market. The purpose of this phase is to ensure the device is not only effective but also safe. In order to determine safety, the product is tested on a small group of people in order to see if there are any major side effects or risks. Once all risks are eliminated, testing begins for effectiveness.
As with every other stage before, if any new risk surfaces during this process, testing stops immediately. It may be possible that some devices don’t make it through Phase 2. Every manufactured device needs to be safe and effective for patients.
During this phase, devices in risk classes IIa, IIb, III, and IVD B, C, D must be tested and approved by Notified Bodies, like the FDA and MHRA. Products in lower risk classes (I and A) can be approved by the manufacturer.
This is a very important phase, which is why it’s often referred to as pivotal. Phase 2 testing determines whether or not a product can be sold to patients and put on store shelves. If an issue arises during this stage, the company would need to go back and address those concerns before resuming testing.
Stage 3: After Market Stage
Once the device has received market approval, it enters a phase where they look to answer the question, “What else do we need to know?”. This post market phase ensures the device is effective and safe for those who use it. It also makes sure that any new findings are communicated and followed.
Manufacturers must monitor the device well beyond production. Some things to focus on include:
- Long-term safety – They may find an increased risk of certain adverse events after long-term use of the device. There may be ways to fix this by changing design or instruction methods.
- Maintaining effectiveness – Even if clinical trials didn’t show much of a difference in effectiveness, more post-market research might find one once more people use the product over time.
- Optimal use – There are several reasons someone might not receive the full benefits from their device, such as not being properly trained to use it correctly. Learning how patients use the device will help them get better outcomes with less harm.
Medical devices need a lot of attention from their infant stage too long beyond mass production. Manufacturers should monitor the device well beyond production. To maintain effectiveness, manufacturers should conduct long-term testing on their patient population. The manufacturer could even go back to earlier stages of research and development if they feel they can make improvements based on newer information.
Resources
Fda.Gov, 2022, https://www.fda.gov/files/medical%20devices/published/FDA-Guidance–Design-Considerations-for-Pivotal-Clinical-Investigations-for-Medical-Devices.pdf. Accessed 1 Dec 2022.
“Early Feasibility Studies (EFS) Program”. U.S. Food And Drug Administration, 2022, https://www.fda.gov/medical-devices/investigational-device-exemption-ide/early-feasibility-studies-efs-program. Accessed 1 Dec 2022.
“Trans: Design Consider For Pivotal Clinical Investigations For Med Dev”. U.S. Food And Drug Administration, 2018, https://www.fda.gov/training-and-continuing-education/cdrh-learn/transcript-design-considerations-pivotal-clinical-investigations-medical-devices. Accessed 1 Dec 2022.
“Step 5: FDA Post-Market Device Safety Monitoring”. U.S. Food And Drug Administration, 2018, https://www.fda.gov/patients/device-development-process/step-5-fda-post-market-device-safety-monitoring. Accessed 1 Dec 2022.
“U.S. Food And Drug Administration”. U.S. Food And Drug Administration, 2022, https://www.fda.gov/. Accessed 1 Dec 2022.
