Modeling Patient Engagement Throughout TPL

When confronted with an unmet medical need, researchers in the device field will come up with an idea for a new product. Once they have a “proof of concept” plan, they will evaluate whether the idea is workable. Those concepts that exhibit promise move forward toward the next stages of development.

In the invention phase, researchers in the device field build a prototype or early version of the device to lay the foundation for further development. This prototype provides a device that can be tested in a lab. At this stage, the device prototype is not for human use.

The device prototype is evaluated in a controlled laboratory setting to provide researchers with important information about how the product may perform once it used in people. By refining the device during this phase, researchers work to reduce as much risk of harm as possible once the product moves into human use.

The term “clinical research” refers to studies, or trials, in which the device is tested in humans. Once a sponsor has sufficient pre-clinical data, the next step is to plan for clinical studies to establish the safety and effectiveness of the product.

Once a device has received marketing authorization from the FDA, there are additional steps the sponsor must take in preparing to make the device available for public use. This includes finalizing the “device master record” (DMR), as well as setting up coverage submissions, payor enrollments, a network for distributing the product to providers and the public, developing marketing materials, and registering with the FDA.

Even after granting marketing authorization for a medical device, the sponsor continues to monitor how it performs once it is commercially available. Although pre-market clinical trials provide important information on a device’s safety and effectiveness, it is possible new safety concerns will emerge. Post-marketing surveillance is critically important to ensuring patient safety.