Total Product Life Cycle (TPLC)

Before a new medical device can receive marketing authorization, regulators must evaluate its safety and effectiveness. One of the most important questions asked is whether the clinical benefit of a medical device outweighs its risk. Patients can provide valuable input about how they evaluate potential risks and benefits of a medical device and provide insight into the design and development of new technology. Patients, caregivers, and patient advocates have a deep and personal understanding of what it is like to live with a disease, and they often have valuable insights on how a device could affect their quality of life.

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What is the Total Product Life Cycle (TPLC)?

As noted in the diagram, the pathway to successful device development is an iterative process, with ideas generated, tested, improved, re-tested, optimized, and finalized.

This process includes initial ideation and concept development for addressing unmet medical need, prototype development and refinement, pre-clinical testing, clinical studies, regulatory approval, product launch, and ongoing post-market evaluation.

Throughout the total product lifecycle, device developers and regulators are taking similar steps to ensure that a new device can be safe and effective when used by the patient population for which it has been designed.

Discovery & Ideation
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.
Invention & Prototyping
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.
Pre-Clinical
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.
Clinical

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. The Federal Food, Drug, and Cosmetic Act established a risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes (Class I, Class II or Class III) based on the level of control necessary to provide reasonable assurance of its safety and effectiveness and the level of regulatory control.

Regulatory Decision

If the clinical studies yield sufficient information on a device’s safety and effectiveness, the sponsor can submit an application to FDA to market the device to the public. There are several types of applications, depending on which class of device is being developed.

If appropriate, FDA can consult an Advisory Committee at a public meeting. FDA Advisory Committees consist of groups of experts who provide FDA with independent advice on whether a product should be approved or not. After the Advisory Committee meets, FDA decides about the approvability of the device or request additional information. By law, FDA must publish its decision with all supporting evidence in the Federal Register.

Product Launch

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), which includes all the records relating to the procedures and specifications for a finished device. It is often recommended that a sponsor work on finalizing the DMR in parallel with the development cycle to make the process of bringing the device to market once authorized as seamless as possible.

Additional steps the sponsor must take during the product launch phase include setting up a network for distributing the product to providers and the public, developing marketing materials, and registering with the FDA.

Post-Market Monitoring

Even after granting marketing authorization for a medical device, the FDA 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 that new safety concerns will emerge once the device is widely used by people. FDA has several programs that allow manufacturers, health professionals, and consumers to report problems associated with approved medical devices to make sure that any safety issues are identified and can be addressed. This ongoing, post-marketing surveillance is critically important to ensuring patient safety.