The Patient Perspective

The U.S. Food and Drug Administration (FDA) has encouraged medical device companies to include patient perspectives across the medical device development lifecycle. But device manufacturers still need more specific guidelines on collecting and using patient views across the medical device development life cycle. The Science of Patient Input initiative has developed resources to begin to address this issue.

Total Product Life Cycle (TPLC)

Before approving a new medical device, regulators must evaluate its safety and effectiveness. One of the most important questions they ask is whether the clinical benefit of a medical device outweighs its risk. Patients can provide valuable input into the potential risks and benefits of a medical device and provide insight into the design and development of new technology. Patients and their families 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. And in the end, patients are the ones who take risks to achieve the benefits of medical therapies.

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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.

For example, for many years, patients with implanted pacemakers use to be denied the benefits of MRI scanning because the electromagnetic effects of the MRI could cause the pacemaker to overheat or move out of position. Recognizing this unmet medical need, researchers worked to analyze the effects of MRI systems on pacemakers and develop techniques for predicting the safety of specific pacemaker designs in MRI scanners. Device developers were then able to design and test an implantable pacemaker that could be compatible with MRI exams. As a result of this work, today multiple MRI-compatible pacemakers and other implantable devices are available to patients.

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