Manager, Regulatory Affairs Boston Scientific - ENTERPRISE
The FDA has issued several guidance documents over the past few years encouraging incorporation of patient input throughout the medical device total product lifecycle (TPLC). Patient input may take the form of patient engagement, patient-generated health data (PGHD) as real-world data (RWD), patient preference information or patient-reported outcomes used through the phases of product development and regulatory decision-making. Medical devices have become a permanent part of patients’ lives. As designed, medical devices can deliver improvements in patients’ health, daily functioning, and quality of life. Patient engagement early in the lifecycle of device development offers an opportunity for manufacturers to leverage a target population’s insights into unmet needs, usability, and product experience. Further, patients’ perspectives on perceived benefits and risks, convenience, usability, and outcomes associated with the disease or its management offer valuable information for product development, study design, quality surveillance, and performance monitoring. Likewise, RWD and PGHD have the potential to give a more comprehensive view of how new technology performs in real-world settings and may help manufacturers, regulators, and clinicians understand the long-term outcomes of medical technology. Patient preference can provide insights into patient’s tolerance for risk as well as how they prioritization outcomes. Leveraging robust patient input data can optimize the alignment of the medical device manufacturers with patients’ priorities, and effectively inform regulatory decision-making. The purpose of this session is to illustrate the value of implementing patient input throughout the medical device TPLC, including during product development, clinical study design, regulatory decision-making, and post-market surveillance. Examples of patient input data for use in device design and development, risk management, quality review, and regulatory strategy development will be shared. Furthermore, insights from the regulator’s perspective on patient input will be provided.
Describe how patient input data can contribute to pre- and post-market regulatory strategies.
Recognize how valid patient input activities can contribute to a quality strategy.
Discuss the role patient input data play in regulatory submissions and decision-making.