4. Considering Total Product Life Cycle (TPLC) research: Generating evidence from the time of early adoption of technologies is an important priority to support attainment of startup funds. Registries for breakthrough technologies can be designed to include specific factors needed for evaluation of effectiveness (eg, Transcatheter aortic valve replacement (TAVR)); and to facilitate later transformation into a quality registry, by ensuring collection of minimum core data fields necessary for surveillance. A key issue is to not confuse the purpose of the registry with specific investigations that should be ‘nested’ within it: the latter can include collection of additional data elements. Using RWE in clinical trials is feasible, particularly in ‘pragmatic trials’ where patients and device operators included are broadly representative of the target population. To evaluate long-term outcomes, mature CRNs need to demonstrate robust linkage with relevant data sources that enable enhancement of data and longitudinal follow-up.d e
TPLC domain describes the total life cycle of a device and the notion that registries can serve as the infrastructure for conducting both clinical research and device surveillance at different stages of device evaluation. Registry core minimum data elements and research modules should ensure relevance of the collected data from stakeholder perspective (see also Data Quality domain). In addition, the use of registries may allow for a seamless integration of evidence generation at the point of care throughout the device life cycle. A critical aspect of lifecycle research is obtaining long-term outcome data with efficient methodology. This domain is aligned with FDA’s TPLC vision.	Level 1 EarlyLearner	Developed a plan for conducting short-term or long-term clinical outcome studies (eg, direct follow-up or data linkages) and surveillance.
	Level 2 Making Progress	Developed some capacity (eg, IT infrastructure system) for conducting short-term or long-term clinical outcome studies and surveillance.
	Level 3 Defined Path to Success	Registry has experience with at least one short-term or long-term clinical study or surveillance during product lifecycle that assists regulatory decision making. However, it has limited capacity for analytics and burdensome/inadequate iv process to obtain long-term outcome data (eg, linking registry to EHRs or claims data) for research and surveillance.
	Level 4 Well Managed	Registry has experience with at least one study during the product lifecycle that assists regulatory decision making. Developed sustainable capacity for analytics and an adequate iv process to obtain long-term outcome data (eg, linking registry to EHRs or claims data) for research and surveillance.
	Level 5 Optimised	Registry has substantial experience (eg, three or more studies) that assisted regulatory decision making, has sustainable capacity for analytics, and an adequate iv process to obtain long-term outcome data (eg, linking registry to EHRs or claims data) for research and surveillance.
iv If direct follow-up is conducted, greater than 80% achievement might be adequate. When using data linkages, greater than 90% might be adequate.
dColumbo JA, Martinez-Camblor P, O'Malley AJ, et al. Long-term Reintervention After Endovascular Abdominal Aortic Aneurysm Repair. Ann Surg. 2019;July 8, 2019 - Volume Publish Ahead of Print - Issue - p.
eColumbo JA, Sedrakyan A, Mao J, et al. Claims-based surveillance for reintervention after endovascular aneurysm repair among non-Medicare patients. J Vasc Surg. 2019;70(3):741-747.