The Brookings Institute laid out its vision of a comprehensive medical device postmarket surveillance system in a report to various device industry stakeholders. The report's ideas were further detailed and debated during a series of moderated discussions at the think tank featuring the CEOs of Medtronic ($MDT) and Edwards Lifesciences ($EW), and the head of FDA's device arm, CDRH.
The ambitious plan calls for a public-private partnership to spend $250 million over the next 5 years to implement and maintain the system. Its primary purpose will be enhancing patient safety and balancing pre- and postmarket data collection, but all speakers agreed that its focus should also include providing data for comparative effectiveness studies, reimbursement decisions and quality improvement, among other uses.
The report recommends implementing the system over 7 years, with the FDA leading the charge. In years 3 to 7, the public-private partnership's leadership "should set and oversee the system's strategic development priorities, begin to build and sustain broader stakeholder participation, oversee implementation of the organizational plan, and establish system performance measures," the report says.
It recommends the initiation of three pilot projects to get the initiative off the ground, such as implementing "implantable device surveillance using patient-reported information." But the movement toward increased postmarket surveillance is already underway.
The unique device identification system being implemented by the FDA promises to make the surveillance easier to carry out by allowing stakeholders to track individual device performance, while the proposed expedited access PMA approval pathway will rely on enhanced monitoring following commercialization in return for faster approval of select devices deemed critical by the FDA.
In addition, the FDA has some rudimentary, passive postmarket surveillance systems in place, such as the Medical Device Reporting regulations. They are generally believed to be insufficient. "Technology limitations and the number of reports overwhelm CDRH's surveillance resources, increasing the risk of data error and misclassification. Incomplete reporting often inhibits safety signal identification, and subsequent investigation and actions by manufacturers and FDA," the report says.
Finding the optimal balance between pre- and postmarket data collection is critical, Dr. Jeffrey Shuren, the head of CDRH, said during his remarks. That's because there is sometimes a tension between the FDA's dual missions of promoting public health and promoting access to medical technology.
Currently, tough premarket requirements mean the FDA is slower to approve cutting-edge devices than its counterpart in Europe, sometimes by 5 years or more. The promise of faster device approvals in return for enhanced monitoring following commercialization means the initiative has a good chance of receiving industry buy-in.
|Medtronic CEO Omar Ishrak|
Medtronic CEO Omar Ishrak focused on the need to identify and develop "clear value propositions" for device manufacturers in order to secure needed investment in the postmarket surveillance system.
"If you want something to get paid for, in essence, an investment has to be made, you've got to have a return on that investment. And you've got to be granular about where that financial return is. This cannot be investment and then a qualitative (as opposed to quantitative) return. You might get some people whose arms are twisted to invest in that, but you will not get enthusiastic endorsement unless you see a real financial return," he said.
The potential benefits to industry of enhanced postmarket surveillance are numerous. In addition to faster approval times, increased use of real-world data could quicken the speed of medical device reimbursement, which some say is a problem that now exceeds the FDA's tough regulations.
Edwards Lifesciences famously benefited from data collection via the TVT postmarket data registry that was used to expand the indication of its Sapien transcatheter aortic valve for heart patients too frail for open heart surgery.
But industry fears the information could be used to scare consumers from using their products based on incomplete or flawed analysis.
"In (the) short term you can get abuse, or you can get unintended abuse, of extrapolation of views that may or may not be accurate, and you can create a whole series of problems that are completely unintended and distracts from the whole affair," Ishrak said.
All agreed that a strong data governance program is needed to avoid pitfalls like that.
However, the technical implementation to get to the stage where misuse of the data is a present danger poses a bigger hurdle at the moment.
|Edwards Lifesciences CEO Michael Mussallem|
Data standardization is lacking, the panelists said. Right now, different electronic health records are not interoperable, and insurance claims data is plagued by the use of various coding systems, which mean that their content can't be aggregated easily using computing power.
In addition, filling out data registries can be cumbersome and time-consuming for doctors. Edwards CEO Michael Mussallem said they should include as few variables as possible. Other panelists said using electronically prefilled forms is another solution.
The FDA tasked Brookings with coming up with the report, and touted its recommendations on the agency's blog.