By Nick Otto
Recently, an executive from industry giant Edwards Lifesciences addressed a congressional committee on the dwindling state of medical device innovation in the United States.
Michael A. Mussallem, chairman and CEO of Edwards Lifesciences, provided a testimony to the U.S. House Committee on Energy and Commerce, voicing his concerns on the downward spiral the U.S. is facing in device innovation as part of the government’s “21st Century Cures: Examining Barriers to Ongoing Evidence Development and Communication” initiative.
In his testimony, Mussallem provided lawmakers with three recommendations to help spark U.S. innovation:
- Evidence development mechanisms can be improved to reduce costs and delays
- Economic incentives need to be aligned with promoting innovation
- FDA’s vision to improve the regulatory process must be accelerated
Pulling from past experiences at Edwards, Mussallem said in the testimony that to be successful, innovators need to have “an unwavering focus on patients,” pointing to specific obstacles that Edwards faced in bringing its SAPIEN aortic valves to market.
Reflecting on those experiences, he said the FDA has recently taken some promising, supportive initiatives to lessen the burdens of the premarket clinical trial process.
In his testimony, Mussallem said that Edwards is supportive of many of the FDA’s time-saving measures, such as “streamlining the investigational device exemption approval process … [and] addressing potentially duplicative clinical evidence through the consideration of surrogate endpoints and greater use of data developed outside of the U.S.”
However, hurdles still remain, and one example Mussallem points to is the obstacle concerning trial registries. Agreeing that quick and easy access to data is a good thing, he said the financial and time burdens are still great.
For example, the patient data registry form for the TVT Registry, created by the Society of Thoracic Surgeons and the American College of Cardiology, for transcatheter aortic valve replacement procedures is eight pages long and consists of more than 300 separate fields. It also requires “special staffing, and dedicated personnel, and hours of work to complete this exhaustive form,” according to Mussallem.
To address these issues, Mussallem supported AdvaMed’s recommended series of “threshold questions” to assure that the creation of a “registry is the appropriate mechanism for meeting the defined objective.”
In addition to the “threshold questions,” AdvaMed’s principles outline some other elements that should be taken into consideration when developing a clinical device registry:
- Establishment of a data governance committee to oversee issues on ownership, as well as access to and use of any data collected
- Prospective registry design, to establish clear objectives and data analysis plans
- Policies for sharing data collected with qualified scientific or medical researchers
- Policies for the use and publication of registry data
The “21st Century Cures” hearing also included testimony from other industry experts including Gregory Schimizzi, cofounder, Carolina Arthritis Associates; Josh Rising, director, medical devices at The Pew Charitable Trusts; and Mary Grealy, president, Healthcare Leadership Council.