A noted serial device entrepreneur and two experienced industry executives have joined a public-private Planning Board tasked with spearheading reforms to the US medical device postmarket surveillance system.

The appointments of three industry veterans and one academic, announced Dec. 7, were targeted at "increasing the diverse range of stakeholders involved" in developing the National Medical Device Surveillance System, according to the Planning Board, which is administered by the Brookings Institution with participation by FDA and other government agencies. The board sought nominations to support its next two-year phase of development. (See Also see "Device Surveillance Reform Board Looks To Add Small-Firm Experience" - Medtech Insight, 14 October, 2015..)

Prior to the latest additions, the only device industry member of the board was Patricia Shrader, VP of Global Regulatory Affairs for Medtronic, who remains on the board.

The new board members include Mark Deem, managing partner for The Foundry LLC incubator, Ken Reali, CEO of device firm Clinical Innovations LLC, and Bill Murray, who heads the Medical Device Innovation Consortium. The board also appointed Barbara Evans, the director of the Center for Biotechnology and Law at University of Houston Law Center, who is an expert on patient privacy protections and confidentiality issues.

Prior to the latest additions, the only device industry member of the board was Patricia Shrader, VP of Global Regulatory Affairs for Medtronic PLC, who remains on the board.

Deem, who Brookings says was selected to represent the "medical device innovation" perspective, co-founded The Foundry in 1998. Since then, the firm has created more than 15 companies valued to $2 billion in total, including Ardian Inc., Concentric Medical Inc. and Transcend Medical Inc. (See Also see "Foundry Founders Take Stock" - Medtech Insight, 14 July, 2014..) Deem leads the early-stage efforts of the incubator's companies before they appoint permanent leadership.

Reali, who was selected to represent the small device company representative on the board, joined Clinical Innovations, which develops devices to improve labor and delivery, earlier this year after serving as CEO of spine device firm Baxano Surgical Inc., which filed for bankruptcy in 2014. (See [A#01141124002].) He also previously held leadership roles at Smith & Nephew PLC and other orthopedic device firms.

Murray is already directly involved with some similar issues to those addressed by the Planning Board as part of his leadership of the Medical Device Innovation Consortium, which is another public-private initiative involving FDA. He was brought onto the board for his experience with public-private partnerships, according to Brookings. Murray has also previously held executive posts at a range of device firms, including large ones like Medtronic and smaller companies such as ReShape Medical Inc.

The National Medical Device Surveillance System Planning Board, first convened in 2014, is supported by an FDA grant and includes FDA membership, but it is run outside of the agency to gain insight and buy-in from clinicians, researchers, industry, payers and patient groups, among others. It issued its first report earlier this year proposing a seven-year plan to get a new device surveillance framework up and running including the launch of near-term pilot projects to enhance use of Unique Device Identification, registries and other surveillance networks. (See Also see "Planning Board Proposes Postmarket Device Surveillance Timeline" - Medtech Insight, 24 February, 2015..)

Over the coming year, the board plans to focus on establishing the leadership structure for its coordinating center and to set priorities to begin the development of the national system. It plans a follow-up report with new recommendations in Fall 2016. The group's efforts are intended to complement work by another public-private partnership, the Medical Device Epidemiology Network’s Medical Device Registries Task Force, which issued its own report in August. (See Also see "Task Force Advocates Making Registries Better Than Sum Of Their Parts" - Medtech Insight, 25 August, 2015..)

Postmarket Surveillance Reform Board Gets Injection Of Device Industry Experience

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