Medical Devices

Public Workshop - Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices, April 30, 2018

The Food and Drug Administration (FDA) announced a public Workshop entitled "Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices." 

The purpose of the workshop was to discuss the development of Orthopaedic SMART Devices. The workshop was intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopaedic SMART Devices. Public input and feedback gained through this workshop may aid in the efficient development of innovative, safe and effective, Orthopaedic SMART Devices, for better patient care.


Date, Time and Location

This meeting was held April 30, 2018, beginning at 8:00 a.m. - 5:30 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Webcast Archive

Agenda

8:00am

Outline of Events

Andrew Baumann, PhD (FDA)

8:05am

Introduction of Collaboration/Importance and Keynote Speakers

Jeffrey Lotz, PhD (University of California, San Francisco)

8:10am

FDA Welcome and Purpose of Workshop

Edward Margerrison, PhD (FDA)

8:25am

Industry Welcome, Purpose, and Introduction to Engineering Session

Euan Thomson, PhD (DePuy Synthes)

8:40am

Break

Engineering and Technology Considerations

8:45am

Current Landscape of SMART Technology in Orthopaedics

Mark Allen, PhD (University of Pennsylvania)

9:00am

Utilization of SMART Technology: Passive Monitoring, Diagnostics, Automated Treatment

Shuvo Roy, PhD (University of California, San Francisco)

9:15am

Industry Perspective on Market Considerations for SMART Technology

Lisa Ferrara, PhD (OrthoKinetic Technologies, LLC)

9:30am

Future Applications for SMART Technology

Michel Maharbiz, PhD (University of California, Berkeley)

9:45am

Panel Discussion

Moderators and Panelists
Moderators: Anton Dmitriev, PhD (FDA) and Vijay Goel, PhD (University of Toledo)

10:25am

Break

Clinical and Patient Perspective

10:40am

Clinician Welcome, Purpose, and Introduction to Clinical and Patient Panel Session

Joseph Kvedar, MD (Partners HealthCare, Harvard Medical School)

11:00am

Clinical Impact of SMART Technology

Aenor Sawyer, MD (University of California, San Francisco)

11:15am

SMART Technology in the Hands of a Surgeon: What Information Would Benefit Your Practice?

Stefano Bini, MD (University of California, San Francisco)

11:30am

Utility of SMART Technology in Clinical Studies

Mark Froimson, MD (American Association of Hip and Knee Surgeons)

11:45am

Advancing Osseointegrated Amputee Care Though SMART Technolgy: Clinical and Patient Perspective

Rickard Brånemark, MD, PhD (University of California, San Francisco and University of Gothenburg, Sweden)

12:00 noon

Fireside Chat

Stefano Bini, MD;  Rickard Brånemark, MD, PhD and Patients

12:20pm

Panel Discussion

Moderators and Panelists
Moderators: Stephen Weber, MD (FDA) and Adolph J. Yates Jr., MD, FAOA (University of Pittsburgh Medical Center)

1:05pm

Lunch

Cybersecurity Considerations

1:50pm

Cybersecurity in Healthcare

Salwa Rafee, MS (IBM Security, Healthcare and Life Sciences)

2:05pm

Healthcare / SMART Data Management Considerations

Darren Lacey, JD (Johns Hopkins University)

2:20pm

Cybersecurity Regulatory Considerations

Seth Carmody, PhD (FDA)

2:35pm

Panel Discussion

Moderators and Panelists
Moderators: Linda Ricci (FDA) and Beau Woods (FDA)

3:05pm

Break

Regulatory Considerations

3:20pm

Regulatory Overview and Pathways

Michael Owens, MS (FDA)

3:35pm

Clinical Trial Innovation

Joshua Chetta, PhD (FDA)

3:50pm

Digital Health Initiatives

Bakul Patel, MS, MBA (FDA)

4:05pm

Orthopaedic SMART Device Evaluation

Colin O'Neill, MS (FDA)

4:20pm

Panel Discussion

Moderators and Panelists
Moderators: Constance Soves, PhD (FDA) and Janice Hogan, JD (Hogan Lovells)

5:00pm

Closing Remarks

Anton Dmitriev, PhD (FDA)

Registration to Attend the Workshop

As of April 20, online registration is closed. On-site registration will be available the morning of the workshop on April 30, 3018.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to speak during the open comment sessions at the meeting you must have indicated this at the time of registration. FDA requests that comments focus on the areas defined in the Federal Register Notice. FDA will do its best to accommodate requests to speak.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications and Education Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact:

Andy Baumann,
Food and Drug Administration,
Center for Devices and Radiological Health,
10903 New Hampshire Ave., Bldg. 62 rm. 2110, Silver Spring, MD 20993-0002,
Tele: 301-796-2508,
Email: andrew.baumann@fda.hhs.gov

Page Last Updated: 06/18/2018
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