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FDA's Center for Devices and Radiological Health (CDRH) has undertaken an initiative to proactively facilitate medical device innovation to address unmet public health needs defined as illnesses and injuries that meet the following criteria: (1) Are serious or have moderate adverse impact on health, but affect many individuals; (2) could be cured, significantly improved, or prevented by the development or redesign of a device; and (3) the device(s) is not being developed or redesigned due to barriers that the Federal Government can directly or indirectly remove or minimize, where those barriers are out of proportion to what is warranted based on the public health needs.
Medical device development and/or redesign is responsible for significant public health benefits, including the prevention, treatment, diagnosis, and monitoring of serious or life-threatening diseases and improved quality of life. However, unnecessary barriers to market may exist either due to market failures or regulatory inefficiencies. For example, payment practices can affect financial incentives for manufacturers to develop a new or improved technology. A predictable and consistent regulatory pathway can encourage would-be innovators to invest in the development of an innovative device.
As part of this initiative, CDRH established a Council on Medical Device Innovation composed of participants from federal agencies. Agencies represented include the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Defense, the Defense Advanced Research Projects Agency, and the Department of Veterans Affairs. The purpose of the Council is to identify the most important unmet public health needs, the barriers to innovative medical device development or redesign that could address those needs, and actions the Federal Government can take to reduce those barriers while assuring the safety, effectiveness, and quality of medical devices marketed in the United States.
The Council seeks input from a wide range of constituencies to include but not be limited to industry, academia, patient/consumer advocacy groups, professional organizations, and other State and Federal bodies under aligned public health missions, to address the issues outlined in this document.
During the public workshop, there will be an open dialogue between Federal Government Council members and experts from the private and public sectors regarding the topics described in this document. Workshop participants will not be expected to develop consensus recommendations, but rather to provide their perspectives on priority areas in which medical device innovations can have the highest positive impact on public health. Participants will also be encouraged to comment on devices not being developed or redesigned due to barriers that the Federal Government can and should directly or indirectly remove or minimize.
II. Public Participation
If you wish to make an oral presentation during the public workshop, you must indicate this at the time of registration. There are two types of opportunities for participation planned for the public workshop. In one, formal presentations will address one of the two topics (see section III of this document) that will be limited to 15 minutes and require submission of the presentation in advance of the meeting. The other will be time-limited, based on the number of requests, as part of the public comment period. When registering, you will be required to identify the title of the topic you wish to address in your presentation and answer all the related questions on the web registration form. FDA will do its best to accommodate requests to present and will focus discussions to the topics described in this document (see section III of this document). Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for joint presentations. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is to begin.
III. Issues for Discussion
The workshop will focus on three topics: (1) Identification of the most important unmet public health needs; (2) delineation of the barriers to the development, redesign, and patient and healthcare professional access to medical devices that can cure, significantly improve, or prevent these illnesses or injuries; and (3) identification of the actions the Federal Government can take to remove or minimize these barriers. The discussion of these general topics should not be limited by current statutes or regulations and will include, but not be limited to, discussion of the following questions:
- Identifying areas of public health need:
- Which unmet public health needs could be most effectively addressed by the development of new, or the redesign of existing, medical devices?
- How should the Council set priorities amongst the identified public health needs? Are there specific factors that should be considered? If so, which and why?
- Addressing barriers to development and/or redesign of medical devices:
- What are the significant barriers facing innovators, academics, and/or industry that limit the availability and clinical use of medical devices that have the potential to improve public health?
- How should any perceived or actual barriers be evaluated to determine whether federal intervention is appropriate?
- How should federal agencies - including those present and others not represented - address those barriers that are out of proportion to what is warranted based on the public health needs?
The scope of the input sought by the Council extends across disease areas as well as encompassing consideration of the setting of use, including use within and outside health care facilities. The draft agenda is subject to change.
Agenda and Presentations
Presentations are available in Adobe PDF format.
|8:00am||Welcome||Jeffrey Shuren, MD, JD|
|8:10am||Review of Meeting Objectives||Jonathan Sackner-Bernstein, MD|
|8:20am||Introduction of Council Members||All|
|8:35am||Federal Agency Efforts to Facilitate Innovation (FDA and NIH)||All|
|Session 1: Public Presentations (15 minutes followed by 10 minutes Q&A)|
Research Associate, Consumer & Patient Alliance Coordinator
Center for Medical Technology Policy, Baltimore, MD
Engaging Stakeholders in Priority Setting: Real World Experience
|9:55am||David Klonoff, MD, FACP|
Medical Director, Diabetes Research Institute
Mills-Peninsula Health Services, San Mateo, CA
Standards & Interoperability for Better Diabetes Technology
|10:20am||*** BREAK ***|
|10:35am||Richard Ehman, MD|
Chair, Department of Radiology
Mayo Clinic, Rochester, MN
Development and Introduction of New Medical Imaging Technology: Lessons Learned in the Trenches
|11:00am||Jack W. Lasersohn|
Board of Directors, National Venture Capital Association (NVCA)
Past Chairman, Medical Industry Group, NVCA
Founding General Partner, The Vertical Group, Summit, NJ
Interagency Collaboration in Support of Medical Device Innovation
|11:25am||Interim Summary and Discussion|
|12:00pm||*** LUNCH ***|
|1:15pm||Open Public Comment|
|Session 2: Public Presentations (15 minutes followed by 10 minutes Q&A)|
Director, Quality Assurance & Regulatory Affairs
Intel Corp/Digital Health Group, Folsom, CA
Home Health: Barriers to Innovation
|3:10pm||Joseph Smith, MD, PhD|
Chief Medical and Science Officer
West Wireless Health Institute, La Jolla, CA
Wireless Healthcare: Cost as an Imperative for Innovation
Senior Director for Global Regulatory Affairs
Medtronic, Inc, Minneapolis, MN
AdvaMed Recommendations on Approaches to Addressing Unmet Public Health Needs
|4:30pm||Conclusion and next steps|
- Robert Campbell, Childrens Hospital Of Philadelphia, The Need For Better Metrics For Pediatric Device Evaluation.
- Robert Granier, Massachusetts General Hospital, The Point-Of-Care Solution: A Diagnostic Infrastructure Model For Increasing Access To Healthcare.
- Mark Sobel, MD, PhD, Association For Molecular Pathology, Barriers To Innovative Diagnostics: The AMP Perspective.
- Sean Bauman, PhD, ImmunoMyocologics, Inc., High impact cryptococcal antigen diagnostics: meeting the needs of the developing world
- David Crais, CMG, LLC, Disease Management Technologies, And Also Disaster Health Planning And Recovery.
- Cynthia Rice, Juvenile Diabetes Research Foundation, Accelerating Improved Technologies To Treat Diabetes.
- Zen Chu, Wyss Institute, Harvard Medical School, Academic / Industrial Partnerships For Innovation & Commercial Translation.
- Jose Bolanos, MDV1.Com, Mass Open Collaboration In Creating Tomorrow’s Innovation.
- Konstantin Goranov, SALUTARIS, Predicament Of New Devices And Old Predicates.
- Richard Eaton, Medical Imaging & Technology Alliance (MITA), Barriers To Development And/Or Redesign Of Medical Devices.
- Matthew Johnson, SIR, SIR’s Communications On Overcoming Barriers To Innovation By Standardization Of Trial Design And Endpoints.
- Dan Cohen, Enteromedics, Inc., Systemic Change to the US Medical Device Approval Process.
- Richard Eaton, MTA, Inc., The importance of predictability in the regulatory process to product innovation
- Craig A. Hunter, Neocure Group, Determining the best evidence standards given the specific needs of the marketplace.
- Maha Sallam, Vuessence, Inc., Intelligent Image Processing For Identifying And Characterizing Patterns Of Disease.
- Carl Rosner, Cardiomag Imaging, Inc., EARLY, SAFE DETECTION OF HEART DISEASE POSSIBLE - Huge Savings In Lives And Money.
- Lisa Salberg, HCMA - Hypertrophic Cardiomyopathy Association, Patients With Genetic Cardiac Disorders Requiring A Lifetime Of Therapy - New Options Needed.
- Peg Graham, QUA INC, Self-Managed Bedside Commode: Avoidable Falls, Institutionalizations And Workers Comp Costs.
- Roland Winger, Ash Access Technology, Inc., The Need For An Approved Antimicrobial Hemodialysis Catheter Lock Solution.
- David Hawkes, Crocker Spinal Technologies, Inc., Need For Spinal Total Disc Replacement.
- Beluh Ginting, MINISTRY OF HEALTH OF REPUBLIC OF INDONESIA, THE DEVELOPMENT OF HEALTH CARE TECHNOLOGY IN INDONESIA.
- Dennis J. Dannemiller, Temarex Corporation.
- Richard Longland, The Arthroplasty Patient Foundation, Inc.
- Belinda Seto, NIH
- Louis Jacques, MD, CMS
- Gerald Cross, MD, VA
- Jean Slutsky, AHRQ
- Lt. Col. Daniel Wattendorf, MD, DARPA
- Col. John Bullock, PA-C, DOD
- No CDC – they were deployed to the Gulf
- Jeff Shuren, MD, JD, FDA
- Jonathan Sackner-Bernstein, MD, FDA
- Federal Agency Efforts - FDA
- Federal Agency Efforts - NIH
- Richard L. Ehman M.D. - "Development and Introduction of New Medical Imaging Technology: Lessons Learned in the Trenches"
- David Klonoff, MD, FACP - "Standards & Interoperability for Better Diabetes Technology"
- Jack W. Lasersohn - "Interagency Collaboration in Support of Medical Device Innovation"
- Michael Morton - "AdvaMed Recommendations on Approaches to Addressing Unmet Public Health Needs"
- Bonnie Norman - "Home as the Center of Care Barriers to Innovation"
- Justine Seidenfeld - "Engaging Stakeholders in Priority-Setting: Real World Experience"
- Joseph Smith, MD, PhD - "Wireless Healthcare: Cost as an Imperative for Innovation"
This meeting will be held June 24, 2010, beginning at 8:00 a.m. and ending at 5:00 p.m., at the following location:
Hilton Hotel Washington DC
North/Gaithersburg, 620 Perry Pkwy
Gaithersburg, MD 20877
The meeting will not be videotaped or webcasted.
Registration has been closed as of June 9, 2010.
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. Registration on the day of the Workshop will be permitted on a space-available basis beginning at 7:30am.
If you wish to make an oral presentation during any of the open comment sessions at the meeting (see section II above), you must have indicated this at the time of registration. FDA requests that presentations focus on the areas defined in section III above. Those requesting to deliver formal presentations will be contacted by email by the Center to learn about your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.
If you need special accommodations due to a disability, or additional information regarding registration, please contact Melanie Fleming, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5424, FAX: 301-847-8510, firstname.lastname@example.org.
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, MD 20993