Greetings,
The
Center for Devices and Radiological Health at the U.S. Food and Drug
Administration would like to make you aware of an upcoming event. Next
Monday the independent non-profit Medical Device Innovation Consortium (MDIC)
will be announcing a new public-private partnership between the MDIC, FDA, other
government agencies, non-profits, academia, and the medical device
industry designed to address emerging device regulatory science issues.
Additional information on the MDIC can be found at http://www.deviceconsortium.org/
As key
health technology stakeholders, we would be pleased for you to join us to hear
the Commissioner discuss this important new initiative. The Consortium is
designed to improve outcomes for patients by fostering innovation, increasing
the tools available to evaluate new medical devices to make sure they are safe
and effective, and to ensure these improvements in care get to patients as
expeditiously as possibly while safeguarding public health.
Please
join us if you can,
Michelle
McMurry-Heath
Associate
Director for Science, Acting Chief Scientist
Office
of the Center Director
Center
for Devices and Radiological Health
U.S.
Food and Drug Administration
---------------------------------------------------------
You are
invited to attend the Senate MedTech Caucus briefing:
Monday,
December 3rd, 10:30 am – 12:00 pm
Room
106, Dirksen Senate Office Building
Announcing: “Medical
Device Innovation Consortium”
Featuring:
FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and
Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
The
program will include a briefing on the creation of the Medical Device
Innovation Consortium (MDIC).
The
MDIC is a Public-Private Partnership (PPP) whose mission is to improve health
through the application of shared knowledge in medical device regulatory
science. It is the first-ever PPP created to focus exclusively on
advancing medical device regulatory science.
The MDIC will create a collaborative
environment where nationwide representatives from industry, non-profits, and
FDA can work together to keep pace with the needs of patients in the United
States.
Speakers
will include:
Senator
Amy Klobuchar
Senator
Al Franken
FDA
Commissioner, Margaret Hamburg, M.D.
FDA’s
Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren,
M.D., J.D.
Centers
for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis
Group, Tamara Syrek Jensen, J.D.
Immucor,
Inc., CEO, William Hawkins
LifeScience
Alley CEO, Dale Wahlstrom
http://www.deviceconsortium.org
The Medical Device
Innovation Consortium is a public private partnership whose mission is to
improve health through the application of shared knowledge in regulatory
science.
Focused on the Medical
Device Industry
The MDIC is the only
public private partnership focused exclusively on the strategic needs of the
medical device industry. The MDIC is designed to create a collaborative
environment where the private sector can partner with the FDA’s Center for
Devices and Radiological Health to solve technical issues that affect the
industry.
Focused on Regulatory
Science
Regulatory science refers
to the development and evaluation of new tools, methods, standards and applied
science that support a better understanding and improved evaluation of product
safety, quality, effectiveness, and manufacturing throughout the product life
cycle.
Focused on Improving
Health
The MDIC has been formed
to add value at the intersecting needs of the medical device industry, the FDA,
and the related organizations that are together responsible for a vibrant
medical device industry that serves the public health needs of the U.S.
Founding Members
FDA
Medtronic
Life Science Alley
About Us
The MDIC is the first ever
Public Private Partnership (PPP) created with the sole objective of advancing
medical device regulatory science. The intent is to be a national 501c(3)
organization that operates in partnership with the FDA.
•
The PPP relationship was
formalized with the signing of a Memorandum of Understanding between
LifeScience Alley, Inc., a Minnesota trade association, and the FDA on December
7, 2011. In August 2012, Articles of Incorporation were filed to formally
establish the MDIC.
•
Membership and participation in the MDIC will be open to
representatives of organizations that are substantially involved in medical
and/or medical device research, development, treatment, or education; the
promotion of public health; or who have expertise in regulatory science.
Governance Structure
The MDIC will be governed
by a Board of Directors that will oversee the MDIC’s subcommittees and assist
in identifying sources of funding. Subcommittees will represent industry
sectors or technology areas (eg. Modeling, interoperability, orthopedics,
neurological devices).
•
Each subcommittee will be
responsible for establishing working groups chartered with identifying key
issues affecting their industry segment.
•
The working groups will
bring forward project plans for prioritization and funding allocation.
What We Do
Strategies
The MDIC will pursue
several strategies in support of its mission:
1.
Create a forum for
collaboration and dialogue, working within a flexible governance structure to
encourage broad participation from the different industry stakeholders
including FDA.
2.
Make strategic investments
in regulatory science, utilizing working groups to identify and prioritize key
issues and to request, evaluate, and implement project proposals that support
the MDIC’s mission.
3.
Provide tools to drive
cost effective innovation, emphasizing education and the development of new
methods and approaches with well documented data and details to enable
implementation.
Value
The activities and output from the MDIC will:
•
Ensure innovative technology is readily available to U.S.
patients
•
Make the medical device regulatory process more
expeditious, transparent and effective
•
Reduce the risk and expense of clinical research
•
Reduce the time and cost of medical device development
Projects
The MDIC will accept
project proposals specifically focused on advancing medical device regulatory
science.
After the initial meeting
of the MDIC Board of Directors (early in CY13), the first sector subcommittees
will be commissioned.
•
The subcommittees will
organize working groups to develop rigorous project plans for prioritized
topics.
•
Detailed project plans
will be used to solicit project specific funding from companies who will
benefit from their outcome and foundations interested in supporting the
initiative.
The advantages of
conducting research within the MDIC include:
•
Involvement of the FDA at
all stages of the work thereby building awareness of and support for specific
product development tools and approaches.
•
The ability to share best
practices across industry and academia.
•
Exposure to a range of perspectives representing
multiple constituents which can ensure more robust project development
and data interpretation.
•
A mechanism for sharing
the expense of research in the regulatory science, non-competitive domain.
TOP
Join
The core operations of the
MDIC are funded through contributions from members.
•
Pricing for annual
membership is determined based upon the operating expenses for the MDIC.
•
The goal is to keep the
membership low enough to encourage broad, cross-industry participation while
still meeting the operational needs of the organization.
•
It is anticipated that as
the membership base is increased, there is the potential that the dues per
member will decrease.
Membership will be offered
at several levels based on organization type and, if applicable, annual
revenue. Project specific funding will be obtained from companies and
foundations as a result of working group development of rigorous project plans.
•
$150,000 contribution
annually: Companies with annual revenue >$10 B
•
$100,000 contribution
annually: Companies with annual revenue between $5–10 B
•
$50,000 contribution
annually: Companies with annual revenue between $1–4.9 B
•
$10,000 contribution
annually: Companies with annual revenue <$1 B
•
$5,000 contribution annually: Nonprofit Sector
Benefits of Membership
The MDIC will provide its
members with:
•
A mechanism through which
to influence the future of the medical device industry by virtue of direct,
collaborative discussions and projects with FDA.
•
A process for identifying,
documenting, prioritizing and removing issues affecting the industry.
•
Processes, policies,
support staff and pooled project funding to enable efficient regulatory science
research in areas of strategic importance to the industry.
•
Educational forums in
which to learn about the evolving regulatory science process, new tools,
standards and test methods.
•
Searchable databases and
links to relevant reports and methods.
•
Regular updates on the
status of the MDIC’s activities and opportunities for involvement.
TOP
Contact Us
To receive further
information and to discuss next steps and membership details, please contact:
Maura Donovan, Ph.D.
Interim Executive Director, MDIC
763-505-4515
maura.donovan@medtronic.com
or
Dale Wahlstrom
CEO of LifeScience
Alley
952-542-3077
dwahlstrom@biobusinessalliance.org
TOP
Press
Minnesota Device-Makers
Join Forces with FDA to Advance Regulatory Science
Regulatory Intelligence | Posted: 8 December 2011
Minnesota-based medical device lobbying group, LifeScience Alley, signed a memorandum of understanding with
the US Food and Drug Administration (FDA), making official a year-long
partnership to continue developing best practices in regulatory science. Center
for Devices & Radiological health chief Dr. Jeffrey Shuren signed the
memorandum, formalizing more than a year of joint effort toward developing
regulatory science — a set of tools and methods for evaluating the safety,
effectiveness, quality and performance of medical devices. If the pilot version
of the program works in Minnesota, it may serve as a national model for device
safety and clearance. (Mass Device)
Join the discussion on Regulatory Exchange
http://www.massbio.org/news/181-sen_brown_co-chairs_medical_technology_caucus/news_detail
Sen. Brown co-chairs Medical
Technology Caucus
April
4, 2011
WASHINGTON, DC— U.S.
Senators Scott Brown (R-MA) and Amy Klobuchar (D-MN) announced today
that they will serve as
co-chairs for the new Senate
Medical Technology Caucus in the 112th Congress. The caucus aims to increase awareness about issues
facing the medical technology sector, an industry that creates life-saving
and life-enhancing innovations that improve patient care.
“In Massachusetts, we have more than 200 medical device
companies and hundreds of bio and pharma companies, all of which provide
good-paying jobs to thousands of citizens,” Brown said. “It is critical that we
provide a business environment for them to innovate, grow and thrive. I’m
pleased to be the Republican chair of this bipartisan caucus, and look forward
to working with my colleagues on both sides of the aisle to give our medical device and
technology companies the tools and resources they need to continue their
important work.”
“These businesses not only spark
medical breakthroughs, they save lives,” Klobuchar said. “Every day in
every state small medical technology companies are driving the innovation
agenda we need to compete in a global economy. I will continue to work to
make sure that Minnesota remains a leader in health care innovation by
developing innovative products while maintaining patient safety.”
The
United States is the world’s only net exporter of medical devices, with a
$5.4-billion annual trade surplus. Minnesota is home
to 400 medical device practices that support over 50,000 jobs in the state. The
industry provides good-paying jobs to more than 400,000 Americans, with total direct and indirect
employment exceeding two million.
Klobuchar has led
the effort to cut red tape that threatens innovation in
this industry. After a December report surveyed over 200 medical technology
companies and found that confusing and contradictory regulations are stifling
innovation, Klobuchar and Brown pushed the Food and Drug Administration (FDA)
to reform its slow and inconsistent 510(k) approval process for medical devices
to maintain safety, protect patients, and encourage innovation. Klobuchar is
the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation,
and Export Promotion, and plans to hold a hearing to examine the medical device
approval process and to examine ways to improve export options.
