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News
Contact:
Humera
Fasihuddin, Principal
413-222-5400
Bud
Beaudry, Principal
413-265-3716
For
Immediate Release
EDICAL MAY
ANNOUNCES NEW ADVISORS
Former
Deputy Director of Medicare/Medicaid and President of FDA
Regulatory Approval Consulting Firm join Advisory Board
Chicopee, MA – July 1, 2005 -
Massachusetts firm, Edical May, announced today that it has
added Dick Coyne, the former deputy director of Medicare’s
Coverage and Analysis Group, and William Morton, the president
of Medical Device Consultants Inc., to its advisory board. The
move enables client companies access to highly-connected and
knowledgeable reimbursement and regulatory executives.
“Early-stage medical device
inventors often underestimate the reimbursement and regulatory
hurdles that must be addressed prior to commercialization,” said
Humera Fasihuddin of Edical May. “We rely heavily on our
advisors to vet deals and provide our client companies with
strong, aligned strategies.” Adds Bud Beaudry of Edical May,
“We’ve found that our clients value the expertise and reach-back
of our advisory board.”
As the former deputy director
of the Center for Medicare Services (CMS) Coverage and Analysis
Group, Dick Coyne was credited with leading the implementation
of a more open, accountable and predictable process for the
reimbursement of new technologies. Leading the 50-person group,
Coyne’s changes accelerated decisions that formerly took years
to a matter of months. His insights into policy and contacts
within the current administration will be invaluable in
developing Edical May client company strategy.
As founder and president of
Medical Device Consultants Inc., Bill Morton has helped hundreds
of companies gain FDA approval. Prior to founding MDCI in 1980,
he was Director of Regulatory Affairs and Clinical Studies for
AVCO Medical Products Division of AVCO Corporation.
Both Coyne and Morton join a
select group of advisors that advise Edical May clients on
important facets of medical device commercialization:
Industry and Scientific
Experience
Greg Endress: President of NeoDiagnostics, a cancer
diagnostics reference lab. Former Chief Scientific Officer of
Protedyne, a Biotech and Lab Automation company. Endress
possesses over 20 patents in his name.
Dr. Steve Richter:
President/CEO of MicroTest Laboratories, a 90-person contract
manufacturing and test organization serving the Pharmaceutical,
Biotech and Medical Device industry. Richter is a
microbiologist and former FDA scientist.
Medicare/Medicaid
Dick Coyne: Former deputy
director of Centers for Medicare & Medicaid Services.
Regulatory, FDA
Bill Morton: President/CEO of
Medical Device Consultants Inc., a FDA regulatory consulting
practice.
Finance
Joseph Steig: Chief Financial
Officer, Entrepreneur and Director of River Valley Investors,
Angel Investor Network.
Political
Jeff Ciuffreda: Vice President
of Legislative Affairs for the Greater Springfield Chamber of
Commerce and the Western Mass Economic Development Council.
Registered lobbyist and aid to former Congressman Sylvio Conti.
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ABOUT Edical May
The mission of Edical May is to enable
entrepreneurs, surgeons, engineers and other innovators to
successfully commercialize new medical devices. Through its
extensive contact base and manufacturing capability, Edical May
helps customers ramp-up quickly and gain significant traction in
their respective marketplaces. By providing a personalized,
hands-on-approach and a strong business development savvy,
Edical May works to increase the opportunities of its customer’s
success in the medical device industry. The team brings an
extensive and diverse contact base in support of any given
business opportunity, on top of eighty years of combined
manufacturing and medical devices experience in plastics,
precision machining, electronics and assembly. Team members have
worked with such companies as Boston Scientific, Laerdal,
Genzyme, Respironics and Abbott Laboratories. For more about
Edical May, visit
www.edicalmay.com or
call 413-593-3568.
Biographies:
DICK COYNE
Dick Coyne recently completed a career of more than 34 years
with the Federal Government. 24 of those years were with the
Centers for Medicare and Medicaid Services (CMS), serving in
increasingly responsible positions. From 1998 until July of
2004, Dick was the Deputy Director of the Coverage and Analysis
Group of CMS. In that capacity, he played a major role in
designing, implementing and operating an evidence-based process
to make decisions on which new and controversial medical
technologies Medicare would cover on a nationwide basis. These
decisions impacted millions of lives and hundreds of millions of
dollars.
Immediately preceding the Coverage assignment, Dick was the
Acting Deputy Director of the Office of Clinical Standards and
Quality, CMS. That office has oversight of the CMS Quality
Improvement Organizations; the standard setting function for
providers such as home health agencies; many of the agency
clinical quality measurement and health assessment programs; the
End Stage Renal Disease Programs, and the Coverage function.
Other assignments included Acting Director of the Office of
Intergovernmental Affairs, Director of the Office of Beneficiary
Education and Assessment, and Agency lead for developing and
implementing the breakthrough Vaccines for Children Program.
The experience, judgment and reputation as a trusted partner
that Dick developed during his career equips him well to offer
key strategic and tactical advice to parties looking to navigate
the often tricky processes of Medicare and Medicaid, FDA review
and approval and looking to build alliances to further business
interests.
WILLIAM MORTON
Bill Morton has over thirty years of experience
in the field of medical device research, development, and
regulatory compliance. Prior to founding MDCI in 1980, he was
Director of Regulatory Affairs and Clinical Studies for AVCO
Medical Products Division of AVCO Corporation. Bill has
contributed numerous publications to the scientific literature,
is a member of the Regulatory Affairs Professionals Society
(RAPS) and the American Society of Artificial Internal Organs (ASAIO).
He is on the Editorial Advisory Board for the journal Medical
Product Outsourcing and serves as Chairman of the Regulatory
Affairs Certification Board for RAPS. He holds a B.S. degree in
Materials Science from San Jose State College and is Regulatory
Affairs Certified (RAC).
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