Tip Sheet
Contact: Cassandra Cranston |
Phone: (919) 549-7500 |
Tip Sheet for CED's MedTech 2008
TIP SHEET
Medical device and healthcare technology companies from
Maryland to Florida will gather at the Council for Entrepreneurial
Development’s MedTech 2008 on March 6, 2008, at the Fuqua
School of Business on the Duke University campus in Durham,
N.C. The event, the only one of its kind in the Southeast
and Mid-Atlantic regions, features panel discussions, expert
commentaries and networking opportunities for medical technology
companies, investors and service providers. We have developed
a few story ideas to aid in your coverage. For more information
on the conference, or to arrange interviews, please contact
Cassandra Cranston at ccranston@cednc.org or 919.226.0460.
Offshore Clinical Trials Generate Data, Speed
Approvals
With a rapidly aging population and growing demand for better
devices, treatments and diagnostics, American medical technology
companies are racing to put proven products on the market.
That means more first-in-man (FIM) studies through global
clinical trials. Why? FIM studies create significant clinical
data that can be presented to the Federal Drug Administration
in an effort to establish safety and efficacy and to secure
faster approval. Additionally, product approvals are 18
to 24 months faster in the European Union, enabling products
to get into the marketplace and establish wide usage. A
final benefit: revenues from European sales can fund trials
in the U.S. or Japan, where the process is much lengthier.
Three industry experts will discuss global clinical trials
in a panel discussion from 3P to 4P, and will be available
for interviews:
- H. Richard Davis, CTO, Tryton Medical, Inc., the Newton, Mass., maker of stents which has done extensive FIM studies in Germany and the Netherlands.
- James F. Buck, vice president of marketing and business development, InnerPulse, Inc., the RTP-based developer of an implantable cardioverter defibrillator designed to treat sudden cardiac arrest.
- John Funkhouser, president and CEO, nContact Surgical, Inc., the Morrisville-based medical device company that developed a cardiac coagulation device for the treatment of arrhythmias of the heart.
Convergence: Evaluating A Promising Trend in
Medical Technology
Convergence is one of the most promising, but elusive, trends
in advanced medical technology. Integrating drugs, devices,
nanotechnology, software and engineering into smart devices
that treat diseases, correct deformities and improve the
quality of life is the holy grail. There have been some
big successes—specially-coated stents that reduce reblocking
and spinal fusion to connect bones of the back with metal
cages and proteins—but in general, it’s hard to determine
which technologies can converge effectively. Complicating
the matter further is the fact that most companies don’t
have all the elements necessary to build these convergent
solutions, meaning that several organizations must collaborate
to create the ultimate product. A panel of experts from
the front lines of convergence will share their thoughts
from 1:45P to 3P, and will be available for interviews:
- Fred McCoy, vice chairman, Synecor LLC, an RTP-based business generator and financial incubator of new medical device companies with offices in Santa Rosa and Silicon Valley, Calif.
- Geoffrey Erickson, Ph.D., president and CEO of Humacyte, Inc., an Orlando-based company that grows medical devices from human cells to integrate easily within the body and act as replacement tissues.
- John J. Smith, M.D., J.D., partner, Hogan & Hartson LLP, a Washington, D.C.-based law firm with 22 offices worldwide and a strong regulatory affairs practice.
LOCAL ANGLE ON CONVERGENCE: Some of the leading sources of convergent technology are right here in the Triangle. If the future is drugs on devices and software on devices, then the Research Triangle area—traditionally strong in pharmaceuticals and software development—is uniquely positioned to be at the forefront of this exciting new era in medicine. Several local companies working on convergence will be at MedTech 2008, including Humacyte (see above), Alnis BioSciences, Inc. (RTP-based developer of a nanotechnology solution to cancer drug delivery and tumor detection); and Liquidia Technologies (Morrisville-based developer of drug delivery systems using nanotechnology).
LOCAL ANGLE: Advanced Medical Technologies are
Big Business in North Carolina
Small devices are big business in the Old North State according
to "North Carolina's Strategic Plan for Advanced Medical
Technologies", a report by the N.C. Biotechnology Center.
The report notes that 31 medical technology companies have
opened in the state since 2001. Statewide medical device
industry employment has increased about 17 percent over
the last 10 years to 7,200, with 2006 average wages of $40,648.
The industry is forecast to bring $9.5 billion to North
Carolina within the next year. Between 1999 and 2006, more
than $545 million in private and public equity has been
raised so far by Tar Heel medical device, diagnostics and
medical information technology companies. Learn more about
what’s driving growth in this sector of the state’s economy,
and meet the companies that are doing it at MedTech 2008.
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