NCMD

Bringing Together North Carolina’s Medical Device Community

SBIR Seminar Introduction to NCMD

March 24, 2005 Andrew DiMeo North Carolina Medical Device Organization [email protected]

www.NCMedicalDevice.org

Phone: 919.606.1337

Fax: 919.573.9423

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Summary

• NCMD mission and vision • Why focus on medical devices?

• North Carolina’s assets • Defining the NCMD space • Target Cluster • Services • Board of Directors • Event Outlook

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NCMD Mission & Vision

• Mission: Position North Carolina’s medical device and diagnostic industry as a research, development, and production world leader • Vision: Enhance North Carolina’s medical device and diagnostic industry through public policy, networking, training, and business development

Why focus on medical devices?

• NC consistently in top

3-5 states for Biotech

, yet not positioned in the medical device market •

$94 billion market

growing at 7% per year • Creates

high paying jobs

– both in research for areas like RTP and in manufacturing in the more rural parts of the state • According to economic census data, there are currently

15,000

medical device related jobs in NC Page 4

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Why? (continued)

• Harvard Professor Michael Porter Medical devices are an “under-realized opportunity” for North Carolina • RTI International “Identify and task an organization to serve a professional catalyst role by inventorying medical device and diagnostics capabilities and needs, conducting networking events, and addressing industry needs.”

North Carolina’s Assets

• 246 medical equipment manufacturing facilities • Commitment to employer training in Bioscience by investing in programs at many community colleges • 4 world class medical schools (UNC, ECU, Duke, & Wake Forest) • 4 Biomedical Engineering programs (UNC, NCSU, Duke, & Wake Forest) • 1 of only 27 US veterinary schools (NCSU) • Leading biology experts and growing Medical Physics program (UNCC) • Growing Biomedical Engineering group (ECU) • Triangle region second only to Boston in NIH funding for medical schools

Medical Equipment Manufacturing Facilities Map prepared by the NC Dept. of Commerce Div. of Policy, Research & Strategic Planning Source: Harris InfoSource referenced August 2004

•

Legend Manufacturing Locations

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Defining the NCMD space:

…intended to affect the structure or any function of the body… Page 7 • • • • • Pharmaceutical/Drugs – Manufactured by a chemical process • Biotechnology/Biologics – Manufactured by a biological process

Medical Devices

– Mechanical, Electrical, etc.

– Neither chemical nor biological mfg. process

Combination Products

– Two or Three of the above combined/kitted –

Forecast to be a $9.5 billion market by 2009 Diagnostic Products Medical Information Systems

Target Cluster

• Research/Develop/Manufacture Medical: – Devices, combo products, diagnostics, and info systems – Platform technology for above product types • Suppliers and Service Companies – Including Contract Manufacturers • Hospitals and Clinics – Individual Clinicians – Individual Departments (such as Sports Medicine) • Academic Institutions – Individual Researchers – Departments (such as Biomedical Engineering Programs) • Any interested individual or organization Page 8

NCMD Services

• Host

Training programs & forums

with expert speakers discussing relevant topics and to promote networking • • Assemble a statewide

device & diagnostic directory Advocate for policy

to create best environment for existing & new companies, and for recruitment to NC • • Hold an

annual conference

for the state, bringing together and showcasing NC’s medical device industry • Maintain a

job board

to assist in searches for NC device & diagnostic companies

Maximize intra-state business

among existing companies to help create more jobs Page 9

• • • • • • • • • • • • • •

Board of Directors

Rich West

, Adigy CEO - NCMD Chairman and executive committee member

Peyton Anderson

, Affinergy CEO - NCMD Chair-elect & executive committee member

Sam Taylor

, Exec. VP, NCBIO - NCMD Finance Chair & executive committee member

Jeff Clark

, Managing General Partner, The Aurora Funds

Monica Doss

, President, CED - NCMD executive committee member

Geff Erickson

, Ph.D., Sr. Associate, A.M. Pappas & Associates - NCMD executive committee member

Richard Kindberg

, Sr. VP & General Manager, Medical Products Div., Teleflex Medical

Garheng Kong

, M.D., Ph.D., Partner, Intersouth Partners

Dayn McBee

, SunTech Medical CEO

Neil C. Olson

, D.V.M., Ph.D., NC State University - NCMD executive committee member

Dan Pelak

, President and CEO, Closure Medical

Bob Singletary

, Exec. Director, Research & Technology, WakeMed Health and Hospitals

Sam Tetlow

, Principal, Research Triangle Ventures

Rob Tyler

, Partner, Hutchison+Mason PLLC - NCMD executive committee member Page 10

Event Outlook

• 5/16/05 – NCMD Regulatory Forum – Patricia Love, Associate Director, FDA, Office of Combination Products – Heather Rosecrans, Director of the Premarket Notification (510(k)) Staff, FDA, Office of Device Evaluation • Aug/Sept ’05 – NC MedTech Outlook (Charlotte?) • November ’05 – ½ day device day conference • February ’06 – NCMD Meet new companies and venture forum (Winston-Salem?) Page 11