FDA Medical Device Industry Coalition

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Industry Associations

Advanced Medical Technology Association (AdvaMed)

AdvaMed is the world's largest medical technology association representing manufacturers of medical devices, diagnostic products and medical information systems. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, please visit www.advamed.org.

Primary Representative – Michael Bollinger
Smith & Nephew Endoscopy
76 S. Meridian Avenue
Oklahoma City, OK 73107
michael.bollinger@smith-nephew.com
(405) 917-8584

Alternate Representative – Brian Blankenship
Smith & Nephew Endoscopy
76 S. Meridian Avenue
Oklahoma City, OK 73107
brian.blankenship@smith-nephew.com
(405) 917-8556

American College of Clinical Engineering (ACCE)

Founded in 1990, ACCE is committed to enhancing the profession of clinical engineering. With members in the USA and around the world, ACCE is the only professional society for clinical engineers with international recognition. Fore more information, please visit www.accenet.org.

Primary Representative – Steven Juett
RTKL Healthcare Technologies
1717 Pacific Avenue
Dallas, TX 75201
SJuett@RTKL.com
(214) 468-7908

Alternate Representative - George E. Maliakal
Baylor University Medical Center
3500 Gaston Ave.
Dallas, TX 75246
georgmal@baylorhealth.edu
(214) 820-7424

American Society for Quality (ASQ) Biomedical Division

ASQ Biomedical Division is a leader in providing educational information to the medical device community through publications, website, discussion groups, and conferences. One of the organization's primary objectives is providing information and learning opportunities relating to quality for the worldwide biomedical community. For more information, please visit www.asq.org/biomed/.

Primary Representative – Cheryl Boyce
Boyce Consulting
4007 Cedarview Road
Dallas, TX 75257
cab@boyceconsulting.com
(972) 250-0778

Alternate Representative – Rebecca Ellis
OsteoMed LP
3885 Arapaho Road
Addison, TX 75001
rellis@osteomed.com
(972) 677-4787

BioAustin

Austin Chamber of Commerce, Bio AustinBioAustin, formed under the auspices of the Austin Chamber of Commerce, represents over 100 life science companies with over 7,000 employees operating in the five-county Austin and Central Texas region. Companies included in BioAustin operate in the areas of bio-related activities including research, diagnostics, reference laboratories, pharmaceutical, CRO, medical device, agbio and bioveterinary. For more information, please visit http://www.bioaustin.com/.

Primary Representative - Randall Thoma, PhD
Zimmer, Inc.
9301 Amberglen Blvd., Bldg. J, Suite 100
Austin, TX 78729
randy.thoma@zimmer.com
(512) 506-3810

Alternate Representative - Vacant

Contact Lens Manufacturers Association (CLMA)

CLMA organized in 1961, is made up of contact lens laboratories and material, solution and equipment manufacturers in the United States and abroad. The mission of the CLMA is to increase awareness and utilization of custom manufactured contact lenses. For more information, please visit www.clma.net.

Primary Representative – Naomi “Jo” Svochak
Tru-Form Optics, Inc.
400 S. Industrial Blvd., Ste 100
Euless, TX 76040
Jo_Svochak@tfoptics.com
(817) 267-9261 ext. 212 or 312

Alternate Representative – Vacant

Medical Device Manufacturers Association (MDMA)

Since 1992, MDMA has been the chief advocate of the research-based entrepreneurial sector of the medical device industry. MDMA represents over 200 innovators and manufacturers of medical devices, diagnostic products and health care information systems. For more information, please visit www.medicaldevices.org.

Primary Representative – Vacant

Alternate Representative – Vacant

Regulatory Affairs Professionals Society (RAPS)

RAPS is the foremost worldwide member organization creating and upholding standards of ethics, credentialing and education for the regulatory affairs (RA) profession within the health product sector. RAPS is a nonprofit educational/scientific organization with headquarters in Rockville, MD, and members in 45 countries. For more information, please visit www.raps.org.

Primary Representative – Audrey Swearingen (Industry Co-Chair)
Zimmer Orthobiologics
9301 Amberglen Blvd, Suite 100
Austin, TX 78729
audrey.swearingen@zimmer.com
(512) 506-3295

Alternate Representative – Al Alonso
DJO Surgical
9800 Metric Boulevard
Austin, TX 78758
al.alonso@djosurgical.com
(512) 834-6235

Government Agencies

US Food and Drug Administration (FDA)

FDA is one of the nation's oldest and most respected consumer protection agencies. FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, to monitor products for continued safety after they are in use, and to help the public get the accurate, science-based information needed to improve health. For more information, please visit www.fda.gov.

FDA Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, TX 75204

Reynaldo Rodriguez
District Director
reynaldo.rodriguez@fda.hhs.gov
(214) 253-5201

Scott Nichols
Supervisory Consumer Safety Officer
scott.nichols@fda.hhs.gov
(214) 253-5248

Sue Thomason
Senior Support Specialist
sue.thomason@fda.hhs.gov
(214) 253-5203

FDA Southwest Regional Office
4040 N. Central Expressway, Suite 900
Dallas, TX 75204

David Arvelo (Regulatory Co-Chair)
Small Business Representative
david.arvelo@fda.hhs.gov
(214) 253-4952

Texas Department of State Health Services (DSHS)

DSHS provides programs that help protect all Texans from illness, prevent the spread of disease, provide direct health services and promote emergency preparedness. With the consolidation of the four agencies, DSHS now includes treatment and prevention for mental illness and substance abuse in its public health framework. The focus is on improving the health of all Texans. For more information, please visit www.dshs.state.tx.us.

Department of State Health Services
1100 West 49th Street
Austin, TX 78756-3199
(512) 834-6755

Tom Brinck
Group Manager, Drugs & Medical Devices
tom.brinck@dshs.state.tx.us

Jeff Mansell
Medical Device Compliance Officer
jeff.mansell@dshs.state.tx.us

Academic Institution

Texas A&M University

Texas A&M University is a land-grant, sea-grant and space-grant institution located in College Station, Texas. The fundamental mission of the Department of Biomedical Engineering is to serve the growing biotechnology and biomedical device industry in Texas via technology transfer and educating the workforce, and to serve our profession through the discovery and dissemination of knowledge. For more information, please visit biomed.tamu.edu.

Dr. William Hyman
Professor
Biomedical Engineering
Texas A & M University
College Station, TX 77843-3120
w-hyman@tamu.edu
(979) 845-5593

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Last modified: 12/03/07