Daphne Allen

October 1, 1997

5 Min Read
California Home to Almost One-Fifth of U.S. Device Industry

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1997 Column

BOTTOM LINE

The Golden State has nearly 2000 medical device manufacturers and contract manufacturers, making the Pacific the largest region for device makers in the United States.

With almost one out of every five medical device manufacturers, California tops every other state in the union. This year the Golden State boasts nearly 20% of the total number of U.S. device manufacturers with just under 2000 companies, according to figures compiled by the FDA Center for Devices and Radiological Health's Division of Small Manufacturers Assistance (DSMA).

Figure 1. A breakdown of U.S. medical device manufacturers (including contract manufacturers) showing their geographic distribution among the top six states and the remaining states.

DSMA's deputy director, Lynne Rice, has noticed little rotation among the states. "Over the years, five states—California, New York, Illinois, Massachusetts, and Texas—have consistently led the list," she explains. "Unfortunately, because DSMA doesn't factor into the statistics the types of devices the firms manufacture, we can't pinpoint whether there is a relation between products and location."

The main reasons DSMA compiles these numbers, says Rice, are for planning workshops and watching for any shifts in the industry. "We want to know where the regulated industry is so we know where to put our resources," Rice explains.

Overall, the total number of registered medical device establishments, a group that includes initial distributors of imported devices, domestic distributors, manufacturers and contract manufacturers, specification developers, rebuilders and refurbishers, contract sterilizers, and repackagers and relabelers, has also grown (Table I). Every establishment category save for one—repackagers and relabelers—has expanded. Since 1994, the number of repackagers and relabelers has been declining. But 1997's drop of 313 was the most significant, as compared to 1995's decline of 143 and 1996's decline of 132.

Establishment Types

1994

1995

1996

1997

Initial distributors of imported devices

12,162

11,446

11,378

11,502

Domestic distributors

844

830

783

862

Contract manufacturers

2,297

2,423

2,106

2,196

Manufacturers

8,993

9,043

9,132

9,252

Specification developers

2,037

2,252

2,129

2,328

Rebuilders and refurbishers

670

778

805

826

Contract sterilizers

173

179

152

158

Repackagers and relabelers

4,116

3,973

3,841

3,528

Total

31,292

30,924

30,326

30,652



Table I. A breakdown of the number of FDA-registered establishments by type in August 1994, August 1995, July 1996, and July 1997.

The number of U.S. registered medical device manufacturers, including contract manufacturers, increased only slightly (2%), from 10,230 in 1996 to 10,420 this year. Such small growth doesn't necessarily mean the industry is stagnating, however. "It is just the natural growth of the industry," says Rice. "It represents the number of firms both entering and leaving the industry. When there is even a slight growth, it means we have more firms entering than leaving."

A few states did record notable growth, such as California, Texas, and Florida, which acquired 24, 24, and 20 new firms, respectively. (See Table II for the number of manufacturers registered in each state.)

State

Manufacturersa

Percentage
of Total
Manufacturersa

Total
Establishmentsb

California

1971

18.92

4667

New York

791

7.59

2595

Illinois

633

6.07

1534

Massachusetts

587

5.63

1039

Texas

531

5.10

1162

Florida

497

4.77

1329

Pennsylvania

389

3.73

757

New Jersey

379

3.64

1026

Minnesota

334

3.21

565

Ohio

314

3.01

546

Connecticut

254

2.44

522

Michigan

253

2.43

507

Colorado

226

2.17

374

Maryland

214

2.05

470

Wisconsin

213

2.04

340

Indiana

204

1.96

335

Missouri

203

1.95

371

North Carolina

191

1.83

327

Virginia

178

1.71

432

Washington

163

1.56

389

Georgia

161

1.55

430

Arizona

157

1.51

310

Tennessee

156

1.50

291

Utah

137

1.31

212

Oregon

129

1.24

222

Puerto Rico

127

1.22

291

New Hampshire

96

0.92

148

Kansas

81

0.78

146

Oklahoma

72

0.69

138

Alabama

68

0.65

130

South Carolina

67

0.64

126

Rhode Island

66

0.63

130

Nevada

65

0.62

147

Iowa

52

0.50

90

Maine

45

0.43

76

Nebraska

45

0.43

73

Louisiana

44

0.42

93

Kentucky

42

0.40

81

Arkansas

39

0.37

77

Mississippi

37

0.36

58

New Mexico

34

0.33

58

Idaho

30

0.29

45

Vermont

26

0.25

50

West Virginia

24

0.23

42

Montana

21

0.20

35

South Dakota

21

0.20

35

Delaware

18

0.17

43

Hawaii

16

0.15

220

North Dakota

9

0.09

22

Washington, DC

7

0.07

55

Wyoming

3

0.03

7

Alaska

0

0.00

5

Guam

0

0.00

2

Virgin Islands

0

0.00

3

Totals

10,420

100.00

23,178

a Includes contract manufacturers.

b Includes initial distributors of imported devices, domestic distributors, contract manufacturers, manufacturers, specification developers, rebuilders and refurbishers, contract sterilizers, and repackagers and relabelers.

Source: FDA Division of Small Manufacturers Assistance.



Table II. State-by-state breakdown of the number of FDA-registered manufacturers and establishments as of July 30, 1997.

Home to such large FDA districts as Los Angeles and San Francisco, the Pacific region continues to contain the most manufacturers, nearly 25% of the entire industry. The Northeast region follows with just under 18% (Figure 2).

Figure 2. The number (and percent of U.S. total) of device manufacturers and contract manufacturers registered with FDA as of July 30, 1997, by region.

Copyright ©1997 Medical Device & Diagnostic Industry

About the Author(s)

Daphne Allen

Daphne Allen is editor-in-chief of Design News. She previously served as editor-in-chief of MD+DI and of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Daphne has covered design, manufacturing, materials, packaging, labeling, and regulatory issues for more than 20 years. She has also presented on these topics in several webinars and conferences, most recently discussing design and engineering trends at IME West 2024 and leading an Industry ShopTalk discussion during the show on artificial intelligence.

Follow Daphne on X at @daphneallen and reach her at [email protected].

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like