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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
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