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                   Tijuana: North America’s

                   Medical Device Manufacturing Capital



                                       June 2012
Tijuana: the Capital for Medical Device Manufacturing
Deciding where to grow your company should always include an objective analysis of real
information – using facts, independent professional assessments, and looking at the true
experiences of other companies and their executives. The medical device industry is no
different, and in today’s highly competitive (and regulated) environment, it can sometimes
come as a surprise that the quality, IP protections, lower-cost and logistical benefits of the
City of Tijuana have allowed it to grow the largest concentration of medical device
manufacturing employment in North America.
                                                                                          2010/2012 Medical Device Mfg
It’s a bold statement, but one backed up by a healthy dose of facts                        Employment in Key Regions*
about today’s Tijuana. As seen at right, Tijuana actually leads in
                                                                                               City of Tijuana*                                31,079
employment levels amongst all other medical device manufacturing
regions of North America1 – with over 31,000 employees in 2012.                       Minneapolis-St. Paul                                22,099
                                                                                               New York State                          18,233
Tijuana is also only minutes from Downtown San Diego, and (with                                  Boston Metro                        15,229
nearly 1.7 million residents) it’s the second-largest city on the                               Chicago Metro                        12,789
West Coast of North America. The next few pages are meant to                            Los Angeles County                          12,570
provide a fact-based introduction to help potential investors
                                                                                                Michigan State                      11,261
understand why – in 2012 – Tijuana is not only still the number-
                                                                                               Orange County                        11,528
one city in Mexico for the number of nearshore, maquiladora
(IMMEX) manufacturing companies2, but also a leading city on                               San Diego County                         10,360

the frontiers of medical device manufacturing.                                          Santa Clara County                          9,859
                                                                                    *data for Q2-2012   *see endnotes for estimation methodology used



A Growing Cluster of Medical Device Firms
As of Q2-2012, there were at least 40 medical device manufacturers operating in Tijuana,
making a wide range of high- and low-tech products including: dentures, electronic
thermometers, hemodialysis components, infusion pumps, IV administration sets, lenses,
nebulizers, orthopedic braces, oximeters, pacemakers, stents, surgical kits and equipment,
urinary catheters, wheelchairs, x-ray film marking systems3 – and much more. While most of
these companies are stand-alone subsidiaries, there are also at least 14 medical device
contract manufacturers, as well as companies using shelter maquiladora services. As seen
below, the number of employees also continues to grow in this sector, with over 11,000 positions
added and an average annual growth rate of 7.2% since 20044.

                                                                                             Tijuana's Medical Device
                            “I don’t think that many of us in San                           Manufacturing Employment
                            Diego were fully aware of the
                            quality      of     medical     device                  35,000
                            manufacturing in Tijuana…I can                          30,000
                            certainly      confirm     they    are
                                                                                    25,000
                            comparable to facilities found in the
                                                                                                                                               31,079
                                                                                                                                      30,070
                                                                                                                           27,280




                            United States.       I have no doubt                    20,000
                                                                                                                 22,060
                                                                                                        19,690




                            device companies will be looking at                     15,000
                            the opportunities there firsthand,
                                                                                    10,000
                            just as I did.” 5
                                                               -Joe Panetta          5,000
                                                                          CEO              -
                                     November 25, 2009 edition of Biocommunique 5
                                                                      BIOCOM                        2004 2006 2008 2010 2012




                         www.TijuanaEDC.org || contact@tijuanaedc.org
Call us toll free from the US & Canada: 1-855-558-5332 ||    ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788
Why Mexico and Why Tijuana? The Experts Agree…
Competing in a global environment isn’t just a goal, it’s often a                         KPMG Competitive
requirement for today’s medical device companies who face                                  Alternatives 2012
                                                                                         Cost Index for Medical
increasing competition from around the world. This force of
                                                                                         Device Manufacturing
globalization is, in fact, why the U.S. FDA has established 10
overseas offices to foster better international oversight and
collaboration – including one in Mexico.6                                            China                   67.8
                                                                                   Mexico                     76.7
As more options exist for offshore and nearshore manufacturing,
                                                                                     Brazil                        90.6
it’s also useful to note that Mexico was ranked as one of the
lowest-cost countries among fourteen analyzed by KPMG in their                          UK                          94.8
2012 Competitive Alternatives study. This study evaluated the                       France                          96.0
“impact of 26 significant business cost components that are most
                                                                                   Canada                           96.2
likely to vary by location”, finding (as seen at right) that Mexico
provided medical device manufacturers with more than a 23%                               US                         100.0
cost advantage compared to the U.S., as well as significant cost                 Germany                            101.2
advantages compared to other global locations – with only slightly
                                                                                              0   25   50   75 100 125
higher costs than China, but significantly lower than even Brazil. 7

Also notable: while many regions market themselves as possible locations for globally-expanding
companies, no other international city offers the unique combination of:
       A large base of 40+ existing medical device manufacturers;
       A “next-door”, nearshore location to the U.S. with quick logistical access to the West
       Coast, and adjacent to several major
       international seaports and airports;
       A trained, quality-conscious and highly                     Using sample data derived from industry
       bilingual workforce – in a low union,                       representatives and the Tijuana EDC,
       business-friendly environment;                              significant savings can be gained for
       Strong intellectual property-rights                         both smaller and larger medical device
       protections guaranteed via NAFTA, TRIPS,                    manufacturing operations in Tijuana:
       and other Free Trade Agreements; and
       Savings with lower-cost (as seen in the
       sample at right8), just-in-time production
       capabilities and experience.



                “I have been involved with three
                global companies all over the
                world. At the end of the day,
                Tijuana is one of the best options
                for quality, service and cost – not
                to mention a prime location.”
                                 -Gerardo de la Concha
                                  VP Operations Mexico
                                      Medtronic Mexico



                         www.TijuanaEDC.org || contact@tijuanaedc.org
Call us toll free from the US & Canada: 1-855-558-5332 ||   ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788
Access to Customers &
      Suppliers
      Just-in-time production isn’t
      just a theoretical concept for
      Tijuana’s medical device
      companies – it’s a real,
      strategic logistical benefit
      that allows many of the city’s
      manufacturers to not only
      reduce or avoid inventories,
      but also to ship finished
      product into the U.S. market
      in as little as a few hours.

      Physically located only 15-
      minutes from downtown San
      Diego, California, companies
      operating in Tijuana are both
      easy to access for corporate
      communications and control,
      and actually have easy access
      to transportation infrastructure so medical device products can be trucked to anywhere in the
      U.S. within one- to five-days (with global or time-sensitive shipments flown from SAN, LAX, SNA,
      TIJ and other cargo airports to customers in only hours).

      Great access isn’t just about geographic proximity – it’s also what medical device manufacturers
      get with their suppliers. Tijuana’s existing medical device companies already take advantage of
      a well-developed network of suppliers – many of them in Southern California and the Southwest
      United States. These networks grow larger each year with industry-sponsored “Supplier Day”
      events that are organized in Tijuana as yet another way to support the medical device cluster
      (note: the next supplier event is scheduled for June 13, 2012).

      This high-degree of industry access and cooperation, in fact, has attracted another key supplier
      to Tijuana: the e-beam sterilization provider, Avantti Mediclear, expected to be in operation by
      2013, and located adjacent to the binational cargo facilities at the Otay Mesa Port of Entry9.


Nearly all of Tijuana’s 40+ medical device manufacturing firms operate under FDA or CE marking
regulatory requirements (depending on final market for products, and if a regulated device). In
addition, over 90% of all manufacturing firms with 250+ employees are certified under ISO
13485, ISO 9000 or other quality management standards. Below are just a few of the medical
device firms currently growing in the world-class manufacturing city that is Tijuana:




                               www.TijuanaEDC.org || contact@tijuanaedc.org
      Call us toll free from the US & Canada: 1-855-558-5332 ||   ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788
Tijuana: the Future Outlook
The City of Tijuana offers a wide range of benefits for companies in the medical device
manufacturing sector. Its well-trained, highly-bilingual workforce has not only attracted
companies from California and the U.S., but also from around the world – including Germany,
Singapore, Sweden, New Zealand, Iceland, and other locations in Asia and Europe. These
globally-competitive companies have helped Tijuana grow
the largest concentration of medical device manufacturing
employment in North America – and in the process they              Tijuana’s changing. To learn more,
have gained from the city’s lower-cost production, strong          come visit us at the only Gold LEED-
IP protections, immediate proximity to U.S. customers and          certified building in Northwest
transportation hubs, and supplier networks.                        Mexico – home to the Tijuana EDC.
Industry synergies have also led to a growing number of at
least 14 medical device contract manufacturers, the
formation of the 25+ member public-private Medical
Device Cluster of the Californias (a trade group based in
Tijuana), and other opportunities connecting life sciences
firms and research institutions in the Cali-Baja Mega
Region and throughout Southern California. As Tijuana
becomes better known as North America’s capital for the
medical device manufacturing industry, it’s not hard to
imagine that the Tijuana-San Diego Bio Border will
continue to evolve, and remain a prime location for life
sciences-related manufacturing and development for
decades to come.

For more information about this Analysis, or about investing in the City of Tijuana,
contact the Tijuana Economic Development Corporation at 1-855-55-TJEDC from
the US or Canada – or email us at contact@tijuanaedc.org

1
 US regional data derived from Crossborder Group analysis of 2010 NAICS-based employment data from U.S. Bureau of
Labor Statistics’ Quarterly Census of Employment and Wages (http://www.bls.gov/cew/data.htm) accessed April 2012.
County- and State-level data for NAICS codes 325413, 333314, 334510,334516, 334517, 339112, 339113, 339114, and 339115
was aggregated to measure “medical device manufacturing” industry employment in each area in the US. Data from Tijuana
based on Crossborder Group survey of 34 medical device firms in Tijuana, plus employment estimates for 7 firms; data for
Chicago Metro region based on 2010 BLS CES data for NAICS codes 325413, 333314, 334510,334516, 334517, and 3391.
2
 INEGI firm data for Industria manufacturera, maquiladora y de servicios de exportación (IMMEX) industry, accessed June
2012 (http://ow.ly/buiEb)
3
 Research by Crossborder Group of FDA medical device database, interviews with company represent atives, and Baja
California’s Medical Device Cluster trade group (http://www.industriamedica.org/).
4
 Tijuana medical device industry survey of 41 firms (34 complete responses) performed by Crossborder Group (May-June
2012). Company representatives verified approximate average employment over previous 60 days (to avoid seasonal
variations).
5
    Quotation from Nov. 25, 2009, BIOCOM newsletter (http://www.biocom.org/bcq/archive/44/cover_story/).
6
    “FDA Expands Presence Outside U.S. with Opening of Mexico City Post,” FDA press release (Dec. 15, 2009).
7
  “Competitive Alternatives: KPMG’s Guide to International Business Location – 2012 Edition”, p. 24-25
(http://www.competitivealternatives.com/).
8
    Cost estimate based on average US and Tijuana manufacturing industry wages; source: the Tijuana EDC.
9
    El Economista article, May 2012 (http://eleconomista.com.mx/estados/2012/05/29/faltan-empresas-esterilizacion-baja-california)




                                  www.TijuanaEDC.org || contact@tijuanaedc.org
Call us toll free from the US & Canada: 1-855-558-5332 ||                  ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788

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2012: "Tijuana: North America's Medical Device Manufacturing Capital"

  • 1. photo courtesy of Medegen/Carefusion photo: Antonio Mercado Tijuana: North America’s Medical Device Manufacturing Capital June 2012
  • 2. Tijuana: the Capital for Medical Device Manufacturing Deciding where to grow your company should always include an objective analysis of real information – using facts, independent professional assessments, and looking at the true experiences of other companies and their executives. The medical device industry is no different, and in today’s highly competitive (and regulated) environment, it can sometimes come as a surprise that the quality, IP protections, lower-cost and logistical benefits of the City of Tijuana have allowed it to grow the largest concentration of medical device manufacturing employment in North America. 2010/2012 Medical Device Mfg It’s a bold statement, but one backed up by a healthy dose of facts Employment in Key Regions* about today’s Tijuana. As seen at right, Tijuana actually leads in City of Tijuana* 31,079 employment levels amongst all other medical device manufacturing regions of North America1 – with over 31,000 employees in 2012. Minneapolis-St. Paul 22,099 New York State 18,233 Tijuana is also only minutes from Downtown San Diego, and (with Boston Metro 15,229 nearly 1.7 million residents) it’s the second-largest city on the Chicago Metro 12,789 West Coast of North America. The next few pages are meant to Los Angeles County 12,570 provide a fact-based introduction to help potential investors Michigan State 11,261 understand why – in 2012 – Tijuana is not only still the number- Orange County 11,528 one city in Mexico for the number of nearshore, maquiladora (IMMEX) manufacturing companies2, but also a leading city on San Diego County 10,360 the frontiers of medical device manufacturing. Santa Clara County 9,859 *data for Q2-2012 *see endnotes for estimation methodology used A Growing Cluster of Medical Device Firms As of Q2-2012, there were at least 40 medical device manufacturers operating in Tijuana, making a wide range of high- and low-tech products including: dentures, electronic thermometers, hemodialysis components, infusion pumps, IV administration sets, lenses, nebulizers, orthopedic braces, oximeters, pacemakers, stents, surgical kits and equipment, urinary catheters, wheelchairs, x-ray film marking systems3 – and much more. While most of these companies are stand-alone subsidiaries, there are also at least 14 medical device contract manufacturers, as well as companies using shelter maquiladora services. As seen below, the number of employees also continues to grow in this sector, with over 11,000 positions added and an average annual growth rate of 7.2% since 20044. Tijuana's Medical Device “I don’t think that many of us in San Manufacturing Employment Diego were fully aware of the quality of medical device 35,000 manufacturing in Tijuana…I can 30,000 certainly confirm they are 25,000 comparable to facilities found in the 31,079 30,070 27,280 United States. I have no doubt 20,000 22,060 19,690 device companies will be looking at 15,000 the opportunities there firsthand, 10,000 just as I did.” 5 -Joe Panetta 5,000 CEO - November 25, 2009 edition of Biocommunique 5 BIOCOM 2004 2006 2008 2010 2012 www.TijuanaEDC.org || contact@tijuanaedc.org Call us toll free from the US & Canada: 1-855-558-5332 || ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788
  • 3. Why Mexico and Why Tijuana? The Experts Agree… Competing in a global environment isn’t just a goal, it’s often a KPMG Competitive requirement for today’s medical device companies who face Alternatives 2012 Cost Index for Medical increasing competition from around the world. This force of Device Manufacturing globalization is, in fact, why the U.S. FDA has established 10 overseas offices to foster better international oversight and collaboration – including one in Mexico.6 China 67.8 Mexico 76.7 As more options exist for offshore and nearshore manufacturing, Brazil 90.6 it’s also useful to note that Mexico was ranked as one of the lowest-cost countries among fourteen analyzed by KPMG in their UK 94.8 2012 Competitive Alternatives study. This study evaluated the France 96.0 “impact of 26 significant business cost components that are most Canada 96.2 likely to vary by location”, finding (as seen at right) that Mexico provided medical device manufacturers with more than a 23% US 100.0 cost advantage compared to the U.S., as well as significant cost Germany 101.2 advantages compared to other global locations – with only slightly 0 25 50 75 100 125 higher costs than China, but significantly lower than even Brazil. 7 Also notable: while many regions market themselves as possible locations for globally-expanding companies, no other international city offers the unique combination of: A large base of 40+ existing medical device manufacturers; A “next-door”, nearshore location to the U.S. with quick logistical access to the West Coast, and adjacent to several major international seaports and airports; A trained, quality-conscious and highly Using sample data derived from industry bilingual workforce – in a low union, representatives and the Tijuana EDC, business-friendly environment; significant savings can be gained for Strong intellectual property-rights both smaller and larger medical device protections guaranteed via NAFTA, TRIPS, manufacturing operations in Tijuana: and other Free Trade Agreements; and Savings with lower-cost (as seen in the sample at right8), just-in-time production capabilities and experience. “I have been involved with three global companies all over the world. At the end of the day, Tijuana is one of the best options for quality, service and cost – not to mention a prime location.” -Gerardo de la Concha VP Operations Mexico Medtronic Mexico www.TijuanaEDC.org || contact@tijuanaedc.org Call us toll free from the US & Canada: 1-855-558-5332 || ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788
  • 4. Access to Customers & Suppliers Just-in-time production isn’t just a theoretical concept for Tijuana’s medical device companies – it’s a real, strategic logistical benefit that allows many of the city’s manufacturers to not only reduce or avoid inventories, but also to ship finished product into the U.S. market in as little as a few hours. Physically located only 15- minutes from downtown San Diego, California, companies operating in Tijuana are both easy to access for corporate communications and control, and actually have easy access to transportation infrastructure so medical device products can be trucked to anywhere in the U.S. within one- to five-days (with global or time-sensitive shipments flown from SAN, LAX, SNA, TIJ and other cargo airports to customers in only hours). Great access isn’t just about geographic proximity – it’s also what medical device manufacturers get with their suppliers. Tijuana’s existing medical device companies already take advantage of a well-developed network of suppliers – many of them in Southern California and the Southwest United States. These networks grow larger each year with industry-sponsored “Supplier Day” events that are organized in Tijuana as yet another way to support the medical device cluster (note: the next supplier event is scheduled for June 13, 2012). This high-degree of industry access and cooperation, in fact, has attracted another key supplier to Tijuana: the e-beam sterilization provider, Avantti Mediclear, expected to be in operation by 2013, and located adjacent to the binational cargo facilities at the Otay Mesa Port of Entry9. Nearly all of Tijuana’s 40+ medical device manufacturing firms operate under FDA or CE marking regulatory requirements (depending on final market for products, and if a regulated device). In addition, over 90% of all manufacturing firms with 250+ employees are certified under ISO 13485, ISO 9000 or other quality management standards. Below are just a few of the medical device firms currently growing in the world-class manufacturing city that is Tijuana: www.TijuanaEDC.org || contact@tijuanaedc.org Call us toll free from the US & Canada: 1-855-558-5332 || ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788
  • 5. Tijuana: the Future Outlook The City of Tijuana offers a wide range of benefits for companies in the medical device manufacturing sector. Its well-trained, highly-bilingual workforce has not only attracted companies from California and the U.S., but also from around the world – including Germany, Singapore, Sweden, New Zealand, Iceland, and other locations in Asia and Europe. These globally-competitive companies have helped Tijuana grow the largest concentration of medical device manufacturing employment in North America – and in the process they Tijuana’s changing. To learn more, have gained from the city’s lower-cost production, strong come visit us at the only Gold LEED- IP protections, immediate proximity to U.S. customers and certified building in Northwest transportation hubs, and supplier networks. Mexico – home to the Tijuana EDC. Industry synergies have also led to a growing number of at least 14 medical device contract manufacturers, the formation of the 25+ member public-private Medical Device Cluster of the Californias (a trade group based in Tijuana), and other opportunities connecting life sciences firms and research institutions in the Cali-Baja Mega Region and throughout Southern California. As Tijuana becomes better known as North America’s capital for the medical device manufacturing industry, it’s not hard to imagine that the Tijuana-San Diego Bio Border will continue to evolve, and remain a prime location for life sciences-related manufacturing and development for decades to come. For more information about this Analysis, or about investing in the City of Tijuana, contact the Tijuana Economic Development Corporation at 1-855-55-TJEDC from the US or Canada – or email us at contact@tijuanaedc.org 1 US regional data derived from Crossborder Group analysis of 2010 NAICS-based employment data from U.S. Bureau of Labor Statistics’ Quarterly Census of Employment and Wages (http://www.bls.gov/cew/data.htm) accessed April 2012. County- and State-level data for NAICS codes 325413, 333314, 334510,334516, 334517, 339112, 339113, 339114, and 339115 was aggregated to measure “medical device manufacturing” industry employment in each area in the US. Data from Tijuana based on Crossborder Group survey of 34 medical device firms in Tijuana, plus employment estimates for 7 firms; data for Chicago Metro region based on 2010 BLS CES data for NAICS codes 325413, 333314, 334510,334516, 334517, and 3391. 2 INEGI firm data for Industria manufacturera, maquiladora y de servicios de exportación (IMMEX) industry, accessed June 2012 (http://ow.ly/buiEb) 3 Research by Crossborder Group of FDA medical device database, interviews with company represent atives, and Baja California’s Medical Device Cluster trade group (http://www.industriamedica.org/). 4 Tijuana medical device industry survey of 41 firms (34 complete responses) performed by Crossborder Group (May-June 2012). Company representatives verified approximate average employment over previous 60 days (to avoid seasonal variations). 5 Quotation from Nov. 25, 2009, BIOCOM newsletter (http://www.biocom.org/bcq/archive/44/cover_story/). 6 “FDA Expands Presence Outside U.S. with Opening of Mexico City Post,” FDA press release (Dec. 15, 2009). 7 “Competitive Alternatives: KPMG’s Guide to International Business Location – 2012 Edition”, p. 24-25 (http://www.competitivealternatives.com/). 8 Cost estimate based on average US and Tijuana manufacturing industry wages; source: the Tijuana EDC. 9 El Economista article, May 2012 (http://eleconomista.com.mx/estados/2012/05/29/faltan-empresas-esterilizacion-baja-california) www.TijuanaEDC.org || contact@tijuanaedc.org Call us toll free from the US & Canada: 1-855-558-5332 || ph (011-52) 664-681-8344 | fax (011-52) 664-681-8788