Risk and Challenges of Healthcare Systems Internationalization

Medical device manufacturers have identified “emerging markets” as their principal source of revenue growth in the coming years. However, during the last Economist’s Health Forum in Boston, major academics and industry’s players discussed the risks and challenges associated with rising demands in these countries.

The discussion explored a growing concern that the healthcare model in the United States and Europe isn’t sustainable or even necessary to meet the healthcare needs in many cultures. These nations will need to create a “more of an outpatient-oriented and prevention-oriented delivery system” that will require behavioral changes by physicians and patients.

“(...) replicating a hospital-based system in less-developed nations requires not only new infrastructure, but wholesale change in the behavior and practice of patients and physicians. (...) also demand a financial investment that even Western nations are having difficulty paying(...)” Peter Berman, a professor at Harvard University’s School of Public Health

Victor Joseph Dzau, MD, president of the Institute of Medicine brought an academic, clinical, and corporate perspective. He stated that every culture is different and needs specific solutions. “You won’t succeed unless you are really on the ground and really understand the culture”. Device companies must create local solutions to local problems in order to succeed.

References: http://www.mddionline.com/article/%E2%80%98globalization-not-americanization%E2%80%99-when-it-comes-healthcare-09-22-2014

Brazilian Health Surveillance Agency simplifies Import processes

Anvisa (Brazilian Health Surveillance Agency) is adopting actions in order to improve the import processes of healthcare products. RDC 15/2014 introduces significant changes to the Certificate of Good Manufacturing Practices and aims to help the new technologies’ registration in Brazil.

First significant change is to validate auditing reports made by third parties  (other regulatory agencies). Also, Anvisa will no longer emit certificates for lower risk products, as gloves, syringes and some surgical devices. Although this measure removes the need for inspection,  it does not change the criteria of effectiveness and security required. Finally, Brazilian Health Surveillance Agency will allow that the protocol of the certificate request is accepted to submit registration applications, maintenance and amendments of highest risk products. This means that a manufacturer will no longer need to wait  for grant of certificate to have an analysis of his products started. With the two processes happening concurrently, the time of arrival of new equipment in the market should be reduced.

References: http://saudeweb.com.br/42867/anvisa-simplifica-processo-de-importacao-de-produtos-de-saude/

Brazilian Health Devices keeps Impressing

Healthcare companies supported by Brazilian Health Devices, and ABIMO’s (Brazilian Association of Medical Devices and Equipment Industry) project, perform better than the national industry as a whole when it comes to exports. In collaboration with APEX-Brasil (Brazilian Trade and Investment Promotion Agency), the 160 medtech companies that participate in the project exported together US$ 190 million in 2012 and their main exports partners were USA, Mexico, Peru, Germany, Venezuela. While the Brazilian industry has reduced imports by 14.8% between 2011 and 2013, the healthcare companies that integrate ABIMO’s project increased their exports by 7.1%.

ABIMO and APEX-Brasil renewed their agreement to keep boosting Brazilian medical and dental devices exports. However, the Brazilian Health Devices’ Manager explained that besides boosting the exports, the Brazilian Trade and Investment Promotion Agency seeks an effective process of internationalization for Brazilian healthcare companies, focusing not only on trade expansion, but also in developing the competitiveness of Brazil.

References: http://www.abimo.org.br/modules/news/article.php?article_id=485

Outsourcing and Innovation: Medtech OEMs

Outsourcing seems to be an increasing trend in the medical device industry and it’s expected to grow by 40%, reaching US$ 12 billion by 2018. Due to the pressure companies are under to develop devices that offer real value and not just incremental benefit, OEMs are focusing on innovation and core capabilities.

As a result, medical devices companies are asking more of their contract partners, responsibilities from front-end design to back-end services including warehousing, distribution, and regulatory assistance. According to the Millennium Research Group report, “overall trends in the medical device outsourcing space indicate that [contract manufacturers] are broadening their range of services, growing organically or through acquisition to become one-stop-shop manufacturers.”

     Another trend of OEM strategy is no longer to manufacture devices in China or Mexico for distribution in the United States and Europe. Instead, these companies are making products in emerging countries for regional and local distribution.

“To line up with our global customers, who are manufacturing in Asia for Asia, Europe for Europe, and the Americas for the Americas, we need to have capabilities in each of those geographies.”

Phillips-Medisize president and CEO Matt Jennings

References: http://www.mddionline.com/article/medtech-oems-focus-innovation-suppliers-step-their-services

Brazilian Healthcare Industry: first semester of 2013

In the first semester of 2013, the Brazilian medical device sector increased 6,5% (compared to the same period of 2012). This is according to Abimed (Brazilian Association of High Technology Equipment, Products and Medical Supplies). This association represents 150 healthcare companies which are responsible for almost 60% of the Brazilian medical device sector.

According to the report, the sales were also increased by 8,6% and the sector was responsible for the creation of 3500 new jobs, both industrial and commercial sector. These numbers are way above national economy average.

The healthcare sector represents 0,6% of Brazil’s GDP, gathers 13 thousand companies responsible for 120 thousand jobs and its revenue was about US$ 9 billion in 2012.

References: http://www.abimed.org.br/notPadrao.aspx?idNoticia=110

Emerging Markets: Brazil and the Medical Device Industry

Since the 2008 crisis that took place mainly in the United States and Europe, it’s been said a lot about the opportunities in emerging countries. But one shall be careful when analyzing these markets and try to evaluate its potential as objectively as possible.

        When it comes about Brazil and the medical device industry, some challenges one may face when trying to approach this market. Some of them are the bureaucracy, strong regulatory system added to long timelines and delays, high taxes and a structure that varies according to the product which makes hard to know in advance how much the price will be for the final customer.

        However, when you overcome the language and the cultural barriers, it is all worthwhile because Brazil is a huge market, with more than 190 million people, a large public healthcare system which represents 4.1% of its GDP, a US$4 billion in imports and US$700 million in exports of medical devices.

References: http://www.emdt.co.uk/article/medical-devices-brazil-oportunity?cid=nl.emdt03

Brazilian Healthcare Market 2012: a retrospective

    As an innovative industry, the Brazilian healthcare industry exports to more than 180 countries and generates around 100 thousand jobs in the national territory. The sector is considered an important component in the Brazilian economy. And so, it is important to analyze its updated market numbers.

   ABIMO is the Brazilian Healthcare, Medical and Dental Equipment Industry Association. It releases healthcare market numbers every year. One can access some of the 2012 statistics in ABIMO’s official webpage. There are information about the healthcare national production value, productivity, investment, international trade, national production and demand, Brazilian taxes, etc. Some indicators draw more attention than others. The “healthcare national production value” is one of them, as it reached almost R$5 billion (more than US$2.17 billion) last year. “Investments” is as well an important indicator and it represented more than R$300 million (more than US$130 million) in 2012.

    Unfortunately, the Brazilian healthcare industry must be careful about the numbers of international trade (imports surpassed exports) and the national production only represents 38,9% of the national demand.

References: http://www.abimo.org.br/modules/content/content.php?page=dados-economicos

Brazilian Medical Device Sector: national supply, imports and investments

Since the domestic supply of medical devices in Brazil is not able to fulfill the Brazilian increasing demand, imports continue to be an important resource. In 2012, the country imported approximately $4 billion in medical equipment and it can hit $9 billion over the next 2 years.

To prevent Brazil from becoming too dependent on imported medical device products, the Brazilian government is trying to change this scenario. Public and private investment in healthcare research may reach $7 billion over the next four years (almost 0,30% of the GDP). These assets come from the National Bank of Economic Development (BNDES), Brazilian Innovation Agency (FINEP), National Health Ministry, Science and Technology Ministry and Pharmaceutics’ Labs. The research agenda is guided by the needs of the Brazilian Healthcare Public System (SUS).

References: http://www.qmed.com/news/brazilian-medical-device-imports-hit-9-billion-2018?cid=nl_qmed_daily

http://www.anpei.org.br/imprensa/noticias/pesquisa-em-saude-tera-investimento-de-r-13-bilhoes-em-quatro-anos/

Medical Device Industry Growth in Latin America and Brazil

Since every crisis might be seen as an opportunity, strategic measures must be taken in these days. Emerging markets can be considered as a strategic target market to escape from the international crisis. One region that is getting international medical device investors is Latin America.

Because of cost advantages, suppliers and medical OEMs are entering Latin America. The region expects a growth by double digits in the coming years. Today, the Latin America medical device market is worth U$10.5 billion and it is expected to reach US$20 billion by 2015. The exports of Costa Rica’s medical device represented 11.8% of its total exports of good. The government of Peru invested U$333 million to improve public healthcare. In 2011, Colombia imported U$799.3 million in medical equipment and supplies.

As for Brazil, the largest market in Latin America, the exports of medical device reached US$555.1 million in 2011. The growing of middle-income families and aging population makes Brazil a special target. Despite of the expected growth in the medical device industry, high import prices and a bifurcated public/private system could impede a higher expansion.

References: http://www.mddionline.com/article/latin-americas-medtech-market-growing-double-digits-infographic

http://www.mddionline.com/article/brazil%E2%80%99s-growing-economy-fuels-vascular-delivery-device-sales-despite-market-limiters

Outsourcing as the key to Competitiveness

As the industry suffers from uncertainty pressures, the trend to remain competitive is turning to outsource. A Study surveyed MD+DI’s readership about outsourcing in the medical device sector ranked a list of concerning issues for the next 5 years. Regulatory hurdles, intellectual property, R&D and device tax were the most mentioned.  

The majority of the respondents agreed that outsourcing is an answer to save costs and time. For the next five years, most of them are looking for increasing the numbers of contract service. Besides manufacturing service, companies are interested in legal and regulatory services as well as R&D and design capabilities.

US-based service providers are the most common when outsourcing a project, however Russia and Latin America are the regions that the respondents most expect to expand outsourcing activity in the coming years.

Biokyra Pesquisa e Desenvolvimento is a Brazilian medical device company that may become one of the providers to the US industry when it decides to expand its contract service to Latin America.

References: http://www.mddionline.com/article/5-years-medtech-firms-will-outsource-design-legal-and-regulatory-services-over-manufacturing

Patent Application in Brazil increases 6% in 2012

Despite the international uncertainty, patent application in Brazil increased 6% between 2011 and 2012[1]. The growth started back in 2010, after the first symptoms of the global crisis in 2008 and 2009 which reduced the numbers of patent application.

Whether in universities, companies, multinationals or research institutes, innovation is the main concern among all of them, in every sector. Not only has the production raised but also the need for intellectual protection in a large emerging market.

Growing demand claims for more efficiency. The INPI (Brazilian National Institute of Intellectual Property) is taking its steps towards better efficiency by offering the inventors a system that enables online applications and monitoring, similar to the ones that the USPTO (USA) and EPO (European Union) already have. This is expected to make the patent filing process in Brazil simpler and more straightforward.

References: http://www.inpi.gov.br/portal/artigo/pedidos_de_patentes_apresentam_crescimento_de_6_no_ano_passado

---

[1] For further information about INPI statistics, go to http://www.inpi.gov.br/images/stories/downloads/patentes/pdf/Patentes_Depositadas_e_Concedidas.pdf

Brazilian Health Devices Industry Growth Disappoints

The Brazilian Association of High Tech Industry of Medical Equipment, Products and Supplies (Abimed) has recently shown the unsatisfactory results of the Brazilian health devices industry in 2012. Although it has grown above Brazilian growth rate (around 2%), the sector expected a higher progress at the beginning of the year.

The health devices market presented an increase of 4,2%, the industry showed a rise of 3,2% and the sector has created 5 thousand new jobs, which represents an increase of 3,2%.

There are many explanations for this disappointing fact. The national economic growth presented a terrible performance (not only because of the international crisis, but also because of the Brazilian structural problems), the National Health Surveillance Agency strike which jeopardized the health market supply and the slowness on inspections at international factories. Abimed also indicates that the devaluation of the exchange rate and the absence of support for innovation and local production postponed the development.

However, the Association believes there is space for a 10% rate of growth in 2013.

“Brazil is the sixth economy in the world and it represents a 2,8% in World’s GDP, but only a 0,5% in the world’s health devices market. (…) we believe in the economic recovery.”

Carlos Goulart

President of Abimed

References: http://saudeweb.com.br/34165/setor-de-produtos-para-a-saude-cresce-abaixo-do-previsto-diz-abimed/

Be welcome, Innovation.

From Europe 2020 to Strategy for American Innovation. From Brasil Maior to Industrial R&D Promotion Programme. All the governmental programs mentioned above try to create conditions and stimulate a national foundation for innovative industries in the European Union, United States, Brazil and India. Innovation seems to be the answer for national development and sustainable economic growth.

Seeking to increase a better understanding of innovative approaches and measurement, the Organization for Economic Co-operation and Development (OECD) developed the Oslo Manual[1], which provides guidelines for collecting and interpreting innovation in an internationally comparable manner. Even with limitations, every new edition of the Oslo Manual represents a step forward to the understanding of the innovation process.

Using the meanings and criteria of the Oslo Manual, the UNESCO Institute of Statistics presented the 2011 UIS Pilot Data Collection of Innovation Statistics[2]. Comparing 12 countries from different regions and at different levels of development, it seeks to show the different stages of innovation process around the world, taking especial attention to developing countries.

As one shall conclude, innovation is a concern for both developed and developing countries. With different levels of innovation process, each one acts according to its needs and goals. Catching up is the main target for developing countries in order to not fall behind in international trade and development. As for developed countries, they have reached a stage of progress that the only way of not becoming outdated is with

“(…)Investments, technology development, innovation and good management practices(…)”

President Dilma’s speech, April 3^rd, 2012

References: http://ec.europa.eu/europe2020/

http://www.whitehouse.gov/

http://www.brasilmaior.mdic.gov.br/

http://india.gov.in/

http://www.oecd.org/

http://www2.planalto.gov.br/

---

[1] For further information about the Oslo Manual, access http://epp.eurostat.ec.europa.eu/cache/ITY_PUBLIC/OSLO/EN/OSLO-EN.PDF

[2] For further information about the 2011 UIS Pilot Data Collection of Innovation Statistics, access http://www.uis.unesco.org/ScienceTechnology/Documents/Innovation-statistics-en%20(2).pdf

Medical Devices Industry in Developing Countries

With the arrival of the 21^st century, a new era both in global technology industry and economic growth model began. Developed countries left the second industrial revolution behind and started focusing on the new generation of technologies: information technology, nanotechnology, internet, biotechnology. We are led to think that developing countries are still not capable of supporting this kind of industry, for requiring huge investments in R&D departments and qualified teams (without mentioning investments in infrastructure, energy and transportation). But there are some countries that are showing the world that this change is happening in the medical device sector.

 It is known that United States is the biggest global importer in this sector and verifying its top 5 importers partners of “Instruments, appliances for medical, etc science, nes” (UN Comtrade HS901890), one will find that two of them in the last four years are developing countries: Costa Rica and Dominican Republic.

The exports of HS901890 from Costa Rica to the USA sum twice the exports from Canada and Japan to the USA combined and it is higher than the export from Ireland (another top 5 import partner of the USA) to the USA. In the “Case of Costa Rica – Facts and Implications for Trade Policy”, presented by the Minister of Foreign Trade from Costa Rica in the WTO public forum, September 19, 2011, we can verify Costa Rica’s evolution on the structure of industrial exports since 1994 until 2010 and it shows that it is possible for countries in development to improve its industries, technologies and R&D departments. In 2010, Costa Rica’s top 10 export products included microchips, medical prosthesis, pharmaceutical, computer parts and transfusion equipment. In 2003, Costa Rica was consolidated as one of the main Foreign Direct Investment (FDI) locations in Latin America and in 2010, the first high-tech exporter in the continent.

The recipe of this success is simple and well known: political and economy stability (hence, FDI attraction), solid export platform, investments in human resource base (education, language skills), good geographic location (in the middle of America and close to the USA market). But according to the CIA – World Factbook of 2012, there are still things remaining to be improved like bureaucracy and legal uncertainties.

For the studies of international trade, however, exports are considered as belonged to the country of origin. But if we make a deeper analysis, we will see that, in the case of Costa Rica, the majority of the medical device companies are multinationals with international resources and not a national initiative. Nevertheless, even if the main investments are from abroad and there has to be royalties and profit transmission, Costa Rica is responsible for the attractiveness of foreign direct investments. If this country wouldn’t have created reliable conditions for multinationals, they wouldn’t have been established in its territory. With the construction of this scenario, Costa Rica is earning international visibility and confidence, which are responsible for the creation of jobs and national development.

In the case of Brazil, country where Biokyra is established, the production in this area is still shy.

       The Brazilian capacity utilization is insufficient to supply its demand. One of the reasons why this happens is the size of the market. Brazil is the 5th biggest country in population and it has a public health care that attends everyone. Apart of its demand and needs, the national production and offer are still taking their first steps. Considering that the USA is the biggest export and import player in this sector, Brazil is its 11th biggest export partner, but only its 32nd import partner (based on HS901890, UN Comtrade). The reasons why Brazilian medical device industry is falling behind other developing countries industries are the same reasons for the entire Brazilian industrial complex. Basic investments needs in energy, infrastructure, transportation, and logistics are still an obstacle for Brazilian development. Bureaucracy, slowness in legal procedures, high taxes and low-qualified labor represent some other difficulties faced by entrepreneurs, export/import and logistics professionals.

As one shall see in the graphic, the deficit between imports and exports is still huge. In 2010, while Brazilians were exporting U$600 million, they were importing more than U$3 billion of this kind of medical device. In the graphic, based on HS901890, we can see clearly the difference between imports and exports. Nevertheless, there are governmental programs and financial aid to promote any kind of export in Brazil. In the case of medical devices, the program is called “Brazilian Health Devices”, which is supported by ABIMO (Brazilian Association of Medical Devices and Equipment), in association with Apex-Brasil (Brazilian Agency of Export and Investments Promotion). It brings together 140 enterprises of this sector and it has helped increase international sales in 260%. Stimulus to get the FDA certificate, internationalization program, strategic planning and international trade missions are examples of actions that “Brazilian Health Devices” provides. Even if there are still many obstacles to be overcome, Brazilian governmental is trying to make Brazil a great nation for R&D and technologies investments.

           

References: http://www.abimo.org.br/modules/content/content.php?page=apex-brasil

http://www.wto.org/english/forums_e/public_forum11_e/made_in_the_world_the_case_of_cr_wto_19_09_11_fv_anabel_e.pdf

Strategic Action in a Global Market

International market is an opportunity for business growth. Enterprises become more profitable and competitive once they have to face global market and foreign competitors.  In the 21^st century, companies can’t escape from internationalization or the effects that it causes in national economies. The health industry is no different. In 2009, the sales in this sector reached U$289 billion worldwide and it is expected to reach U$487 billion in 2016, with an annual growth of 7%; there are more than 27 thousands enterprises around the world, employing more than one million people.

Since it is an industry that requires new technologies, high investments in R&D and a highly qualified team, most of medical devices production concentrates in developed countries.

    

As shown in the graphic, the global top 5 exporters[1] of “Instruments, appliances for medical, etc science, nes” concentrate more than half of exports, which reached more than U$40 billion in 2011.

Once an enterprise decides to internationalize, it has to consider: if its country belongs to any free trade area or bilateral agreement (it is usually easier to export to these countries); size and growth rate of the market, national and international competitors in the destination country, as well as national taxes of imports, definition of a strategy, logistics of exports. One important detail one shall consider, when deciding to export, is the non-tariff barrier. Even when there is no significant tariff barrier or national taxes of imports, there might be a barrier like quotas, technical or sanitary standards, administrative and bureaucratic delays at the entrance. Due to a strong international regulatory system about tariff barriers, countries are adopting non-tariff barriers as a way to protect their national industry and, in the same time, not “disobey” standards and rules in international trade.

The strategy for enterprises in this sector has had to be reviewed after what happened to the global economy in 2008 and 2009. Big medical devices companies are now paying attention to China, India and Brazil. Looking at the size of the population and the way they are gaining higher buying power, companies are trying to learn and understand how to approach these markets.

But, like in any other sector, selling a medical device in a developed country is not the same as selling it in a developing country. The different scenarios and culture complicate the sale of a standard product. Therefore, products are been created specifically for these emerging markets. Instead of selling the same product to developing and developed countries, companies are creating products for emerging markets. We have to consider that not all the companies are taking this step. Most of them are wary and skeptical about the returns they will obtain taking this strategy. There are a few enterprises that are already doing business in these countries, especially the European ones.

Like in any other company that has to customize their product according to the different countries or areas, there has to be two (or more) strategies and two (or more) lifecycles working in the same organization. So, it is important to have a good marketing team that deeply studies and examines the target market.

References: http://comtrade.un.org/

                 http://brazilianhealthdevices.com.br/market 

         http://www.mddionline.com/article/domestic-medtech-industry-  emerging-markets-elicit-excitement-and-caution

---

[1] One shall consider that Mexico belongs to the North America Free Trade Agreement (NAFTA); the USA is the biggest importer in the world representing 20% of the world’s demand and Mexico is its biggest provider.