Innovation in the Medical Device Sector

The concept of Innovation is always linked to the idea of creativity, novelty, technology. Nevertheless, it doesn’t restrict itself to gigantic transformations in expensive technologies. Innovation is usually seen when the problem is identified and better or new methods are created to solve it or to improve a daily process.

In the medical device industry, this preconception is frequently made. Even in this sector, innovation does not necessarily involve large investments but, most importantly, it involves the comprehension of the patient’s needs and its fulfillment to save his life or to improve his quality of life.

Unlike the consumer space where there are no barriers to different ideas, the medical device sector deals with regulatory systems, which dictate the requirements that the industry must meet. Obviously, the regulatory system is concerned about setting high standards for the safety of the patient, but sometimes it can inhibit innovative ideas.

References: http://www.mddionline.com/article/medtech-innovation-doesnt-have-be-expensive

Another Attempt to Globalize the Medical Device Industry

When it comes to a globalized economy, one obstacle always bothers the free trade: the regulatory systems of the countries. To stimulate the global economy and favor the free international trade, it is important to think of a way to converge rules and so, the free movement of goods will not become a slow bureaucratic process. As for a harmonized regulatory system for medical devices, the task is even harder because it also deals with national health laws.

This was the concern when in 1992 the European Union (EU), the United States, Canada, Japan and Australia gathered together to establish a method to harmonize the regulations on medical device. The voluntary group was called Global Harmonization Task Force (GHTF) and brought together representatives from medical device regulatory agencies and the regulated industry from its founding members.

Almost 20 years later, the new economic scenario called for new representatives. So, “to build on the strong foundation work of the GHTF and to accelerate international medical device regulatory harmonization and convergence”, the International Medical Device Regulators Forum (IMDRF) was conceived in February 2011, replacing the GHTF. Besides the original 5 founding members of the GHTF, it included Brazil to the discussion of future directions in forming an international harmonized and convergent regulatory system for medical devices.

The membership of China and Russia are currently being confirmed and the new Forum, including the 6 official members, China and the WHO (World Health Organization, an observer member), met in Ottawa in October 2011 to establish strategic topics for its operation.

Trying to standardize rules among the GHTF member countries was a big challenge, now with the creation of the IMDRF and new members added, the debate becomes even harder. Despite the adversity, the future results might turn out to be stronger and more creative once it takes into consideration different points of view. There is still a long way of hard work to build a harmonized and convergent regulatory system, which provides solutions to all the five countries and EU’s concerns. We hope the members create an environment of dialog to accelerate the harmonization and convergence of their regulatory systems, so that we could have a real “international medical device regulatory system”.

References: http://www.imdrf.org/

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/

Happy Holidays, everyone!

Biokyra wishes you a New Year full of peace and hope.

Happy Holidays, everyone!

Sincerely,
Team Biokyra.

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/

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[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

Cardiovascular Diseases: a Global Concern

Although the world of the new millennium has seen many improvements in the health sector, the path of healing diseases is far to be overcome. Cardiovascular diseases (CVD) are still huge challenges for the medical society.  More people die annually from this kind of illness than from any other cause and that is the reason why it has been given an especial attention worldwide.

According to the World Health Organization (WTO), an estimated 17.3 million people died from cardiovascular diseases in 2008, representing 30% of global deaths. Coronary heart diseases and stroke are the main causes of these deaths (almost 80%). It is well known worldwide the main factors that increase the probability of getting a stroke: unhealthy diet, physical inactivity, overweight, high blood pressure, tobacco use and harmful use of alcohol.

Besides, low and middle-income countries are the most affected, about 80% of world’s death from CVD. As reported by the WHO, “people in low and middle-income countries are more exposed to risk factors such as tobacco (…). At the same time they often do not have the benefit of prevention programs compared to people in high-income countries.” Meanwhile, at a macro-economic level, it represents a heavy burden on the economies of low and middle-income countries. Non-communicable diseases – including cardiovascular and diabetes – are estimated to reduce GDP by 6,77% in low and middle-income countries facing rapid economic development.

The programs to fight against cardiovascular diseases are highly expensive. Integrated actions at country level, led by governments, are the means to maintain the people away from risk factors and, hence, not allowing it to become a burden on national economies.

There is no difference in Brazil. Around 300 thousands of people die from cardiovascular diseases each year, according to the Brazilian government. Nevertheless, by the public healthcare system (SUS), the government provides many preventive actions programs, diagnosis and free treatments for CVD.

References: http://www.who.int/en/

http://portalsaude.saude.gov.br/portalsaude/

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