Breaking into Emerging Markets

As the crisis of 2008 continues to effect the growth of developed countries like USA, European Union and Japan, it seems like the key to boost business all over the world is knowing how to approach emerging markets.

However, this step requires a special strategy. Since there are clearly differences between developed and developing economies, one must take into consideration these facts when deciding to formulate a strategy.  One frequently mentioned advice is not to approach emerging markets alone. Local partnership is recommended because the national partner has the know-how of the market, key-suppliers, regulatory environment, etc.

Another advice concerns to pricing. Local firms are used to lower labor cost so the final price is low. Pricing the product properly is essential to successful sales in these kinds of markets.

“ (…)it's imperative for device firms to recognize that cheaper does not mean lower quality.”

By Arundhati Parmar, Senior Editor, MD+DI

References: http://www.mddionline.com/article/going-it-alone-poor-strategy-trying-break-emerging-markets-0

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

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

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.