Does Medical Device industry need start-ups to continue the innovation process?

Big companies seek innovation and efficiency to meet the market demands that is always running in a high competitiveness environment, meanwhile the start-ups with good ideas and solutions need to ensure economic survival to bring their products to market.

In a global scenario, and with specific knowledge of the brazilian market, brazilians start-ups gain notoriety not only due to challenges such as risk taking in business, but also by bringing to market the benefits of their innovative ideas. This business model has drawn attention of big companies.

Start-ups do not have the strong, hard and slow structures a big company has. The creative environment and people who can generate new ideas make possible to make mistakes and try again fast and agile.

Typically, start-ups must focus on one idea at a time; however, if that first idea is not as disruptive as first hoped, the end of that idea could also be the end of the company. Those that do survive often form the backbone of larger corporations’next-generation offerings, through acquisition or licensing.

Despite the crucial role that start-ups play in the medical technology industry, the current economic climate cannot be overlooked. Continuing the trend of previous years, in the USA in 2011 we have seen a decline in early stage investment in medical technology start-ups. The investment that has been made has focused on start-ups whose technologies are perceived to have a simpler regulatory pathway to market. The most complex regulatory pathways are often associated with complex technology areas (for example, in vivo imaging and surgical implants) and one could argue that it is these areas that most need disruptive technologies.

For their part, the more progressive medical corporations continue to recognize the importance of these smaller companies (approximately 73% of the United States’ 5300 medical device companies had a head-count of less than 20 in 2007) and many are taking a more collaborative approach to fostering new technologies. Rather than buying an idea outright before significant development has occurred, they are working with start-ups to bring products closer to market through equity or resource investment.

That could be also a great way and opportunity to develop the domestic brazilian medical device industry, that it, working with start-ups to bring products closer to market through equity or resource investment.

To read more about it, please, visit: http://medtechinsider.com/archives/26930

Patent granting in Brazil

A patent is a form of intellectual property granted to an inventor for a limited period of time. The procedure for granting patents varies widely from country to country, but it usually requires novelty and non-obviousness. The exclusive right granted to a patentee in most countries is the right to prevent others from making, using, selling, or distributing the patented invention without permission.

Granting patents is important to promote invention, once that developing new products, for example, takes time and money. If there is little opportunity to benefit from the initial investment, then inventors and companies won’t focus on creating new products.

In Brazil, the law 9.279, of 1996, establishes the rights and duties concerning to patents. According to Isaias Masiero Filho, one of the founders of Biokyra, obtaining right over a patent is extremely important for those who work on the development of new products because it protects the inventor and guarantees the return on the investment made in the initial phases.

The INPI (National Institute of Intellectual Property) is the office responsible for analyzing patent applications. In Brazil the application can be issued by the inventor him/herself, but it is highly recommended to have the orientation of a lawyer because the process involves several deadlines and documents. The average application fee in Brazil is R$200 (US$108).

To know more about patent granting in Brazil, check out the following websites:

http://www.revistagestaoenegocios.com.br/gestao-motivacao/33/artigo225232-1.asp

http://www.inpi.gov.br/index.php/english

Brazilian healthcare industry – economic data

In 2010 the Brazilian healthcare industry generated R$8 bi in business, employing more than 100.000 people. Most healthcare companies are mid-sized or small (71.5%) companies and 7.1% of the products/services are exported. The most important trading countries in 2010 were the United States, Argentina, and Venezuela.

You can find the complete data on: http://www.abimo.org.br/content.php?page=DADOS_ECONOMICOS_PT

The Brazilian healthcare industry will grow more than the Brazilian GDP

In 2011, it’s expected that the Brazilian healthcare industry will grow 19%, achieving R$13.5 bi. This growth is much higher than the Brazilian GDP growth, which is expected to grow less than 4.5%. Throughout the year, 6.000 jobs were created in the healthcare industry. Some of the reasons for such a good performance are the strengthening of the Brazilian economy, the creation of new jobs, and the dollar price. 

To read more about it, please, visit:http://www.hospitalar.com/index.php

Brazil and the Global Harmonization Task Force (GHTF)

According to the FDA, the Global Harmonization Task Force (GHTF) fosters international harmonization in the regulation of medical devices. Regulatory and industry authorities from Europe, Asia-Pacific and North America collaborate to encourage the harmonization of regulatory practices to ensure the safety, effectiveness and quality of medical devices.

The GHTF was founded in 1992 and its main purpose is to standardize medical device regulations around the world by the exchange of information. Some of the benefits of the standardization are the convergence in regulatory practices related to ensuring safety and facilitating international trade.

On November 11, Brazil, Argentina, Colombia and Cuba’s regulatory agencies agreed to work in cooperation, through the inspection of manufacturers of medical devices in each country. The Brazilian regulatory agency (ANVISA) requires a Good Manufacturing Practices (GMP) certification from medical devices manufacturers, and the inspection is conducted by the agency itself. From January of 2013 the GMP certification issued by the Argentinean, Colombian, and Cuban agencies will be accepted in Brazil as well, which means more efficiency in the certification process.    

Opportunities for the healthcare industry in Brazil

Emerging countries have been attracting attention from investors in the last years, and in the healthcare industry Brazil is especially promising, since it has the 7th largest nominal gross domestic product in the world and one of the largest populations, that is about 200 million people. Some recent changes, such as the higher income per capita and the aging population point for an even higher demand for healthcare services and products. For many years, healthcare expenditure in the country has been growing at a double-digit percent annually. On an absolute basis, Brazil's healthcare expenditure is nearly as high as China's and a multiple of India's.

Healthcare services, medical devices and the pharmaceutical industry are the most promising in the country, and it is even more attractive for companies that can offer innovative products and services. However, even though there are big opportunities, it is important to notice that there are also many barriers for those planning to do business in Brazil. Some of these barriers are the social differences among regions, the regulatory system, and the available sources for financing. The opportunities seem to overcome the barriers but it may be better to count on local specialists who know the country and its particularities in depth. 

Innovation and medicine: a possible connection?

Life expectancy has risen significantly in the last decades throughout the world and medicine has played a key role in this change. However, the scenario for the healthcare industry has also substantially changed, what includes a more intense participation of emerging countries, the development of new technologies and devices, among others.

A challenge that is being faced by many countries is the limited budget for the healthcare system, and in what concerns to it, innovation can make an important contribution. Innovation, research, and  development of new devices, techniques, drugs, and procedures are fundamental for improving the quality of the healthcare sector while cutting its costs. By doing so, we believe that it is possible to make quality of life available to everyone, everywhere.

It’s clear that this goal is not easy to achieve, but if the many actors involved in the healthcare industry (such as policy makers, healthcare manufacturers, hospitals and healthcare professionals, just to mention some) do their best to accomplish it, the situation can improve significantly.

This blog was created driven by the cause of working towards a better and more efficient healthcare system. With that in mind, we will gather information about innovation and medicine, the healthcare industry in Latin American countries, especially in Brazil, the policies and programs pursued by different governments, and so on. We aim not only to provide information, but also to make people question themselves about how they are related to our cause.

Send your comments and contact us if you have any consideration about the subject. It would be great to hear from you!