Keys for the Commercialization of Medical Devices in the US

Keys for the Commercialization of Medical Devices in the US

Laws and regulations
By Maria Jose Lopez Barragan, Ph.D. Markentry USA Partner and Juan Rivera-Mata, Ph. D. Markentry USA Partner Many companies plan their entry into the American market without a good understanding of the legal requirements that govern their products in the US. The FDA (Food and Drug Administration) regulates the consumption not only of drugs and food, but also of veterinary products, cosmetics, tobacco, and so-called “medical devices”.About one-fifth of what American consumers spend is, in one way or another, regulated by the FDA Under the category of medical devices there is a wide variety of products that ranges from complex devices that assist robotic surgery or even artificial organs, to objects that accompany our daily lives and whose perception can be very different from what anyone would consider a medical…
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How to Ensure your International Company Website is Effective in the US

How to Ensure your International Company Website is Effective in the US

Business Development
Introduction At this point, it should be unnecessary to explain why taking care of the online presence of a business is essential if you want to succeed in any market in the world, with very few exceptions. However, it is surprising the high number of errors that can be identified when reviewing the web pages of international companies that are devoting large amounts of resources to entering the US market. In this article we will identify the most frequent problems and propose some ways to solve them.Think Globally, Act LocallyIn a global or international strategy, it is essential to know the details that must be adapted for important markets. The United States is a country with special characteristics that may lead to the need for not obvious modifications in the message…
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Suspension of the tariffs between the US and the EU derived from disputes over public aid to Boeing and Airbus

Suspension of the tariffs between the US and the EU derived from disputes over public aid to Boeing and Airbus

Business
In a joint statement on March 5th, the US and the European Union have agreed to an immediate suspension of the tariffs that had arisen as a result of disputes associated with public aid to Boeing and Airbus. A similar agreement between the US and the UK was announced the prior day.These conflicts, managed within the framework of the World Trade Organization (WTO), had led to the authorization by WTO of tariffs on a wide range of products from both sides. This confirms the expectations we had explained in our recent article The Biden Era is Coming: Impact on Companies International and in which we said "It is to be hoped that the new administration will resume international collaboration within the framework of the World Trade Organization and seek ways to end…
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Seven deadly sins in US market entry

Seven deadly sins in US market entry

Business
By Gonzalo Garcia, Founder and CEO of Markentry USA CONTENTS Introduction  1. Not adapting the 4 Ps of the ‘marketing mix’ to the target market 2. Ignoring regional differences or acting in the wrong state 3. Landing without the local support of experts in the target market 4. Acting without a subsidiary or choosing an inappropriate structure for it 5. Designing a complex and rigid business plan 6. Underestimating costs and deadlines 7. Underestimating the impact the US can have on the business Conclusion Conclusion Introduction The challenge faced by international companies and foreign entrepreneurs when trying to enter the US market is as great as the payoff obtained from succeeding. We are talking about a market of 330 million people with a per capita income of $65,000, which being…
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The Biden Era Begins: Impact on International Companies

The Biden Era Begins: Impact on International Companies

Business
By Gonzalo Garcia, Founder and CEO of Markentry USA CONTENTS 1. Introduction  2. Biden's real ability to drive meaningful change 3. Biden's priorities 4. People appointed to key positions 5. International trade 6. Immigration and travel bans 7. Opportunities for international companies 8. Conclusions 5. Conclusions 1. Introduction The inauguration of Joe Biden as President of the United States on January 20 represents a radical change of course with respect to what has been the period led by Donald Trump. Without a doubt, it is going to have a significant impact on international companies that compete or want to compete in the US market, which we will analyze in detail in this article.We will study the depth of the expected changes, taking into account the nuances of the US political…
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Biopharma perspectives 2021-24 with Trump or Biden

Biopharma perspectives 2021-24 with Trump or Biden

Business Development
By Juan Rivera-Mata, Markentry USA Partner The US elections may entail different scenarios for the biopharmaceutical industry. During his term, Trump has tried to eliminate “Obamacare” (a law that, among other things, makes it mandatory for companies to provide health insurance to their employees), and Biden has used that possibility as a main element of his campaign. But, at the same time as the President, local and state officials are also elected, and the House of Representatives and 1/3 of the Senate are renewed. It appears that Democrats will remain a majority in the House, but the Senate, now Republican, may go "blue." Trump has appointed 3 members of the Supreme Court - for life -, making it (6/3) conservative. The obligation to have health insurance (and any subsequent reform) will…
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The «Dunning-Kruger» effect and the importance of feasibility studies in business internationalization to the US market

The «Dunning-Kruger» effect and the importance of feasibility studies in business internationalization to the US market

Strategy
By Gonzalo Garcia, Founder and CEO of Markentry USA 1. The Dunning-Kruger effect and other cognitive biases The Argentinian actor Ricardo Darín, in the fabulous film "The secret in their eyes", awarded an Oscar for the best foreign film, defined in an anthological scene two types of idiots: the one who knows he is an idiot and is therefore harmless, and the one who thinks he is a genius and does nothing but generate problems. The truth is that we are all exposed to behaving like both kinds of idiots in many fields, as modern psychology has amply shown. This is the "Dunning-Kruger" effect, discovered by social psychologists David Dunning and Justin Kruger, which is defined as the inability to recognize our own ineptitude. It is a cognitive bias that means that…
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The KICS Principle (Keep It Competitive Stupid): an antidote to the “myopia” that slows down competitiveness

The KICS Principle (Keep It Competitive Stupid): an antidote to the “myopia” that slows down competitiveness

Competitive Assessment
By Raul Peralba, Markentry USA Partner Introduction This article is an adaptation made by the author from the introduction of his book, of the same title, written with Ralph Whitestone. It is currently available in Spanish via Amazon and will be published in English soon. The aeronautical engineer Clarence “Kelly” Leonard Johnson was a true innovator in the aerospace industry. He worked for many years at Lockheed Martin Skunk Works (secret projects department) and was highly regarded for his organizational skills and for dealing with highly complex matters. One of his biggest skills was the ability to break problems down and simplify them so that everybody involved in his projects was very clear about it all. I.e.: he recommended simple and understandable developments which could only cause errors that were…
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How to open a company bank account in the US as a non-resident?

How to open a company bank account in the US as a non-resident?

Business
One of the first steps that foreign companies must take when launching their business in the US market is to open a bank account. This can be complicated when the company does not have employees residing in the country or does not have a permanent physical address, something that happens frequently at the beginning of an internationalization project and even in later phases. Many foreign-owned US companies are permanently managed by non-resident staff, with occasional support from a local representative.  The availability of a US bank account is of great importance for multiple reasons: It will make it easier to get local services and be paid for sales. For example, some online markets require the availability of a bank account in the US.It is an essential element when trying to…
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Trump vs Biden: impact on international trade

Trump vs Biden: impact on international trade

International Trade
By Gonzalo Garcia, Founder and CEO of Markentry USA CONTENTS 1. Introduction  2. Trump 3. Biden 4.Who is going to win? 5. Conclusions 5. Conclusions 1. Introduction Biden or Trump, Trump or Biden. We are just over two months away from the US presidential election. Its result will have a huge impact in all areas and will directly affect the plans of international companies and entrepreneurs with interests in the US market. Very few times in the history of presidential elections have we seen two candidates with such disparate visions of how the country should be led. This is especially relevant when the nation is in the largest recession since the Great Depression 90 years ago and in the middle of a serious health and social crisis caused worldwide by…
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