Medical Device Startups and the FDA

Does the FDA approval process impede innovation? Medical devices must be reviewed for safety and effectiveness by the Food and Drug Administration before being marketed in United States, which encompasses 43 percent of the global market for medical devices. Startups in the medical device industry are often dissatisfied with this approval process, favoring the FDA's European Union peer, CE Marking. Some founders even believe the time consuming and expensive FDA process "holds back the entire indu...
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Global Policy Uncertainty and U.S. Stock Trends

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The Financial Times has predicted that “the rise of Donald Trump may already be casting a shadow over the global economy.” When it comes to the Trump Administration, the world is unsure what policies to expect. Trump’s positions on international trade and tendency toward nationalist policies are a concern for the rest of the world. However, the U.S. stock market is performing at record-breaking highs. Economic research has linked policy uncertainty to stock market slowdowns. If this is so, wh...
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Congress Turns Its Attention to Entrepreneurship and Innovation—But Does It Take Effective Action?

Legislation passed during the first three months of  the 115th Congress pays disproportionate attention to entrepreneurship and innovation. McNair Center research shows that in a typical congressional session, less than 2 percent of legislation introduced is relevant to E&I issues. As of March 23, three of the ten bills that have become law during the 115th Congress directly address entrepreneurship and innovation. A focus on entrepreneurship and innovation issues does not alone make for ef...
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The International Entrepreneur Rule: The US Startup Visa

The Obama administration proposed new provisions for immigrant entrepreneurs in August 2016. The administration designed the proposal to attract international entrepreneurial talent to the United States, especially in advanced technology fields. In mid-January, with only days left in President Obama’s term, the United States Citizenship and Immigration Services (USCIS) finalized the details of the "International Entrepreneur Rule." It is scheduled to go into effect on July 17, 2017. Whether it g...
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Reducing Recidivism through Entrepreneurship

Reducing Recidivism through Entrepreneurship High rates of recidivism in the United States negatively affect prisons, inmates, the government and tax-paying citizens. In 2013, the U.S. imprisoned 2,220,300 people. A Bureau of Justice Statistics study found that within three years of release, 67.8% of released prisoners were rearrested. Within five years, 76.6% of released prisoners were rearrested. Researchers typically link recidivism to unemployment, low levels of education, mental health ...
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Patents and the Cancer Moonshot

Patents and the Cancer Moonshot: How Subject Matter Eligibility Affects Research When standard cancer treatments fail, some doctors are turning to the developing field of immunotherapy. Immunotherapy involves treatments that use the patient’s own immune system to combat cancer. Both pharmaceutical companies and the federal government see the promise in funding research in this innovative field. However, R&D in cancer treatments is a time-intensive process, and it takes months, if not years,...
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True Impact of the Bayh-Dole Act

Addressing the True Impact of the Bayh-Dole Act Since the passage of the Bayh-Dole Act in 1980, many researchers have debated its contribution to the transfer of technology from universities to industry. Some credit the act as an engine of economic growth responsible for the emergence of the biotechnology industry. Critics say that the law decreased data sharing and basic research and increased health care costs. Others think that the act had little impact and that changes in university patenti...
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Bureaucracy and Public Sector Innovation

Hierarchies can often be complex and make it difficult for employees on the lower end of the hierarchy to be heard or seen by senior leadership. https://pixabay.com/en/silhouettes-hierarchy-human-man-81830/
The public benefits greatly when there are innovations in how our government approaches policymaking and regulation. However, sometimes barriers created by bureaucratic structures can slow implementation. When regulation and rigidity are holding us back, leaders are responsible for ensuring that our government institutions are allowing for change when our old ways of approaching challenges become antiquated. Innovation in the Public Sector Our traditional idea of innovation tends to point scie...
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Entrepreneurship Weekly Roundup: 12/02/2016

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news. Here is what you need to know about entrepreneurship this week: Keep Austin Entrepreneurial Eliza Martin, Research Assistant, McNair Center for Entrepreneurship and Innovation In 2016, Austin was ranked as the number one U.S. city for startup activity by the Kauffman Foundation. Austin’s entrepreneurial ecosystem began in the 1970s and 1980s, and was orig...
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Obama in the White House

Generating an Innovation Nation The Obama administration’s policies toward small business and entrepreneurship have received mixed reactions. While Obama elevated the administrator of the Small Business Administration to a cabinet position and the SBA increased its lending to small businesses, some small business owners felt that the government bailed out big businesses at their expense after the 2008 financial crisis. Many small business owners are concerned about the effects of the Affordable...
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