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  • All HBS Web  (445)
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    • News  (141)
    • Research  (248)
  • Faculty Publications  (116)

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  • All HBS Web  (445)
    • People  (1)
    • News  (141)
    • Research  (248)
  • Faculty Publications  (116)
← Page 7 of 445 Results →
  • 2023
  • Article

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices... View Details
Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.

    Sophus A. Reinert

    Sophus Reinert is T.J. Dermot Dunphy Professor of Business Administration and of History in the Business, Government, and the International Economy Unit at Harvard Business School and in the History Department and Harvard University. He has won numerous awards... View Details

    Keywords: food; food; food; food; food; food; food
    • 01 Dec 2023
    • News

    Elevator Pitch: Feedback

    space for a for-profit business that is mission-driven has been really rewarding. This is not a hard sell. People get it immediately.” Status Update: Bright Feeds’ first manufacturing facility, located in Connecticut, began production in... View Details
    Keywords: Illustration by Drue Wagner; Photo by ChiChi Ubiña
    • 29 Sep 2014
    • Research & Ideas

    Why Do Outlet Stores Exist?

    usually located in rural areas near the factory and selling damaged or irregular clothing, often to employees themselves. Even though most apparel manufacturing has long ago moved overseas, outlet stores have continued to exist—despite... View Details
    Keywords: by Michael Blanding; Apparel & Accessories; Fashion; Retail
    • Web

    Mid-US - Global

    address four key pillars: culture, infrastructure, nutrition education, and food access. This case explores how Campbell’s navigated complex partnerships, power dynamics, and contextual differences across cities to drive sustainable... View Details
    • Web

    Sample Student Projects - Institute For Strategy And Competitiveness

    Peru Lima Financial Services Cluster (2016) Asparagus Cluster in Peru (2012) Peru Tourism Cluster (2010) Philippines The Philippines Electronics Components Manufacturing (2017) Medical Tourism in the Philippines (2008) The Philippines... View Details
    • 01 Jun 2023
    • HBS Case

    A Nike Executive Hid His Criminal Past to Turn His Life Around. What If He Didn't Have To?

    grocery stores, restaurants, and manufacturing plants, with median annual earnings of about $10,000. Higher-paying, professional opportunities remain scarce. View VideoVideo: Hise Gibson shares why business leaders need to hear Larry... View Details
    Keywords: by Dina Gerdeman; Apparel & Accessories
    • 07 Dec 2010
    • First Look

    First Look: Dec. 7

    on renewable energy, clean technology, waste management, water and sanitation, food and agribusiness, affordable housing, healthcare, and education and livelihood creation? Is the board ready to incorporate development banking into the... View Details
    Keywords: Sean Silverthorne
    • 26 Jun 2020
    • Research & Ideas

    Why Japanese Businesses Are So Good at Surviving Crises

    delivers food to victims CEO Takeshi Niinami of Lawson, a chain of convenience stores, watched out his Tokyo office window as skyscrapers swayed. Just minutes before the tsunami reached the Tohoku shore, he sent an order to employees:... View Details
    Keywords: by Dina Gerdeman
    • 25 Aug 2014
    • HBS Case

    Starbucks Reinvented

    of its VIA Ready Brew line; the launch of a loyalty program; investment in and engagement with social media; focus on a global expansion strategy; and the extension of social programs. The company closed stores, restructured its View Details
    Keywords: by Julia Hanna; Food & Beverage
    • 27 Feb 2019
    • Research & Ideas

    The Hidden Cost of a Product Recall

    manufacturing processes and stem reputational damage. In one of the costliest recalls in history, Johnson & Johnson spent more than $100 million in 1982 (more than $260 million in today’s dollars) to recall 31 million bottles of... View Details
    Keywords: by Danielle Kost; Manufacturing; Manufacturing; Manufacturing; Manufacturing

      William A. Sahlman

      William Sahlman is a Baker Foundation Professor of Business Administration at Harvard Business School.

      Mr. Sahlman received an A.B. degree in Economics from Princeton University (1972), an M.B.A. from Harvard University (1975), and a Ph.D. in Business... View Details

      Keywords: food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing; food processing
      • 22 Aug 2005
      • Research & Ideas

      Restoring a Global Economy, 1950–1980

      United States made major efforts to secure radical reductions in tariff rates. During the middle of this decade there was a comprehensive reduction of barriers to trade in manufactured goods. By the end of the 1960s, however, the... View Details
      Keywords: by Geoffrey Jones
      • Web

      Human Behavior & Decision-Making - Faculty & Research

      NC, and Hanover, PA with a $5 million commitment over 5 years. Full Futures brought together diverse partners across corporate, nonprofit, and school district sectors to address four key pillars: culture, infrastructure, nutrition education, and View Details
      • Web

      Curriculum - Business & Environment

      their business. Still others helped a Moroccan company that converts used cooking oil into a cleaner form of biodiesel to start collecting oil from the catering, restaurant, and food manufacturing sectors.... View Details
      • Web

      Advisory Board - Entrepreneurship

      community. She was recently appointed to the Board of Trustees of the Economic Stabilization Trust by Massachusetts Governor Mitt Romney. The Trust provides direct loans and guarantees to manufacturing businesses. She is a member of the... View Details
      • 19 Sep 2023
      • Blog Post

      2023 Summer Internships in Business & Environment

      company growing crops hydroponically in the US. Their method of growing uses 80% less water, 90% less land, and 95% less shipping fuel than long-distance field grown produce. Utilizing greenhouses allows BrightFarms to grow and deliver healthy View Details
      • 31 Oct 2023
      • News

      Securing a Resilient Future for Senegal

      private sector and employment; distribution of food kits and food stamps to more than a million households; and water and electricity payments for a portion of the population. It also included a financing... View Details
      • 19 Apr 2010
      • Research & Ideas

      The History of Beauty

      necessary finance, there are contract manufacturers and perfumers that will provide a product for you. This is also an industry subject to sudden shifts in fashion and fads, which disrupt incumbent positions and provide opportunities for... View Details
      Keywords: by Sean Silverthorne; Beauty & Cosmetics
      • Web

      The 20th Century Zeitgeist - Leadership

      revolutionizes manufacturing Space shuttle Influence: Medium-High 90 1990 s Boom in connectivity Cloning, stem cell research DVDs Influence: Medium 1900 s 19 Progressivism The Jungle sparks food and work... View Details
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