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  • 2024
  • Article

Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway

By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States
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    Preparing Hospitals for the Next Pandemic

    The Covid-19 epidemic response has shown that the U.S. is blessed with heroic physicians and other health care providers, researchers, and facilities. But it has also revealed a health care system that was woefully unprepared for the surge of pandemic patients. In the... View Details
    • Research Summary

    Fairness and Efficiency in Resource Allocation

    In studying the relationship of fairness and efficiency, Professor Trichakis takes the novel approach of looking at varied industries for unifying factors, and he pays special attention to inequities by incorporating both quantitative work in social welfare and the... View Details

    • 02 Oct 2006
    • Research & Ideas

    Negotiating in Three Dimensions

    "interests," or what each side really cares about. Failure to uncover interests often leads to mistakes in our second dimension, deal design, such as treating potentially more cooperative... View Details
    Keywords: by Martha Lagace
    • Article

    Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study

    By: Noy Alon, Ariel Dora Stern and John Torous
    BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous... View Details
    Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile and Wireless Technology; Applications and Software; Framework
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    • September 2014 (Revised May 2017)
    • Case

    Fresno's Social Impact Bond for Asthma

    By: John A. Quelch and Margaret L. Rodriguez
    In 2014, Social Impact Bonds (SIBs) were quickly gaining popularity as an investment vehicle which joined together private investors and nonprofits to tackle social issues. Although numerous SIB projects and proposals had cropped up across the U.S. following the launch... View Details
    Keywords: Social Enterprise; Health Care; Marketing; Bonds; Financing; Asthma; Air Pollution; Air Quality; Chronic Disease; Public Health; Health; Health Care and Treatment; Finance; Health Industry; Financial Services Industry; United States
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    • February 24, 2022
    • Article

    Want to Prevent the Next Hospital Bed Crisis? Enlist the SEC

    By: Regina E. Herzlinger and Richard Boxer
    During the initial phases of the COVID-19 pandemic, many U.S. hospitals could not provide enough beds to meet demand. Solving the problem of inadequate capacity is of utmost importance in the “new normal,” which requires recognizing the ongoing need for hospital-based... View Details
    Keywords: COVID; COVID-19 Pandemic; Hospital Capacity; SEC Regulation; Health Pandemics; Crisis Management; Performance Capacity; Planning
    Related
    • December 2017 (Revised April 2018)
    • Case

    The Children's Hospital of Philadelphia: Network Strategy 2016

    By: Michael E. Porter, Thomas W. Feeley and Toyin J. Okanlawon
    Children’s Hospital of Philadelphia (CHOP) began as a stand-alone hospital in the heart of downtown Philadelphia in 1855. By 2016 the CHOP Care Network stretched across Pennsylvania, New Jersey, and the New York metropolitan area, providing a wide range of services... View Details
    Keywords: Communication; Health Care and Treatment; Service Delivery; Organizational Structure; Networks; Integration; Strategy; Health Industry; Philadelphia
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    • 02 Sep 2022
    • News

    Strength in Numbers

    ineffective.” Their solution? The Goodness Web, a nonprofit that finds its strength in connection, in “a web of people who can aggregate resources—whether that is philanthropic... View Details
    • 25 Jul 2009
    • News

    Some Inconvenient Truths About Medicare and the New 'Public Plan'

    • March 2023 (Revised March 2024)
    • Case

    The Purdue Pharma Bankruptcy: Settling the Opioid Crisis

    By: Kristin Mugford, Carin-Isabel Knoop and Susan Pinckney
    How to get to a fair outcome for claimants in the Purdue Pharma bankruptcy given its significant role in the U.S. opioid crisis. View Details
    Keywords: Regulation; Ethics; Fairness; Insolvency and Bankruptcy; Government Legislation; Courts and Trials; Laws and Statutes; Lawsuits and Litigation; Legal Liability; Crime and Corruption; Negotiation Offer; Negotiation Participants; Negotiation Style; Product Design; Product Development; Brands and Branding; Marketing Strategy; Trust; Government and Politics; Law; Negotiation; Operations; Ownership; Marketing; Social Psychology; Health Care and Treatment; Pharmaceutical Industry; United States
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    • August 2012 (Revised January 2013)
    • Case

    Public Health Insurance Exchanges: The Massachusetts Experience

    By: Regina Herzlinger and Jordan Bazinsky
    The CEO of Tufts Health Plan, James Roosevelt, is wondering whether to offer insurance products on the Massachusetts Connector, the first U.S. exchange. He wonders if he should enter these uncharted waters at all. And, if yes, with a broad network or a narrow network... View Details
    Keywords: Health Insurance Exchange; Healthcare Reform; Public Health Insurance Exchange; Decision Making; Market Entry and Exit; Emerging Markets; Health Care and Treatment; Insurance Industry; Health Industry; Massachusetts
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    • 18 Nov 2021
    • News

    Strength in Numbers

    American Cancer Society for the mental health field—an organization that can increase awareness, reduce the stigma, and rally donors to make large, multiyear funding... View Details
    Keywords: April White
    • 07 Jun 2016
    • First Look

    June 7, 2016

    strategic, financial, and operational objectives. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=51110 May 2016 Oncology How the Affordable Care Act Has Affected View Details
    Keywords: Sean Silverthorne
    • March 2021 (Revised January 2023)
    • Case

    The Trouble with TCE

    By: Vincent Pons, Rafael Di Tella and Galit Goldstein
    Trichloroethylene, or TCE, was a chemical used by tens of thousands of businesses in the United States. It was an affordable tool for many. Yet, TCE had been associated with important health risks, including cancer and autoimmune disease. TCE potentially posed other... View Details
    Keywords: Trichloroethylene; Toxicity; Lobbying; Chemicals; Health Disorders; Governing Rules, Regulations, and Reforms; Policy; Ethics; Business and Government Relations; Chemical Industry; United States
    Related
    • February 2001 (Revised February 2002)
    • Case

    Estee Lauder and the Market for Prestige Cosmetics

    By: Nancy F. Koehn
    Opens with a brief history of the U.S. cosmetics market and its rapid development in the 1920s. Also recounts Lauder's initial involvement in the sector, making skin care products and selling them in Manhattan beauty parlors during the Great Depression. Pays particular... View Details
    Keywords: Fluctuation; Organizational Change and Adaptation; Market Entry and Exit; Entrepreneurship; Luxury; Business Strategy; Society; Beauty and Cosmetics Industry; United States
    Related
    • November 2018
    • Case

    The National Hockey League

    By: Robert F. Higgins, John Masko and James Weber
    In 2015, National Hockey League (NHL) commissioner Gary Bettman was weighing two major decisions: whether to expand the league to a new city, and whether to conclude a digital media rights deal with Major League Baseball Advanced Media (MLBAM). Expansion required a... View Details
    Keywords: NHL Expansion; Digital Media Rights; Sports; Expansion; Media; Decisions; Sports Industry; Canada
    Related
    • September 2014 (Revised February 2015)
    • Case

    Pfizer and AstraZeneca: Marketing an Acquisition (A)

    By: John A. Quelch and James Weber
    In 2014, Pfizer proposed a friendly acquisition of AstraZeneca, but the AstraZeneca board resisted over price and strategy concerns. Was this good for pharmaceutical consumers? Pfizer, like pharmaceutical companies in general, faced difficulties in growing sales due to... View Details
    Keywords: Health Care Policy; Mergers And Acquisitions; Marketing; Government Relations; Crisis Management; Decision Making; Growth and Development; Management; Markets; Strategy; Pharmaceutical Industry; United Kingdom; United States
    Related
    • 06 Sep 2019
    • Blog Post

    The Business of Medicine: MD/MBA Students Having an Impact

    investigation with market research to evaluate access to cancer biopsy devices in East Africa. With her dual degree, Wagner plans to continue her work in health View Details
    • June 2018
    • Teaching Note

    Sandra Brown Goes Digital

    By: Rosabeth Moss Kanter and Jonathan Cohen
    As a middle manager at a biotechnology company, Sandra Brown harnessed digital tools and social media to engage others and build campaigns for change in the company. This Teaching Note presents strategies for teaching the Sandra Brown case series, which follows Brown's... View Details
    Keywords: Change Leadership; Change Management; Digital; Engagement; Stakeholder Engagement; Grassroots Movement; Health Care Industry; Career Path; Innovation; Leading Change; Management; Innovation and Management; Personal Development and Career; Organizational Change and Adaptation; Quality
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