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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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  • Web

Degrees, Certifications & Alumni Status | About

Graduate School of Arts and Sciences offers PhD programs that reflect the changing world of business, society, and education. PhD programs are offered in the following areas: Accounting & Management, Business Economics (includes Finance), View Details
  • 13 Jan 2003
  • Research & Ideas

The Subconscious Mind of the Consumer (And How To Reach It)

about consumer behavior and in using that knowledge to benefit consumers. These firms include McNeil Consumer Health Care, McCann-Erickson, Procter & Gamble, Hallmark, Bank of America, Kraft, Samsung Electronics, IBM, Pfizer, J.... View Details
Keywords: by Manda Mahoney
  • Program

Agribusiness Seminar

constraints Leverage data and technology to improve decision making, operating efficiency, and responsiveness to customers Defend against commodification and drive profitability through product and marketing innovation Design robust,... View Details
Keywords: Agriculture; Agriculture
  • July 1994 (Revised March 1996)
  • Case

Baxter International: OnCall as Soon as Possible?

Baxter Healthcare is heir to the fabled ASAP ordering system, one of the best-known examples of the use of technology to provide strategic marketing advantage. By 1994, the proprietary ASAP system is well established. Baxter is beginning to launch On-Call EDI, which is... View Details
Keywords: Information Technology; Competitive Advantage; Business Strategy; Information Technology Industry; Information Technology Industry
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  • 12 Jan 2022
  • News

Harvard Business School’s Bold Agenda

    Paul A. Gompers

    Paul Gompers, Professor of Business Administration at the Harvard Business School, specializes in research on financial issues related to start-up, high growth, and newly public companies. Professor Gompers has an appointment in both the View Details
    Keywords: health care; health care; health care; health care; health care; health care; health care; health care
    • Web

    Marketing - Faculty & Research

    FDA approval to bring his technology to patients in the US. As time ticked by, GLP-1 drugs came like a tsunami, seemingly conquering the weight-loss market. With approval seemingly coming soon, Gaur had to decide what his strategy should... View Details
    • Web

    Podcasts - Managing the Future of Work

    retention. Also, how technology can accelerate the adoption. Read the Transcript Previous Episodes The business logic of supporting carers in the workforce 23 OCT 2024 | Managing the Future of Work Employers can benefit by remapping their... View Details
    • Web

    Publications - Institute For Strategy And Competitiveness

    Article The Agenda for the Next Generation of Health Care Information Technology The Agenda for the Next Generation of Health Care Information View Details
    • 23 Jul 2020
    • Blog Post

    Why Plume? To Make a Difference in the World

    cancelled and recruiting heated up, I continued to find myself thinking about Plume. Each case in Strategy and TEM transformed into a lens through which I looked at our mission and market. Midway through the semester, I joined the team formally as Head of Growth. Plume... View Details
    • August 2024
    • Case

    Sky Therapeutics: Innovating in Digital Therapeutics

    By: Satish Tadikonda, Olivia Reszczynski and William Marks
    Shad Faraz and Alex Youssef were intrigued by the opportunities in the relatively new area of Digital Therapeutics. Despite initial successes, early entrants had struggled with reimbursement and revenue-predictability challenges. However, venture investors still... View Details
    Keywords: Business Startups; Entrepreneurship; Mission and Purpose; Health Care and Treatment; Technological Innovation; Business Strategy; Health Industry; Health Industry
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    • 21 Jun 2017
    • News

    A New Approach to Safely Sharing Cancer Patients’ Data

    • 06 Mar 2012
    • First Look

    First Look: March 6

    productive. The authors have studied when 161 countries adopted 104 technologies over the past 200 years, and they conclude that profound economic advantages-as measured by per capita income-accrue to early adopters of technology. Read... View Details
    Keywords: Sean Silverthorne
    • May 2023 (Revised June 2023)
    • Case

    Novartis (A): Reimagining Medicine

    By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
    This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,... View Details
    Keywords: Health Care and Treatment; Business Model; Leadership; Pharmaceutical Industry; Switzerland
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    • Web

    Program Requirements - Doctoral

    Health Policy (Management) Program Requirements Students in the Health Policy (Management) program will learn how theories and concepts from fields such as technology and... View Details
    • Article

    Beyond Statistics: The Economic Content of Risk Scores

    By: Liran Einav, Amy Finkelstein, Raymond Kluender and Paul Schrimpf
    "Big data" and statistical techniques to score potential transactions have transformed insurance and credit markets. In this paper, we observe that these widely-used statistical scores summarize a much richer heterogeneity, and may be endogenous to the context in which... View Details
    Keywords: Analytics and Data Science; Risk and Uncertainty; Insurance Industry
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    • Web

    Key Concepts - Institute For Strategy And Competitiveness

    Measure Outcomes & Cost for Every Patient Aligning Reimbursement with Value Systems Integration Geography of Care Information Technology Key Concepts Value-based health care is one of the most important... View Details
    • December 2003 (Revised April 2004)
    • Case

    Dragon's Teeth Vineyards

    By: Alan D. MacCormack, Marius Leibold, Sven Voelpel and Kerry Herman
    Dragon's Teeth Vineyards (DTV) is a South African wine producer that is considering whether to use genetically modified organisms (GMOs) in its wine-making process. GMOs promise to lower the costs of wine production significantly through increased yields and reduced... View Details
    Keywords: Technological Innovation; Growth and Development Strategy; Genetics; Transition; Brands and Branding; Product Development; Product Design; Organizational Change and Adaptation; Technology Adoption; Food and Beverage Industry; Biotechnology Industry; South Africa
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    • 11 Nov 2014
    • First Look

    First Look: November 11

    reached their limits; third, some products affecting the health and rights of the people as well as the related entities' behavior are challenging the legal and moral bottom line. These three aspects are required to establish a new... View Details
    Keywords: Sean Silverthorne