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- 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...
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- January 2023
- Module Note
LCA Action Planning: Responsibility and Accountability
By: Sandra J. Sucher and Marilyn Morgan Westner
LCA action plans integrate responsibility and accountability into decision-making and planning. This module note was designed for the LCA course and reviews six steps leaders can follow to develop a practical LCA action plan for their business. It shows how integrating...
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- January 2023
- Supplement
Apple: Privacy vs. Safety (B)
By: Henry McGee, Nien-hê Hsieh and Christian Godwin
In 2020, as the COVID-19 pandemic swept across the globe, Apple and Google partnered to develop a contact tracing application that would collect information about users infected with the disease and notify those who they had been in contact with. While Apple/Google’s...
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Keywords:
Iphone;
Encryption;
Data Privacy;
Customers;
Customer Focus and Relationships;
Decision Making;
Ethics;
Values and Beliefs;
Globalized Firms and Management;
Government and Politics;
Health;
Health Pandemics;
Leadership;
Markets;
Safety;
Social Issues;
Information Technology;
Telecommunications Industry;
Technology Industry;
Consumer Products Industry;
Electronics Industry;
Health Industry;
United States;
Europe
- 13 Jan 2023 - 14 Jan 2023
- Conference Presentation
India’s Quest for Sustainable Growth in a New Global Reality:: The Need for a Region- and Sector-Driven Approach
- January 2023
- Case
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
By: Regina Herzlinger and Brian Walker
How can a successful executive assess her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to find a therapeutic window for Cleave Therapeutics oncology drug was on track but faced an uncertain future. Overseeing the...
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- 2023
- Working Paper
The Subjective Expected Utility Approach and a Framework for Defining Project Risk in Terms of Novelty and Feasibility—A Response to Franzoni and Stephan (2023), ‘Uncertainty and Risk-Taking in Science’
In their Discussion Paper, Franzoni and Stephan (F&S, 2023) discuss the shortcomings of existing peer review models in shaping the funding of risky science. Their discussion offers a conceptual framework for incorporating risk into peer review models of research...
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- 2023
- Working Paper
Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Floor?
By: Katherine Baicker, Amitabh Chandra and Mark Shepard
The United States spends substantially more on health care than most developed countries, yet leaves a greater share of the population uninsured. We suggest that incremental insurance expansions focused on addressing market failures will propagate inefficiencies and...
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- January–February 2023
- Article
The Overlooked Key to a Successful Scale-Up
By: Jeffrey F. Rayport, Davide Sola and Martin Kupp
Many start-ups experience enormous popularity and runaway growth, but only a few go on to become stable giants. What separates them from the pack? They all go through a developmental stage called extrapolation, say three business school professors.
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- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...
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- December 2022
- Teaching Note
Leonard Bernstein: Changing the World
By: Robert Simons and Shirley Sun
Teaching Note for HBS Case No. 122-056. The case traces the rise of Leonard Bernstein from a middle-class family in Boston to the conductor of the New York Philharmonic Orchestra. The case describes how he studied music intensely as a young man and developed mentors to...
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- Working Paper
Diversification as an Adaptive Learning Process: An Empirical Study of General-Purpose and Market-Specific Technological Know-How in New Market Entry
By: Dominika Kinga Randle and Gary P. Pisano
An enduring trait of modern corporations is their propensity to diversify into multiple lines of business. Penrosian theories conceptualize diversification as a strategy to exploit a firm’s fungible, yet “untradeable,” resources and point to redeployment of...
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- December 2022
- Technical Note
Risks and Opportunities from the Transition to a Low Carbon Economy: A Business Analysis Framework
By: George Serafeim
The transition to a low carbon economy introduces many risks and opportunities for businesses. Risks emerge from regulatory actions, such as carbon taxes and cap and trade systems, technological innovation that develop alternatives for customers making existing...
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Keywords:
Risk Assessment;
Opportunities;
Environmental Sustainability;
Carbon Footprint;
Risk Management;
Competitive Dynamics;
Business Analysis;
Climate Change;
Accounting;
Finance;
Valuation;
Business and Shareholder Relations;
Technological Innovation;
Transition;
Product Positioning;
Renewable Energy;
Analysis
- 13 Dec 2022
- Interview
Why Some Start-Ups Fail to Scale
By: Jeffrey Rayport and Curt Nickisch
Managing rapid growth is a huge challenge for young businesses. Even start-ups with glowing reviews and skyrocketing sales can fail. That’s because new ventures and corporate initiatives alike have to sustain profitability at scale, according to Harvard Business School...
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- 2022
- Working Paper
Nailing Prediction: Experimental Evidence on the Value of Tools in Predictive Model Development
Predictive model development is understudied despite its importance to modern businesses. Although prior discussions highlight advances in methods (along the dimensions of data, computing power, and algorithms) as the primary driver of model quality, the value of tools...
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Keywords:
Analytics and Data Science
- December 2022
- Case
Iberdrola: Leading the Energy Revolution
By: Juan Alcácer and Emer Moloney
At the end of 2019, Ignacio Galán, the Chairman and CEO of the world's third largest utility, Iberdrola, relected on his almost 20 years at the company. He managed a portfolio of three very different businesses, each with their own specific opportunities and...
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Keywords:
Energy;
Energy Generation;
Energy Sources;
Non-Renewable Energy;
Renewable Energy;
Engineering;
Innovation and Management;
Innovation Leadership;
Innovation Strategy;
Technological Innovation;
Leadership;
Growth and Development Strategy;
Market Timing;
Industry Growth;
Mission and Purpose;
Strategy;
Energy Industry;
Green Technology Industry;
Utilities Industry;
Transportation Industry;
Auto Industry;
Spain;
United Kingdom;
United States;
Brazil;
Mexico
- December 2022 (Revised January 2023)
- Case
Cann: High Hopes for Cannabis Infused Beverages
By: Ayelet Israeli and Anne V. Wilson
Founded in 2018 by Jake Bullock and Luke Anderson, Cann sold “social tonics,” or cannabis-infused beverages. By 2022, the company had several notable celebrity investors and talent partners, had sold over 10 million beverages to consumers, was distributing in six...
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Keywords:
Stigma;
Product Innovation;
Product Introduction;
Product Differentiation;
New Products;
New Product Marketing;
New Product Management;
Brand Management;
Branding;
Packaging;
Positioning;
Growth Strategy And Execution;
Growth;
Cannabis Industry;
Purpose;
Purpose Brands;
LGBTQ;
Direct-to-consumer;
DTC;
Regulations;
Channels Of Distribution;
Product Development;
Product Marketing;
Product Positioning;
Product;
Innovation and Invention;
Brands and Branding;
Marketing;
Marketing Communications;
Marketing Channels;
Advertising;
Advertising Campaigns;
Digital Marketing;
Market Entry and Exit;
Governing Rules, Regulations, and Reforms;
Food and Beverage Industry;
Food and Beverage Industry;
United States;
Canada;
North America
- December 8, 2022
- Article
What Companies Still Get Wrong about Layoffs
By: Sandra J. Sucher and Marilyn Morgan Westner
Research has long shown that layoffs have a detrimental effect on individuals and on corporate performance. The short-term cost savings provided by a layoff are often overshadowed by bad publicity, loss of knowledge, weakened engagement, higher voluntary turnover, and...
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- December 2022
- Background Note
Brief Note on Staggered Boards
By: Lynn S. Paine and Will Hurwitz
This background note discusses the evolution, use, and prevalence of staggered boards. By comparison with unitary boards whose members are all elected annually for one-year terms, staggered boards are divided into subsets of directors, with one subset up for election...
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- December 13, 2022
- Article
6 Ways Companies Fail to Help Workers Grow
By: Joseph Fuller, Matthew Sigelman and Nik Dawson
The authors recently studied Fortune 250 companies and ranked them based on the lived experience of three million of their U.S. workers. One of their key findings was that even top-ranked firms fail to deliver consistently on worker advancement. To understand why this...
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- 2022
- Working Paper
Demand-and-Supply Imbalance Risk and Long-Term Swap Spreads
By: Samuel G. Hanson, Aytek Malkhozov and Gyuri Venter
We develop and test a model in which swap spreads are determined by end users' demand for and constrained intermediaries' supply of long-term interest rate swaps. Swap spreads reflect compensation both for using scarce intermediary capital and for bearing convergence...
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