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- May 9, 2023
- Response
Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Yi Zhu and Ariel D. Stern
- March 2023
- Case
Woven Planet - Designing Software for the Car of the Future
By: Gary P. Pisano and Catherine Piner
Founded in 2021, Woven Planet Holdings—a subsidiary of Toyota Motor Corporation—was developing Arene, an automotive software platform consisting of an operating system, development and simulation tools, and a cloud-based service that could store and analyze vehicle...
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- 2023
- Working Paper
Unselfish Alibis Increase Choices of Selfish Autonomous Vehicles
Human drivers routinely make implicit tradeoffs between their selfish interests and the safety of passengers, as when they perform a rolling stop in order to reach their destination faster. Here I explore whether they are comfortable with autonomous vehicles (AVs) that...
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- February 2023
- Article
Increasing the Demand for Workers with a Criminal Record
By: Zoë Cullen, Will Dobbie and Mitchell Hoffman
State and local policies increasingly restrict employers’ access to criminal records, but without
addressing the underlying reasons that employers may conduct criminal background checks.
Employers may thus still want to ask about a job applicant’s criminal record...
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- 2023
- Book
Workplace Conditions
By: Jill Maben, Jane Ball and Amy C. Edmondson
This Element reviews the evidence for three workplace conditions that matter for improving quality and safety in healthcare: staffing; psychological safety, teamwork, and speaking up; and staff health and well-being at work. The authors propose that these are...
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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
- January 2023
- Article
Psychological Safety Comes of Age: Observed Themes in an Established Literature
By: Amy C. Edmondson and Derrick P. Bransby
Since its renaissance in the 1990s, psychological safety research has
flourished—a boom motivated by recognition of the challenge of navigating uncertainty and change. Today, its theoretical and practical significance
is amplified by the increasingly complex and...
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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
- Case
KKR at CHI Overhead Doors (A)
By: Dennis Campbell and Ethan Rouen
This case examines the decision by private equity firm KKR to grant equity to every employee at portfolio company CHI Overhead Doors upon purchasing the company in 2015. The case explores whether this initiative will create shared value, growing profits through better...
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- December 2022
- Article
I Don't 'Recall': The Decision to Delay Innovation Launch to Avoid Costly Product Failure
By: Byungyeon Kim, Oded Koenigsberg and Elie Ofek
Innovations embody novel features or cutting-edge components aimed at delivering desired customer benefits.
Oftentimes, however, we observe the need to recall new products shortly after their introduction. Indeed, a firm
may rush an innovation to market in an attempt...
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- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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- 2022
- Working Paper
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...
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- 2022
- Book
Healthy Buildings: How Indoor Spaces Can Make You Sick—or Keep You Well
By: Joseph G. Allen and John D. Macomber
For too long we’ve designed buildings that haven’t focused on the people inside—their health, their ability to work effectively, and what that means for the bottom line. An authoritative introduction to a movement whose vital importance is now all too clear, Healthy...
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- 2023
- Working Paper
The Dark Side of Generative AI: Chatbots and Mental Health
By: Julian De Freitas, Ahmet Kaan Uğuralp, Zeliha Uğuralp and Stefano Puntoni
Chatbots are now able to engage in sophisticated conversations with consumers. Due to the
‘black box’ nature of the algorithms, it is impossible to predict in advance how these
conversations will unfold. Behavioral research provides little insight into potential...
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- July 2022 (Revised November 2022)
- Case
Building a Mishap-Free U.S. Navy
In 2021, Kevin “Bud” Couch, a retired Navy captain who was now working as a civilian employee of the Navy Safety Center, was trying to determine how best to reduce the risk of Navy mishaps. The Navy had experienced a series of major mishaps in 2017 that had led to a...
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Keywords:
National Security;
Safety;
War;
Ship Transportation;
Risk Management;
Operations;
Singapore;
Tokyo;
San Diego
- July, 2022
- Article
Telehealth Visits After Shoulder Surgery: Higher Patient Satisfaction and Lower Costs
By: Evan A. O'Donnell, Jillian E. Haberli, Andres Muniz Martinez, Daniel Yagoda, Robert S. Kaplan and Jon J.P. Warner
Purpose and Methods: The study compared the cost of telemedicine visits with in-person clinic visits for routine follow-up after common shoulder surgeries. It also evaluated the safety and patient experience with telemedicine visits. Time-driven activity-based costing...
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- Article
A Career Life-Cycle Perspective on Women's Health and Safety
By: Robert S. Kaplan, Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator and Michael D. Parkinson
Women's health has demanded more attention from employers as women integrated into the workforce. Traditionally male-dominant fields and occupations require special attention to workplace design, physical standards for entry, employment practices, equipment, and health...
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- March 2022 (Revised May 2022)
- Case
Doubling Down: Elon Musk's Big Bets in 2022
By: David Yoffie and Daniel Fisher
2021 was a banner year for Elon Musk. CEO of the electric vehicle manufacturer Tesla, the aerospace manufacturer SpaceX, and a few smaller startups, Musk became the richest person on Earth after Tesla reached a market capitalization of $1 trillion and SpaceX a private...
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Keywords:
Innovation and Management;
Competitive Advantage;
Competitive Strategy;
Information Infrastructure;
Applications and Software;
Transportation;
Strategic Planning;
Leadership Style;
Leading Change;
Goals and Objectives;
Aerospace Industry;
Auto Industry;
Battery Industry;
United States;
Europe;
China
- 7 Mar 2022
- Other Presentation
How to Let Go of Perfectionism
By: Amy C. Edmondson
Harvard Business School professor Amy Edmondson joins Ofosu Jones-Quartey and Leah Santa Cruz to discuss why so many of us have perfectionistic tendencies. She explains how giving ourselves permission to fail can actually lead to more success.
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