Publications

30 Nov 2017
News

Happy Meals (Are Here Again)

she says. For a company the size of McDonald’s, it posed a massive operational challenge. Hurdles included everything from structure—McDonald’s kitchens were designed to operate in two separate “day parts,” breakfast and everything else—to securing global View Details

Keywords: Dan Morrell; photographed by Saverio Truglia

08 Jan 2001
What Do You Think?

Have We Extended the Boundaries of the Firm Too Far?

Summing Up "What we are looking at is a fundamental challenge to our assumptions about which corporate structures work," commented Daniel Hayes in response to the recent piece on the future bounds of the organization. Raman Julka was just as dramatic:... View Details

Keywords: by James Heskett

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

August 2023
Case

Augmenix: Space to Think Differently

By: Satish Tadikonda and Sidhant Jena

Amar Sawhney, a serial medtech entrepreneur, had founded Augmenix to develop and commercialize a hydrogel-based medical device called SpaceOAR as an adjunctive technology to core radiation therapy. This technology was used to protect organs at risk (OAR) during... View Details

Keywords: Entrepreneurship; Health Care and Treatment; Technology Adoption; Innovation Strategy; Technological Innovation; Product Development; Commercialization; Medical Devices and Supplies Industry

June 2023
Article

Managing Medical Device Liability Through Innovation: A Strategic Approach

By: Alberto Galasso and Hong Luo

In this article, we discuss several aspects of the relationships among product liability risk, safety, and innovation strategies of medical device companies. View Details

Keywords: Safety; Public Opinion; Legal Liability; Product; Medical Devices and Supplies Industry

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

Keywords: Product Design; Safety; Medical Devices and Supplies Industry

February 2020
Teaching Note

Theranos: Who Has Blood on Their Hands? (A) and (B)

By: Nien-he Hsieh and Christina R. Wing

Teaching Note for HBS Nos. 619-039 and 320-091. View Details

Keywords: Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Lawsuits and Litigation; Medical Devices and Supplies Industry; California; United States

Article

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer

Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details

Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry

November 2018 (Revised January 2019)
Case

Investor Relations Practices at Edwards Lifesciences

By: C. Fritz Foley and F. Katelynn Boland

In January 2017, the senior leadership team at Edwards Lifesciences were preparing for the quarterly earnings call that would cover the fourth quarter of 2016. They faced questions about what types of information they should disclose on the call, as well as during... View Details

Keywords: Investor Relations; Medical Devices; Corporate Disclosure; Decisions; Business and Shareholder Relations; Medical Devices and Supplies Industry; United States

September 2018
Article

An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India

By: Budhaditya Gupta and Stefan Thomke

Recent research has studied innovation in emerging economies. However, microlevel product development processes in these economies are relatively unexplored, and the mechanisms by which the emerging economy context might affect such processes are still unclear. In this... View Details

Keywords: India; Product Development; Emerging Markets; Situation or Environment; Medical Devices and Supplies Industry; India

Find at Harvard

April 2017
Case

Luminopia: Improving Treatment for Visual Disorders

By: Doug J. Chung and Sarah Mehta

Luminopia—a start-up founded in January 2016 by three Harvard College freshmen—uses virtual reality technology to treat amblyopia (more commonly called “lazy eye”), the single biggest cause of visual disorders among children. By February 2017, the three founders had... View Details

Keywords: Pricing; Virtual Reality; Startup; Marketing; Marketing Channels; Product Marketing; Product Launch; Product Positioning; Business Startups; Price; Medical Devices and Supplies Industry; Cambridge; Massachusetts; United States

January 2017
Article

Innovation Under Regulatory Uncertainty: Evidence from Medical Technology

By: Ariel Dora Stern

This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)... View Details

Keywords: Technological Innovation; Medical Devices and Supplies Industry

Find at Harvard

February 2018
Article

Maintaining Beliefs in the Face of Negative News: The Moderating Role of Experience

By: Bradley R. Staats, Diwas S. KC and F. Gino

Many models in operations management involve dynamic decision making that assumes optimal updating in response to information revelation. However, behavioral theory suggests that rather than updating their beliefs, individuals may persevere in their prior beliefs. In... View Details

Keywords: Information; Announcements; Service Operations; Decision Making; Medical Specialties; Experience and Expertise; Medical Devices and Supplies Industry

Find at Harvard

June 2016
Case

Aggressive Growth Plans For Zimmer Spine

By: Kevin Schulman and Miranda Shaw

Steve Healy, the President of Zimmer Spine, has to transform his organization into a market leader. Zimmer is a major medical device firm, but the Spine division has underperformed, and its core technology did not get the expanded FDA label that had been expected. The... View Details

Keywords: Medical Device; Organizational Innovation; Organizational Growth; Organizations; Growth and Development Strategy; Medical Devices and Supplies Industry