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- All HBS Web
(3,627)
- People (2)
- News (452)
- Research (2,873)
- Events (11)
- Multimedia (34)
- Faculty Publications (2,228)
Thomas W. Mastin
to research and development enabled Lubrizol to become the world leader in the supply of chemical additives. Under his leadership, the company enjoyed a decade of progressive growth with zero debt. View Details
Keywords: Chemicals & Industrial
- 17 Oct 2012
- Research & Ideas
America Needs a Manufacturing Renaissance
Erosion Of The Industrial Commons From, Producing Prosperity: Why America Needs a Manufacturing Renaissance By Gary P. Pisano and Willy C. Shih In times past, farmers and local townspeople would bring their livestock to the commons—a... View Details
- 12 Mar 2018
- Op-Ed
Op-Ed: Why BlackRock CEO Larry Fink Is Not a Socialist
cost-cutting; in fact, cutting infrastructure, supply chain costs, and excess expenses should be done all the time, in good times and bad. This is the approach used by ExxonMobil as it has been one of the... View Details
- 07 Nov 2005
- What Do You Think?
Is Less Becoming More?
Amazon stimulates sales by its listing of thousands of books that would otherwise be out of print, given their meager sales through traditional channels. Internet technology and supply chain efficiencies... View Details
- 09 Mar 2016
- Lessons from the Classroom
In This Classroom, Beer Can Improve Your Grade
combined into one “industry” in which those teams compete, independent from the other industry groupings. With each round, teams can see how they’re faring and how their rivals are performing, altering their path as needed. The game... View Details
- 01 Jun 2009
- News
Bright Future for Green Business
Partners — touched on several systemic problems that hold the green tech industry back. One is a failure to think about the interrelationship of resources: You can grow great biofuels, for example, but only if you have an abundant View Details
- 31 May 2016
- First Look
May 31, 2016
additively separable in its state variables, leading to conquering the curse of dimensionality and the opportunity to manage the supply chain using independently acting managers. We develop conditions under... View Details
Keywords: Sean Silverthorne
- 2011
- Working Paper
Quantity vs. Quality: Exclusion by Platforms with Network Effects
By: Andrei Hagiu
This paper provides a simple model of platforms with direct network effects, in which users value not just the quantity (i.e., number) of other users who join, but also their average quality in some dimension. A monopoly platform is more likely to exclude low-quality... View Details
Keywords: Multi-sided Platforms; Exclusion; Quality And Quantity; Cost; Governing Rules, Regulations, and Reforms; Network Effects; Market Participation; Digital Platforms; Monopoly; Quality; Motivation and Incentives; Strategy
Hagiu, Andrei. "Quantity vs. Quality: Exclusion by Platforms with Network Effects." Harvard Business School Working Paper, No. 11-125, May 2011.
- 24 Sep 2014
- Op-Ed
Tackling Climate Change Will Cost Less Than We Think
costs fell by more than 60 percent. We've seen change of a similar magnitude in civilian industries as well. Less than 2 percent of the US population/workforce now works on the land, but agricultural production has only continued to... View Details
- 05 Jan 2022
- News
Untapped Potential
investments approach. ”It is a niche market,” he says. “It just happens to be one that is well on the way to being a trillion-dollar industry.” Ferguson also believes that the industry—everything from water supply to sewerage to water... View Details
- 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
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "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." Art. 29. npj Digital Medicine 7 (2024).
- 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
Tadikonda, Satish, and Sidhant Jena. "Augmenix: Space to Think Differently." Harvard Business School Case 824-031, August 2023.
- 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
Galasso, Alberto, and Hong Luo. "Managing Medical Device Liability Through Innovation: A Strategic Approach." Health Management, Policy and Innovation 8, no. 1 (June 2023).
- 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
Everhart, Alexander O., Yi Zhu, and Ariel D. Stern. "Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 18 (May 9, 2023): 1609–1610. (Reply to original paper.)
- 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
- 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
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
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
- 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
Foley, C. Fritz, and F. Katelynn Boland. "Investor Relations Practices at Edwards Lifesciences." Harvard Business School Case 219-058, November 2018. (Revised January 2019.)
- 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
Gupta, Budhaditya, and Stefan Thomke. "An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India." R&D Management 48, no. 4 (September 2018): 485–501.
- 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
Chung, Doug J., and Sarah Mehta. "Luminopia: Improving Treatment for Visual Disorders." Harvard Business School Case 517-065, April 2017.
- 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
Stern, Ariel Dora. "Innovation Under Regulatory Uncertainty: Evidence from Medical Technology." Journal of Public Economics 145 (January 2017): 181–200.