Publications

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2024
Working Paper

Product Liability Litigation and Innovation: Evidence from Medical Devices

By: Alberto Galasso and Hong Luo

We examine the relationship between product liability litigation and innovation by systematically combining data on product liability lawsuits with data on new product introductions in a panel dataset of leading medical device firms. We first document a decline in... View Details

Keywords: Lawsuits and Litigation; Product Development; Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

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April 2010 (Revised September 2011)
Case

Supply Chain Partners: Virginia Mason and Owens & Minor (A) (Abridged)

By: V.G. Narayanan and Lisa Brem

Owens & Minor (O&M) performed lean inventory services for Virginia Mason (VM) as its Alpha Vendor, but the outdated industry pricing model created perverse incentives and could not capture O&M's costs. Together, O&M and VM created an activity-based pricing model: Total... View Details

Keywords: Supply Chain Management; Partners and Partnerships; Activity Based Costing and Management; Business Model; Non-Governmental Organizations; Nonprofit Organizations; Motivation and Incentives; Asset Pricing; Cost Accounting; Fair Value Accounting; Medical Devices and Supplies Industry

17 Apr 2018
Working Paper Summaries

Digital Innovation with High Costs of Entry: Evidence from Software-Driven Medical Devices

Keywords: by Cirrus Foroughi and Ariel Dora Stern; Medical Devices & Supplies; Medical Devices & Supplies

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

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November 2004
Case

ClozeX Medical (A): The New Standard of Wound Closure

By: William A. Sahlman and Ryland Matthew Willis

Describes a set of decisions confronting the founder of a company with a revolutionary new wound-closure product. He must decide how to finance and exploit his venture. View Details

Keywords: Business or Company Management; Corporate Entrepreneurship; Product Launch; Medical Specialties; Corporate Finance; Medical Devices and Supplies Industry

2012
Report

Competing by Saving Lives: How Pharmaceutical and Medical Device Companies Create Shared Value in Global Health

By: Mark R. Kramer, Kyle Peterson, Matthew Rehrig, Mike Stamp and Samuel Kim

Examples of how pharmaceutical and medical companies are addressing unmet health needs in low- and middle- income economies, creating shared value by providing products and services that tackle global health problems. View Details

Keywords: Shared Value; Low- And Middle-income Economies; Health Care and Treatment; Global Range; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

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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

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May 2024
Case

SofMedica Group: Managing Growth

By: Boris Groysberg and Sarah L. Abbott

SofMedica Group had expanded from its origins as a medical equipment distributor in Romania to a holding company with four business lines operating in six countries. This expansion had been driven by SofMedica’s mission: to make cutting edge medical technology... View Details

December 1984
Teaching Note

Medical and Environmental Electronic Devices Corp. (A) and (B), Teaching Note

By: Michael Beer

Keywords: 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

January 2018
Article

The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

By: Aaron V. Kaplan and Ariel D. Stern

The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details

Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States

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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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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

February 2024
Case

More than Optics: Olympus's Vision to Become a Leading Global MedTech Company

By: David J. Collis and Haisley Wert

In August 2022, CEO Yasuo Takeuchi reflected on Olympus Corporation’s recent transformation from being known as a Japanese consumer camera company to becoming a leading global medical technology (MedTech) company. Over the past dozen years, Takeuchi and prior... View Details

Keywords: Global Human Resource Management; Medical Technology; Corporate Strategy; Transformation; Globalization; Business Model; Leading Change; Organizational Structure; Organizational Change and Adaptation; Medical Devices and Supplies Industry; Japan; United States

April 2010
Teaching Note

Supply Chain Partners: Virginia Mason and Owens & Minor (TN) (A), (B), and (A) (Abridged)

By: V.G. Narayanan and Lisa Brem

Teaching Note for [109076], [109077], and [110063].. View Details

Keywords: Medical Devices and Supplies Industry

March 2013 (Revised May 2013)
Case

Omar Ishrak: Building Medtronic Globally

By: Bill George and Natalie Kindred

Omar Ishrak, Medtronic's first non-American CEO, aims to reinvigorate the medical device maker's growth by focusing on emerging markets, therapy innovation, and creative business models. In 2012, budget constraints in mature economies, the lack of new medical therapies... View Details

Keywords: Healthcare; Medical Devices; Medtronic; Globalization; Innovation; Reverse Innovation; Leadership; Multinational Firms and Management; Globalized Markets and Industries; Management Teams; Business Model; Emerging Markets; Global Strategy; Health Care and Treatment; Acquisition; Innovation and Invention; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; China

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 2014
Case

Radiometer, 2013

By: John R. Wells and Galen Danskin

In 2013, Radiometer continued to lead the world in blood gas analysis equipment and accessories, selling direct and through distributors to hospital central laboratories, point-of-care locations, and non-hospital medical locations. Founded in 1935 and based in Denmark,... View Details

Keywords: Medical Devices; Medical Equipment ＆ Devices; Mergers ＆ Acquisitions; Strategic Analysis; Strategic Change; Family Business; Strategy; Mergers and Acquisitions; Medical Devices and Supplies Industry; Denmark; United States