Publications

July 2019
Article

Challenges and Opportunities in Software-Driven Medical Devices

By: William J. Gordon and Ariel Dora Stern

The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care. View Details

Keywords: Medical Devices; Healthcare; Health Care; Health Care and Treatment; Applications and Software; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

June 2006 (Revised July 2009)
Case

MassMEDIC: The Massachusetts Medical Device Industry Council

By: Willis M. Emmons III, Michael E. Porter and Spencer Wallace

Set in 2004, as Massachusetts Medical Device Industry Council (MassMEDIC) President Tom Sommer contemplates the future direction of a successful medical device cluster association. Focuses on the formation of cluster organizations and their roles and effectiveness,... View Details

Keywords: Economic Growth; Industry Clusters; Nonprofit Organizations; Social and Collaborative Networks; Cooperation; Massachusetts

Educators

28 Aug 2019
Working Paper Summaries

Who Drives Digital Innovation? Evidence from the US Medical Device Industry

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

2022
Working Paper

Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions

By: George P. Ball, Jeffrey T. Macher and Ariel Dora Stern

Medical device firms operate at the frontiers of innovation. When functioning properly, innovative medical devices can prolong and improve lives; when malfunctioning, the same devices may harm patients and lead to product recalls. Product recalls create significant... View Details

Keywords: New Product Development; Recalls; Product Failures; Medical Devices; FDA; Health Care; Product Development; Product; Failure; Competition; Opportunities; Medical Devices and Supplies Industry

01 Oct 2018
Working Paper Summaries

Negative Shocks and Innovation: Evidence from Medical Device Recalls

Keywords: by George P. Ball, Jeffrey T. Macher, and Ariel Dora Stern; Medical Devices & Supplies; Medical Devices & Supplies

Fast Answer

Careers, associations and events: medical devices

Where can I find information about major industry associations and events for my career development in medical devices sector? Careers HBS MBA... View Details

February 1981
Case

Medical and Environmental Electronic Devices Corp. (B)

By: Michael Beer

Keywords: Medical Devices and Supplies Industry

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

February 1996
Background Note

Note on the FDA Review Process for Medical Devices

Describes the FDA's classification scheme for the three classes of medical devices and the review processes. View Details

Keywords: Business and Government Relations; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States

Educators

June 2004
Case

Medical Technology Industry and Japan (A), The

In a five-year effort, the Health Industry Manufacturers Association (HIMA) tried to influence government health policy in Japan. In 1993, HIMA mobilized in response to fears the Japanese government was planning to target the U.S. medical devices industry. The case... View Details

Keywords: Health Care and Treatment; Policy; Globalized Markets and Industries; Government and Politics; Medical Devices and Supplies Industry; Japan; United States

Educators

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... View Details

Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

February 1981 (Revised June 1982)
Case

Medical and Environmental Electronic Devices Corp. (A)

By: Michael Beer

Keywords: Medical Devices and Supplies Industry

February 1993 (Revised August 1995)
Case

Medicare Payment for Drugs and Medical Devices

By: Regina E. Herzlinger

Keywords: Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; 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

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

28 Nov 2016
Research & Ideas

Challenging the Belief that Liability Laws Kill Medical Device Innovation

United States Patent and Trademark Office on the number of medical device patents in states during the same period. They found, on average, that once a state passed laws... View Details

Keywords: by Michael Blanding; Medical Devices & Supplies

May 2022
Article

When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants

By: Alberto Galasso and Hong Luo

Liability laws designed to compensate for harms caused by defective products may also affect innovation. We examine this issue by exploiting a major quasi-exogenous increase in liability risk faced by U.S. suppliers of polymers used to manufacture medical implants.... View Details

Keywords: Product Liability; Innovation; Tort; Medical Devices; Vertical Foreclosure; Product; Innovation and Invention; Legal Liability; Laws and Statutes; Medical Devices and Supplies Industry