Publications

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2019
Working Paper

Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry

By: Cirrus Foroughi and Ariel Dora Stern

Does the large-scale technological change that is characteristic of an industry-wide digital transformation entrench industry leaders or enable the rise of new entrants? We offer a novel approach to this question by studying the medical device industry, a unique... View Details

Keywords: Innovation; Medical Devices; Digitization; Medical Technology; Technological Innovation; Applications and Software; Market Entry and Exit; Industry Growth; Medical Devices and Supplies Industry; United States

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

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

January 2020
Article

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System

By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz

Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has... View Details

Keywords: Medical Devices; Health Testing and Trials; Analysis; Sales

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

May 2021
Article

Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices

By: Alberto Galasso and Hong Luo

We study the impact of consumers’ risk perception on firm innovation. Our analysis exploits a major surge in the perceived risk of radiation diagnostic devices following extensive media coverage of a set of over-radiation accidents involving CT scanners in late 2009.... View Details

Keywords: Risk Perception; Innovation; Medical Devices; Liability Risk; Risk and Uncertainty; Perception; Technological Innovation

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14 Aug 2012
News

New Medical Devices Get Smart

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 students: See MBA Career & Professional Development... View Details

01 Oct 2013
News

Bill George on Medical Device Tax, U.S. Shutdown

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

January–February 2021
Article

Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer

As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded... View Details

Keywords: Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards

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

28 Nov 2016
Research & Ideas

Challenging the Belief that Liability Laws Kill Medical Device Innovation

in passing tort reform laws to limit the amount of damages patients can receive. Less attention has been paid to the effect such reforms can have on medical device innovation. Under the chilling effect of... View Details

Keywords: by Michael Blanding; Medical Devices & Supplies

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

10 Aug 2015
Research & Ideas

New Medical Devices Get To Patients Too Slowly

While the US Food and Drug Administration has chiseled away pharmaceutical review times over the years to speed innovative drugs to market, the opposite seems to have occurred in the agency's approval of medical devices. Instead of... View Details

Keywords: by Michael Blanding; Health; Technology

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

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