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- All HBS Web
(557)
- People (1)
- News (67)
- Research (395)
- Events (3)
- Multimedia (8)
- Faculty Publications (303)
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- 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
Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.
- 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
Foroughi, Cirrus, and Ariel Dora Stern. "Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry." Harvard Business School Working Paper, No. 19-120, June 2019.
- 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
Ball, George P., Jeffrey T. Macher, and Ariel Dora Stern. "Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions." Harvard Business School Working Paper, No. 19-028, September 2018. (Revised March 2022.)
- 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
Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
- 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
Emmons, Willis M., III, Michael E. Porter, and Spencer Wallace. "MassMEDIC: The Massachusetts Medical Device Industry Council." Harvard Business School Case 706-498, June 2006. (Revised July 2009.)
- 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
Teisberg, Elizabeth O., and James Leonard. "Note on the FDA Review Process for Medical Devices." Harvard Business School Background Note 796-063, February 1996.
- 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
Galasso, Alberto, and Hong Luo. "Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices." Management Science 67, no. 5 (May 2021): 3022–3040.
- 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).
- 01 Oct 2018
- Working Paper Summaries
Negative Shocks and Innovation: Evidence from Medical Device Recalls
- 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
- 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
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- 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
- February 1981
- Case
Medical and Environmental Electronic Devices Corp. (B)
By: Michael Beer
Keywords: Medical Devices and Supplies Industry
Beer, Michael. "Medical and Environmental Electronic Devices Corp. (B)." Harvard Business School Case 481-063, February 1981.
- 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
Galasso, Alberto, and Hong Luo. "Product Liability Litigation and Innovation: Evidence from Medical Devices." Harvard Business School Working Paper, No. 24-063, March 2024.
- 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
Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- 28 Aug 2019
- Working Paper Summaries
Who Drives Digital Innovation? Evidence from the US Medical Device Industry
- February 1981 (Revised June 1982)
- Case
Medical and Environmental Electronic Devices Corp. (A)
By: Michael Beer
Keywords: Medical Devices and Supplies Industry
Beer, Michael. "Medical and Environmental Electronic Devices Corp. (A)." Harvard Business School Case 481-062, February 1981. (Revised June 1982.)
- February 1993 (Revised August 1995)
- Case
Medicare Payment for Drugs and Medical Devices
Keywords: Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
Herzlinger, Regina E. "Medicare Payment for Drugs and Medical Devices." Harvard Business School Case 193-099, February 1993. (Revised August 1995.)
- 17 Apr 2018
- Working Paper Summaries
Digital Innovation with High Costs of Entry: Evidence from Software-Driven Medical Devices
- 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
Galasso, Alberto, and Hong Luo. "When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants." American Economic Journal: Economic Policy 14, no. 2 (May 2022): 366–401.