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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
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.
- 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.
- 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.)
- 28 Aug 2019
- Working Paper Summaries
Who Drives Digital Innovation? Evidence from the US Medical Device Industry
- 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.)
- 01 Oct 2018
- Working Paper Summaries
Negative Shocks and Innovation: Evidence from Medical Device Recalls
- 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
- 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.
- 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.
- 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.
- 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.)
- 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.
- 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
Watkins, Michael D., and Terri Zavada. "Medical Technology Industry and Japan (A), The." Harvard Business School Case 904-018, June 2004.
- 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).
- 17 Apr 2018
- Working Paper Summaries
Digital Innovation with High Costs of Entry: Evidence from Software-Driven Medical Devices
- 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
- 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; Pharmaceutical Industry; Pharmaceutical Industry
Kramer, Mark R., Kyle Peterson, Matthew Rehrig, Mike Stamp, and Samuel Kim. "Competing by Saving Lives: How Pharmaceutical and Medical Device Companies Create Shared Value in Global Health." Report, FSG, 2012.
- 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 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.