Filter Results:
(551)
Show Results For
- All HBS Web
(551)
- News (72)
- Research (439)
- Multimedia (1)
- Faculty Publications (301)
Show Results For
- All HBS Web
(551)
- News (72)
- Research (439)
- Multimedia (1)
- Faculty Publications (301)
- 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.
- April 2009 (Revised June 2010)
- Supplement
Supply Chain Partners: Virginia Mason and Owens & Minor (B)
By: V.G. Narayanan and Lisa Brem
The epilogue to Supply Chain Partners: Virginia Mason and Owens & Minor (A), the B case details the outcome of the issues discussed in Case A; namely that Virginia Mason and Owens & Minor did implement the TSCC contract. Virginia Mason also kept the suture contract... View Details
Keywords: Health Care and Treatment; Supply Chain Management; Partners and Partnerships; Measurement and Metrics; Contracts; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
Narayanan, V.G., and Lisa Brem. "Supply Chain Partners: Virginia Mason and Owens & Minor (B)." Harvard Business School Supplement 109-077, April 2009. (Revised June 2010.)
- 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.
- 2022
- Working Paper
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details
Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry
Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
- 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.)
- 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.
- 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
Narayanan, V.G., and Lisa Brem. "Supply Chain Partners: Virginia Mason and Owens & Minor (A) (Abridged)." Harvard Business School Case 110-063, April 2010. (Revised September 2011.)
- 17 Apr 2018
- Working Paper Summaries
Digital Innovation with High Costs of Entry: Evidence from Software-Driven Medical Devices
- 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
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
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
- 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
- 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
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.
- 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
Gupta, Budhaditya, and Stefan Thomke. "An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India." R&D Management 48, no. 4 (September 2018): 485–501.
- 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
Keywords: Growth; Healthcare Access; Healthcare; Medical Devices; Medical Equipment ＆ Devices; Medical Care; Eastern Europe; Quality Management System; Health Care and Treatment; Growth Management; Education; Organizational Change and Adaptation; Quality; Leadership; Mission and Purpose; Expansion; Developing Countries and Economies; Technological Innovation; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Europe; Romania
Groysberg, Boris, and Sarah L. Abbott. "SofMedica Group: Managing Growth." Harvard Business School Case 424-027, May 2024.
- 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
Everhart, Alexander O., Yi Zhu, and Ariel D. Stern. "Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 18 (May 9, 2023): 1609–1610. (Reply to original paper.)
- 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
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- 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
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "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." Art. 29. npj Digital Medicine 7 (2024).
- 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
Collis, David J., and Haisley Wert. "More than Optics: Olympus's Vision to Become a Leading Global MedTech Company." Harvard Business School Case 724-426, February 2024.
- 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
Schulman, Kevin, and Miranda Shaw. "Aggressive Growth Plans For Zimmer Spine." Harvard Business School Case 316-106, June 2016.