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Show Results For
- All HBS Web
(285)
- News (47)
- Research (186)
- Events (1)
- Multimedia (2)
- Faculty Publications (63)
- Research Summary
The Role of Institutions in Overcoming Imperfect Monitoring in Relational Contracting (with Carmit Segal)
In a world in which firms can be hit by transitory adverse shocks it may be too costly for any single worker to verify the true state of the world. In this case, it may not be possible for firms to lower wages in response to adverse shocks and still have the workers... View Details
- 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.
- 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).
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of... View Details
Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
- 28 Mar 2023
- Research & Ideas
The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation
it through clinical development faster were just as safe as drugs that went through a longer, more costly development process. The study’s findings could have wide-ranging implications for not only drugmakers trying to advance innovation, but View Details
- 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.
- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so... View Details
Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
- April 2014 (Revised January 2015)
- Background Note
Note on Mobile Healthcare
By: John A. Quelch and Margaret L. Rodriguez
Delivering health care to the global population was a challenge. Health care costs accounted for ten percent of world GDP by 2013. In the U.S., health care costs were expected to top $3.1 trillion in 2014. New technologies, shortages of trained personnel and... View Details
Keywords: Health Care; Mobile; Mobile App; Public Health; Startups; Hardware; Software; Telemedicine; Global; Medical Devices; Medical Services; Medical Solutions; Entrepreneurs; Government And Business; Technological Change; Health Care and Treatment; Entrepreneurship; Government and Politics; Technological Innovation; Applications and Software; Information Infrastructure; Health Industry; Technology Industry
Quelch, John A., and Margaret L. Rodriguez. "Note on Mobile Healthcare." Harvard Business School Background Note 514-122, April 2014. (Revised January 2015.)
- February 2024 (Revised December 2024)
- Case
Best Buy Health: Enabling Care at Home
This case explores retailer Best Buy’s decision to enter health care. Best Buy Health aims to enable care at home across three prongs: consumer health, active aging, and virtual care. A key pillar of Best Buy Health's strategy is leveraging the Geek Squad—the company's... View Details
Keywords: Business Ventures; Health Care and Treatment; Innovation and Invention; Business Strategy; Market Entry and Exit; Service Delivery; Service Operations; Electronics Industry; Health Industry; Retail Industry; United States; Minnesota
Huckman, Robert S., Rosabeth Moss Kanter, Antonio Moreno, Bradley Staats, and Sarah Mehta. "Best Buy Health: Enabling Care at Home." Harvard Business School Case 624-009, February 2024. (Revised December 2024.)
- November 2021 (Revised December 2024)
- Case
Kermit PPI
By: Kyle Myers, Matt Grennan and Sarah Mehta
Launched in 2011, Kermit PPI helped hospitals save money on expensive orthopedic implants and devices by enabling them to renegotiate their contracts with device manufacturers and better monitor compliance. In 2021, as they look to grow, they are entertaining two... View Details
Keywords: Health; Health Care and Treatment; Strategy; Expansion; Information Technology; Applications and Software; Supply Chain; Supply Chain Management; Contracts; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; Maryland
Myers, Kyle, Matt Grennan, and Sarah Mehta. "Kermit PPI." Harvard Business School Case 622-007, November 2021. (Revised December 2024.)
- 2019
- Working Paper
Biometric Monitoring, Service Delivery and Misreporting: Evidence from Healthcare in India
By: Thomas Bossuroy, Clara Delavallade and Vincent Pons
Developing countries increasingly use biometric identification technology in hopes of improving the reliability of administrative information and delivering social services more efficiently. This paper exploits the random placement of biometric tracking devices in... View Details
Keywords: Biometric Technology; Health Care and Treatment; Technological Innovation; Analytics and Data Science; Quality; Performance Improvement; India
Bossuroy, Thomas, Clara Delavallade, and Vincent Pons. "Biometric Monitoring, Service Delivery and Misreporting: Evidence from Healthcare in India." NBER Working Paper Series, No. 26388, October 2019. (Revise and resubmit requested, Review of Economics and Statistics.)
- 23 Apr 2019
- Video
X-Cor Therapeutics Final Pitch New Venture Competition 2019 Alumni Track
- February 2025
- Case
Abiomed: A Change of Heart
By: Satish Tadikonda, Faith Robertson and William Marks
After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability... View Details
Keywords: Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; European Union; United States
Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: A Change of Heart." Harvard Business School Case 825-011, February 2025.
- October 2024
- Case
Allurion: Competing in the Age of GLP-1
By: Satish Tadikonda, Rajiv Lal, David Lane and Sarah Sasso
Shantanu Gaur had built Allurion into a formidable business internationally, providing obesity patients with a less invasive option long before GLP-1 drugs became the latest craze. Selling Allurion's medical device across 60+ countries, he awaited FDA approval to bring... View Details
- Research Summary
Overview
Patient Portals: The Provider Role
Patient portals are widespread, but evidence of impact is limited. In this study, we use a large dataset spanning 2 years and >1 million patients across 650 primary care practices to explore the "other side" of portals: health... View Details
Patient portals are widespread, but evidence of impact is limited. In this study, we use a large dataset spanning 2 years and >1 million patients across 650 primary care practices to explore the "other side" of portals: health... View Details
- September 2006 (Revised April 2007)
- Case
Medtronic Vision 2010
Describes the company's year-long efforts to transition from a medical device company selling products to physicians for use with patients suffering chronic end-stage disease, to a medical technology company providing life-long solutions for people with chronic... View Details
Keywords: Business Plan; Transition; Decision Choices and Conditions; Corporate Entrepreneurship; Financial Management; Financing and Loans; Health Care and Treatment; Innovation and Invention; Strategic Planning; Health Industry
Applegate, Lynda M. "Medtronic Vision 2010." Harvard Business School Case 807-051, September 2006. (Revised April 2007.)
- March 2000
- Case
Aspect Medical Systems
By: Richard M.J. Bohmer and Naomi Atkins
Entrepreneur Nassib Chamoun has created an innovative anesthesiology device that monitors patients' consciousness levels during surgery. This case tracks how Chamoun and his executive team built the infrastructure of the company and actively managed the adoption... View Details
Keywords: Decision Choices and Conditions; Entrepreneurship; Independent Innovation and Invention; Infrastructure; Product Design; Product Development; Problems and Challenges; Adoption; Competitive Strategy; Technology Industry
Bohmer, Richard M.J., and Naomi Atkins. "Aspect Medical Systems." Harvard Business School Case 600-076, March 2000.
- 30 Jul 2018
- News
Open offices can lead to closed minds
- 2019
- Article
Time-Driven Activity-Based Cost Analysis for Outpatient Anticoagulation Therapy: Direct Costs in a Primary Care Setting with Optimal Performance
By: Robert S. Kaplan, Rohit A. Bobade, Richard A. Helmers, Thomas M. Jaeger, Laura J. Odell and Derek A. Haas
Objectives: To determine how overall cost of anticoagulation therapy for warfarin compares with that of Novel Oral Anticoagulants (NOACs). Also, to demonstrate a scientific, comprehensive, and an analytical approach to estimate direct costs involved in monitoring and... View Details
Keywords: Time-Driven Activity-Based Costing; Activity Based Costing and Management; Health Care and Treatment; Analysis
Kaplan, Robert S., Rohit A. Bobade, Richard A. Helmers, Thomas M. Jaeger, Laura J. Odell, and Derek A. Haas. "Time-Driven Activity-Based Cost Analysis for Outpatient Anticoagulation Therapy: Direct Costs in a Primary Care Setting with Optimal Performance." Journal of Medical Economics 22, no. 5 (2019): 471–477.
- January 2001 (Revised October 2002)
- Case
The American Medical Association-Sunbeam Deal (A): Serpent on the Staff Meets Chainsaw Al
By: Ashish Nanda and Kimberly A. Haddad
Facing dwindling membership and looking to increase its revenue, the American Medical Association (AMA) signed an endorsement deal with Sunbeam Corp., a leader in the small home appliance industry, in August 1997. In the deal, the AMA would receive significant... View Details
Keywords: Conflict of Interests; Organizations; Health Care and Treatment; Health Industry; United States
Nanda, Ashish, and Kimberly A. Haddad. "The American Medical Association-Sunbeam Deal (A): Serpent on the Staff Meets Chainsaw Al." Harvard Business School Case 801-326, January 2001. (Revised October 2002.)