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Show Results For
- All HBS Web
(286)
- News (47)
- Research (186)
- Events (1)
- Multimedia (2)
- Faculty Publications (63)
- 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–December 2015
- Article
Active Postmarketing Drug Surveillance for Multiple Adverse Events
By: Joel Goh, Margrét V. Bjarnadóttir, Mohsen Bayati and Stefanos A. Zenios
Postmarketing drug surveillance is the process of monitoring the adverse events of pharmaceutical or medical devices after they are approved by the appropriate regulatory authorities. Historically, such surveillance was based on voluntary reports by medical... View Details
Keywords: Drug Surveillance; Health Care; Stochastic Models; Queueing; Diffusion Approximation; Brownian Motion; Health Care and Treatment; Analytics and Data Science; Analysis
Goh, Joel, Margrét V. Bjarnadóttir, Mohsen Bayati, and Stefanos A. Zenios. "Active Postmarketing Drug Surveillance for Multiple Adverse Events." Operations Research 63, no. 6 (November–December 2015): 1528–1546. (Finalist, 2012 INFORMS Health Applications Society Pierskalla Award.)
- March 2019
- Article
Evidence of Upcoding in Pay-for-Performance Programs
By: Hamsa Bastani, Joel Goh and Mohsen Bayati
Recent Medicare legislation seeks to improve patient care quality by financially penalizing providers for hospital-acquired infections (HAIs). However, Medicare cannot directly monitor HAI rates and instead relies on providers accurately self-reporting HAIs in claims... View Details
Keywords: Medical Coding; Health Policy; Healthcare-acquired Conditions; Medicare; Health Care and Treatment; Policy; Performance Improvement; Quality; Measurement and Metrics; Government Legislation
Bastani, Hamsa, Joel Goh, and Mohsen Bayati. "Evidence of Upcoding in Pay-for-Performance Programs." Management Science 65, no. 3 (March 2019): 1042–1060. (2015 INFORMS Health Applications Society best student (H. Bastani) paper award.)
- 29 Jun 2015
- HBS Case
Consumer-centered Health Care Depends on Accessible Medical Records
health, the process is a bit like throwing a lasso around a tsunami. That's why integrated medical data has now become a major goal of health care reform. Integrating patient records, such as physicians' notes, diagnoses, medical View Details
- February 2025
- Case
Abiomed: Clinical Trials and Tribulations
By: Satish Tadikonda, Faith Robertson and William Marks
After receiving 510(k) clearance for the Impella 2.5 device, Abiomed had proceeded to conduct a premarket approval (PMA) process as well to prove clinical superiority, earn greater protection, and extend commercial runway. However, in the middle of the clinical trial... View Details
Keywords: Corporate Disclosure; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Launch; Medical Devices and Supplies Industry
Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: Clinical Trials and Tribulations." Harvard Business School Case 825-096, February 2025.
- 12 Sep 2023
- Cold Call Podcast
Can Remote Surgeries Digitally Transform Operating Rooms?
Keywords: Health
- May 2024
- Article
True Costs of Uterine Artery Embolization: Time-Driven Activity-Based Costing in Interventional Radiology Over a 3-Year Period
By: Julia C. Bulman, Nicole H. Kim, Robert S. Kaplan, Sarah Schroeppel DeBacker, Olga R. Brook and Ammar Sarwar
The study used time-driven activity-based costing (TDABC) to estimate the costs to perform uterine artery embolization (UAE). Utilization times for patients undergoing outpatient UAE for fibroids or adenomyosis were captured from electronic health record timestamps and... View Details
Bulman, Julia C., Nicole H. Kim, Robert S. Kaplan, Sarah Schroeppel DeBacker, Olga R. Brook, and Ammar Sarwar. "True Costs of Uterine Artery Embolization: Time-Driven Activity-Based Costing in Interventional Radiology Over a 3-Year Period." Journal of the American College of Radiology 21, no. 5 (May 2024): 721–728.
- November 2001 (Revised March 2002)
- Case
Digital Angel
By: Youngme E. Moon and Kerry Herman
Digital Angel is considering the appropriate marketing plan for the launch of its new locator device. The device, a watch and pager worn in combination, provides GPS location information and monitors heart rate and body temperature via body sensors. Parents of young... View Details
Keywords: Information; Safety; Rights; Market Entry and Exit; Ethics; Product Launch; Brands and Branding; Product Development
Moon, Youngme E., and Kerry Herman. "Digital Angel." Harvard Business School Case 502-021, November 2001. (Revised March 2002.)
- 29 Jan 2019
- First Look
New Research and Ideas, January 29, 2019
a concurrent change in electronic transaction standards allowed hospitals to document a larger number of diagnoses per claim, which had the effect of reducing risk-adjusted patient readmission rates. Prior studies of the HRRP relied upon... View Details
Keywords: Dina Gerdeman
- 14 Nov 2017
- First Look
New Research and Ideas: November 14, 2017
defibrillators, have prolonged and improved the quality of life for millions of patients worldwide. Medical device innovation requires a robust ecosystem that involves medical technology innovators, often at... View Details
Keywords: Carmen Nobel
Satish K. Tadikonda
Satish Tadikonda is a Senior Lecturer in the Entrepreneurial Management Unit at Harvard Business School. In the MBA program, Satish teaches The Entrepreneurial Manager, a required first-year MBA course, and Entrepreneurship in Life Sciences, an elective course for... View Details
- 24 Jun 2013
- Research & Ideas
Is Your iPhone Turning You Into a Wimp?
What kind of a device are you using to read this article? And what does your body posture look like? Are you hunching over a smartphone screen, arms tightly at your side? Are you slouching over an iPad or laptop? Or are you stretched out... View Details
- 03 Jul 2018
- First Look
New Research and Ideas, July 3, 2018
link: https://www.hbs.edu/faculty/Pages/item.aspx?num=54665 forthcoming R&D Management An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India By: Gupta, Budhaditya, and Stefan... View Details
Keywords: Dina Gerdeman
- June 2010 (Revised August 2010)
- Case
Dr. Cameron Powell and AirStrip Technologies: After the Apple Worldwide Developers Conference
Dr. Cameron Powell and his partner, Trey Moore, co-founders of the innovative company, AirStrip Technologies, have developed a series of apps for the iPhone and other smartphones that can help doctors monitor the vital signs of their patients anytime, anywhere. They... View Details
Keywords: Information Technology; Entrepreneurship; Applications and Software; Health Care and Treatment; Mobile and Wireless Technology; Product Development; Information Technology Industry; Health Industry; United States
Chakravorti, Bhaskar, and N. Venkatraman. "Dr. Cameron Powell and AirStrip Technologies: After the Apple Worldwide Developers Conference." Harvard Business School Case 810-143, June 2010. (Revised August 2010.)
- March 2020 (Revised June 2023)
- Case
EyeControl: Inspiring Communication
By: Paul A. Gompers and Danielle Golan
Eye-controlled communication device startup EyeControl was founded in Tel Aviv, Israel in 2016 by cofounders with a shared personal connection to locked-in syndrome—a neurological disorder that left sufferers cognitively sound, yet paralyzed, with the exception of eye... View Details
Keywords: Health Disorders; Communication Technology; Business Startups; Expansion; Finance; Decision Making; Social Enterprise; Medical Devices and Supplies Industry
Gompers, Paul A., and Danielle Golan. "EyeControl: Inspiring Communication." Harvard Business School Case 820-078, March 2020. (Revised June 2023.)
- 17 Dec 2007
- Research & Ideas
The Rise of Medical Tourism
first for-profit hospital in the southern city of Chennai in 1983. Today the Apollo Hospitals Group manages more than 30 hospitals and treats patients from many different countries, according to the case. Tarun Khanna, a Harvard Business... View Details
- March 2022 (Revised August 2022)
- Case
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern and Alpana Thapar
In mid-January 2022, Nadine Hachach-Haram, founder and CEO of Proximie, was thinking about the company’s growth plans. Launched in 2016, Proximie was a platform that enabled clinicians, proctors, and medical device company personnel to be virtually present in operating... View Details
Keywords: Growth and Development Strategy; Technological Innovation; Partners and Partnerships; Strategic Planning; Health Care and Treatment; Analytics and Data Science; Digital Platforms; Health Industry; Lebanon; United Kingdom; United States
Stern, Ariel D., and Alpana Thapar. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Case 622-082, March 2022. (Revised August 2022.)
- February 2014
- Article
Developing a System to Track Meaningful Outcome Measures in Head and Neck Cancer Treatment
By: Ronald S. Walters, Heidi W. Albright, Randal S. Weber, Thomas W. Feeley, Ehab Y. Hanna, Scott B. Cantor, Carol M. Lewis and Thomas W. Burke
The health care industry, including consumers, providers, and payers of health care, recognize the importance of developing meaningful, patient-centered measures. This article describes our experience using an existing electronic medical record largely based on free... View Details
Keywords: Cancer Treatment; Cancer Care In The U.S.; Outcomes Measurement; Health Care and Treatment; Measurement and Metrics; Health Industry; North and Central America
Walters, Ronald S., Heidi W. Albright, Randal S. Weber, Thomas W. Feeley, Ehab Y. Hanna, Scott B. Cantor, Carol M. Lewis, and Thomas W. Burke. "Developing a System to Track Meaningful Outcome Measures in Head and Neck Cancer Treatment." Head & Neck 36, no. 2 (February 2014): 226–230. (e-Pub 6/2013. PMID: 23729280.)
- November–December 2022
- Article
The Value of Descriptive Analytics: Evidence from Online Retailers
By: Ron Berman and Ayelet Israeli
Does the adoption of descriptive analytics impact online retailer performance, and if so, how? We use the synthetic difference-in-differences method to analyze the staggered adoption of a retail analytics dashboard by more than 1,500 e-commerce websites, and we find an... View Details
Keywords: Descriptive Analytics; Big Data; Synthetic Control; E-commerce; Online Retail; Difference-in-differences; Martech; Internet and the Web; Analytics and Data Science; Performance; Marketing; Retail Industry
Berman, Ron, and Ayelet Israeli. "The Value of Descriptive Analytics: Evidence from Online Retailers." Marketing Science 41, no. 6 (November–December 2022): 1074–1096.
The Value of Descriptive Analytics: Evidence from Online Retailers - Marketing Science
Does the adoption of descriptive analytics impact online retailer performance, and if so, how? We use the synthetic difference-in-differences method to analyze the staggered adoption of a retail analytics dashboard by more than 1,500 e-commerce websites, and we... View Details