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All HBS Web
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- Faculty Publications (41)
- 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...
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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.)
- 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).
- 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...
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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.
- 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...
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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.)
- 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...
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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 2018 (Revised June 2018)
- Case
Medtronic: Navigating a Shifting Healthcare Landscape
By: Robert S. Kaplan, Michael E. Porter, Thomas W. Feeley and Alee Hernandez
Medtronic is adapting its strategy to changes in healthcare competition and payments. It has decided to develop new relationships with payers, hospitals, and physicians to become more accountable for patient outcomes and total costs. The case describes new forms of...
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Keywords:
Value Based Health Care;
Bundled Payments;
Health Care and Treatment;
Cost Management;
Value Creation;
Supply Chain Management;
Customer Value and Value Chain;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States;
Netherlands
Kaplan, Robert S., Michael E. Porter, Thomas W. Feeley, and Alee Hernandez. "Medtronic: Navigating a Shifting Healthcare Landscape." Harvard Business School Case 718-471, January 2018. (Revised June 2018.)
- 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...
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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.
- June 2017 (Revised October 2017)
- Case
Becton Dickinson: Innovation and Growth (A)
By: Raffaella Sadun, Michael Beer and James Weber
In late 2015, CEO Vince Forlenza was reviewing Becton Dickinson’s transformation efforts designed to enable the company to innovate and grow in a changing environment. Becton Dickinson had been a successful medical device company for over 100 years. In recent years,...
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Keywords:
Transformation;
Change Management;
Innovation Leadership;
Mergers and Acquisitions;
Organizational Change and Adaptation;
Organizational Culture;
Organizational Design;
Strategy;
Growth and Development Strategy;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States
Sadun, Raffaella, Michael Beer, and James Weber. "Becton Dickinson: Innovation and Growth (A)." Harvard Business School Case 717-419, June 2017. (Revised October 2017.)
- 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...
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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.)
- October 2013 (Revised April 2015)
- Case
Myomo: Getting Sales in Motion
By: Frank V. Cespedes, Shikhar Ghosh and Matthew Preble
In late 2012, the management team of Myomo, a startup which had designed a unique myoelectric arm brace for patients with dysfunctional arms, was deciding which of the three sales models the company had tested to pursue as its sales strategy going forward. Each model...
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Keywords:
Technological Innovation;
Information Technology;
Marketing Strategy;
Decision Choices and Conditions;
Health Care and Treatment;
Business Startups;
Sales;
Growth and Development Strategy;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry
Cespedes, Frank V., Shikhar Ghosh, and Matthew Preble. "Myomo: Getting Sales in Motion." Harvard Business School Case 814-034, October 2013. (Revised April 2015.)
- September 2012 (Revised May 2015)
- Case
Philips-Visicu
By: Regina E. Herzlinger, Natalie Kindred and Sara M. McKinley
Would the advent of global payment models and ACOs create sufficient demand for a telemedicine offering covering the care continuum, from hospitals to the home? This was the decision facing Royal Philips Electronics (Philips), the Netherlands-based producer of...
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Keywords:
Health Care;
Philips;
Visicu;
Telemedicine;
eICU;
Accountable Care Organization;
ACO;
Bundled Payment;
Hospital To Home;
Patient Monitoring Devices;
Home Health Care;
Health Care and Treatment;
Communication Technology;
Quality;
Safety;
Performance Productivity;
Performance Capacity;
Performance Efficiency;
Consumer Behavior;
Emerging Markets;
Health Industry;
Telecommunications Industry;
Netherlands
Herzlinger, Regina E., Natalie Kindred, and Sara M. McKinley. "Philips-Visicu." Harvard Business School Case 313-015, September 2012. (Revised May 2015.) (As companion reading for this case, see Regina E. Herzlinger and Charles Huang, "Note on Bundled Payment in Health Care," HBS No. 312-032 (Boston: Harvard Business Publishing, 2012).)
- October 2009
- Case
Medisys Corp.: The IntensCare Product Development Team
By: Anne Donnellon and Joshua D. Margolis
Key topics include designing teams, managing teams, managing conflict, group dynamics, project management, product development, interdepartmental relations, and organizational change. MediSys, a U.S.-based medical equipment maker, has been developing IntensCare, a new...
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Keywords:
Project Management;
Interdepartmental Relations;
Organizational Change;
Leadership;
Conflict Management;
Interpersonal Communication;
Groups and Teams;
Product Design;
Product Development;
Organizational Change and Adaptation;
Health Care and Treatment;
Power and Influence;
Medical Devices and Supplies Industry;
United States
Donnellon, Anne, and Joshua D. Margolis. "Medisys Corp.: The IntensCare Product Development Team." Harvard Business School Brief Case 094-059, October 2009.
- September 2008 (Revised March 2020)
- Supplement
Medtronic: Patient Management Initiative (B)
The (B) case provides the denouement to the (A) case about Medtronic's introduction of the Chronicle and remote monitoring business.
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Keywords:
Health Care and Treatment;
Measurement and Metrics;
Information Technology;
Competitive Strategy;
Medical Devices and Supplies Industry
Herzlinger, Regina E. "Medtronic: Patient Management Initiative (B)." Harvard Business School Supplement 309-064, September 2008. (Revised March 2020.)
- 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...
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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.)
- 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...
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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.)
- July 2001 (Revised March 2020)
- Case
Medtronic: Patient Management Initiative (A)
By: Regina E. Herzlinger and Mark P. Allyn
Herzlinger, Regina E., and Mark P. Allyn. "Medtronic: Patient Management Initiative (A)." Harvard Business School Case 302-005, July 2001. (Revised March 2020.)
- 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...
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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.)
- January 1990 (Revised March 1991)
- Case
American Red Cross Blood Services: Northeast Region
By: Robert L. Simons
Recounts the financial difficulties and management changes experienced by American Red Cross Blood Services: Northeast Region (NER) during the 1980s. After summarizing industry-wide changes in the collection, testing, and distribution of blood and blood products, the...
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Keywords:
Change Management;
Budgets and Budgeting;
Financial Management;
Restructuring;
Health;
SWOT Analysis;
Social Enterprise;
Marketplace Matching;
Management Style;
Organizational Culture;
Organizational Change and Adaptation;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
North and Central America
Simons, Robert L. "American Red Cross Blood Services: Northeast Region." Harvard Business School Case 190-078, January 1990. (Revised March 1991.)
- Research Summary
Overview
By: Ayelet Israeli
Professor Israeli utilizes econometric methods and field experiments to study data driven decision making in marketing context. Her research focuses on data-driven marketing, with an emphasis on how businesses can leverage their own data, customer data, and market data...
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- Forthcoming
- Article
Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms
By: Caroline Marra and Ariel D. Stern
Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Product Development;
Health Testing and Trials;
Governing Rules, Regulations, and Reforms
Marra, Caroline, and Ariel D. Stern. "Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms." Clinical Pharmacology & Therapeutics (forthcoming). (Pre-published online February 2, 2024.)