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- November 2022
- Teaching Note
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern, Alpana Thapar and Menna Hassan
Founded by Nadine Hachach-Haram in 2016, Proximie was a digital medicine platform that used mixed reality and a host of digital audio and visual tools to enable clinicians, proctors, and medical device company personnel to be virtually present in operating rooms (ORs),...
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- August 2022
- Article
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
By: John Torous, Ariel Dora Stern and Florence T. Bourgeois
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a...
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Keywords:
Emerging Technologies;
Governing Rules, Regulations, and Reforms;
Innovation and Invention;
Medical Devices and Supplies Industry
Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
- 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...
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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.)
- Article
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern...
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Keywords:
Wearables;
Regulatory Changes;
Medical Technology;
Medical Devices;
Market Access;
Market Entry and Exit;
Information Technology;
Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
United States;
Germany;
Belgium
Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Sensors 21, no. 14 (July 2021).
- March 2021
- Case
VideaHealth: Building the AI Factory
By: Karim R. Lakhani and Amy Klopfenstein
Florian Hillen, co-founder and CEO of VideaHealth, a startup that used artificial intelligence (AI) to detect dental conditions on x-rays, spent the early years of his company laying the groundwork for an AI factory. A process for quickly building and iterating on new...
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Keywords:
Artificial Intelligence;
Innovation and Invention;
Disruptive Innovation;
Technological Innovation;
Information Technology;
Applications and Software;
Technology Adoption;
Digital Platforms;
Entrepreneurship;
AI and Machine Learning;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
North and Central America;
United States;
Massachusetts;
Cambridge
Lakhani, Karim R., and Amy Klopfenstein. "VideaHealth: Building the AI Factory." Harvard Business School Case 621-021, March 2021.
- 2021
- Book
Remote Work Revolution: Succeeding from Anywhere
By: Tsedal Neeley
The rapid and unprecedented changes brought on by COVID-19 have accelerated the transition to remote working, requiring the wholesale migration of nearly entire companies to virtual work in just weeks, leaving managers and employees scrambling to adjust. This massive...
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Keywords:
Remote Work;
Health Pandemics;
Employment;
Disruption;
Organizational Change and Adaptation;
Management
Neeley, Tsedal. Remote Work Revolution: Succeeding from Anywhere. New York: Harper Business, 2021.
- August 2020 (Revised January 2022)
- Case
1928 Diagnostics: Fighting Antibiotics Resistance
By: Ariel D. Stern and Daniela Beyersdorfer
In 2019, the co-founders of the Swedish medical start-up 1928 Diagnostics, CEO Dr. Kristina Lagerstedt and COO Dr. Susanne Staaf, had to pick the right business model to commercialize their novel technology to hospitals and health care providers. Developed in...
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Keywords:
Health Care and Treatment;
Entrepreneurship;
Leadership;
Science-Based Business;
Growth and Development Strategy;
Business Growth and Maturation;
Business Model;
Information Technology;
Digital Platforms;
Health Disorders;
Market Entry and Exit;
Value Creation;
Business and Stakeholder Relations;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Europe;
Sweden
Stern, Ariel D., and Daniela Beyersdorfer. "1928 Diagnostics: Fighting Antibiotics Resistance." Harvard Business School Case 621-025, August 2020. (Revised January 2022.)
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...
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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- 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...
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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.
- 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).
- September 2018 (Revised December 2019)
- Case
Zebra Medical Vision
By: Shane Greenstein and Sarah Gulick
An Israeli startup founded in 2014, Zebra Medical Vision developed algorithms that produced diagnoses from X-rays, mammograms, and CT-scans. The algorithms used deep learning and digitized radiology scans to create software that could assist doctors in making...
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Keywords:
Radiology;
Machine Learning;
X-ray;
CT Scan;
Medical Technology;
Probability;
FDA 510(k);
Diagnosis;
Business Startups;
Health Care and Treatment;
Information Technology;
Applications and Software;
Competitive Strategy;
Product Development;
Commercialization;
Decision Choices and Conditions;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Israel
Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Case 619-014, September 2018. (Revised December 2019.)
- September 2018 (Revised January 2020)
- Case
Apple Pay and Mobile Payments in Australia (A)
By: Feng Zhu, Susan Athey and David Lane
In summer 2016, four of Australia’s top five banks petitioned regulators for permission to bargain collectively with Apple over the terms under which they would support its digital wallet, Apple Pay. They argued that doing so would force concessions from Apple that...
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Keywords:
Payment Methods;
Mobile Payment;
Apple;
Banks and Banking;
Cooperation;
Problems and Challenges;
Policy;
Digital Platforms;
Banking Industry;
Australia
Zhu, Feng, Susan Athey, and David Lane. "Apple Pay and Mobile Payments in Australia (A)." Harvard Business School Case 619-010, September 2018. (Revised January 2020.)
- Article
The Impact of the 'Open' Workspace on Human Collaboration
By: Ethan Bernstein and Stephen Turban
Organizations’ pursuit of increased workplace collaboration has led managers to transform traditional office spaces into “open,” transparency-enhancing architectures with fewer walls, doors, and other spatial boundaries, yet there is scant direct empirical research on...
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Keywords:
Open Office;
Transparency;
Collaboration;
Collective Intelligence;
Workspace;
Workspace Design;
Architecture;
Cubicles;
Boundaries;
Spatial Boundaries;
Human Behavior;
Propinquity;
Co-location;
Interaction;
Sociometers;
People Analytics;
Buildings and Facilities;
Communication;
Design;
Human Resources;
Leadership;
Management;
Organizational Design;
Organizational Structure;
Networks;
Social and Collaborative Networks;
Technology;
United States
Bernstein, Ethan, and Stephen Turban. "The Impact of the 'Open' Workspace on Human Collaboration." Art. 239. Philosophical Transactions of the Royal Society B, Biological Sciences 373, no. 1753 (August 19, 2018).
- February 2018
- Case
Amazon, Google, and Apple: Smart Speakers and the Battle for the Connected Home
By: Rajiv Lal and Scott Johnson
Amazon, Google, and Apple all offer their own smart speaker. The devices represent each firm's entry point into the connected home market. All three companies come into the space with their own strengths and weaknesses. Who will win?
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Keywords:
Apple;
Apple Inc.;
Google;
Amazon;
Amazon.com;
Google Home;
Homepod;
Echo;
Smart Home;
Connected Home;
Voice;
Artificial Intelligence;
Machine Learning;
Internet Of Things;
Smart Speaker;
Connected Speaker;
Intelligent Assistants;
Virtual Assistants;
Voice Assistants;
Alexa;
Google Assistant;
Siri;
Technological Innovation;
Disruptive Innovation;
Competitive Strategy;
Business Strategy;
Adoption;
Information Infrastructure;
Information Technology;
Internet and the Web;
Mobile and Wireless Technology;
Applications and Software;
Technology Adoption;
Digital Platforms;
Household;
AI and Machine Learning;
Electronics Industry;
Technology Industry;
United States
Lal, Rajiv, and Scott Johnson. "Amazon, Google, and Apple: Smart Speakers and the Battle for the Connected Home." Harvard Business School Case 518-035, February 2018.
- Article
Why Every Organization Needs an Augmented Reality Strategy
By: Michael E. Porter and James E. Heppelmann
While the physical world is three-dimensional, most data is trapped on two-dimensional pages and screens. This gulf between the real and digital worlds prevents us from fully exploiting the volumes of information now available to us. Augmented reality (AR), a set of...
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Keywords:
Technological Innovation;
Innovation Strategy;
Organizational Change and Adaptation;
Performance Effectiveness
Porter, Michael E., and James E. Heppelmann. "Why Every Organization Needs an Augmented Reality Strategy." Harvard Business Review 95, no. 6 (November–December 2017): 46–57.
- April 2017 (Revised May 2022)
- Case
King Digital Entertainment
By: Jeffrey F. Rayport, Davide Sola, Federica Gabrieli and Elena Corsi
Riccardo Zacconi was the co-founder and CEO of King Digital Entertainment, the video game company that had quickly established itself as the world’s leading maker of casual games for mobile devices after the sensational success of its game “Candy Crush Saga.” Zacconi...
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Keywords:
Entrepreneurship;
Information Technology;
Growth and Development Strategy;
Organizational Structure;
Acquisition;
Decision Choices and Conditions;
Video Game Industry;
Europe;
Sweden
Rayport, Jeffrey F., Davide Sola, Federica Gabrieli, and Elena Corsi. "King Digital Entertainment." Harvard Business School Case 817-117, April 2017. (Revised May 2022.)
- November 2016 (Revised April 2018)
- Case
reMarkable: e-Writing the Future
By: Elie Ofek and Curtis Hsu
Magnus Wanberg is the creator of reMarkable, a breakthrough e-writer device set apart from similar products on the market by having solved the frustrating “slow ink” problem typically experienced on pen-based electronic devices, thus providing a “pen and paper” like...
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Keywords:
Entrepreneurial Marketing;
Innovation Management;
Go To Market Strategy;
Marketing Plan;
Target Market;
Digital Devices;
Consumer Electronics;
Forecasting;
Information Technology;
Marketing Strategy;
Innovation and Management;
Marketing Channels;
Entrepreneurship;
Forecasting and Prediction;
Product Marketing;
Product Development;
Electronics Industry
Ofek, Elie, and Curtis Hsu. "reMarkable: e-Writing the Future." Harvard Business School Case 517-018, November 2016. (Revised April 2018.)
- May 2015 (Revised September 2015)
- Case
Philips Healthcare: Marketing the HealthSuite Digital Platform
By: John A. Quelch and Margaret L. Rodriguez
In June 2014, leading healthcare and consumer technology company, Royal Philips ("Philips"), announced its HealthSuite Digital Platform to house healthcare data and enable applications used by physicians and patients. Philips had strong equity in the healthcare...
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Keywords:
Health;
Healthcare;
Digital;
Platform;
Ecosystem;
Health Care and Treatment;
Technological Innovation;
Information Technology;
Product Development;
Applications and Software;
Digital Platforms;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Netherlands;
United States
Quelch, John A., and Margaret L. Rodriguez. "Philips Healthcare: Marketing the HealthSuite Digital Platform." Harvard Business School Case 515-052, May 2015. (Revised September 2015.)
- May 2014
- Article
Digital Dark Matter and the Economic Contribution of Apache
By: Shane Greenstein and Frank Nagle
Researchers have long hypothesized that research outputs from government, university, and private company R&D contribute to economic growth, but these contributions may be difficult to measure when they take a non-pecuniary form. The growth of networking devices and...
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Keywords:
Open Source;
Apache;
Economic Measurement;
Digital Economics;
Measurement and Metrics;
Open Source Distribution;
Internet and the Web;
Information Technology;
Applications and Software;
Economic Growth;
Research and Development;
Web Services Industry;
Information Technology Industry;
United States
Greenstein, Shane, and Frank Nagle. "Digital Dark Matter and the Economic Contribution of Apache." Research Policy 43, no. 4 (May 2014): 623–631. (Lead Article.)
- April 2014 (Revised March 2015)
- Case
GE and the Industrial Internet
By: Karim R. Lakhani, Marco Iansiti and Kerry Herman
CEO Jeff Immelt considers whether GE is moving fast enough on its new Industrial Internet initiative. The undertaking includes building out an Industrial Internet, connecting machines and devices, collecting their data and operations, and providing services to clients...
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Keywords:
Technology;
Operations Management;
Strategy;
Big Data;
Business Analysis;
Corporate Strategy;
Digital Technology;
Digital Innovation;
General Management;
General Strategy;
Global Competitiveness;
Global Strategy;
Innovation;
Innovation And Management;
Industrial Internet;
GE;
Innovation and Invention;
Information Technology;
Analytics and Data Science;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
North and Central America;
Asia;
Europe;
Middle East;
Latin America
Lakhani, Karim R., Marco Iansiti, and Kerry Herman. "GE and the Industrial Internet." Harvard Business School Case 614-032, April 2014. (Revised March 2015.)