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- 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...
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- 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...
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- October 2022
- Case
Podimetrics: Next Steps for Diabetes Cases
By: Regina E. Herzlinger and Ben Creo
Podimetrics, a virtual care management company treating adults with acute diabetes, sat at the intersection of medical device technology, data, and health services. Their leadership team considered the best next step for the company to take—would it be expanding the...
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Keywords:
Health Care;
Health Care Delivery;
Health Care Entrepreneurship;
Health Care Outcomes;
Diabetes;
Chronic Disease;
Chronic Illness;
Health Care and Treatment;
Health Disorders;
Medical Specialties;
Technological Innovation;
Innovation Strategy;
Product Development;
Business Model;
Customer Focus and Relationships;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry
- 2022
- Article
Rapid Growth of Remote Patient Monitoring Is Driven by a Small Number of Primary Care Providers
By: Mitchell Tang, Ateev Mehrotra and Ariel Dora Stern
Growing enthusiasm for remote patient monitoring has been motivated by the hope that it can improve care for patients with poorly controlled chronic illness. In a national commercially insured population in the U.S., we found that billing for remote patient monitoring...
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- August 2022
- Article
Trends in Remote Patient Monitoring Use in Traditional Medicare
By: Mitchell Tang, Carter Nakamoto, Ariel Dora Stern and Ateev Mehrotra
Remote patient monitoring (RPM), the collection by patients of physiological measurements that are automatically sent to their health care practitioners, has been touted as a promising tool for improving chronic disease management. Interest in RPM has grown because of...
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- 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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- November 2021
- 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...
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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
- 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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- 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...
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- April 15, 2021
- Article
Remote Patient Monitoring—Overdue or Overused?
By: Keizra Mecklai, Nicholas Smith, Ariel Dora Stern and Daniel B. Kramer
As the use of remote patient monitoring services grows—driven by health care limitations imposed by the COVID-19 pandemic—clinicians, payers, and patients face important questions regarding the volume, value, and appropriate use of this care model.
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- March 2021 (Revised January 2022)
- Case
Philips: Redefining Telehealth
By: Regina E. Herzlinger, Alec Petersen, Natalie Kindred and Sara M. McKinley
As one of the world’s largest healthcare companies, Philips sought to reach beyond the walls of the hospital and expand its hospital-to-home program to gain future competitive advantage through technology solutions combining predictive analytics with care delivery. By...
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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
- 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
- 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...
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- January 2021
- Article
Veil-of-Ignorance Reasoning Mitigates Self-Serving Bias in Resource Allocation During the COVID-19 Crisis
By: Karen Huang, Regan Bernhard, Netta Barak-Corren, Max Bazerman and Joshua D. Greene
The COVID-19 crisis has forced healthcare professionals to make tragic decisions concerning which patients to save. Furthermore, the COVID-19 crisis has foregrounded the influence of self-serving bias in debates on how to allocate scarce resources. A utilitarian...
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- 2021
- Working Paper
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...
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- July 2020
- Supplement
Instabeat—Crossing the Finish Line
By: Shikhar Ghosh, Nicole Tempest Keller and Alpana Thapar
Lebanese entrepreneur Hind Hobeika was just 21 years old when she launched her startup, Instabeat, which had developed the first real-time bio-feedback device for swimmers to monitor and improve their performance. It had been an extremely testing 10-year journey to...
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- Other Article
How to Make Remote Monitoring Tech Part of Everyday Health Care
By: Samantha F. Sanders, Ariel Dora Stern and William J. Gordon
Remote patient monitoring is a subset of telehealth that involves the collection, transmission, evaluation, and communication of patient health data from electronic devices. These devices include wearable sensors, implanted equipment, and handheld instruments. During...
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- March 2020
- 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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- 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
- 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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