Patient Monitoring Devices - Publications - Faculty & Research - Harvard Business School

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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

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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

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

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

Keywords: by Kasandra Brabaw; Pharmaceutical

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

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

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

February 2024 (Revised December 2024)
Case

Best Buy Health: Enabling Care at Home

By: Robert S. Huckman, Rosabeth Moss Kanter, Antonio Moreno, Bradley Staats and Sarah Mehta

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

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

23 Apr 2019
Video

X-Cor Therapeutics Final Pitch New Venture Competition 2019 Alumni Track

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

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

Keywords: Corporate Entrepreneurship; Health Care and Treatment; Global Strategy; Competitive Strategy; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; United Kingdom; France; India; Brazil; Middle East

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

Keywords: Healthcare Technology; Electronic Health Records; Health Care Delivery

September 2006 (Revised April 2007)
Case

Medtronic Vision 2010

By: Lynda M. Applegate

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

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

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

30 Jul 2018
News

Open offices can lead to closed minds

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

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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

Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry

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