Publications

December 1994 (Revised January 1995)
Case

When is a product ready for the market? In this case, engineers present a prototype medical device product to the CEO for approval. The product, developed under a tight deadline, is essentially identical to the main competitor's product, but that competitor is... View Details

Keywords: Innovation and Management; Product Development; Medical Devices and Supplies Industry

September 2014
Case

Pfizer's Centers for Therapeutic Innovation (CTI)

By: Gary Pisano, James Weber and Kait Szydlowski

In 2010, Pfizer established four small research units in New York, Boston, San Francisco, and San Diego located close to several premier Academic Medical Centers (AMCs), or hospitals with adjoining medical schools. The goal of these units was to redesign collaboration... View Details

Keywords: Drug Development; Academic Collaboration; Research And Development; Innovation; Translational Research; Management; Operations; Problems and Challenges; Research; Science; Information Technology; Strategy; Biotechnology Industry; Pharmaceutical Industry; North and Central America; Europe; Asia

February 2023
Article

Maintaining Health Care Innovations After the Pandemic

By: Regina E. Herzlinger, Barak D. Richman and Kevin A. Schulman

The COVID-19 pandemic exposed the worst failings of the health care system, but it also stimulated a flurry of innovations that could lead to a much-improved delivery system. These were innovations that were born out of necessity: telemedicine access and use... View Details

Keywords: Health Care; Health Care Industry; Health Care Outcomes; Innovation; Innovation In Healthcare Delivery; COVID; COVID-19 Pandemic; Pandemics; Telemedicine; Telehealth; Ambulatory Care; Vaccines; Innovation and Invention; Change; Health Industry

June 2023
Article

Managing Medical Device Liability Through Innovation: A Strategic Approach

By: Alberto Galasso and Hong Luo

In this article, we discuss several aspects of the relationships among product liability risk, safety, and innovation strategies of medical device companies. View Details

Keywords: Safety; Public Opinion; Legal Liability; Product; Medical Devices and Supplies Industry

2024
Article

Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway

By: Mateo Aboy, Cristina Crespo and Ariel Stern

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States

01 Oct 2018
Working Paper Summaries

Negative Shocks and Innovation: Evidence from Medical Device Recalls

Keywords: by George P. Ball, Jeffrey T. Macher, and Ariel Dora Stern; Medical Devices & Supplies; Medical Devices & Supplies

May 2020
Article

Value-Based Health Care in Undergraduate Medical Education

By: Jessica N. Holtzman, Bhushan R. Deshpande, Jessica C. Stuart, Thomas W. Feeley, Mary Witkowski, Edward M. Hundert and Jennifer Kasper

Problem: Value-based health care (VBHC) is an innovative framework for redesigning care delivery to achieve better outcomes for patients and reduce cost; however, providing students with the skills to understand and engage with these topics is a challenge to... View Details

Keywords: Value-based Health Care; Health Care and Treatment; Higher Education; Curriculum and Courses

10 Aug 2015
Research & Ideas

New Medical Devices Get To Patients Too Slowly

While the US Food and Drug Administration has chiseled away pharmaceutical review times over the years to speed innovative drugs to market, the opposite seems to have occurred in the agency's approval of View Details

Keywords: by Michael Blanding; Health; Technology

28 Jun 2010
HBS Case

Cincinnati Children’s Hospital Medical Center

Health-care reform is more than a political football. For twenty years it's been a ground-level topic of increasing importance for the administrators, physicians, nurses, and frontline employees who interact with patients every day. "Cincinnati Children's Hospital... View Details

Keywords: by Julia Hanna; Health

2017
Working Paper

Tort Reform and Innovation

By: Alberto Galasso and Hong Luo

Current academic and policy debates focus on the impact of tort reforms on physicians’ behavior and medical costs. This paper examines whether these reforms also affect incentives to develop new technologies. We develop a theoretical model which predicts that the... View Details

Keywords: Lawsuits and Litigation; Laws and Statutes; Innovation and Invention; Medical Devices and Supplies Industry

December 2017
Article

Is There a Doctor in the House? Expert Product Users, Organizational Roles, and Innovation

By: Riitta Katila, Sruthi Thatchenkery, Michael Christensen and Stefanos A. Zenios

We explore the impact on innovation that professional end-users of a product have as inventors, executives, and board members in a young firm. In contrast to prior literature, which has emphasized technology roles, we put the spotlight on the executive and governance... View Details

Keywords: Innovation; User Innovation; Healthcare; Innovation and Management; Entrepreneurship; Medical Devices and Supplies Industry

Find at Harvard

September 2024
Case

The Health Equity Accelerator at Boston Medical Center

By: Susanna Gallani, Mary Witkowski and Katie Sonnefeldt

This case describes how Boston Medical Center, a hospital and safety net organization, changed its strategic approach to health equity after realizing that previous efforts were not sufficient to address the health disparities among their patients. In 2021, the Health... View Details

Keywords: Health Care and Treatment; Health Disorders; Innovation and Management; Innovation Leadership; Innovation Strategy; Adaptation; Business Strategy; Mission and Purpose; Decisions; Organizational Change and Adaptation; Organizational Structure; Diversity; Race; Ethnicity; Urban Scope; Local Range; Equality and Inequality; Health Industry; Boston

August 2009 (Revised June 2015)
Case

MINTing Innovation at NewYork-Presbyterian (A)

By: Richard G. Hamermesh and David Kiron

Several top surgeons at NewYork-Presbyterian Hospital (NYP) are receiving financial and administrative support to advance their surgical device inventions through the earliest stages of commercialization. View Details

Keywords: Health Care; Innovation ＆ Entrepreneurship; Hospital; Entrepreneurship; Financing and Loans; Investment; Health Care and Treatment; Innovation and Invention; Intellectual Property; Commercialization; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; New York (state, US)

August 2017
Article

Tort Reform and Innovation

By: Alberto Galasso and Hong Luo

Current academic and policy debates focus on the impact of tort reforms on physicians’ behavior and medical costs. This paper examines whether these reforms also affect incentives to develop new technologies. We develop a theoretical model that predicts that the impact... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technological Innovation; Legal Liability; Medical Devices and Supplies Industry

Find at Harvard

August 1998 (Revised July 2002)
Case

Innovation at 3M Corporation (A)

By: Stefan H. Thomke and Ashok Nimgade

Describes how 3M Corp. introduces and learns a new and innovative methodology called Lead User research to understand future customer and market needs. A team from 3M's Medical-Surgical Markets Division applies the Lead User methodology to the field of surgical... View Details

Keywords: Innovation and Management; Innovation Strategy; Managerial Roles; Marketing Strategy; Demand and Consumers; Market Timing; Product Development; Problems and Challenges; Business Strategy; Medical Devices and Supplies Industry

March 2013 (Revised May 2013)
Case

Omar Ishrak: Building Medtronic Globally

By: Bill George and Natalie Kindred

Omar Ishrak, Medtronic's first non-American CEO, aims to reinvigorate the medical device maker's growth by focusing on emerging markets, therapy innovation, and creative business models. In 2012, budget constraints in mature economies, the lack of new medical therapies... View Details

Keywords: Healthcare; Medical Devices; Medtronic; Globalization; Innovation; Reverse Innovation; Leadership; Multinational Firms and Management; Globalized Markets and Industries; Management Teams; Business Model; Emerging Markets; Global Strategy; Health Care and Treatment; Acquisition; Innovation and Invention; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; China

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