Publications

2024
Chapter

The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

By: Ariel Dora Stern

For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details

April 1978 (Revised January 1985)
Case

Searle Medical Instruments Group (Abridged)

By: Steven C. Wheelwright

SMIG, a division of G.D. Searle, was a fast growing high market-share company in the field of nuclear medical instruments. It manufactured two basically different product lines, one very successful and the other less so. Although marketing was separate for these... View Details

Keywords: Change; Brands and Branding; Market Participation; Production; Success; Performance Capacity; Expansion; Medical Devices and Supplies Industry

September 2017 (Revised February 2018)
Case

Becton Dickinson: Global Health Strategy

By: Mark R. Kramer and Sarah Mehta

Becton, Dickinson and Company (BD) was a medical technology firm headquartered in Franklin Lakes, New Jersey, with 43,000 employees and 2016 revenues of $12.5 billion. For several years, the company had pursued developing products that created shared value, defined as... View Details

Keywords: Shared Value; Creating Shared Value; Odon Device; Medical Technology; Value Creation; Values and Beliefs; Philanthropy and Charitable Giving; Health; Health Care and Treatment; Health Testing and Trials; Emerging Markets; Social Issues; Competitive Strategy; Medical Devices and Supplies Industry; Africa; Asia; Middle East

Fast Answer

Medical devices: Competitive products

What are the substitute and/or competitative medical products? You may begin with the following approaches: Check market research reports. You may begin with: BCC Research Frost & Sullivan Medical... View Details

November 2001
Teaching Note

Catalyst Medical Solutions (TN)

By: Richard M.J. Bohmer, Amy C. Edmondson and Laura Feldman

Teaching Note for (9-601-014). View Details

Keywords: Medical Devices and Supplies Industry

September 2014
Case

Radiometer, 2003

By: John R. Wells and Galen Danskin

In 2003, Radiometer was the world's leading supplier of blood gas analysis equipment and accessories for critical care patients. Based in Denmark, Radiometer sold through a combination of sales subsidiaries and distributors around the world, and generated sales of over... View Details

Keywords: Medical Devices; Medical Equipment ＆ Devices; Mergers ＆ Acquisitions; Strategic Analysis; Strategic Change; Family Business; Strategy; Medical Devices and Supplies Industry; Denmark; United States

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

Read Now

2022
Working Paper

The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

By: Ariel Dora Stern

For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details

Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry

Find at Harvard

03 Feb 2014
News

Eyes on Medical Breakthroughs

harder than her male classmates to succeed. From her father, a Hungarian immigrant with no business training who bought New York City's Chelsea Hotel and turned it into one of the Big Apple's most famous addresses, she learned to take risks and work hard to see them... View Details

Keywords: Ralph Ranalli; Management; Ambulatory Health Care Services; Health, Social Assistance

November 2022
Case

Ajax Health: A New Model for Medical Technology Innovation

By: Regina E. Herzlinger and Ben Creo

This case teaches key success factors for both startup and established MedTech firms. It examines how to structure a firm to maximize innovation and financial returns with organizational structures that better align the incentives for the different skill sets... View Details

Keywords: Business Startups; Success; Innovation Strategy; Mergers and Acquisitions; Market Entry and Exit; Financial Strategy; Business Model; Partners and Partnerships; Entrepreneurship; Private Equity; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

02 Jul 2019
Working Paper Summaries

Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices

Keywords: by Alberto Galasso and Hong Luo; Medical Devices & Supplies

29 Jun 2015
HBS Case

Consumer-centered Health Care Depends on Accessible Medical Records

health, the process is a bit like throwing a lasso around a tsunami. That's why integrated medical data has now become a major goal of health care reform. Integrating patient records, such as physicians' notes, diagnoses, View Details

Keywords: by Dina Gerdeman; Health; Technology

August 1995
Teaching Note

Medical Products Company TN

By: Robert H. Hayes

Teaching Note for (9-694-065). View Details

Keywords: Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Europe

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

April 2006 (Revised May 2009)
Case

Inverness Medical Innovations - Born Global (A)

Ron Zwanziger has just started his third company, having just sold the last one for $1.3 billion to Johnson & Johnson. As part of the deal with J&J, certain assets were transferred to the new company, Inverness Medical Innovations, which, at the time of its creation,... View Details

Keywords: Globalized Firms and Management; Mergers and Acquisitions; Entrepreneurship; Health Care and Treatment; Corporate Finance; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Waltham

August 2002 (Revised June 2003)
Teaching Note

General Electric Medical Systems (TN)

By: Tarun Khanna

Teaching Note for (9-702-428). View Details

Keywords: Medical Devices and Supplies Industry; China