Publications

January 2006 (Revised April 2007)
Case

General Electric Healthcare, 2006

By: Tarun Khanna and Elizabeth Raabe

In January 2006, Joe Hogan, head of General Electric (GE) Healthcare Technologies, prepared to step into William Castell's shoes as CEO of GE Healthcare, the world's leading manufacturer of diagnostic imaging equipment. In 2004, former CEO Jeff Immelt acquired Amersham... View Details

Keywords: Corporate Entrepreneurship; Cost vs Benefits; Growth and Development Strategy; Mergers and Acquisitions; Machinery and Machining; Global Range; Multinational Firms and Management; Product Design; Technological Innovation; Expansion; Value Creation; Business Subsidiaries; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

March 2009
Case

Incept LLC and Confluent Surgical (A)

By: Bhaskar Chakravorti, Toby E. Stuart and James Weber

A venture capitalist must decide whether to invest in a medical technology company that licenses intellectual property from a privately held IP holding company based on a platform technology. Entrepreneurs Amar Sawhney and Fred Khosravi founded Incept LLC to... View Details

Keywords: Business Model; Entrepreneurship; Intellectual Property; Rights; Agreements and Arrangements; Partners and Partnerships; Trust; Medical Devices and Supplies Industry

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... View Details

Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile and Wireless Technology; Applications and Software; Framework

Read Now

17 Mar 2009
First Look

First Look: March 17, 2009

care services are internationally renowned for quality. In 2008, The Clinic is restructuring the organization into teams defined around patient needs, rather than traditional medical specialties. "Patients First!" takes shape as... View Details

Keywords: Martha Lagace

31 Jan 2017
First Look

First Look at New Research: January 31, 2017

Abstract—The Food and Drug Administration approves new medical devices after in-depth reviews of safety and effectiveness data. Some have advocated for shorter review times to encourage innovation. We... View Details

Keywords: Carmen Nobel

July 2011 (Revised January 2013)
Case

Digital Microscopy Is Making Me Crazy!

By: Willy Shih

For Carl Zeiss Microimaging, modular hardware and software enabled customers to tailor Zeiss's broad range of microscopy systems hardware and software to meet a wide range of needs from basic scientific research in the biological and medical sciences to clinical... View Details

Keywords: Information Infrastructure; Applications and Software; Corporate Strategy; Disruptive Innovation; Science-Based Business; Management Analysis, Tools, and Techniques; Business Conglomerates; Digital Platforms; Opportunities; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

10 Jul 2018
First Look

New Research and Ideas, July 10, 2018

Bangladesh, Africa, and Chile, benefiting the public as well as their own enterprises. He then describes how an Indian health care organization is tackling institutional voids as it expands into medical tourism in the Cayman Islands. An... View Details

Keywords: Dina Gerdeman

09 Aug 2016
First Look

August 9, 2016

paper: https://www.hbs.edu/faculty/Pages/item.aspx?num=51309 Innovation under Regulatory Uncertainty: Evidence from Medical Technology By: Stern, Ariel Dora Abstract—This paper explores how the regulatory approval process affects... View Details

Keywords: Sean Silverthorne

12 Mar 2013
First Look

First Look: March 12

use of limited malaria medications and preventing increased resistance to first-line malaria treatment. However, despite the evident potential benefits of RDTs, many clinicians in Zambia do not use them or simply ignore their results. Why... View Details

Keywords: Sean Silverthorne

05 Dec 2022
What Do You Think?

How Would Jack Welch’s Leadership Style Fare in Today’s World?

(iStockphoto/josefkubes) Jack Welch’s leadership practices and accomplishments as CEO of General Electric for 20 years have once again come under scrutiny. He is the subject of two recent books. Their titles—David Gelles’ The Man Who Broke Capitalism and William... View Details

Keywords: by James Heskett; Medical Devices & Supplies; Medical Devices & Supplies; Medical Devices & Supplies; Medical Devices & Supplies

12 Feb 2019
First Look

New Research and Ideas, February 12, 2019

Devices: Challenges and Opportunities for U.S. Regulators and Innovators By: Gordon, William J., and Ariel Dora Stern Abstract— Software has become an increasingly important component of medical device... View Details

Keywords: Dina Gerdeman

17 Sep 2021
Research & Ideas

The Trial of Elizabeth Holmes: Visionary, Criminal, or Both?

after dropping out of Stanford University, knew the product didn’t deliver while she solicited new business and investments. Defense attorneys say Holmes “believed” in the revolutionary blood-testing device and that “trying hard and... View Details

Keywords: by Christina Pazzanese, Harvard Gazette; Medical Devices & Supplies; Medical Devices & Supplies; Medical Devices & Supplies

27 May 2009
First Look

First Look: May 27, 2009

these fundamental questions must be answered. A medical doctor himself, Bohmer explains that health-care professionals are tasked with providing two very different types of care—sequential and iterative. With sequential care, a patient... View Details

Keywords: Martha Lagace

28 Mar 2023
Research & Ideas

The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation

vaccines are now widely considered safe and effective, the public’s fears were a reflection of a broader hesitation about faster-than-expected R&D processes, Stern says. “Regulation in health care product markets exists for a very good reason,” she says. “We don't... View Details

Keywords: by Kasandra Brabaw; Pharmaceutical

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... View Details

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

December 2011
Case

Bergerac Systems: The Challenge of Backward Integration

By: David A. Garvin and Sunru Yong

Bergerac Systems is a small, rapidly growing manufacturer of diagnostic instruments used in veterinary practices. The company introduced the OmniVue chemistry analyzer, which enables veterinarians to run a wide range of blood and blood chemistry tests on their animal... View Details

Keywords: Financial Analysis; Manufacturing Strategy; Strategy; Production; Supply Chain Management; Vertical Integration; Performance Capacity; Financial Strategy; Medical Devices and Supplies Industry

August 2017
Case

RoboTech: Storming into the U.S. Market

By: Christopher A. Bartlett, Rachel Gordon and John J. Lafkas

This case describes the challenges facing the CEO of a small, Singapore-based industrial robotics company that decides to diversify away from its core industrial robot business by leveraging its expertise into the medical-devices industry. It launches an innovative... View Details

Keywords: Market Entry and Exit; Diversification; Product Launch; Competitive Strategy; Globalized Firms and Management; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Singapore; United States