Publications

November 2007
Case

Center for Integration of Medicine and Innovative Technology (CIMIT)

By: H. Kent Bowen and Courtney Purrington

Translating innovative ideas form the clinician to the patient remains a major problem in the field of medicine. Dr. John Parrish and colleagues created an organization (CIMIT) that brings the technical, financial, and administrative resources to these innovative... View Details

Keywords: Financing and Loans; Innovation and Invention; Technological Innovation; Resource Allocation; Alliances; Research and Development; Health Industry; Service Industry

June 2016
Case

Aggressive Growth Plans For Zimmer Spine

By: Kevin Schulman and Miranda Shaw

Steve Healy, the President of Zimmer Spine, has to transform his organization into a market leader. Zimmer is a major medical device firm, but the Spine division has underperformed, and its core technology did not get the expanded FDA label that had been expected. The... View Details

Keywords: Medical Device; Organizational Innovation; Organizational Growth; Organizations; Growth and Development Strategy; 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

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December 2005 (Revised October 2013)
Case

Fred Khosravi and AccessClosure (A)

By: Richard Hamermesh and Liz Kind

Fred Khosravi is a serial medical device entrepreneur. In his latest venture, he must decide whether to sell now or continue to develop his current product and whether to market it, sell the company, or IPO. View Details

Keywords: Negotiation; Medical Devices; Venture Capital; Life Sciences; Health Care Industry; Healthcare Technology; Healthcare Ventures; Business Startups; Decision Choices and Conditions; Entrepreneurship; Growth and Development Strategy; Medical Devices and Supplies Industry; United States

August 2022
Article

Regulatory Considerations to Keep Pace with Innovation in Digital Health Products

By: John Torous, Ariel Dora Stern and Florence T. Bourgeois

Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a... View Details

Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry

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September 2008
Background Note

Background on the Technology of Molecular Diagnostics

By: Regina E. Herzlinger and Jason Sanders

To be used as background reading for the "EXACT Sciences Corp.: Commercializing a Diagnostic Test" and "Diagnostic Genomics" cases, HBS nos. 308-090 and 309-040. View Details

Keywords: Health Testing and Trials; Technology; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

Web

Information Technology - Institute For Strategy And Competitiveness

HBS ISC Health Care Health Care Value-Based Health Care Health Care Courses Fast Facts Value-Based Health Care Value-Based Health Care Cases & Teaching Notes Key Concepts Key Stakeholders Publications Team Work With Us Presentations Key Concepts Key Concepts Organize... View Details

January 2015 (Revised July 2019)
Case

CVS Health: Promoting Drug Adherence

By: Leslie John, John Quelch and Robert Huckman

Email mking@hbs.edu for a courtesy copy.

The case describes a program that CVS Health recently implemented to improve medication adherence, an important problem from a societal, public policy, and firm... View Details

01 Jun 2010
News

Cardiac Kid

has more than 1,000 workers and expects revenues of about $280 million this year. “The company was founded basically to prevent heart attacks,” Huennekens told the San Diego Union-Tribune (January 25, 2010). To that end, Volcano makes systems to detect and treat artery... View Details

Keywords: medical devices; Ambulatory Health Care Services; Health, Social Assistance; Management of Companies and Enterprises; Management

July 2021
Article

Electronic Trace Data and Legal Outcomes: The Effect of Electronic Medical Records on Malpractice Claim Resolution Time

By: Sam Ransbotham, Eric Overby and Michael C. Jernigan

Information systems generate copious trace data about what individuals do and when they do it. Trace data may affect the resolution of lawsuits by, for example, changing the time needed for legal discovery. Trace data might speed resolution by clarifying what events... View Details

Keywords: Analytics and Data Science; Lawsuits and Litigation; Digital Transformation; Welfare; Health Industry

09 Jul 2018
Research & Ideas

Overcoming the Challenges of Selling Brand New Technology (Hey, Need a 3-D Printer?)

things like making machine parts and medical implantations. Still, the printers were large, unreliable, and expensive. Starting around 2011 the revolution began. 3-D printers began to shrink, grow in quality, and become considerably less... View Details

Keywords: by Michael Blanding; Technology; Technology; Technology; Technology; Technology; Technology; Technology; Technology

Awards

Best Paper Award, 2022 Conference of the Accounting and Finance Association of Australia and New Zealand – Technology Section

By: Susanna Gallani

Winner of the Best Paper Award at the 2022 Conference of the Accounting and Finance Association of Australia and New Zealand, Technology Section, for "The Effects of Electronic Medical Records on Hospital Utilization Costs" with Luminita Enache, Xue Guo, and Eddie... View Details

June 2005 (Revised July 2006)
Background Note

Note on the Convergence Between Genomics & Information Technology

By: David B. Yoffie, Dharmesh M Mehta and Rachel Sha

Focuses on the convergence between the genomics and semiconductor industries, in particular organ printing, DNA computing, biomolecular sensory networks, and DNA microarrays. Explains what this newly converged world looks like based on current research and findings in... View Details

Keywords: Genetics; Information Technology; Business Model; Disruptive Innovation; Information Technology Industry; Information Technology Industry; Information Technology Industry; Information Technology Industry

March 2015
Teaching Note

CVS Health: Promoting Drug Adherence

By: Leslie John, John Quelch and Robert Huckman

Email mking@hbs.edu for a courtesy copy.

This Teaching Note explains the theory of the case and teaching plan for the case: CVS Health: Promoting Drug Adherence (515010). The case finds Helena Foulkes, Executive... View Details

March 2000
Teaching Note

Disruptive Technology a Heartbeat Away: Ecton, Inc. TN

By: Clayton M. Christensen and Tara Donovan

Teaching Note for (9-699-018). View Details

Keywords: Medical Devices and Supplies Industry

15 Apr 2014
News

Bertarelli Foundation Gift Names Deans' Health & Life Sciences Challenge Prize

Life Sciences Challenge, launched in 2012 and chaired by Dean Nohria and Dr. Jeffrey S. Flier, dean of the Faculty of Medicine, Harvard Medical School. In recognition of the donor's generosity, the Deans' Challenge prize will be named the... View Details

Keywords: i-Lab; Harvard Medical School; Scientific Research and Development Services

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

April 1993 (Revised October 1995)
Case

ALZA and Bio-Electro Systems (A): Technological and Financial Innovation

By: Josh Lerner and Peter Tufano

To develop the next generation of risky products, ALZA, a mature and profitable biotechnology firm specializing in drug delivery systems, must raise $40 million. Organizational constraints and competitive concerns demand that the work be done inside the firm. However,... View Details

Keywords: Risk and Uncertainty; Technological Innovation; Business Subsidiaries; Decision Choices and Conditions; Corporate Finance; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry