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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

31 Jul 2018
Working Paper Summaries

How Does Product Liability Risk Affect Innovation? Evidence from Medical Implants

Keywords: by Alberto Galasso and Hong Luo

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

December 1998 (Revised March 1999)
Case

Disruptive Technology a Heartbeat Away: Ecton, Inc.

By: Clayton M. Christensen and Edward G Cape

Describes an innovating start-up company with a disruptive technology to the large, expensive echocardiography machines that leading cardiologists use to create images of heart functions for diagnostic purposes. Ecton's machine is small, cheap, portable, and can't... View Details

Keywords: Business Startups; Disruption; Machinery and Machining; Entrepreneurship; Innovation and Invention; Marketing; Product; Commercialization; Technology; 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

March 2022 (Revised August 2022)
Case

Proximie: Using XR Technology to Create Borderless Operating Rooms

By: Ariel D. Stern and Alpana Thapar

In mid-January 2022, Nadine Hachach-Haram, founder and CEO of Proximie, was thinking about the company’s growth plans. Launched in 2016, Proximie was a platform that enabled clinicians, proctors, and medical device company personnel to be virtually present in operating... View Details

Keywords: Growth and Development Strategy; Technological Innovation; Partners and Partnerships; Strategic Planning; Health Care and Treatment; Analytics and Data Science; Digital Platforms; Health Industry; Lebanon; United Kingdom; United States

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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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

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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

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

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

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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

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

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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

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

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

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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

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

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