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  • All HBS Web  (942)
    • People  (3)
    • News  (246)
    • Research  (503)
    • Events  (4)
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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
Keywords: Growth; Healthcare Access; Healthcare; Medical Devices; Medical Equipment & Devices; Medical Care; Eastern Europe; Quality Management System; Health Care and Treatment; Growth Management; Education; Organizational Change and Adaptation; Quality; Leadership; Mission and Purpose; Expansion; Developing Countries and Economies; Technological Innovation; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Europe; Romania
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Groysberg, Boris, and Sarah L. Abbott. "SofMedica Group: Managing Growth." Harvard Business School Case 424-027, May 2024.
  • 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
Keywords: Health Care; Mobile; Mobile App; Public Health; Startups; Hardware; Software; Telemedicine; Global; Medical Devices; Medical Services; Medical Solutions; Entrepreneurs; Government And Business; Technological Change; Health Care and Treatment; Entrepreneurship; Government and Politics; Technological Innovation; Applications and Software; Information Infrastructure; Technology Industry; Technology Industry
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Quelch, John A., and Margaret L. Rodriguez. "Note on Mobile Healthcare." Harvard Business School Background Note 514-122, April 2014. (Revised January 2015.)
  • 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
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Christensen, Clayton M., and Edward G Cape. "Disruptive Technology a Heartbeat Away: Ecton, Inc." Harvard Business School Case 699-018, December 1998. (Revised March 1999.)
  • 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
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Kramer, Mark R., and Sarah Mehta. "Becton Dickinson: Global Health Strategy." Harvard Business School Case 718-406, September 2017. (Revised February 2018.)
  • 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
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Stern, Ariel D., and Alpana Thapar. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Case 622-082, March 2022. (Revised August 2022.)
  • 22 Feb 2022
  • Research & Ideas

Lack of Female Scientists Means Fewer Medical Treatments for Women

Women are more likely to invent medical treatments for endometriosis, cervical cancer, and other female conditions, but the dearth of women scientists limits the potential for such life-saving innovations. Female research teams are 35... View Details
Keywords: by Kristen Senz
  • 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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Bowen, H. Kent, and Courtney Purrington. "Center for Integration of Medicine and Innovative Technology (CIMIT)." Harvard Business School Case 608-036, November 2007.
  • 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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Aboy, Mateo, Cristina Crespo, and Ariel Stern. "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." Art. 29. npj Digital Medicine 7 (2024).
  • 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
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Hamermesh, Richard, and Liz Kind. "Fred Khosravi and AccessClosure (A)." Harvard Business School Case 806-044, December 2005. (Revised October 2013.)
  • 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
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Schulman, Kevin, and Miranda Shaw. "Aggressive Growth Plans For Zimmer Spine." Harvard Business School Case 316-106, June 2016.
  • 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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Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
  • 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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Herzlinger, Regina E., and Jason Sanders. "Background on the Technology of Molecular Diagnostics." Harvard Business School Background Note 309-050, September 2008.
  • 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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Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
  • 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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Ransbotham, Sam, Eric Overby, and Michael C. Jernigan. "Electronic Trace Data and Legal Outcomes: The Effect of Electronic Medical Records on Malpractice Claim Resolution Time." Management Science 67, no. 7 (July 2021): 4341–4361.
  • 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
Keywords: Medication Adherence; Affordable Care Act (ACA); Marketing Strategy; Communication Strategy; Customer Value and Value Chain; Decisions; Health Care and Treatment; Goals and Objectives; Resource Allocation; Marketing Communications; Consumer Behavior; Measurement and Metrics; Service Delivery; Behavior; Motivation and Incentives; Social Issues; Information Technology; Value Creation; Health Industry; Pharmaceutical Industry; Insurance Industry; Public Relations Industry; Retail Industry; United States
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John, Leslie, John Quelch, and Robert Huckman. "CVS Health: Promoting Drug Adherence." Harvard Business School Case 515-010, January 2015. (Revised July 2019.) (Email mking@hbs.edu for a courtesy copy.)
  • 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
  • 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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Yoffie, David B., Dharmesh M Mehta, and Rachel Sha. "Note on the Convergence Between Genomics & Information Technology." Harvard Business School Background Note 705-500, June 2005. (Revised July 2006.)
  • 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
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Christensen, Clayton M., and Tara Donovan. "Disruptive Technology a Heartbeat Away: Ecton, Inc. TN." Harvard Business School Teaching Note 600-129, March 2000.
  • 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
Keywords: Medication Adherence; Affordable Care Act (ACA); Marketing Strategy; Communication Strategy; Customer Value and Value Chain; Decisions; Health Care and Treatment; Goals and Objectives; Resource Allocation; Marketing Communications; Consumer Behavior; Measurement and Metrics; Service Delivery; Behavior; Motivation and Incentives; Social Issues; Information Technology; Value Creation; Health Industry; Pharmaceutical Industry; Insurance Industry; Public Relations Industry; Retail Industry; United States
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John, Leslie, John Quelch, and Robert Huckman. "CVS Health: Promoting Drug Adherence." Harvard Business School Teaching Note 515-086, March 2015. (Email mking@hbs.edu for a courtesy copy.)
  • 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
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Wells, John R., and Galen Danskin. "Radiometer, 2003." Harvard Business School Case 715-409, September 2014.
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