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    • All HBS Web  (867)
      • Faculty Publications  (224)

      Medical Device StartupRemove Medical Device Startup →

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      • February 2025
      • Case

      Abiomed: A Change of Heart

      By: Satish Tadikonda, Faith Robertson and William Marks
      After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability... View Details
      Keywords: Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; European Union; United States
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      Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: A Change of Heart." Harvard Business School Case 825-011, February 2025.
      • February 2025
      • Case

      Abiomed: Clinical Trials and Tribulations

      By: Satish Tadikonda, Faith Robertson and William Marks
      After receiving 510(k) clearance for the Impella 2.5 device, Abiomed had proceeded to conduct a premarket approval (PMA) process as well to prove clinical superiority, earn greater protection, and extend commercial runway. However, in the middle of the clinical trial... View Details
      Keywords: Corporate Disclosure; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Launch; Medical Devices and Supplies Industry
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      Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: Clinical Trials and Tribulations." Harvard Business School Case 825-096, February 2025.
      • January 2025
      • Case

      Summer Health: Raising an AI-First Company?

      By: Jeffrey J. Bussgang, Sarah Mehta and Maxim Pike Harrell
      In October 2023, Summer Health CEO Ellen DaSilva arrived at a defining juncture for her pediatric telehealth startup. Founded in 2021, Summer Health offered parents rapid access to licensed pediatricians via text message. DaSilva, an experienced telehealth executive,... View Details
      Keywords: AI and Machine Learning; Technology Adoption; Entrepreneurship; Leadership; Business Startups; Health Care and Treatment; Business Strategy; Product Development; Health Industry; Telecommunications Industry; United States
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      Bussgang, Jeffrey J., Sarah Mehta, and Maxim Pike Harrell. "Summer Health: Raising an AI-First Company?" Harvard Business School Case 825-083, January 2025.
      • January 2025
      • Case

      A Tiger in the Tank: Exxon Sues Investors

      By: Clayton S. Rose, Sarah Sasso and James Weber
      In June 2024, investors were trying to make sense of ExxonMobil’s (Exxon) lawsuit against two impact investors, Arjuna Capital (Arjuna) and Follow This, that had just been dismissed by the U.S. District Court of Northern Texas. Exxon’s suit challenged the rights of two... View Details
      Keywords: Disruption; Talent and Talent Management; Customer Satisfaction; Decision Making; Demographics; Ethics; Corporate Accountability; Employees; Recruitment; Retention; Leadership; Crisis Management; Risk Management; Corporate Social Responsibility and Impact; Mission and Purpose; Organizational Change and Adaptation; Civil Society or Community; Social Issues; Adaptation; Investment Activism; Lawsuits and Litigation; Business and Shareholder Relations; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; Netherlands; Norway
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      Rose, Clayton S., Sarah Sasso, and James Weber. "A Tiger in the Tank: Exxon Sues Investors." Harvard Business School Case 325-015, January 2025.
      • November 2024
      • Teaching Note

      Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams

      By: Debora L. Spar and Julia M. Comeau
      Teaching Note for HBS Case No. 323-039. In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At... View Details
      Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Growth and Development Strategy; Product Development; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; District of Columbia
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      Spar, Debora L., and Julia M. Comeau. "Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams." Harvard Business School Teaching Note 325-058, November 2024.
      • October 2024
      • Case

      Allurion: Competing in the Age of GLP-1

      By: Satish Tadikonda, Rajiv Lal, David Lane and Sarah Sasso
      Shantanu Gaur had built Allurion into a formidable business internationally, providing obesity patients with a less invasive option long before GLP-1 drugs became the latest craze. Selling Allurion's medical device across 60+ countries, he awaited FDA approval to bring... View Details
      Keywords: Corporate Entrepreneurship; Health Care and Treatment; Global Strategy; Competitive Strategy; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; United Kingdom; France; India; Brazil; Middle East
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      Tadikonda, Satish, Rajiv Lal, David Lane, and Sarah Sasso. "Allurion: Competing in the Age of GLP-1." Harvard Business School Case 525-011, October 2024.
      • August 2024
      • Case

      Scaling Seven Starling

      By: Ryan W. Buell and Carin-Isabel Knoop
      Seven Starling, a maternal mental health startup, is scaling its digital clinic model. Seven Starling addresses perinatal mental health challenges by providing licensed therapists, peer support, and medication to mothers across five states, with a hybrid care model... View Details
      Keywords: Business Model; Business Startups; Health Care and Treatment; Growth and Development Strategy; Mission and Purpose; Health Industry
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      Buell, Ryan W., and Carin-Isabel Knoop. "Scaling Seven Starling." Harvard Business School Case 625-046, August 2024.
      • July 2024
      • Case

      Roja Garimella: Developing a Founder's Judgment

      By: Reza Satchu and Patrick Sanguineti
      Roja Garimella’s path to becoming a founder was anything but straight. Setting her sights on a career in medicine since childhood, she committed to medical school with her acceptance to college. And yet, throughout her studies, she continually explored alternative... View Details
      Keywords: Entrepreneurship; Personal Development and Career; Entrepreneurial Finance; Business Startups; Judgments; Financial Services Industry; Health Industry
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      Satchu, Reza, and Patrick Sanguineti. "Roja Garimella: Developing a Founder's Judgment." Harvard Business School Case 825-006, July 2024.
      • July–August 2024
      • Article

      The Middle Path to Innovation

      By: Regina E. Herzlinger, Duke Rohlen, Ben Creo and Will Kynes
      Too many companies are failing to innovate. One reason, say the authors, is the polarized approach companies take to innovation. At one end of the spectrum, corporate R&D efforts tend to focus on product refreshes and incremental line upgrades that generate modest... View Details
      Keywords: Innovation Strategy; Medical Devices and Supplies Industry
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      Herzlinger, Regina E., Duke Rohlen, Ben Creo, and Will Kynes. "The Middle Path to Innovation." Harvard Business Review 102, no. 4 (July–August 2024): 134–145.
      • June 2024
      • Supplement

      Legacy Partners (A)

      By: Richard S. Ruback and Royce Yudkoff
      Instructors should consider the timing of making videos available to students, as they may reveal key case details.

      Stephen Holbrook and Austin Pulsipher (both HBS '19) had been leading Nutrishare since acquiring the company six months earlier in mid-2021.... View Details
      Keywords: Acquisition; Small Business; Cost vs Benefits; Decisions; Corporate Entrepreneurship; Leadership Style; Leading Change; Business or Company Management; Problems and Challenges; Health Care and Treatment; Health Disorders; Medical Specialties; Nutrition; Supply Chain Management; Growth Management; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; California
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      Ruback, Richard S., and Royce Yudkoff. "Legacy Partners (A)." Harvard Business School Multimedia/Video Supplement 224-725, June 2024.
      • June 2024
      • Supplement

      Legacy Partners (B)

      By: Richard S. Ruback and Royce Yudkoff
      Pre-abstract: Instructors should consider the timing of making videos available to students, as they may reveal key case details.

      Abstract: Stephen Holbrook and Austin Pulsipher (both HBS '19) had been leading Nutrishare since acquiring the company six... View Details
      Keywords: Acquisition; Small Business; Cost vs Benefits; Decisions; Business Education; Corporate Entrepreneurship; Leadership Style; Leading Change; Business or Company Management; Problems and Challenges; Health Care and Treatment; Health Disorders; Medical Specialties; Nutrition; Supply Chain Management; Growth Management; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; California
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      Ruback, Richard S., and Royce Yudkoff. "Legacy Partners (B)." Harvard Business School Multimedia/Video Supplement 224-726, June 2024.
      • 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.
      • February 2024
      • Case

      More than Optics: Olympus's Vision to Become a Leading Global MedTech Company

      By: David J. Collis and Haisley Wert
      In August 2022, CEO Yasuo Takeuchi reflected on Olympus Corporation’s recent transformation from being known as a Japanese consumer camera company to becoming a leading global medical technology (MedTech) company. Over the past dozen years, Takeuchi and prior... View Details
      Keywords: Global Human Resource Management; Medical Technology; Corporate Strategy; Transformation; Globalization; Business Model; Leading Change; Organizational Structure; Organizational Change and Adaptation; Medical Devices and Supplies Industry; Japan; United States
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      Collis, David J., and Haisley Wert. "More than Optics: Olympus's Vision to Become a Leading Global MedTech Company." Harvard Business School Case 724-426, February 2024.
      • January 2024 (Revised April 2024)
      • Teaching Note

      Somatus: Value-Based Kidney Care (A) & (B)

      By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
      This teaching note accompanies case no. 622-009 and 622-045 (Somatus: Value-Based Kidney Care, A and B). View Details
      Keywords: Business Startups; Disruption; Entrepreneurship; Health Care and Treatment; Health Disorders; Medical Specialties; Innovation and Invention; Disruptive Innovation; Management; Business Strategy; Value Creation; Health Industry; United States; Virginia
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      Stern, Ariel D., Robert S. Huckman, and Sarah Mehta. "Somatus: Value-Based Kidney Care (A) & (B)." Harvard Business School Teaching Note 624-013, January 2024. (Revised April 2024.)
      • October 2023
      • Case

      Hey Jane: Delivering Abortion Pills to the Doorstep

      By: Rembrand Koning, Geraldine Pena-Galea and Sarah Mehta
      This case tells the story of Hey Jane, a telehealth clinic founded in 2020 that provides virtual medication abortion services to eligible patients in nine U.S. states. By January 2023, the company had served more than 20,000 patients and raised nearly $10 million in... View Details
      Keywords: Operations; Business Startups; Health Care and Treatment; Growth and Development Strategy; Health Industry; Technology Industry; United States
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      Koning, Rembrand, Geraldine Pena-Galea, and Sarah Mehta. "Hey Jane: Delivering Abortion Pills to the Doorstep." Harvard Business School Case 724-408, October 2023.
      • September 2023
      • Teaching Note

      Nexleaf Analytics: Saving the World Using the Internet of Things

      By: Frank Nagle
      Teaching Note for HBS Case 722-414. View Details
      Keywords: Corporate Strategy; Collaborative Innovation and Invention; Technological Innovation; Nonprofit Organizations; Competitive Strategy; Patents; Expansion; Information Technology; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
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      Nagle, Frank. "Nexleaf Analytics: Saving the World Using the Internet of Things." Harvard Business School Teaching Note 724-381, September 2023.
      • September 2023
      • Case

      Healthy.io: The Negotiation for the Medical Selfie

      By: Amit Goldenberg and Kumba Sennaar
      Healthy.io, an Israeli digital health company, prepares to enter the U.S. market with its chronic kidney disease test. A product safety approval is delayed, putting the company’s cash runway at risk. How should the CEO negotiate his offer to insurance companies ahead... View Details
      Keywords: Negotiation; Entrepreneurship; Venture Capital; Operations; Business Startups; Market Entry and Exit; Health Industry; Israel; United Kingdom; United States
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      Goldenberg, Amit, and Kumba Sennaar. "Healthy.io: The Negotiation for the Medical Selfie." Harvard Business School Case 924-001, September 2023.
      • August 2023
      • Case

      Augmenix: Space to Think Differently

      By: Satish Tadikonda and Sidhant Jena
      Amar Sawhney, a serial medtech entrepreneur, had founded Augmenix to develop and commercialize a hydrogel-based medical device called SpaceOAR as an adjunctive technology to core radiation therapy. This technology was used to protect organs at risk (OAR) during... View Details
      Keywords: Entrepreneurship; Health Care and Treatment; Technology Adoption; Innovation Strategy; Technological Innovation; Product Development; Commercialization; Medical Devices and Supplies Industry
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      Tadikonda, Satish, and Sidhant Jena. "Augmenix: Space to Think Differently." Harvard Business School Case 824-031, August 2023.
      • January–February 2023
      • Article

      Data-Driven COVID-19 Vaccine Development for Janssen

      By: Dimitris Bertsimas, Michael Lingzhi Li, Xinggang Liu, Jennings Xu and Najat Khan
      The COVID-19 pandemic has spurred extensive vaccine research worldwide. One crucial part of vaccine development is the phase III clinical trial that assesses the vaccine for safety and efficacy in the prevention of COVID-19. In this work, we enumerate the first... View Details
      Keywords: COVID-19; Health Testing and Trials; Forecasting and Prediction; AI and Machine Learning; Research; Pharmaceutical Industry
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      Bertsimas, Dimitris, Michael Lingzhi Li, Xinggang Liu, Jennings Xu, and Najat Khan. "Data-Driven COVID-19 Vaccine Development for Janssen." INFORMS Journal on Applied Analytics 53, no. 1 (January–February 2023): 70–84.
      • 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
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      Herzlinger, Regina E., and Ben Creo. "Ajax Health: A New Model for Medical Technology Innovation." Harvard Business School Case 323-043, November 2022.
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