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July 2001 (Revised August 2005)
Case

Medicines Company, The

By: John T. Gourville

It is early 2001 and the Medicines Co. just received FDA approval to market Angiomax, a blood thinner to be used during angioplasties and heart procedures. It is intended to be a better alternative to Heparin, an 80-year-old drug that costs less then $10 per dose. The... View Details

Keywords: Business Model; Change Management; Decision Choices and Conditions; Cost Management; Price; Product Marketing; Product Launch; Product Development; Risk and Uncertainty; Health Industry; Pharmaceutical Industry

April 1998
Case

Cephalon, Inc.

By: Peter Tufano

In early 1997, Cephalon, awaited an FDA panel's decision on whether its drug, Myotrophin, would be approved. If the drug was approved, the firm might need substantial additional funds to commercialize as well as to buy back rights to it (which had been sold earlier to... View Details

Keywords: Risk Management; Financing and Loans; Health Care and Treatment; Pharmaceutical Industry; United States

May 2021 (Revised May 2022)
Case

Headspace vs. Calm: A Mindful Competition

By: Ayelet Israeli and Anne Wilson

By 2021, the mindfulness app wars reached their apex. Over 2,000 meditation apps were available to consumers, but two apps, Headspace and Calm, dominated the space, jointly holding about 70% of the total market. Headspace had established itself as the approachable... View Details

Keywords: Marketing Communication; Integrated Strategy; Brand; Brand ＆ Product Management; Brand Communication; Brand Differentiation; Brand Building; Brand Management; E-Commerce Strategy; Ecommerce; App; App Development; Applications; COVID; COVID-19; Pandemic; Pricing; Pricing Strategy; Subscription Model; Subscription; Partnerships; Strategic Partnerships; B2B Vs. B2C; B2B; Health ＆ Wellness; Wellbeing; Digitization; Commoditization; Mobile App; Mobile App Industry; Mobile Healthcare; Mobile Marketing; Digital Brand; Digital Health; Consumer Health; Apps; Online Business; Online Competition; Online Community; Online Entertainment; Entertainment And Leisure; Meditation; Marketing; Marketing Communications; Brands and Branding; Price; Strategy; Competition; Competitive Strategy; Competitive Advantage; Partners and Partnerships; Health; Well-being; Mobile and Wireless Technology; Communication; Communication Strategy; Disruption; Consumer Behavior; Digital Marketing; E-commerce; Applications and Software; Health Industry; Technology Industry; Communications Industry; United States; North America; United Kingdom

December 2014 (Revised August 2015)
Case

Improving Melanoma Screening: MELA Sciences

By: Regina E. Herzlinger, Kevin Schulman and Frédéric Dijols

MELA is a start-up medical device company looking to develop a novel technology to help physicians diagnose a deadly skin cancer, melanoma. The case reviews the FDA medical device development process, the development path pursued by MELA, and the regulatory and... View Details

Keywords: Healthcare Industry; Health Care; Health; Health Care and Treatment; Health Testing and Trials; Health Industry; United States

April 2020
Article

Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning

By: Ariel Dora Stern and W. Nicholson Price, II

In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging... View Details

Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms

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11 Apr 2019
News

The DNA of Sustained Innovation

January 2014
Supplement

Fred Khosravi and AccessClosure (C)

By: Richard Hamermesh and Lauren Barley

On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the... View Details

Keywords: Medical Devices; Vascular Closure Device; Patent Litigation; Patenting; Biomedical Research; Biotechnology; Biotech; Technological Innovation; Patents; Health Care and Treatment; Biotechnology Industry; United States

August 2008 (Revised September 2008)
Case

The Flaxil Label (A)

This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Product Launch; Negotiation Process; Business and Government Relations; Safety; Pharmaceutical Industry

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; Health Industry; United States; United Kingdom; France; India; Brazil; Middle East

August 2012 (Revised December 2023)
Background Note

Note on Health Insurance Coverage, Coding, and Payment

By: Regina E. Herzlinger and Jo Ellen Slurzberg

This note explains how health care technology and service innovators receive payment from government insurers, in the U.S. and abroad, and from private insurers. It describes each of the three steps needed to obtain reimbursement: coverage, coding, and payment. It also... View Details

Keywords: Health Care Delivery; Health Care Costs; Health Insurance; Health Insurance Marketplaces; Health Care and Treatment; Cost; Insurance; Innovation and Invention; Private Sector; Public Sector; Decision Making; Information Technology; Health Industry; Insurance Industry

2022
Article

Missing Novelty in Drug Development

By: Joshua Krieger, Danielle Li and Dimitris Papanikolaou

We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to... View Details

Keywords: Drug Development; Risk Aversion; Research and Development; Innovation and Invention; Investment; Pharmaceutical Industry

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January 2018
Case

Spark Therapeutics: Pioneering Gene Therapy

By: Robert F. Higgins and Tina Liu

Spark Therapeutics is a pioneering gene therapy startup. It was spun out of The Children’s Hospital of Philadelphia (CHOP). The company had taken with it much of the intellectual property and talent that CHOP had developed. The company is considering an initial public... View Details

Keywords: Health Care and Treatment; Innovation and Invention; Business Startups; Opportunities; Problems and Challenges; Strategy

2023
Article

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic

Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices... View Details

Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

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November 2018
Case

David Hysong and SHEPHERD Therapeutics

By: Ananth Raman, John Masko and Aldo Sesia

In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his... View Details

Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges

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

January 2020
Case

Celata Bioinnovations

By: John R. Wells and Benjamin Weinstock

In December 2019, Jon Hu (HBS ‘19) and Dr. Samantha Dale Strasser, co-founders of Celata Bioinnovations, were raising $1 million to launch their company. They had founded Celata less than six months earlier with the aim of redefining the drug discovery process.... View Details

November 2012 (Revised January 2013)
Case

Companion Diagnostics: Uncertainties for Approval and Reimbursement

By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews

The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory... View Details

Keywords: Models Of Reimbursement; Personalized Medicine; Regulation; Healthcare Reform; Health Care and Treatment; Health Industry; United States

16 Jul 2019
News

JUUL: Leading the Vaping Revolution

15 Jan 2019
First Look

New Research and Ideas, January 15, 2019

December 19, 2018 NEJM Catalyst It's Time to Reform the Orphan Drug Act By: Bagley, Nicholas, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern Abstract—No abstract available. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=55448 January 2019... View Details

Keywords: Dina Gerdeman

March 2017
Case

From mHealth Hackathon to Reality: Diabetes Care

By: Kevin Schulman and Curry Cheek

This case explores the development of a business plan for a mobile health application for diabetes care. The case depicts a student team excited about the opportunity to improve the care of patients with diabetes by contracting an app. They go through a rigorous... View Details

Keywords: Innovation; Mobile Health Technologies; Health Care; Health Care Industry; Behavioral Economics; Applications and Software; Health Care and Treatment; Mobile and Wireless Technology; Innovation and Invention; Health Industry; Telecommunications Industry

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