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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

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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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

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

November 2007
Case

Antegren: A Beacon of Hope

By: Joshua D. Margolis, Thomas J. DeLong and Terence Heymann

The CEO of Biogen Idec faces a set of difficult decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series focuses on operational decisions triggered by the drive for early approval. Sparks discussion... View Details

Keywords: Demand and Consumers; Leadership; Ethics; Corporate Social Responsibility and Impact; Decision Choices and Conditions; Crisis Management; Health Testing and Trials; Biotechnology Industry; Pharmaceutical Industry

January 2009 (Revised July 2009)
Case

Targanta Therapeutics: Hitting a Moving Target

By: Arthur A. Daemmrich

This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful... View Details

Keywords: Decision Choices and Conditions; Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Business and Government Relations; Business Strategy; Biotechnology Industry; Pharmaceutical Industry

December 2006 (Revised August 2008)
Case

Pervasis Therapeutics, Inc.

By: Robert F. Higgins and Virginia Fuller

In May 2005, Steve Bollinger was about to become president and chief operating officer of Pervasis Therapeutics, a small cell therapy start-up in Cambridge, Mass. If proven successful, Pervasis' product, Vascugel, could change the way vascular disease is treated and... View Details

Keywords: Business Startups; Venture Capital; Financial Strategy; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Health Testing and Trials; Health Industry; Cambridge

June 2010 (Revised August 2010)
Case

Dr. Cameron Powell and AirStrip Technologies: After the Apple Worldwide Developers Conference

Dr. Cameron Powell and his partner, Trey Moore, co-founders of the innovative company, AirStrip Technologies, have developed a series of apps for the iPhone and other smartphones that can help doctors monitor the vital signs of their patients anytime, anywhere. They... View Details

Keywords: Information Technology; Entrepreneurship; Applications and Software; Health Care and Treatment; Mobile and Wireless Technology; Product Development; Information Technology Industry; Health Industry; United States

January 2001 (Revised July 2003)
Case

Pharmacyclics: Financing Research & Development

By: Malcolm P. Baker, Richard S. Ruback and Aldo Sesia

Pharmacyclics (NASDAQ: PCYC), a pharmaceutical company that manufactures products that will improve existing therapeutic treatments for cancer, arteriosclerosis, and retinal disease, was considering a $60 million private placement in February 2000. The company had more... View Details

Keywords: Valuation; Cash Flow; Financing and Loans; Business Startups; Financial Strategy; Medical Devices and Supplies Industry; Pharmaceutical Industry; Health Industry

October 2010 (Revised November 2010)
Background Note

Plavix: Drugs in the Age of Personalized Medicine

By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon

PIavix, one of the world's best selling drugs in 2010, appears to have a limited future. Its patent was due to expire soon, and recently new data had been discovered that indicated that a small subset of the population would be at risk for stroke, heart attack, or even... View Details

Keywords: Health Care and Treatment; Product Positioning; Business and Government Relations; Genetics; Competitive Strategy; Pharmaceutical Industry

June 2024
Case

Aidoc: Building a Hospital-Centric AI Platform

By: Ariel D. Stern and Susan Pinckney

In 2023, Israel-based AI health care company Aidoc evaluated its future. The company, founded in 2016, had grown from commercializing a single AI product for radiologists to a software platform that could detect 20 conditions and immediately notify care teams of... View Details

April 2017
Case

Imprimis (A)

By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel

This case examines the strategic choices and evolving business model of Imprimis Pharmaceuticals from the perspective of CEO Mark Baum. The (A) case provides a brief history of the company and of the compounding business, outlining the challenges faced by Imprimis in... View Details

Keywords: Strategy; Healthcare; Drug Compounding; Pharmaceuticals; Compounding; Drug Development; Decision-making; Mark Baum; Imprimis; Small Business; Decisions; Cost vs Benefits; Business Strategy; Business Model; Decision Choices and Conditions; Pharmaceutical Industry; United States

November 2009 (Revised August 2010)
Case

NovoCure Ltd.

By: William A. Sahlman and Sarah Flaherty

Venture capitalist William Doyle must raise $35 million for a portfolio company with a promising, novel cancer therapy, just as global capital markets are imploding in the fall of 2008. NovoCure, Ltd., has developed an electrical-field-based therapy, called Tumor... View Details

Keywords: Financial Crisis; Entrepreneurship; Venture Capital; Investment; Health Care and Treatment; Health Testing and Trials; Technological Innovation; Financial Services Industry

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