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- 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...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
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).
- February 2024
- Case
Compass Pathways: Pioneering Psychedelic Treatment
By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu
This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no...
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Keywords:
Commercialization;
Corporate Strategy;
Competitive Strategy;
Product Launch;
Health Testing and Trials;
Research and Development;
Pharmaceutical Industry;
Europe;
United States;
United Kingdom
Zuzul, Tiona, Kisha Lashley, and Gamze Yucaoglu. "Compass Pathways: Pioneering Psychedelic Treatment." Harvard Business School Case 724-412, February 2024.
- January 19, 2024
- Article
Value-Based Health Care Can Transform the Treatment of Patients with Substance Use Disorder
By: Robert S. Kaplan and Sarah E. Wakeman
U.S. overdose deaths currently exceed 100,000 per year. New facilities, known as bridge clinics, are broadening access to high-quality care by offering outpatient substance use disorder (SUD) treatment with few access barriers. But many of the critical services offered...
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Kaplan, Robert S., and Sarah E. Wakeman. "Value-Based Health Care Can Transform the Treatment of Patients with Substance Use Disorder." Health Affairs Forefront (January 19, 2024).
- January 2024 (Revised January 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).
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- January 2024
- Background Note
Evaluating Innovations in the Organization of Primary Care: What Type of Innovation Is It and How Well Does It Align with the Six Factors?
By: Regina E. Herzlinger and James Wallace
How can we evaluate if innovative health care ventures can do good—benefit society—and do well—become financially viable? This question is the topic of the first module in the Innovating in Health Care course book.
This note and "Health Stop (A): What Type... View Details
This note and "Health Stop (A): What Type... View Details
- January 2024
- Article
A Cost Model for a Low Threshold Clinic Treating Opioid Use Disorder
By: Sarah E. Wakeman, Elizabeth Powell, Syed Shehab, Grace Herman, Laura Kehoe and Robert S. Kaplan
The US fee-for-service payment system under-reimburses clinics offering access to comprehensive treatments for opioid use disorder (OUD). The funding shortfall limits a clinic’s ability to expand and improve access, especially for socially marginalized patients with...
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Wakeman, Sarah E., Elizabeth Powell, Syed Shehab, Grace Herman, Laura Kehoe, and Robert S. Kaplan. "A Cost Model for a Low Threshold Clinic Treating Opioid Use Disorder." Journal of Behavioral Health Services & Research 51, no. 1 (January 2024): 22–30.
- January–February 2024
- Article
Shared Service Delivery Can Increase Client Engagement: A Study of Shared Medical Appointments
By: Ryan W. Buell, Kamalini Ramdas, Nazlı Sönmez, Kavitha Srinivasan and Rengaraj Venkatesh
Problem Definition: Clients and service providers alike often consider one-on-one service delivery to be ideal, assuming – perhaps unquestioningly – that devoting individualized attention best improves client outcomes. In contrast, in shared service delivery, clients...
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Keywords:
Health Care and Treatment;
Customer Satisfaction;
Outcome or Result;
Performance Improvement
Buell, Ryan W., Kamalini Ramdas, Nazlı Sönmez, Kavitha Srinivasan, and Rengaraj Venkatesh. "Shared Service Delivery Can Increase Client Engagement: A Study of Shared Medical Appointments." Manufacturing & Service Operations Management 26, no. 1 (January–February 2024): 154–166.
- November 2023 (Revised April 2024)
- Case
BiomX: Bringing Phage Back to the Stage
By: Paul A. Gompers, Elie Ofek, Orna Dan and Emilie Billaud
In the spring of 2023, and following the favorable results of a trial involving its phage cocktail for treating lung infections among cystic fibrosis (CF) patients, the leadership of BiomX had several critical issues to wrestle with. First, given its precarious...
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Keywords:
Working Capital;
Financing and Loans;
Health Testing and Trials;
Product Development;
Research and Development;
Science-Based Business;
Commercialization;
Biotechnology Industry;
Pharmaceutical Industry
Gompers, Paul A., Elie Ofek, Orna Dan, and Emilie Billaud. "BiomX: Bringing Phage Back to the Stage." Harvard Business School Case 524-051, November 2023. (Revised April 2024.)
- November 2023
- Article
Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients with Hypertension
By: Mitchell Tang, Carter Nakamoto, Ariel Dora Stern, Jose Zubizarreta, Felippe Marcondes, Lori Uscher-Pines, Lee Schwamm and Ateev Mehrotra
Background: Remote patient monitoring (RPM) is a promising tool for improving chronic disease management. Use of RPM for hypertension monitoring is growing rapidly, raising concerns about increased spending. However, the effects of RPM are still...
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Tang, Mitchell, Carter Nakamoto, Ariel Dora Stern, Jose Zubizarreta, Felippe Marcondes, Lori Uscher-Pines, Lee Schwamm, and Ateev Mehrotra. "Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients with Hypertension." Annals of Internal Medicine 176, no. 11 (November 2023): 1465–1475.
- 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...
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- 2023
- Working Paper
The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina
By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle
We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed...
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Keywords:
COVID-19;
Health Care and Treatment;
Health Pandemics;
Adoption;
Behavior;
Governing Rules, Regulations, and Reforms;
Learning
Calónico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina." NBER Working Paper Series, No. 31781, October 2023.
- September 2023
- Supplement
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
This PowerPoint accompanies Regina E. Herzlinger's "Fighting the Battle of the Bulge – Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment" teaching note (HBS Case No.324-013) and is designed for instructors to use in the classroom when teaching this...
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- September 2023
- Teaching Note
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
Teaching Note for HBS Case No. 304-009. The case is part of the first module of the Innovating in Health Care course. Its purpose is to demonstrate how to evaluate the “do good” and do well” potential of a health care innovation.
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- 2023
- Article
Evidence from the First Shared Medical Appointments (SMAs) Randomised Controlled Trial in India: SMAs Increase the Satisfaction, Knowledge, and Medication Compliance of Patients with Glaucoma
By: Nazlı Sönmez, Kavitha Srinivasan, Rengaraj Venkatesh, Ryan W. Buell and Kamalini Ramdas
In Shared Medical Appointments (SMAs), patients with similar conditions meet the physician together and each receives one-on-one attention. SMAs can improve outcomes and physician productivity. Yet privacy concerns have stymied adoption. In physician-deprived nations,...
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Sönmez, Nazlı, Kavitha Srinivasan, Rengaraj Venkatesh, Ryan W. Buell, and Kamalini Ramdas. "Evidence from the First Shared Medical Appointments (SMAs) Randomised Controlled Trial in India: SMAs Increase the Satisfaction, Knowledge, and Medication Compliance of Patients with Glaucoma." e0001648. PLoS Global Public Health 3, no. 7 (2023).
- 2023
- Article
Building the Business Case for an Inclusive Approach to Digital Health Measurement with a Web App (Market Opportunity Calculator): Instrument Development Study
By: Mitchell Tang, Yashoda Sharma, Jennifer C. Goldsack and Ariel Dora Stern
Background: The use of digital health measurement tools has grown substantially in recent years. However, there are concerns that the promised benefits from these products will not be shared equitably. Underserved populations, such as those with lower education and...
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Keywords:
Demographics;
Product Development;
Health Care and Treatment;
Medical Devices and Supplies Industry
Tang, Mitchell, Yashoda Sharma, Jennifer C. Goldsack, and Ariel Dora Stern. "Building the Business Case for an Inclusive Approach to Digital Health Measurement with a Web App (Market Opportunity Calculator): Instrument Development Study." JMIR Formative Research 7 (2023).
- Summer 2023
- Article
Do Policies to Increase Access to Treatment for Opioid Use Disorder Work?
By: Eric Barrette, Leemore S. Dafny and Karen Shen
Even among commercially insured individuals, opioid use disorder is undertreated in the United States: nearly half receive no treatment within six months of a new diagnosis. Using a difference-in-differences specification exploiting the extension of insurance parity...
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Keywords:
Opioid Treatment;
Medication-assisted Treatment;
Substance Use Disorder;
Private Insurance;
Insurance;
Health Care and Treatment
Barrette, Eric, Leemore S. Dafny, and Karen Shen. "Do Policies to Increase Access to Treatment for Opioid Use Disorder Work?" American Journal of Health Economics 9, no. 3 (Summer 2023): 297–330.
- June 2023
- Case
Verve Therapeutics: Taking DNA Editing to Heart
By: Shikhar Ghosh and Shweta Bagai
Verve Therapeutics, a public biotech company based in Boston, created a novel approach to addressing cardiovascular disease (CVD) - a leading cause of deaths globally. The company's approach was a single shot treatment to permanently lower cholesterol, thus reducing...
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Keywords:
AI;
Genetic Engineering;
Medicine;
Health Care and Treatment;
Genetics;
Innovation Strategy;
Business and Stakeholder Relations;
Medical Specialties;
Innovation and Invention;
Entrepreneurship;
Biotechnology Industry
Ghosh, Shikhar, and Shweta Bagai. "Verve Therapeutics: Taking DNA Editing to Heart." Harvard Business School Case 823-113, June 2023.
- May 2023 (Revised June 2023)
- Case
Novartis (A): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Care and Treatment;
Business Model;
Leadership;
Pharmaceutical Industry;
Switzerland
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (A): Reimagining Medicine." Harvard Business School Case 723-443, May 2023. (Revised June 2023.)
- May 2023 (Revised June 2023)
- Supplement
Novartis (B): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Care and Treatment;
Business Model;
Production;
Business Strategy;
Pharmaceutical Industry
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (B): Reimagining Medicine." Harvard Business School Supplement 723-444, May 2023. (Revised June 2023.)
- May 2023 (Revised June 2023)
- Supplement
Novartis (C): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Testing and Trials;
Health Care and Treatment;
Business Model;
Problems and Challenges;
Pharmaceutical Industry;
Switzerland
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (C): Reimagining Medicine." Harvard Business School Supplement 723-445, May 2023. (Revised June 2023.)