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- 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...
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- January 2023
- Case
Digital Transformation at Tata Steel
By: Krishna Palepu, Das Narayandas and Radhika Kak
T.V. Narendran, CEO of Tata Steel, India’s oldest steel manufacturing firm, had taken concrete business and cultural transformation steps to future-ready the firm since taking over in 2013. He had deleveraged and instilled financial discipline, acquired new businesses,...
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- January 2023
- Case
Velong: Rethinking 'Made in China'
By: Krishna G. Palepu, Nancy Hua Dai and Billy Chan
Velong is a supplier of kitchen equipment and backyard grills for major global brands and store brands of large western retailers. In light of the Covid-related disruptions to the global supply chains, and the evolving trade tensions between China and the Western...
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Keywords:
Globalization;
Supply Chain Management;
Risk Management;
Manufacturing Industry;
China;
India;
Mexico;
Turkey;
Viet Nam
- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...
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- December 2022
- Supplement
Driving Decarbonization at BMW - Video Supplement
Videos of Thomas Becker, Vice President of Sustainability and Mobility at BMW Group, in support of the case "Driving Decarbonization at BMW" (HBS No. 123-008)
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Keywords:
Decarbonization;
Auto Manufacturing;
Carbon Accounting;
Accounting;
Environmental Accounting;
Energy;
Environmental Management;
Climate Change;
Environmental Sustainability;
Pollution;
Product;
Supply Chain;
Supply Chain Management;
Production;
Product Design;
Transportation;
Transportation Industry;
Europe;
United States;
China
- November 2022
- Case
HTC and Virtual Reality (B)
By: Andy Wu and Matt Higgins
In 2022, Cher Wang, CEO and Chairwoman of HTC, was focused on the company's pivot to virtual reality and the metaverse. Growing competition in consumer virtual reality from Meta, Sony, and Chinese headset manufacturers had altered the competitive landscape since 2017....
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Keywords:
VR;
Virtual Reality;
Strategy;
Metaverse;
Market Entry and Exit;
Competition;
Technology Industry;
Taiwan;
China;
United States
- November 15, 2022
- Article
What Really Makes Toyota’s Production System Resilient
By: Willy C. Shih
Toyota has fared better than many of its competitors in riding out the supply chain disruptions of recent years. But focusing on how Toyota had stockpiled semiconductors and the problems of other manufacturers, some observers jumped to the conclusion that the era of...
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Keywords:
Supplier Relationships;
Manufacturing;
Supply Chain;
Production;
Auto Industry;
United States;
Japan
- November 2022 (Revised November 2022)
- Case
Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams
By: Debora L. Spar and Julia M. Comeau
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 the time, there was little medication...
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- October 2022
- Case
Cost Plus Drugs
By: Alexander MacKay and James Barnett
In September 2022, Mark Cuban Cost Plus Drugs Company CEO Alex Oshmyansky considered the future of the company. Cost Plus Drugs was a retailer for more than 340 generic oral medications, selling their drugs at significantly lower prices than typical pharmacies....
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- October 2022
- Case
Framebridge (A): Reimagining Custom Framing
By: Rembrand Koning and Alicia Dadlani
In December 2018, Susan Tynan, founder and CEO of Framebridge, a four-year-old venture-backed startup that sold online custom framing, formulated plans for the future. Her vision was to revolutionize the $4 billion industry by making custom framing easy, transparent,...
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- September 2022 (Revised November 2022)
- Case
The Uyghur Forced Labor Prevention Act: Forced Labor and Genocide in U.S.-China Relations
By: Jeremy Friedman and David Lane
On June 21, 2022, the Uyghur Forced Labor Prevention Act (UFLPA) went into effect, requiring companies to prove that goods imported from the People’s Republic of China were not made with forced labor. The bill was a reaction to reports of products being made with...
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Keywords:
Ethics;
Multinational Firms and Management;
Globalized Markets and Industries;
Governing Rules, Regulations, and Reforms;
Policy;
Government Legislation;
International Relations;
Labor;
Wages;
Law Enforcement;
Law;
Rights;
Operations;
Supply Chain Management;
Business and Government Relations;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
China;
United States
- September 2022
- Article
Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities
By: Leemore Dafny, Christopher Ody and Teresa Rokos
The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations...
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- August 2022
- Case
Southwick Social Ventures
By: Henry McGee, Mel Martin and Amy Klopfenstein
In 2021, the HBS Impact Investment Fund student team had found a promising potential investment in Southwick Social Ventures (SSV), a worker and management-owned trouser manufacturer. With a 100% immigrant workforce, the co-operative was focused on reviving...
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- August 1, 2022
- Article
The Supply Chain, Explained
By: Willy C. Shih
Why have supply chains been such a mess? For starters, there are a lot more layers than you think. This article describes some common features of supply chains that help the reader to understand how things could have gone so far off track during the pandemic.
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- July 2022 (Revised September 2022)
- Case
Birla Carbon Egypt: Building Soft Power in a Foreign Country
By: Jeremy Friedman and Malini Sen
Birla Carbon, a flagship business of the nearly $60-billion global conglomerate and India-headquartered Aditya Birla Group (ABG), is one of the world's top manufacturers and suppliers of high-quality carbon black. The largest among its 16 manufacturing plants is Birla...
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Keywords:
Acquisition;
Family Business;
Disruption;
Transformation;
Diversity;
Trade;
Energy;
Values and Beliefs;
Cross-Cultural and Cross-Border Issues;
Global Strategy;
Government and Politics;
Private Ownership;
Civil Society or Community;
Risk and Uncertainty;
Value Creation;
Industrial Products Industry;
Industrial Products Industry;
Egypt;
Africa;
India;
Asia;
Atlanta;
United States
- July 2022
- Case
General Mills: Responding to the Killing of George Floyd (A)
By: Debora L. Spar and Alicia Dadlani
Jeff Harmening, CEO of General Mills, one of the world's largest manufacturers of breakfast cereals and packaged foods, was deeply disturbed and instantly aware that he and General Mills would need to respond. George Floyd, an African-American man who had been accused...
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- July 2022
- Supplement
General Mills: Responding to the Killing of George Floyd (B)
By: Debora L. Spar and Alicia Dadlani
Jeff Harmening, CEO of General Mills, one of the world's largest manufacturers of breakfast cereals and packaged foods, was deeply disturbed and instantly aware that he and General Mills would need to respond. George Floyd, an African-American man who had been accused...
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- July 2022
- Teaching Note
The DivaCup: Navigating Distribution and Growth
By: Ayelet Israeli
Teaching Note for HBS Case No. 519-055. When the mother-daughter founders of DivaCup set out with a mission to disrupt the menstrual care industry with an innovative product form, they initially struggled to gain legitimacy and convince retailers to carry their unique...
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Keywords:
Female;
Female Ceo;
Female Entrepreneur;
Female Protagonist;
Health ＆ Wellness;
Healthcare;
Price Policies;
Minimum Advertised Price;
Differentiation;
Positioning;
Growth;
Health;
Health Care and Treatment;
Price;
Disruption;
Distribution;
Distribution Channels;
Competitive Strategy;
Competition;
Growth Management;
Mission and Purpose;
Product Development;
Product Marketing;
Product Launch;
Product Positioning;
Advertising;
Business Startups;
Internet and the Web;
Entrepreneurship;
Social Entrepreneurship;
Social Issues;
Social Enterprise;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Canada;
United States;
United Kingdom
- May 2022
- Article
When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants
By: Alberto Galasso and Hong Luo
Liability laws designed to compensate for harms caused by defective products may also affect innovation. We examine this issue by exploiting a major quasi-exogenous increase in liability risk faced by U.S. suppliers of polymers used to manufacture medical implants....
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- April 2022
- Teaching Note
Tempur Sealy International (A, B & C)
By: Benjamin C. Esty and Daniel Fisher
Teaching Note for HBS Case Nos. 718-422, 718-423, and 718-424. The cases explore the long-term relationship between Tempur Sealy (TPX, a mattress manufacturer) and Mattress Firm (MFRM, a bedding retailer and TPX's largest customer). For almost 20 years, the firms...
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Keywords:
Porter's 5 Forces;
Bargaining Power;
Buyer Power;
Customer Power;
Supplier Power;
Negotiations;
Value Capture;
Private Equity;
Consumer Durables;
Consumer Discretionary;
Mattresses;
B-2-B;
Industry Dynamics;
Leadership;
Compensation;
Corporate Strategy;
Business Strategy;
Value Creation;
Competition;
Cooperation;
Distribution;
Negotiation;
Industry Structures;
Customers;
Relationships;
Distribution Industry;
Distribution Industry;
Distribution Industry;
Distribution Industry;
United States;
South Africa