Tesla was founded in 2003 on the mission to accelerate the world's transition to sustainable transport through the production and sale of electric vehicles. The scope of this mission required staged business model development, beginning with low-volume production of a high-priced electric sports car and moving down-market gradually to produce higher volumes of more affordable electric vehicles. Tesla adapted its operating model at each stage and pursued innovations to unlock product performance and increased scale. With expansions into solar power, energy storage, and autonomous fleets, what business model change should Tesla pursue next?

This case provides an overview of the nonprofit organization PATH and its Safe Water Project-a five-year effort launched in late 2006 with $17 million in funding from the global development unit of the Bill and Melinda Gates Foundation. The purpose of the grant was to evaluate to what extent market-based approaches could help accelerate the widespread adoption and sustained use of household water treatment and safe storage products by low-income populations. Through a portfolio of field-based pilots, PATH intended to experiment with different sales and distribution strategies to improve consumer access to safe water solutions, such as water filters and chlorine-based water purification tablets. It also planned to test different pricing and consumer financing models to address the affordability of these products. However, extensive market research revealed another problem-few products in the space were both effective and designed specifically to meet the unique needs and preferences of these consumers. Accordingly, PATH applied for and was awarded $7 million in additional grant funding from the Gates Foundation to design a water filter product that would meet high standards of efficacy, be desirable-or aspirational-to low income consumers, and work effectively within the rural conditions where the majority of the poor resided. The PATH team would accomplish this through a process that the organization called user-centered design.

This case provides an overview of the nonprofit organization PATH and its Safe Water Project-a five-year effort launched in late 2006 with $17 million in funding from the global development unit of the Bill and Melinda Gates Foundation. The purpose of the grant was to evaluate to what extent market-based approaches could help accelerate the widespread adoption and sustained use of household water treatment and safe storage products by low-income populations. One of the team's primary objectives was to investigate sales and distribution challenges in this space. By conducting a portfolio of field-based pilots, the team hoped to test different models for improving customer access to these safe water products in an effort to identify scalable, sustainable, and replicable solutions. Although specific results varied across the pilots, which spanned India, Vietnam, Cambodia, and Kenya, they collectively gave rise to series of important sales and distribution insights.

This case provides an overview of the nonprofit organization PATH and its Safe Water Project-a five-year effort launched in late 2006 with $17 million in funding from the global development unit of the Bill and Melinda Gates Foundation. The purpose of the grant was to evaluate to what extent market-based approaches could help accelerate the widespread adoption and sustained use of household water treatment and safe storage products by low-income populations. One of the key objectives of this effort was to explore how the private sector could help make HWTS products more affordable. By conducting a portfolio of field-based pilots in collaboration with commercial partners, the PATH team sought to better understand the effect of different pricing, consumer financing, and subsidy models on demand within low-income population in developing countries. Over several years, the Safe Water Project team experimented with different affordability models, including microfinance loans for water filters and a layaway program. Although specific results varied across the pilots, which spanned India, Cambodia, and Kenya, they collectively gave rise to series of important insights about the affordability of HWTS products.

As of 2012, the Physician Payments Sunshine Act of 2009 requires medical device manufacturers to track any payments or gifts they make to physicians that are worth more than $10 and then starting in 2013 to report those that exceed a total of $100 per year to any given doctor. While a majority of doctors, academic medical centers, and pharmaceutical and device companies generally support the principle of greater transparency when it comes to physician-industry collaborations, many have raised concerns that over regulating potential conflicts of interest could be detrimental to the development and commercialization of new treatments. Particularly in the medical device industry, physicians play a host of essential roles that span commercialization and, more importantly, product development. Any requirements that negatively affect the willingness or ability of physicians to partner with industry have the potential to hinder medical device innovation because, by its very nature, it is incremental and doctor-dependent This note provides a taxonomy of the different roles physicians play in device innovation and identifies which ones are most susceptible to conflicts of interest that may not be well managed by today's institutions. It also makes recommendations on how to better manage conflicts without jeopardizing the ability of physicians and companies to collaborate for the betterment of patient care.

In 2005, Stanford Hospital and Clinics (SHC) was internationally recognized as a leading medical institution in terms of its clinical capabilities and specialty expertise. However, the organization was lagging many of its competitors in terms of its operations and information technology (IT). While other major health care providers of a similar caliber had begun to transition to integrated electronic medical records (EMR) systems, SHC was using a patchwork of disjointed and outdated software programs to manage inpatient and outpatient care, as well as its back office functions. Dr. Kevin Tabb, who was the chief quality and medical information officer at the time, along with other executives within the organization, recognized the importance of adopting an EMR system. Yet the implementation of such a system would require a sizable investment over multiple years and would necessitate a major organizational disruption. In parallel with building a business case to justify the cost of the new system (see OIT-101A), Tabb and his colleagues had to think carefully about the implementation strategy that would lead to the successful adoption of the EMR system. This case explains EMR systems, describes SHC's vendor selection process, introduces Epic System Corporation's EMR offering, and explores the key issues that SHC considered in developing its implementation strategy, including the appropriate rollout approach and timing, how to manage system configuration and customization, and how to most effectively staff the project.

"Safety net" providers play an essential role in delivering health care to underserved populations in states such as California. As the prominence of the safety net increases, medtech innovators seeking to make a difference have begun to design and develop new technologies to help these providers improve the quality and cost effectiveness of their care. This note introduces practical considerations that should be taken into account when developing technologies targeted at the safety net. Specifically, by looking downstream in the biodesign innovation process to anticipate issues related to safety net economics, reimbursement, technology assessment, and purchasing behavior, innovators can begin to understand how to adapt their approach and create new technologies that are not just meaningful, but feasible for adoption in the complex safety net system.

As director of the California HealthCare Foundation's (CHCF) Innovations for the Underserved program, Margaret Laws' goal was "to reduce barriers to efficient, affordable healthcare services for the underserved." The path to achieving this goal took multiple forms, including improving the availability of specialty care for low-income, uninsured, non-English speaking and rural Californians. Specialty care was an incredibly constrained resource within the healthcare system, even for insured patients. In order to improve access, increasing specialist throughput became paramount; and this could often be achieved through process improvements. But in conversations with faculty from Stanford University's Program in Biodesign (henceforth referred to as Biodesign), Laws became intrigued by the potential of new device technologies to improve throughput and increase capacity. The question was whether the biodesign innovation process taught at Stanford to develop devices for commercially attractive markets could be adapted to focus on the needs of the underserved, and particularly needs related to limited access to specialists. In order to answer that, the faculty from the Biodesign program and CHCF launched a pilot program that would undertake a condensed version of the identification phase of the biodesign innovation process, which included needs finding and needs filtering. This paper explores that project and what was learned.

This case has been developed to facilitate a negotiation exercise related to the formation of partnership deals in the healthcare industry. It is based on actual information, but reflects a hypothetical situation involving two companies and a product that have all been disguised. The scenario described within the case involves Pharmac, a large pharmaceutical company, and Respire, a small medical start-up. Pharmac and Respire began negotiating a partnership to develop and eventually market an inhaled form of parathyroid hormone (PTH) to treat osteoporosis. If successful, this product would improve the available options for the treatment of osteoporosis. It was also expected to produce "blockbuster" sales since it would make PTH, an already extremely effective treatment option, more convenient and appealing to a large segment of untreated patients who were injection-averse (injection was the standard delivery mechanism for this drug). Development of the product was highly speculative and was expected to take six to seven years due to early stage development of the inhalable delivery system and the multi-year Phase III fracture trials required for approval. Pharmac had released the first man-made, injectable form of parathyroid hormone, called Strocal, in 2002. However, no one had yet developed a non-injectable version of PTH, despite efforts by Pharmac and other companies that spanned more than a decade. Respire's goal was to be the first company to solve this problem by developing an inhaled formulation and a device to deliver Strocal through the lungs in a safe, effective, and reproducible manner. Enough information is provided within the case to enable students to negotiate terms for royalties, milestones, exclusivity provisions, and an equity investment. At the end of OIT-81A, information known to Pharmac (but not to Respire) is provided. In OIT-81B, information known to Respire (but not to Pharmac) is given.

This case has been developed to facilitate a negotiation exercise related to the formation of partnership deals in the healthcare industry. It is based on actual information, but reflects a hypothetical situation involving two companies and a product that have all been disguised. The scenario described within the case involves Pharmac, a large pharmaceutical company, and Respire, a small medical start-up. Pharmac and Respire began negotiating a partnership to develop and eventually market an inhaled form of parathyroid hormone (PTH) to treat osteoporosis. If successful, this product would improve the available options for the treatment of osteoporosis. It was also expected to produce "blockbuster" sales since it would make PTH, an already extremely effective treatment option, more convenient and appealing to a large segment of untreated patients who were injection-averse (injection was the standard delivery mechanism for this drug). Development of the product was highly speculative and was expected to take six to seven years due to early stage development of the inhalable delivery system and the multi-year Phase III fracture trials required for approval. Pharmac had released the first man-made, injectable form of parathyroid hormone, called Strocal, in 2002. However, no one had yet developed a non-injectable version of PTH, despite efforts by Pharmac and other companies that spanned more than a decade. Respire's goal was to be the first company to solve this problem by developing an inhaled formulation and a device to deliver Strocal through the lungs in a safe, effective, and reproducible manner. Enough information is provided within the case to enable students to negotiate terms for royalties, milestones, exclusivity provisions, and an equity investment. At the end of OIT-81A, information known to Pharmac (but not to Respire) is provided. In OIT-81B, information known to Respire (but not to Pharmac) is given.

Historically, the biggest obstacle that healthcare innovators, such as pharmaceutical and medical device manufacturers, needed to overcome on their way to market was securing approval by the U.S. Food & Drug Administration (FDA) or other international regulatory authorities. However, in the last decade, a new (sometimes even more challenging) hurdle had to be cleared: insurance coverage and reimbursement. Payers--either public payers, such as Medicare in the U.S. and the National Health Services (NHS) in the U.K., or private commercial payers, such as Blue Cross/Blue Shield and UnitedHealth Grou--could deny coverage for a technology that had received regulatory approval if they determined that the supporting evidence did not adequately demonstrate that the technology was superior to existing treatment alternatives that were already being reimbursed. This had the potential to create a potentially adversarial relationship between payers and innovators in cases where they had conflicting interpretations of the evidence regarding the cost, benefits, and risks of new technologies. The challenges to innovators in managing this conflict are illustrated in this case study by an example: the 2006 decision by the U.K.'s NHS to deny coverage for Exubera, a new form of inhaled insulin.

EndoNav developed an innovative medical device to make colonoscopy procedures easier and faster to perform and less painful to receive. Despite of excellent technology, IP protection, a reasonably large market, and relatively low regulatory risk, the founder (Jaime Vargas) and his business partner (Kenneth Kelley, GSB MBA, 1987) are unable to secure venture funding. The company eventually decides that it must adapt its product and business plan so that it can be funded on a smaller scale by angel investors.

In late October 2003, Randy Scott and the Genomic Health team had just received the results of Genomic Health's first pivotal trial. The company's product, Oncotype DX, a first-of-its-kind genomic assay that quantified the likelihood of breast cancer recurrence, had exceeded the standard measures of patient age, tumor size, and tumor grade in predicting recurrence outcomes. The study results would be presented at the 2003 San Antonio Breast Cancer Symposium in December and published in the New England Journal of Medicine in December 2004. Scott and his team now faced the challenge of determining how and when to launch this groundbreaking product. The team was eager to get the product to market as quickly as possible. However, extensive market research performed earlier in the year reveals that it had less than 10% awareness in the physician community and even less among consumers. When asked about what factors would influence their adoption, physicians overwhelmingly cited clinical validation studies--and lots of them. Many skeptics within the oncology field felt that the legitimate use of genomics in making treatment decisions was still 10 to 20 years in the future.

By the mid-2000s, no segment of the $180 billion global medical device industry was as dynamic as the market for drug eluting stents (DESs). In the United States, which accounted for nearly three-quarters of the total DES market, only two companies had regulatory approval to sell the small devices: Johnson & Johnson and Boston Scientific. In combination, these two organizations expected 2005 DES sales of approximately $5.5 billion--an increase of 36% from 2004. Forecasts called for the segment to exceed $7 billion by 2008. Driven in part by its size, the DES market was among the most competitive and challenging sectors in the medical device industry. The competitive landscape was marked by intense rivalries and plagued by fierce litigation over intellectual property. Yet, it was also characterized by complex intercompany partnerships, collaboration, and licensing deals. Although DESs had been shown to significantly reduce restenosis rates, new safety concerns were emerging related to the development of life threatening blood clots linked to DESs.

In August 2002, the FDA had notified the executive steering committee for Abbott Laboratories' new rheumatoid arthritis drug to expect approval significantly ahead of schedule. If everything went smoothly, the compound D2E7 (brand name HUMIRA) would be approved for sale in the United States before the end of the year. This gave Abbott and its HUMIRA brand team no more than four months to complete preparations for the product's launch. Abbott acquired D2E7, a biologic disease-modifying antirheumatic drug, when the company purchased Knoll Pharmaceuticals in March 2001. With a significant head start and combined 2002 sales anticipated to exceed $2 billion, Enbrel (from Immunex, later acquired by Amgen) and Remicade (from the Johnson & Johnson subsidiary Centocor) would provide HUMIRA with tough competition. Yet, with the rheumatoid arthritis market expected to grow to over $7.5 billion by 2008, there was still a significant opportunity for Abbott. The executive steering committee knew that the HUMIRA team would have to orchestrate every aspect of the product's global launch carefully to quickly and effectively establish HUMIRA in this challenging market.

In August 2002, the FDA had notified the executive steering committee for Abbott Laboratories' new rheumatoid arthritis drug to expect approval significantly ahead of schedule. If everything went smoothly, the compound D2E7 (brand name HUMIRA) would be approved for sale in the United States before the end of the year. This gave Abbott and its HUMIRA brand team no more than four months to complete preparations for the product's launch. Abbott acquired D2E7, a biologic disease-modifying antirheumatic drug, when the company purchased Knoll Pharmaceuticals in March 2001. With a significant head start and combined 2002 sales anticipated to exceed $2 billion, Enbrel (from Immunex, later acquired by Amgen) and Remicade (from the Johnson & Johnson subsidiary Centocor) would provide HUMIRA with tough competition. Yet, with the rheumatoid arthritis market expected to grow to over $7.5 billion by 2008, there was still a significant opportunity for Abbott. The executive steering committee knew that the HUMIRA team would have to orchestrate every aspect of the product's global launch carefully to quickly and effectively establish HUMIRA in this challenging market.

By the mid-1980s, it was clear that not all transplant centers in the growing organ transplantation market were able to achieve and sustain the same levels of quality and high rates of transplant procedure success. Similarly, significant variation had emerged in the cost of these complex and expensive procedures. Within this dynamic environment, United Resource Networks (URN) was founded in 1989. The express purpose of this new organization was to manage variation in the transplantation process to enable the delivery of higher quality, lower cost, more predictable results to patients, employers, and health insurers. The company would accomplish this by establishing a virtual network of transplant centers that were made available to its customers through preferred contracting arrangements. By 2004, URN had built the largest transplantation network in the United States, growing at an average annual rate of 40% over the last 10 years. With 4,000 customers and 44,000,000 covered lives, the network managed approximately 10% of the nation's organ transplants each year. Explores the URN business model as an example of the innovative strategies being used by health plans to carefully manage complex medical conditions and control the risks associated with expensive procedures, such as organ transplants.

In June 2004, members of the Material Flow Committee at Stanford Hospital and Clinics were faced with the challenge of implementing important process improvements in the operating room. Though notable progress had been made in the recent past, complaints from surgeons, nurses, and technicians regarding the availability of surgical instrumentation had reached an all-time high. Finding a solution was urgent, but opinions varied widely regarding the best course of action. Some individuals believed that instrumentation sterilization and processing should be adopted as a core competency (and made central to employee training and compensation). Others felt the hospital should invest in additional instruments and information technology to improve efficiencies. A third faction believed that instrumentation issues resulted, in large part, from low morale and a lack of cross-functional camaraderie and teamwork within the operating room. A decision had to be made to devote Stanford's limited time and resources to the solution that would have the greatest, most immediate impact on its operating room effectiveness.

In 2006, all major U.S. dialysis providers were facing a daunting set of challenges. Having survived a period of intense consolidation and ever-diminishing operating margins, they were now struggling to understand what lay ahead. With more than 80% of their patients covered by Medicare's End-Stage Renal Disease (ESRD) program and with Medicare reimbursement barely covering costs, these providers increasingly relied on additional reimbursement for certain injectable drugs, as well as on the small percentage of patients with private insurance, for financial viability. However, both of these sources of profitability were coming under pressure. Ongoing demonstration projects by the Center for Medicare and Medicaid Services (CMS) were opening the way for dramatic changes in the reimbursement landscape, and private payers were becoming more restrictive regarding what they would pay for and how much they would pay. These actions by CMS and private payers were sure to have far-reaching implications for patients, providers, and the ESRD program as a whole. Change was imminent and the uncertainty facing providers was creating significant challenges.