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3432 Stanford MedTech: An Innovative CTSA-Supported Pilot Program
- Ashley Dunn, Linda Lucian, Gordon Saul, Paul Yock, Mark Cullen
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- Journal of Clinical and Translational Science / Volume 3 / Issue s1 / March 2019
- Published online by Cambridge University Press:
- 26 March 2019, pp. 126-127
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OBJECTIVES/SPECIFIC AIMS: Helping researchers assess and effectively translate innovations into healthcare improvements is a complex process (Terry et. al., 2013). The Clinical Translational Science Awards (CTSA)—supported by the National Institute of Health (NIH) under the auspices of the National Center for Advancing Translational Sciences (NCATS)— provide the resources and support needed to strengthen our nation’s clinical and translational research (CTR) enterprise. In 2008, Stanford University was awarded a CTSA from the NIH, establishing Spectrum (the Stanford Center for Clinical and Translational Research and Education). Under the Spectrum umbrella, the Byers Center for Biodesign manages the MedTech Pilot Program with the goal of translating discoveries into novel health technologies that address important unmet health needs. The MedTech Pilot Program is an innovative funding mechanism that seeks to (1) stimulate clinical translational research, (2) help promising projects bridge the gap between the bench and the patients’ bedside, and (3) encourage collaborative, transdisciplinary work. Specifically, the Pilot Program offers up to $50,000 to support projects involving medical devices and mobile technologies used for (1) therapeutic applications and (2) device-based patient-specific (or POC) diagnostic applications. This analysis of the MedTech Pilot Program will: 1) describe the Program’s structure and process; 2) highlight the intensive, hands-on mentorship and practical guidance awardees receive that enables them to more efficiently and effectively advance their projects toward patient care; and 3) characterize the progress of the 36 funded projects. METHODS/STUDY POPULATION: Key elements of the Pilot Program’s infrastructure and mentoring processes as they relate to project outcomes were identified. Additionally, outcomes data were collected from two sources: (1) annual survey of Pilot Awardees and (2) publicly available information relevant to the pilot projects. RESULTS/ANTICIPATED RESULTS: The Pilot Program’s framework and infrastructure has supported a diverse group of transdisciplinary projects. These projects were evaluated using both traditional and non-traditional metrics (e.g., patents, startups, publications). The initial investment of $1.5 million to fund 36 projects has led to over $88 million dollars in additional funding. Additionally, taking full advantage of the expertise in Silicon Valley, strong mentorship has helped advance projects along the clinical and translational path. DISCUSSION/SIGNIFICANCE OF IMPACT: The Pilot Program has benefited Stanford innovators and researchers by providing seed funding to help promising projects bridge the gap between the bench and the bedside. The intensive, hands-on mentorship, early pilot funding, and practical guidance pilot awardees receive effectively help translate their technologies into patient care.
Stage 2 - Needs Screening
- from PART I - IDENTIFY
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- Biodesign
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- 11 May 2018
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- 02 February 2015, pp 111-246
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Biodesign
- The Process of Innovating Medical Technologies
- 2nd edition
- Paul G. Yock, Stefanos Zenios, Josh Makower, Todd J. Brinton, Uday N. Kumar, F. T. Jay Watkins, Lyn Denend, Thomas M. Krummel, Christine Q. Kurihara
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- 11 May 2018
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- 02 February 2015
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This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads students, researchers, and entrepreneurs through a proven process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. A wealth of additional material supports the book, including a collection of nearly one hundred videos created for the second edition, active links to external websites, supplementary appendices, and timely updates on the companion website at ebiodesign.org. Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook.
Dedication
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 11 May 2018
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- 02 February 2015, pp v-vi
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Africa
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 10-13
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Summary
Background
Africa is on the rise. The twenty-first century has been called the “African Century” due to the continent's potential for increased economic development in the coming decades. From 2000–2012, economic growth averaged more than 5 percent per year, driven by the recovery of commodity prices, government economic and policy reforms, and restoration of international donor confidence and aid. Africa's collective gross domestic product (GDP) topped US$1.7 trillion in 2012 (making it nearly comparable to Russia or Brazil), and its middle class expanded to more than 34 percent of the continent's 1 billion people.
Poverty is declining, yet Africa still has the highest poverty rate in the world with 47.5 percent of the population living on less than US$1.25 a day. The continent also accounts for 25 percent of the global disease burden. Maternal health, child health, HIV, tuberculosis, and malaria continue to be the continent's greatest health challenges. What may be surprising is that over the next 10 years, Africa will experience the largest increase in deaths from cardiovascular disease, cancer, respiratory disease, and diabetes of any continent in the world. For instance, the World Health Organization estimated that in 2008 the prevalence of hypertension was highest in its Africa region, with nearly half of the population affected, and this figure is on the rise.
Generalities are difficult to apply across this diverse continent. It is a massive, highly fragmented mosaic of more than 50 countries, with an estimated 2,000 languages spoken and thousands of distinct ethnic groups. The continent's diverse population is expected to double by 2050, from 1 billion to more than 2 billion. Africa is endowed with more than 30 million square miles of varied geography and could fit China, India, the United States, and most of Europe within its physical boundaries. Across this great expanse, the continent's health-care infrastructure is evolving. African governments are working to expand healthcare delivery systems through public and private investment, but in the meantime, millions of people must travel vast distances to receive basic medical care.
Focus on Value
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 1-6
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Summary
What do we mean by “value” and why is it so important?
The escalation of healthcare costs is one of the major economic and political issues of our time. The problem is most apparent in the United States, where healthcare as a share of the economy has more than doubled over the past 35 years. Spending on health accounted for 7.2 percent of the nation's gross domestic product (GDP) in 1970, expanded to 16 percent in 2005, and is projected to be as high as 20 percent of GDP by 2015.
Simply put, the US economy cannot sustain this spending trajectory, which has outpaced GDP growth for years (see Figure V1). The problem is not just straining the federal budget: state and local governments have been forced to reduce support for education, infrastructure, and other critical expenditures as they struggle to fund Medicaid and other health programs. In the private sector, the cost of employment-based health insurance is one of the main reasons workers have seen their wages stagnate.
Despite the fact that the US spends two-and-a-half times more per capita on health than most developed countries, it does not necessarily provide the best care to its citizens. In 2000, when the World Health Organization ranked the health systems of its 191 member states for the first time ever, the US found itself in 37th position. In a more recent study that compared the US to Australia, Canada, Germany, the Netherlands, New Zealand, and the United Kingdom on measures of quality, efficiency, access to care, equity, and the ability of citizens to lead long, healthy lives, America occupied last place. As the report pointed out, “While there is room for improvement in every country, the US stands out for not getting good value for its healthcare dollars.”
Against this backdrop, economists, researchers, and policy makers alike have pointed to medical technology as a dominant factor driving increased health expenditures in the US.
China
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 14-17
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Summary
Background
China is perhaps the most impressive economic development story in modern history. Sustaining annual growth rates upwards of 9 percent for more than two decades, the country's gross domestic product (GDP) reached US$8 trillion in 2012 (second only to the United States at US$16 trillion). This remarkable expansion has lifted hundreds of millions of Chinese out of poverty and created a new middle class that is larger than the entire US population.
With more than 1.35 billion people, China has the largest citizenry in the world. In 2011, the country's urban population surpassed its rural population for the first time, with close to 700 million people living in China's cities. Population growth in China has decreased steadily over the last 20 years due to the controversial one-child policy (from approximately 1.2 percent to less than half of one percent) and is expected to continue to decline. The country's median age is just 35 years, compared to nearly 40 years in more developed countries. However, as a whole, the population is aging rapidly; senior citizens will account for as much as 35 percent of the Chinese people by 2053.
One of the most important challenges facing China in the twenty-first century is how to allocate healthcare resources for its massive population. Despite progress in the country's economic transformation, China significantly lags the developed world in its ability to provide even basic health services to the vast majority of its people. The Chinese government spent approximately 5 percent of GDP on healthcare in 2011, compared to roughly 18 percent spent in the US and 9 percent on average in the OECD countries. Per capita spending on medical technologies is just US$ in China versus US$399 in the US.
China's centrally planned economy provides health insurance coverage to approximately 90 percent of the population under three primary programs (an employer-based system, one for urban residents, and another covering the rural population). These insurance schemes are largely inadequate to cover basic care but rather focus on protecting patients from catastrophic health events. As a result, the Chinese typically pay for basic health services out-of-pocket, causing many individuals to delay diagnosis and treatment until they are critically ill.
Stage 1 - Needs Finding
- from PART I - IDENTIFY
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 47-110
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Stage 3 - Concept Generation
- from PART II - INVENT
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 247-282
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PART II - INVENT
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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About the Author Team
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 817-820
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India
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 23-27
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Summary
Background
South Asia is generally considered to include Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka. Over the past 20 years, the region has experienced robust economic growth, averaging 6 percent per year. As a result, poverty rates have declined, with the percentage of South Asians living on less than US$1.25 per day decreasing from 61 percent to 36 percent between 1981 and 2008. While the region is still home to approximately 44 percent of the developing world's poor, growth and development in South Asia are expected to continue.
The largest and most influential country in the region is India. With approximately 1.3 billion people, India is the fourth largest global economy by purchasing power parity (PPP). India's gross domestic product (GDP) reached nearly US$2 trillion in 2012, and it is expected to continue increasing at a healthy rate as the country further integrates into the global economy. Growth will also be driven by increased domestic demand as India's burgeoning middle class expands from roughly 50 million in 2007 to almost 600 million people between by 2025.
India's healthcare system is plagued by low spending levels. Healthcare expenditure per capita was only US$59 in 2011. The country's private and public sector combined spent only about 4 percent of GDP on healthcare in 2011, although the government is planning to increase its share from 1.4 percent to 2.5 percent of GDP over the next five years. In the past half-century, India's public sector has steadily given up market share to the private sector in providing healthcare. Accordingly to one study, the private sector accounted for over 90 percent of all hospitals, 85 percent of doctors, 80 percent of outpatient care, and almost 60 percent of inpatient care.
Fortunately, India's private sector has been responsible for some remarkable innovations in healthcare delivery. Several major hospital systems in the country are able to deliver high-quality outcomes at a fraction of the cost of care in developed country settings. For instance, one cardiac care center offers open-heart
surgery for less than US$2,000 per patient, with outcomes similar to those at US-based centers where the price tag can exceed US$100,000.
Stage 6 - Business Planning
- from PART III - IMPLEMENT
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 699-816
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Index
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 833-839
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Japan
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 28-31
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Summary
Background
At nearly US$6 trillion, Japan has the third largest gross domestic product (GDP) in the world, after the US and China. Real GDP grew at about 1.9 percent in 2012, and it is projected to expand at roughly one percent per year through 2020. The Japanese economy was badly hit by the global recession in 2008–2009 and the massive tsunami in 2011, and it continues to suffer from persistent deflation. Japan's economy has been led by the advanced manufacturing sector, which generates strong export activity. However, the country is looking to bolster domestic demand in order to drive increased growth.
The population of Japan, at more than 128 million people, is decreasing about 0.2 percent each year. Trends indicate that the country's total inhabitants will decline by almost 30 percent by 2060 due to a low birth-rate, limited immigration, and an aging population. Approximately 23 percent of the Japanese people were over 65 years of age in 2012; by 2060, more than 40 percent of the population will be senior citizens. As the population ages, cancer, heart disease, and pneumonia have become the country's leading causes of death.
The Japanese universal healthcare system, known as kaihoken, has been lauded for increasing the quality of life of the Japanese people and is cited as a key reason the Japanese have the longest life expectancy in the world. However, increasing healthcare costs, in combination with the country's rapidly aging population and slow-growth economy, are creating the need for reforms and cost cutting. Japanese patients tend to visit physicians more frequently than their counterparts in the US (13.2 versus 3.9 appointments per person per year). And their hospitals stays are significantly longer (18.8 versus 5.5 days). Japan also has three times as many acute care hospital beds per 1,000 people (8.1 versus 2.7). Moreover, Japanese expenditures on medical devices are the highest in Asia at US$165 per capita, compared to just US$10 per capita in China.
Stage 4 - Concept Screening
- from PART II - INVENT
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 283-454
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PART I - IDENTIFY
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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Preface
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp ix-xiv
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Summary
There is no greater satisfaction than seeing a patient being helped by a technology that you've had a hand in creating. And thanks to continuing advances in science and technology, healthcare is more open for innovation than at any time in history.
Despite this promise, however, medical technology innovators face significant hurdles – especially in the new era of cost containment. If not managed skillfully, patents, regulatory approval, reimbursement, market dynamics, business models, competition, financing, clinical trials, technical feasibility, and team dynamics (just to name a few of many potential challenges) can all prevent even the best idea from reaching patient care.
So, where should you begin as an innovator? What process can you use to improve your chances of success? What lessons can you learn from the inventors, engineers, physicians, and entrepreneurs who have succeeded and failed in this endeavor before? This book delivers practical answers to these important questions.
Who should read it and why?
Biodesign: The Process of Innovating Medical Technologies provides a comprehensive roadmap for identifying, inventing, and implementing new medical devices, diagnostics, and other technologies intended to create value for healthcare stakeholders. It has been written to be approachable for engineering, medical, and business students at both the undergraduate and graduate level, yet comprehensive and sophisticated enough to satisfy the needs of experienced entrepreneurs and medtech executives. For instructors, it provides a proven approach for teaching medical technology innovation that begins pre-idea and extends through preparing for commercialization. It is ideally suited to support team-oriented, project-based learning experiences in academic and industry settings.
The text describes the biodesign innovation process, which we initially developed to support the biodesign innovation and fellowship programs at Stanford University. Over 13+ years, the process has been built and refined based on:
• Presentations and mentoring by more than 200 industry leaders who have participated in our training programs
• Our experience advising more than 150 project teams that have applied the process to their work
• Feedback from those who have learned the process through our executive education courses, as well as input and suggestions from students, fellows, instructors at other universities, and industry representatives using the first edition of the book
• Extensive field-based research
Our confidence that the process is effective is based on the results of the students and fellows trained at Stanford and through our university-based partnerships in India and Singapore.
Contents
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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Stage 5 - Strategy Development
- from PART III - IMPLEMENT
- Paul G. Yock, Stanford University, California, Stefanos Zenios, Stanford University, California, Josh Makower, Stanford University, California, Todd J. Brinton, Stanford University, California, Uday N. Kumar, Stanford University, California, F. T. Jay Watkins, Lyn Denend, Stanford University, California, Thomas M. Krummel, Stanford University School of Medicine, California, Christine Q. Kurihara, Stanford University, California
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- 02 February 2015, pp 455-698
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