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May 15, 2017 
 
 
This case was prepared by Bala Mulloth, PhD, Assistant Professor of Public Policy, Frank Batten School of Leadership and Public 
Policy, University of Virginia; and Jessica Foley, PhD, Chief Scientific Officer, Focused Ultrasound Foundation, Charlottesville, VA. It 
was written as a basis for class discussion rather than to illustrate effective or ineffective handling of an administrative situation. 
Copyright  2017 by the University of Virginia Darden School Foundation, Charlottesville, VA. All rights reserved. To order copies, send 
an e-mail to sales@dardenbusinesspublishing.com. No part of this publication may be reproduced, stored in a retrieval system, used in a spreadsheet, or 
transmitted in any form or by any means—electronic, mechanical, photocopying, recording, or otherwise—without the permission of the Darden School 
Foundation. 
 
 
 
 
Focused Ultrasound Foundation: Paving the Way for Responsible 
Innovation and Social Entrepreneurship in Health Care Services 
 
Introduction 
The model of the Foundation is not meant to be self-sustaining. The ultimate measure of our success will be our 
ability to put ourselves out of business. When focused ultrasound becomes a standard of care and has improved 
the quality of life for countless patients, the Foundation will be obsolete. 
–Dr. Neal Kassell, Founder and Chairman, 
Focused Ultrasound Foundation and 
Professor of Neurosurgery, University of Virginia 
Based in Charlottesville, Virginia, the Focused Ultrasound Foundation (FUSF) was an entrepreneurial 
medical research, education, and advocacy organization whose primary purpose was to improve the lives of 
millions of people with serious medical disorders including essential tremor, Parkinson’s disease, pain, and 
cancer of the prostate, breast and brain, by accelerating the development and adoption of focused ultrasound 
(FUS) technology. FUS was an early stage, noninvasive therapeutic technology with the potential to transform 
the treatment of many medical disorders by using ultrasonic energy to target tissue deep in the body without 
incisions or radiation. The technology had the potential to improve outcomes and decrease costs by serving as 
an alternative or complement to surgery, radiation therapy, drug delivery, and immunotherapy. 
Founded in 2006 by Neal Kassell, a renowned professor of Neurosurgery at the University of Virginia, the 
FUSF was on the leading edge of the venture philanthropy and social entrepreneurship movements and had 
become a model for how donor funding could be used to bridge the gap between laboratory research and 
widespread patient treatment. In the following section, we provide an overview of FUS technology and the 
FUSF. In section 3, we describe the research, development, and growth strategy of the FUSF. A discussion on 
the FUSF’s impact and social implications is provided in section 4. Section 5 highlights some of the future 
challenges the FUSF may face as it continues to scale up. 
Technology and Organization Overview 
Founded in 2006, the FUSF was a tax-exempt [501(c)(3)] organization with a mission to bring FUS 
treatments to patients in the shortest time possible, to improve the quality of life and longevity of millions of 
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patients with serious medical conditions. To do so, the organization strove to be a catalyst for accelerating the 
development and widespread clinical adoption of FUS, clearing the path to global utilization as a standard of 
care with an approach that was market-driven and results-oriented. The FUSF maximized the impact of donors’ 
contributions to the field by forging collaborations and partnerships, to build knowledge and to streamline the 
process and overcome barriers. 
A key attribute of the organization was its carefully curated culture centered on the four values described 
in Table 1. 
Table 1. The FUSF’s cultural attributes. 
Values Significance 
Patient-centric Passionate and committed to decreasing death, disability, and 
suffering for countless patients with serious medical disorders 
around the world. 
Catalytic Nimble and potent organization that uses reputation and 
enthusiasm to instill similar energy in others to precipitate change.
Entrepreneurial Belief that reality can be created from an imagined future through 
human action in an environment where accomplishments will 
exceed the resources available. 
Pioneering Relentless pursuit of excellence through hard work, risk taking, and 
innovation. 
Source: Created by author from information provided by the FUSF management. 
 
FUS was the marriage of two innovative technologies: 
1. FUS—provides the energy to treat tissue deep in the body precisely and noninvasively without damage 
to intervening or surrounding tissues. 
2. Magnetic resonance or ultrasound imaging—used to identify and target the tissue to be treated, guide 
and control the treatment in real time, and confirm the effectiveness of the treatment. 
This novel technology focused beams of ultrasound precisely and accurately on targets deep in the body 
without damaging surrounding normal tissue, similar to how beams of light could be focused on a point with 
a magnifying glass. Where the beams converged, the ultrasound produced a variety of therapeutic effects 
including destroying tissue, delivering drugs in high concentrations, enhancing radiation therapy, and 
stimulating an immune response (see Table 2). 
 
 
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Table 2. Key FUS mechanisms of action. 
 
Source: Based on review of FUSF documents. 
 
The multiple biological effects enabled treatment of a wide range of disorders (see Table 3). Magnetic 
resonance or ultrasound imaging was used to identify the targets and guide and control their treatment in real 
time. 
Table 3. FUS global development landscape. 
 
Source: Based on information provided by the FUSF management. 
It must be noted that the evolution of such a new therapeutic medical technology from laboratory research 
to widespread utilization was a complex process involving many stakeholders with different agendas. 
Consequently, as part of its operational strategy, the FUSF had developed a multipronged strategy, 
amalgamating stakeholders into a cohesive ecosystem to accelerate progress, as explained in the next section. 
Research, Development, and Growth Strategy 
Research, development, and commercialization of FUS was increasing rapidly; however, most potential 
FUS indications were in the early stages of evolution. FUS was approved in the United States for treating 
essential tremor, uterine fibroids, painful bone metastases, and prostate diseases. Outside of the United States, 
the technology was additionally approved to treat patients with many other conditions, including Parkinson’s Do
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disease, neuropathic pain, and tumors of the breast, liver, kidney, pancreas, and bone. Other uses were still in 
the research phase, with preclinical studies and clinical trials ongoing at leading academic institutions around 
the world. 
As the technology became more pervasive, the FUSF had identified six key strategic pillars that were critical 
for growth of the field, as outlined in Table 4. 
Table 4. The FUSF’s strategy and implementation techniques.Strategy Implementation 
Create knowledge Organize, conduct, and fund research. Develop 
intellectual property by making funding freely available. 
Foster collaboration Engage stakeholders and build communities through 
symposia, workshops, and working groups. 
Increase awareness Host awareness events and cultivate media opportunities 
to educate and highlight important milestones. 
Aggregate and share knowledge Provide up-to-date information to various stakeholders 
through the website, newsletter, and social media. 
Overcome barriers Partner with manufacturers and other organizations to 
advance regulatory and reimbursement efforts. 
Cultivate the next generation Provide educational opportunities for clinicians and 
scientists by supporting fellowships and internships. 
Source: Created by author from information provided by the FUSF management. 
More detailed explanation of the key activities involved in implementing these strategies follows. 
Create knowledge 
The FUSF functioned in many capacities, including as the largest nongovernmental funder of FUS research. 
FUSF’s research awards program has had an outsized impact on the development of the body of knowledge 
about FUS, through providing support for both high-risk, early-stage projects as well as translational preclinical 
and first-in-humans clinical trials. The FUSF funded investigator-initiated projects—typically up to $100,000 
for one year—through clinical and high-risk tracks. Funding was also provided for projects in high-interest 
applications of FUS through the Brain and Cancer Immunotherapy Programs, including both invited and 
investigator-initiated projects. Do
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Since its inception in 2006, the FUSF has funded 104 research projects, of which 62 have been completed. 
The FUSF’s investment of $6.8 million into completed projects has resulted in follow-on funding of more than 
$30 million. 
Some of the key projects that had been funded by the FUSF included: 
 World’s first clinical trial using MR-guided FUS to treat essential tremor 
 World’s first clinical trial using MR-guided FUS to treat Parkinson’s dyskinesia 
 World’s first clinical trial using MR-guided FUS to noninvasively and temporarily open the blood-brain 
barrier 
 Preclinical assessment of FUS for immune-based treatment of glioblastoma 
 MR-guided FUS for treatment of adolescents with painful osteoid osteomas 
Foster collaboration: Engaging stakeholders and building communities 
The FUSF fostered collaboration among stakeholders in the FUS ecosystem in order to achieve the 
collective goal of bringing FUS treatments to patients as quickly as possible. Collaboration was a catalyst for 
innovation and a force multiplier for intellectual capital. It was critical for the community to share its 
experiences, ideas, and important data, to streamline research pathways, avoid duplication, and enhance the 
impact of individual contributions to the field. The FUSF cultivated collaboration through engaging 
stakeholders and building communities. 
Engaging stakeholders: FUSF’s scientific team maintained contact with the large FUS community that included 
more than 225 research laboratories and 390 treatment sites around the world. The FUSF also established 
relationships with more than 40 disease-specific organizations, patient support groups, advocacy networks, 
trade organizations, councils, and government bodies in order to facilitate dialogue and provide information 
about FUS. 
Building communities: As the nexus of the FUS community, the FUSF organized and sponsored symposia, 
workshops, and meetings to exchange information, foster collaboration, and stimulate innovation. 
Symposia: On a biennial basis, the FUSF hosted an international symposium, the world’s leading forum for 
sharing the latest translational and clinical advances in FUS. With over 400 attendees in 2016, it was the world’s 
largest gathering of researchers, clinicians, industry, government, and others interested in FUS to date. The 
symposium offered a multifaceted exploration of the field, featuring plenary sessions, panel discussions, poster 
presentations, and technical exhibits. The theme for the 2016 Symposium represented the great progress that 
had been made in the past decade and the promising future for this field: “Focused ultrasound, a field at the 
tipping point.” 
Workshops: The FUSF organized small, invitational workshops to address targeted topics, attended by 
multidisciplinary groups of clinicians, engineers, and scientists from industry, academia, government, and other 
foundations. These workshops produced roadmaps of technical, preclinical, and clinical studies needed to 
further the development and adoption of FUS. Recent workshops included those investigating the use of FUS 
for the treatment of diseases with great unmet clinical need—glioblastoma and Alzheimer’s disease—and those 
aimed at harnessing the unique biological mechanisms of the technology such as amplification of the immune 
response and neuromodulation. Do
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Working groups: The organization convened individuals in topic-specific communities to facilitate sharing of 
information, collaboration, and innovation, through meetings, workshops, and symposia. The organization 
supplemented in-person interaction with online communication tools. To date this included groups with 
interests in various clinical applications of FUS (glioblastoma, Alzheimer’s disease, cancer immunotherapy), key 
FUS biomechanisms (blood-brain barrier opening, neuromodulation), technical topics (imaging, simulations), 
and overcoming barriers (reimbursement). 
Increase awareness 
To increase global awareness about FUS technology and to enhance and broaden the FUS community, the 
FUSF hosted events, actively cultivated media opportunities to highlight research milestones, and took 
advantage of speaking and publication opportunities. 
Awareness events: The FUSF hosted events, ranging from a biennial update with hundreds of attendees, to 
intimate lunches hosted for small groups at the FUSF offices, to one-on-one visits with individuals. The purpose 
of these events was to inform people who could help to spread the word about FUS, and prospective donors 
who had the resources and motivation to invest philanthropic dollars to accelerate the development of this 
revolutionary therapy. 
Media coverage: The FUSF actively cultivated media opportunities building on milestones. Thanks in part to 
its aggressive efforts, in 2016, there were more than 250 news stories about FUS. This included FUS- and 
FUSF-specific stories in top-tier press around the world, including the Wall Street Journal and a cover story in 
Radiology Today. Coverage of the short book The Tumor, written by John Grisham to raise awareness of FUS and 
the FUSF also garnered media attention, resulting in more than 50 stories. The experiences of 15 patients 
treated with FUS were featured as well. Below are some of the media outlets that have covered FUS since its 
founding in 2006: 
TIME, Reuters, ABC News, TED, Today, Washington Post, BBC, Forbes, CBS Evening News, FasterCures, New 
Scientist, Bloomberg, Business Standard, Fortune, AAPM, New England Journal of Medicine, DOTmed HealthCare Business 
News, and Wall Street Journal. 
Aggregate and share knowledge 
The FUSF worked aggressively to provide up-to-date information on the field of FUS to stakeholders in 
the medical community and members of the general public. The organization aggregatedand shared knowledge 
through its website, social media presence, and monthly newsletter. 
Website and social media: The FUSF website1 was the leading online resource for information on FUS 
therapies. The site featured technology news, interviews with experts, information on conditions that FUS had 
shown potential to treat, and databases of treatment and research locations. The site was visited by an average 
of 120,000 visitors annually. 
The web presence of the FUSF also continued to grow as its social media footprint spread. In the past 
year, it had nearly a 30% increase in Twitter followers, and nearly 45,000 views of informational videos and 
those from the 2016 Symposium on its YouTube channel. 
 
1 www.fusfoundation.org. Do
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Newsletter: Each month, FUSF distributed a comprehensive e-newsletter to nearly 9,000 subscribers. The 
newsletter highlighted FUSF news, top stories in the field of FUS research, academic articles, recent media 
coverage, and upcoming FUS community events. 
In addition, the FUSF distributed in-depth news flashes to recognize major milestones for the field. 
Overcome barriers 
The FUSF used its position as a trusted, independent, unbiased third party to form collaborations between 
industry, academia, U.S. Food and Drug Administration (FDA), and payers that facilitated achieving regulatory 
approval and reimbursement for new clinical applications of FUS. 
Regulatory: The FUSF participated in ongoing dialogue with the FDA to support advancement of FUS 
clinical studies and worked with it to facilitate the establishment of technical standards for FUS treatments. The 
FUSF simultaneously supported researchers in developing clinical study protocols that adhered to FDA 
standards, and connected them with regulatory experts for guidance. 
Reimbursement: There was no widespread reimbursement from private or government payers for FUS 
therapy. Until payers were willing to cover FUS therapy, patients had limited access to this noninvasive 
treatment alternative. 
To help make a case for coverage, the FUSF established collaborations and developed methods to heighten 
the likelihood of new applications being considered commercially viable and reimbursable. As new clinical trials 
were designed, the FUSF consulted with researchers to ensure that studies were designed from the start not 
only to demonstrate safety and efficacy, but also to meet insurers’ requirements for superior long-term benefits, 
quality of life, and cost-effectiveness. 
The FUSF had created a working group of researchers, clinicians, and industry experts to identify needs 
and develop strategies to generate and capture required data. This group had conducted several projects 
including creating an evidence dossier on uterine fibroids, which pulls together all citations on the safety, 
efficacy, and durability of treatments. The FUSF also had launched a website, Fibroid Relief, which was the 
leading patient education initiative on current treatment options. The site averaged more than 60,000 visits a 
year, and the companion Facebook account was growing, with more than 8,200 followers. 
Cultivate the next generation 
The FUSF worked to cultivate the next generation of clinicians and scientists through education initiatives 
including an annual fellowship program and two annual internships programs—one regional and one 
international. 
Fellowships: The Richard Merkin Visiting Fellowship in Focused Ultrasound, launched in 2015, was an 
opportunity for a midcareer or senior scientist or clinician to work with the technical and scientific team at the 
FUSF for one year. The fellowship provided opportunities for conducting original research and participating 
in ongoing projects. 
Internships: Launched in June 2012, the FUSF’s Local Internship Program enabled high school, 
undergraduate, and graduate students to work on intensive research projects in collaboration with the FUSF’s 
technical and scientific team in Virginia. These internships were designed to foster understanding of FUS as a 
clinical tool, empower students to address real-world challenges in medical research, and provide opportunities 
for them to contribute to the field. Do
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FUSF Global Internship Program: Launched in 2014, the program was a summertime opportunity for high 
school, undergraduate, and graduate students interested in physical and life sciences to receive funding to 
participate in the FUSF’s research at recognized FUS sites around the world. Figure 1 summarizes the FUSF’s 
key activities. 
Figure 1. FUSF activities. 
Create Knowledge
206 Patients treated in 29 clinical trials
$6.8 million spent on completed projects $33.2 million secured in follow-on funding 
Foster Collaboration: Engaging Stakeholders and Building Communities 
 5 Symposia 53 External meetings 21 Workshops
15 Communities 3 International databases 
Increase Awareness
578 Media placements 112 Events
Aggregate and Share Knowledge
8,900 Newsletter subscribers 120,000 Annual website visits 
Overcome Barriers
3 Reimbursement workshops 18 Working groups 
Cultivate the Next Generation
98 Interns 14 Fellows
Source: Based on information provided by the FUSF management and a review of internal documents. 
Advancing a New Therapy: The Essential Tremor Story 
The activities highlighted above demonstrate the breadth of the activities performed by the FUSF, all with 
the mission to bring patients new FUS-based therapies as quickly as possible. A prime example of their impact 
could be seen with the prevalent but poorly treated condition of essential tremor (ET). ET was the most 
common movement disorder, affecting an estimated 10 million individuals in the United States.2 There was no 
cure for the disease. Current treatments included medications and surgery, which often improved symptoms 
and quality of life but could be fraught with side effects and complications. 
FUS could be a noninvasive alternative to surgery for certain ET patients. With this procedure, magnetic 
resonance imaging was used to guide multiple beams of FUS energy with extreme precision to heat and destroy 
the Vim nucleus in the thalamus (in the central part of the brain) in order to alleviate the tremor. The procedure 
was painless, so it could be performed with the patient awake without anesthesia. It avoided incisions of the 
scalp, burr holes in the skull, or placement of electrodes in the brain, thus decreasing the risk of complications 
such as infections or blood clots. The timeline in Figure 2 shows the role of the FUSF at each step of the 
process from identifying and selecting treatment of ET as a new FUS indication, to funding the first clinical 
trial, to raising awareness for the new treatment as the pivotal trial recruited patients, and preliminary results 
were published. The FDA approved this new treatment in July 2016, and the Center for Medicare and Medicaid 
Services established a payment level for insurance reimbursement. As of this writing, patients had access to this 
noninvasive treatment at approximately five sites within the United States and many more around the world. 
As clinical experience with the treatment grew, it was expected that more widespread physician adoption and 
reimbursement from the public and private payers would follow, enabling even greater patient accessibility. 
 
 
2 International Essential Tremor Foundation website, http://www.essentialtremor.org/(accessed Nov. 15, 2016). Do
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Figure 2. The role of the FUSF in bringing new therapy to ET patients. 
 
Source: Based on information provided by the FUSF management. 
Impact and Social Implications 
A case for responsible innovation and collective impact 
It was well understood that innovation involved creating value from ideas, and successful innovation 
resulted in diffusion to scale. A number of disruptive trends had accelerated the rise of new models of 
innovation in recent decades, including flexible IP policies, university-industry collaborations through 
incubators, microentrepreneurs, venturing, distributed innovation in global locations, open innovation, and 
others. It was therefore important to consider the concept of responsibility in the context of innovation as a 
collective, uncertain, and future-oriented activity.3 In fact, the concept of Responsible Research and Innovation 
(RRI) was referred to as a “transparent, interactive process by which societal actors and innovators became 
mutually responsible to each other with a view on the ethical acceptability, sustainability, and societal desirability 
of the innovation process and its marketable products in order to allow a proper embedding of scientific and 
technological advances in our society.”4 Stilgoe, Owen, and Macnaghten5 provided us with a framework for 
analyzing RRI based on the list of four core principles: 
1. Anticipation—have the consequences of implementing the innovation been explored? What 
alternative scenarios might there be? 
 
3 R. Owen, J. Bessant, and M. Heintz, eds. Responsible Innovation: Managing the Responsible Emergence of Science and Innovation in Society (New York, NY: John 
Wiley & Sons, 2013). 
4 R. Von Schomberg, “Towards Responsible Research and Innovation in the Information and Communication Technologies and Security 
Technologies Fields,” March 2011, SSRN Electronic Journal, 
https://www.researchgate.net/publication/239917899_Towards_Responsible_Research_and_Innovation_in_the_Information_and_Communication_
Technologies_and_Security_Technologies_Field (accessed May 2017). 
5 J. Stilgoe, R. Owen, and P. Macnaghten, “Developing a Framework for Responsible Innovation,” Research Policy, 42, 9 (2013): 1568–80. Do
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2. Reflexivity—have the “owners” of the business model been sufficiently reflective in exploring and 
developing it, or does it represent a single perspective or an implicit dominant design? 
3. Inclusivity—does the model take into account the inputs of relevant stakeholders? For example, 
drawing user ideas into the innovation process and agreeing what constitutes “value” across the system. 
4. Responsiveness—can the innovation be adapted in response to the answers to these questions. Is 
there flexibility in delivery? 
There had been a perceptible shift away from the single organization as a core source of technological 
innovation and a move toward using networks such as the FUSF by leveraging its ecosystems to enhance 
innovation. This ecosystem emphasis by organizations such as the FUSF and its focus on “reflexivity” and 
“inclusivity,” for instance, was a growing trend and presented firms in an ever-increasing number of sectors 
with significant opportunities and challenges.6 It was increasingly clear that change would not occur when single 
organizations operated in a vacuum, and when they failed to understand the needs and perspectives of all 
relevant stakeholders. New networks of innovation and changing mindsets among people had a distinctive way 
of “reperceiving” many of the enormous and urgent challenges in healthcare services into opportunities to 
“leverage the power of markets and business to have transformative, system-wide impacts.”7 Specifically, it had 
been noted that firms, organizations, and governments across various sectors around the globe were adopting 
an innovative approach to achieving large-scale systematic change through “collective impact.”8 Unlike 
traditional cross-sector collaboration, collective impact embodied a holistic approach to large-scale achievement 
and was underpinned by five key conditions for success: a common agenda; shared measurement; mutually reinforcing 
activities; continuous communication; and lastly, backbone support.9 Fostering collective impact not only required 
continuous communication and transparency among participant organizations but was also contingent upon 
the leadership provided by a central organization to serve as the “backbone” for the entire initiative. 
What appealed to me about focused ultrasound is that it was noninvasive, had very little side effects, and 
provided patients with a much higher quality of life. 
–Dorothy Batten, Board of Directors, Focused Ultrasound Foundation 
Based on our interviews with key stakeholders, the FUSF represented an organization focused on collective 
impact and responsible innovation. With over a quarter million website hits in 2015 and a widely subscribed 
newsletter, the FUSF strove to distribute key information to partners in the medical and research communities 
quickly and efficiently. The FUSF enabled multiactor and public engagement in research and innovation, 
enabling easier access to scientific results. In fact, the FUSF even strove to encourage user-driven innovations. 
End users were considered important sources of clinically valuable innovations, both as healthcare 
professionals10 and patients and caregivers.11 It was hypothesized that the “next iteration of healthcare” would 
build on empowered patients—with their ability to innovate—to manage their own health and disease to 
ultimately encourage others to remain healthy or cope better with their health condition. The FUSF not only 
brought patients to the center of decision making but also increased their responsibility and was, thus, to be 
viewed as social innovation. 
 
6 R. Adner, “Match Your Innovation Strategy to Your Innovation Ecosystem,” Harvard Business Review, 84, 4 (April 2006): 98. 
7 J. Inslee, B. Hendricks, “Homegrown Energy,” Apollo’s Fire, 6 (Washington, DC: Island Press, 2007): 153–55. 
8 S. Turner, K. Merchant, J. Kania, and E. Martin, “Understanding the Value of Backbone Organizations in Collective Impact: Part 2,” July 18, 
2012, Stanford SOCIAL INNOVATION Review, 
https://ssir.org/articles/entry/understanding_the_value_of_backbone_organizations_in_collective_impact_2 (accessed May 2017). 
9 Turner, et al. 
10 P. Oliveira, E. von Hippel, and H. DeMonaco, “Patients as Healthcare Innovators: The Case of Cystic Fibrosis,” MIT working paper, 2011. 
11 L. Zejnilović, P. Oliveira, and H. Canhão, “Innovations by and for Patients, and Their Place in the Future Health Care System,” Boundaryless Hospital 
(Springer Berlin Heidelberg, 2016), 341–57. Do
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In addition to providing stakeholders with information on the latest developments in the field, the FUSF 
served as a financial intermediary between investors and philanthropists as well as organizations and firms and 
had facilitated several technology-development initiatives totaling in investments worth millions of dollars. In 
that sense, the FUSF was closer to a new paradigm in public engagementwith science, a deepening of 
relationships and responsibilities of societal stakeholders for granting scientists and innovators a “license to 
practice.” Further, it was also worthwhile to consider that, in many cases, technologies with a competitive 
advantage and a defined need failed, or they did not have the impact on the market that was predicted. 
Evolutionary theory of the firm12 argued that in many cases innovations found boundaries before their 
establishment, and the reason was not only that an innovation could be “good or bad,” but that there was a 
selection mechanism through a system of norms and rules written to “trap or release” an innovation. Thus, 
even though innovations provided economic growth through better solutions, several promising innovations 
were never adopted at all, and others were subsequently abandoned. Organizations such as the FUSF played a 
critical role in anticipating such scenarios and by being “responsive” in driving political, environmental, and 
social factors by involving different stakeholders and defining success criteria as per RRI.13 For example, as the 
field evolved, the number of indications that the FUS could assist with became quite large. However, the FUSF 
did not have the resources and expertise to focus on all of them. There were more barriers in the way with 
certain indications, such as already available and accepted treatments (breast cancer drugs and hysterectomies), 
as well as the time and training involved to get clinicians to learn a new “craft,” or the transfer of treatment 
from one clinician to another (i.e., from surgeon to radiologist). At this stage, the FUSF had to make strategic 
decisions about where to focus its resources. It decided to focus primarily on the brain area because the existing 
brain treatments either were very complicated and messy, had multiple side effects, or were inadequate. Also, 
the brain is an organ that bleeds out more profusely and hence is more critically sensitive in affecting all areas 
of the body. The thinking was that if the FUSF could have great success within the brain, it would make getting 
clearance for other indications much easier in the future. 
Also, the organization decided to focus only on other indications where there were not already acceptable 
treatments, such as pancreatic cancer, or other indications where the existing treatments resulted in adverse 
side effects (i.e., prostate). The fact that FUSF had targeted specific areas quite aggressively was a strong 
indication of its socially driven motivations. Further, the organization also focused on areas where there would 
be easy wins, (i.e., bone metastases and pediatric osteoid osteoma), where we were not focusing on a cure but 
simply on the reduction of debilitating pain. The reason why FUS had taken quite long in making major inroads 
with breast cancer and uterine fibroids was because there already existed acceptable, affordable drug and 
surgical treatments in those areas. And the physicians involved with those treatments were not the clinicians 
who would provide the FUS treatment, so they did not have any incentive to change. 
The FUSF enabled corporate social responsibility that proposed an innovation process where societal 
actors (researchers, citizens, policy makers, business, third-sector organizations, and so forth) worked together 
during the whole research and innovation process, both in negotiating which types of research and innovation 
to pursue and in subsequently (or simultaneously) developing research and innovation. In the healthcare sector, 
the federal government, through the National Institutes of Health, often shouldered major funding for initial 
research in the life sciences. Once the potential of new medical technologies was validated, corporations and 
venture capitalists were financially motivated to support clinical trials and other critical steps toward 
commercialization. The transition between such basic research and medical application included the vital period 
of translational research. The RRI concept acknowledged the power of research and innovation as a mechanism 
for genuine and transformative societal change to shape our collective future. In the words of Geoghegan-
 
12 G. M. Hodgson, “The Approach of Institutional Economics,” Journal of Economic Literature, 36, 1 (1998): 166–92. 
13 R. Owen, J. Bessant, and M. Heintz, eds. Responsible Innovation: Managing the Responsible Emergence of Science and Innovation in Society (New York: John 
Wiley & Sons, 2013). Do
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Page 12 UV7281 
 
Quinn,14 “Research and innovation must respond to the needs and ambitions of society, reflect its values and 
be responsible…Our duty as policy-makers [is] to shape a governance framework that encourages responsible 
research and innovation.” It was here, in the translational phase, that researchers took risks that required 
resources (time, funding) to develop basic scientific concepts into revolutionary new clinical approaches for the 
prevention, diagnosis, and treatment of disease. The phase of translational research was traditionally 
underfunded, and was referred to as “the Valley of Death.” The FUSF had significant impact at this critical 
phase by not only anticipating and funding ventures but by also being responsive and building a network of 
public and private partners both inside and outside of the medical industry equipped with the incentives, 
expertise, know-how, and resources required to successfully develop, commercialize, or apply technology 
relevant to FUS developmental needs. 
Future Challenges 
The single-largest contingency that would impact the future success of the FUSF was whether medical 
practitioners, government regulators, insurance companies, and consumers would adopt FUS as a viable 
medical solution. As an established thought leader and intellectual hub within the space, the FUSF was well 
positioned to leverage the knowledge and resources it had gained in order to finance the continued innovation 
of FUS technology within the medical field. While it had certainly made an impact—$6.8 million in funding for 
completed projects that led to more than $30 million in follow-on funding—the FUSF had largely contributed 
to the cause through grant-based funding. However, in order to craft a more sustainable investment model, the 
FUSF could have had to consider pursuing a return on investment—in essence by serving as a financial 
intermediary between impact investors and the many ultrasound-based medical start-ups and innovators that 
had contributed to the vast pool of knowledge curated by the FUSF. 
In order to carry out this strategy, the FUSF would first have had to restructure at a legal and organizational 
level. One potentially impactful approach may have been to structure the organization as two separate legal 
entities—one as a nonprofit and the other as a for-profit. While the nonprofit wing of the FUSF would continue 
to serve as an intellectual nucleus within the FUS community, the for-profit side would largely manage the 
impact on the investment fund. Not only would this model have potentially had a significant positive impact 
on the balance sheet of the FUSF, but more importantly it may have catalyzed further adoption of the new 
technologies in FUS. The FUSF had successfully proved the therapeutic and medical benefits of using FUS 
through the completion of several research projects. The next step was to prove that this technology was a 
financially viable alternative—and what better way than by investing in profitable and growth-oriented medical 
enterprises. 
As with many organizational leaders of collective impact, the role of the FUSF would surely shift over time. 
Once an overarchingvision and strategy had been established within the FUS community, the FUSF would 
likely pivot from delivering strategic guidance and financial mobilization to the advancement of public policy—
this was particularly relevant within the medical field. 
 
 
14 M. Geoghegan-Quinn, “Winning the Innovation Race,” lecture at 2012 Innovation Summit in Brussels, Belgium, World Wide Web, October 2012, 
http://www.moublog.com/2012/12/winning-innovation-race-maire-geoghegan-quinn-eu-commissioner.html#sthash.9mxmSlCS.dpbs (accessed Jan. 
23, 2017). Do
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This document is authorized for educator review use only by P?s Acad?mico Est?cio, HE OTHER until February 2018. Copying or posting is an infringement of copyright. 
Permissions@hbsp.harvard.edu or 617.783.7860