Building Upon a Legacy of Innovation

From the CEO's Desk

"We make a living by what we get, but we make a life by what we give." – Winston Churchill

As fall is fast approaching, and as I near the eight-month mark as CEO, I'm continually appreciating the direction the organization is taking. September signifies a very special occasion for the Institute, as we celebrate our 10-year anniversary at the beautiful Thomas Fogarty Winery on September 8 with the theme of "Building Upon a Legacy of Innovation."

We are very proud of the progress the Institute has made over the decade in creating programs that cultivate tomorrow's innovators, accelerate the development of new therapies and elevate our global innovation ecosystem.

In this edition, we highlight a successful fourth year of the Lefteroff internship program, with a tremendous group of students from diverse backgrounds who were eager to learn about the healthcare industry. I was pleasantly surprised by their insightful questions -- not only about our field, but also about work/life balance. Their enthusiasm and curiosity were contagious, and we are looking forward to hearing about the impact they are bound to make in the future.

We also profile HeartFlow, the Institute's first company-in-residence and first graduate – an excellent example of how a startup can commercialize a product to manage a pervasive health condition; in this case, coronary artery disease. We also have a Q&A with Allan Will, Fogarty board member and mentor to many, who shared his lessons for team building during our most recent educational seminar. Lastly, we wrap up the edition with the successful outcome of the inaugural year of our Ferolyn Fellowship and introduce our second class.

As we celebrate these 10 years and look forward to the next 10 (and more!), I want to thank you for your continued support. To see how far we have come, I invite you to view our history at the Wine with Heart webpage. While much has been accomplished, there are still so many patient needs to conquer, and it will be exciting to see what milestones come next. Together, we are making a difference every day.

Andrew Cleeland, CEO of the Fogarty Institute

"The number of people who lent their expertise as part of the program was incredible. Over the course of the year, I developed connections with mentors, coaches and other fellows, which I'm confident will last throughout my career." – Matt McLean, first-year Ferolyn Fellow

Fogarty Institute for Innovation Updates

The 2017 Lefteroff intern class during a visit to one of our partner companies.

Learning by Doing: Lefteroff Interns Aim to Find Their Path

"Say yes to every opportunity you get. Be authentic and be yourself." Mentors are often asked what they wish they'd known when they were first starting out, and those are two lessons they repeated over and over to this year's Lefteroff interns – sage advice as these young students will soon begin their journeys as life sciences professionals.

The 10 students completed an intense, hands-on, eight-week program where they were introduced to a broad range of experiences that exposed them to the entire process of developing a therapy – from early concept development to actualization -- with the goal of further inspiring them to pursue careers in the healthcare industry.

A broad range of experiences

Part of the program's focus included establishing relationships with professionals who are involved in every aspect of the medtech innovation community to allow students to see the wide range of opportunities.

During the program, the interns were each paired with one of the Fogarty Institute startups so they could obtain hands-on, real-life experience with developing medical technologies; shadowed physicians at El Camino Hospital; learned from Fogarty Institute graduates on how they launched their companies and met with both startups and more mature companies that had successfully commercialized their products.

To broaden their experience and cultivate interpersonal and professional skills, the interns met with seasoned executives and industry experts and participated in the Institute's educational seminars led by renowned professionals in the field. They also heard firsthand from FDA fellows about the regulatory environment and how to launch and thrive in a career in the life sciences industry, from an MD's role in innovation to the importance of clinical trials and potential success paths for startups.

"This program offers a unique opportunity for the students to learn about the multiple stages of companies as they evolve from small to large," said Fred St Goar, MD, Fogarty Institute vice chairman. "The interns also gained a foundational understanding of what it takes to develop a therapy from early concept development to actualization and the direct benefit to patients. We are very thankful for the El Camino Hospital physicians, who generously shared their time, knowledge and experience to help our interns gain a solid understanding of various practices and practice styles, as well as a real-world view into how devices are used in a hospital setting to benefit patients."

The unforgettable experiences they worked on with the companies-in-residence were broad and wide-ranging. Specific projects included researching retail opportunities for one of the commercially available medical devices; creating training manuals and tutorials for a bedside device that guides medical teams through newborn resuscitation; analyzing gastrointestinal data from patients with Parkinson's; and designing prototypes and developing tests for clinical data.

"The internship went above and beyond my expectations," said Brie Goo, a bioengineering student at Santa Clara University. Her highlights included meeting with seasoned experts to get insight on creating and leading a company, learning firsthand from physicians about the opportunities and challenges in their field and meeting world-renowned reconstructive plastic surgeon Dr. Burt Brent.

"Each of the many learning experiences helped me better understand my career options and reminded me of the importance of taking advantage of every opportunity and never being afraid to ask questions," she said.

Former intern successes

In just four short years, the Lefteroff internship has already seen several success stories. For example:

  • One former participant is now a surgical intern at Stanford and part of the Stanford Biodesign program
  • Another works with Fogarty Institute startup G-Tech
  • Another attends medical school
  • One took a position at PwC (where Tracy Lefteroff was a partner)
  • Another works as the neuroprosthetics lab at Stanford
  • One is working on the next generation of the MitraClip at Abbott Labs

But its biggest success comes from the philosophy instilled in the interns that it's all about the people you are helping.

The internship was created in 2013 to honor Tracy Lefteroff's spirit and passion to cultivate and inspire the next generation of entrepreneurs and innovators in life sciences. Tracy was a former board member and avid supporter of the Fogarty Institute.

Our Companies

Stephen B.: HeartFlow Analysis was used to identify this patient's triple vessel disease, which led to a quadruple bypass that saved his life.

HeartFlow sets the gold standard for diagnosing coronary artery disease

HeartFlow, Inc. the Institute's first company-in-residence and graduate, is changing the way that patients with suspected coronary artery disease (CAD) are managed. Affecting 16.8 million Americans, CAD develops when the coronary arteries are narrowed, reducing blood flow to the heart and causing chest pain, heart attack, or worse, death.

The tests commonly used to diagnose CAD, including stress tests and electrocardiograms, are inaccurate more than 50 percent of the time and often inconclusive, requiring that the patient undergo additional tests such as coronary angiography. An invasive procedure, coronary angiography has been shown to be unnecessary more than 60 percent of the time. Invasive procedures may cause additional risks and worry to the patient and burden the healthcare system.

HeartFlow has developed an innovative technology, the HeartFlow FFRct Analysis, which is the first and only non-invasive technology to provide insight into both the extent of CAD and the impact of the disease on blood flow to the heart. It helps cardiologists design a definitive, personalized treatment plan for each patient.

With HeartFlow's approach, data from a patient's non-invasive coronary CT angiogram are securely uploaded from the hospital's system to the cloud. HeartFlow leverages deep learning to create a personalized, digital 3D model of the patient's coronary arteries, and then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and assess the impact of blockages on coronary blood flow. The HeartFlow FFRct Analysis results are provided to the patient's clinician via a secure web interface to offer actionable information on the optimal course of treatment.

Making substantial strides since graduating from the Institute

HeartFlow has made major advances since graduating from the Institute in 2010. It has raised more than $225 million in funding and has gained tremendous momentum with the adoption of its technology, The HeartFlow FFRct Analysis is commercially available in the United States, Europe and Japan, and more than 13,000 patients have benefitted from this technology. The company is continuously making iterations and providing numerous releases to improve the product and reduce the turnaround time so physicians can have the information as expediently as possible.

The effort has paid off for HeartFlow: Several large trials have clinically validated the technology, and a wealth of evidence-based data supports its clinical and economic benefits. In one large multicenter clinical study, use of the HeartFlow FFRct Analysis resulted in cancellation of a planned invasive coronary angiography in 60 percent of patients. A health economic analysis performed as part of that study found the HeartFlow test reduced the healthcare system's costs by 26 percent, saving thousands of dollars per patient.

Based on this peer-reviewed data, a number of commercial payers have issued positive coverage decisions for the HeartFlow FFRct Analysis, including Aetna, which covers more than 23 million lives, Anthem which covers 37 million, and seven Blue Cross Blue Shield plans throughout the U.S. To date nearly 80 million Americans will have access to the HeartFlow technology. Evidence Street, which provides healthcare technology evaluations for the Blue Cross Blue Shield Association, a national federation of 36 independent Blue Cross and Blue Shield companies that collectively provide healthcare coverage for 105 million Americans, issued a review supporting the HeartFlow FFRct Analysis and indicating an expected improvement in net health outcomes. The National Institute for Health and Care Excellence (NICE) of the U.K.'s National Health Service, which covers 59 million lives, issued positive guidance, recommending the HeartFlow FFRct Analysis to help determine the cause of stable chest pain.

Additionally, the American Medical Association (AMA) issued a set of first-in-class Category III Current Procedural Terminology (CPT®) codes for the HeartFlow FFRct Analysis. Beginning in January 2018, hospitals and clinics utilizing this technology will be able to generate claims with both Medicare and commercial payers when the test is ordered for patients with suspected CAD.

The company has also forged partnerships with the largest manufacturers of computed tomography (CT) scanners, including GE and Siemens, with the goal of increasing the clinical availability and adoption of the HeartFlow FFRct Analysis. Recently announced was a collaboration agreement with Philips to co-promote HeartFlow to its Interventional Cardiology customers.

Saving patients' lives

While it's important to focus on metrics, HeartFlow is equally focused on the real reason for its technology – saving patient's lives.

Its technology has proven to be critical in cases where traditional diagnostic tests missed coronary artery blockage, placing the patient at great risk of a heart attack or even sudden death.

Take Stephen Burke, an avid marathon runner, with no symptoms of CAD. As part of an executive health program, he underwent a 30-minute treadmill test and was sent to a cardiologist for a second opinion. After a CT scan showed significant calcium in one of his coronary arteries, the physician recommended the HeartFlow FFRct Analysis, which found evidence of triple vessel coronary artery disease – resulting in emergency quadruple bypass surgery that saved his life.

What's next

With those positive patient outcomes spurring them on, HeartFlow is looking to the future. The opportunity to expand the use of its technology is significant, and the company plans to enter other markets and launch additional products and features. The company intends to stay independent with the goal of going public at the opportune time.

The Institute has had a positive impact on HeartFlow's success to date.

"The Fogarty Institute provided HeartFlow with an opportunity to share our technology with physicians at Palo Alto Medical Foundation who offered valuable insight," said John Stevens, M.D., CEO of HeartFlow. "We found the Institute's collaborative environment, in which we could brainstorm with other like-minded professionals in a thoughtful and productive manner, to be very helpful. It's unusual to find an atmosphere where you can experience such a solid community and constructive sounding board."

Q&A with Allan Will, CEO of EBR Systems; Director, Fogarty Institute

Corinne Landphere, principal of Corinne Landphere Consulting, holds a "Taking the Patient to Heart" sweatshirt as Allan Will explains the conscious cultural shift he initiated to reinforce how each employee plays a critical role in the care of patients treated by a company's products.

A Silicon Valley Icon Shares His Lessons for Team Building

You can't do it alone. No one knows that better than Allan Will, who credits teamwork with much of his success. With a remarkable track record of founding, funding, running, building and selling medical device companies, Allan has spent the last 31 years of his career as CEO of various Bay-Area venture-backed startups and has co-founded 11 companies, including The Foundry, Ardian, Evalve and Concentric Medical.

During our recent educational seminar on Team and Organizational Development, he shared his insights on how to build successful teams, a privilege for our startups, graduates, interns and staff to hear from one of the most successful medical technology entrepreneurs and VCs in the industry and a mentor to many CEOs and senior executives. An inventor on over 30 patents, he currently serves as CEO of EBR Systems, chairman of the boards of Fractyl Labs and Setpoint Medical and sits on the board of directors of the Fogarty Institute.

His entrepreneurial passion began as CEO of a medical device startup, Devices for Vascular Intervention (DVI), joining when the company had 16 employees and growing it to more than 600 when he left eight years later. His roots with Dr. Fogarty go deep, with Dr. Fogarty serving on his board at DVI over that period of time. Allan then joined AneuRx, a company founded by Dr. Fogarty to develop stent grafts for aortic aneurysms. After selling AneuRx to Medtronic, Allan conceived and launched The Foundry, one of medtech's most successful incubators. While CEO and chairman of The Foundry, he elected to move into venture capital to facilitate funding of Foundry companies. Allan joined St Paul Venture Capital and subsequently Split Rock Partners, a venture capital firm focused on medical devices.

Allan's extensive experience in working in small and large companies as well as on the VC side made him a perfect candidate for our audience as they seek to learn the intricacies of building strong teams and successful companies.

Q. To what do you attribute your ability to develop leaders into CEOs?
A. There are two key factors: whom you attract and how you operate within the company. There were between 20 and 30 medical device CEOs who came out of AneuRx and DVI, and I believe it's because these companies had such a positive work environment with a culture that attracted that kind of committed talent.

There are all kinds of leaders and cultures in businesses. You can be very directive and be successful. Alternatively, some companies are almost cult-like in how they grow and follow a charismatic leader. I happen to believe that a collaborative leadership style is a more powerful way to lead. No one has all the answers – the more you create a team that leads together, the better off you will be. Since I was early in my career when I was CEO at DVI, I recognized that I needed people around me who were very capable.

I am also a strong believer in giving and receiving feedback – frequently and effectively from the top down. I openly shared feedback I'd received on my management style with the entire company and discussed our future direction as well as how I was going to change. Being open and showing that vulnerability allows people to know who you are and builds their trust in you as a leader.

Q. What is your advice for early-stage companies -- how do they develop that level of open conversation and communication to address tough topics?
A. It starts with who you are. People are most comfortable accepting feedback if they know it comes from a place of compassion, caring and desire to make them successful. The more confidence they have in that, the more receptive they are going to be because they will realize that the feedback is coming from the right place to improve their performance. In turn, that will make them better team members and ultimately lead to a more successful company.

Q. How do you manage growth from 16 to 600 employees?
A. Again, it goes back to the need to create a powerful culture. When DVI was acquired and became a larger company, the culture began changing, and I knew we needed to go back to focusing on the patient. When we were just a small company of 16 people, we knew the names of the patients we treated, which blood vessels we were working on, the day of the treatment and the results for each individual patient. It was very clear that every catheter was a patient and every patient had a family. We needed to bring back the experience of looking at every box that came off the manufacturing floor as representative of a patient whom we were helping and reinforcing that each employee had a role in the successful treatment of that patient.

We kicked off the process with a T-shirt design contest that had the theme, "Taking the patient to heart." This reinforced to each employee that what they were doing was very important beyond building a successful company: Their success was based on the patients' health, their lives and their families.

Q. How have things changed from when you were at DVI to now, as CEO of EBR?
A. Today, fundraising takes so much time that CEOs struggle to lead in a way that creates culture. Since I joined EBR as CEO, I have been so involved in fundraising that it has been more challenging to dedicate adequate focus on building the culture. I've been very lucky that there was a strong team in place prior to me joining the company.

One of the things that has been most rewarding in my career, besides creating the types of devices that we have developed, is that I've been so fortunate to have created cultures that foster careers by providing opportunities. There isn't a better job on earth – bringing important healthcare products forward while simultaneously helping employees become the best they can be. I am looking forward to doing that at EBR.

Q. What are the most important priorities for newer CEOs to not only build their companies but also grow and develop personally?
A. You have to be true to yourself and consistent with your ethics, style and beliefs. Know yourself and your skills and think about how they can help you lead. You have to be open to improving, and the best way is to engage the people around you to help you grow. They can provide valuable feedback, but you have to create an environment where they know you are willing to hear it and act on it.

Q. What are some best practices for selecting talent? And how much of their success is innate and how much is coached?
A. Picking people is a big challenge, but it gets easier as your career progresses because you build a network. You can only go so far when you don't know who the person is and that's where your network comes in because you can reach out to those who have worked with the candidates before and can help assess them from experience.

On the question as to whether leaders are born or made – I think it's both, a combination really. Everyone has a different leadership style, and there's not one specific background that leads to being a successful CEO. While some of it might be about who you are and where you come from, a lot of it also comes by learning from others – both good and bad lessons.

Q. What do you wish you knew about VCs when you were first starting out?
A. I learned that VCs are not risk takers – their job is to make an investment and then eliminate as many risks as possible, which means they are going to focus on what could go wrong. The better you can be at addressing those concerns from the start, the better you will be at fundraising. It's getting harder though, because now VCs, in general, know less about the industry than they used to, which makes it harder to raise money for products that require significant capital.

Q. How do you ultimately determine success?
A. Success comes from inside – who you are and what you care about. The most powerful measure of success in our industry is the patients we treat, the families we help and the career development we provide to our employees. When you make it all about the people – both the patients and your employees -- revenue, profitability and success will follow.

Monthly Spotlight: Ferolyn Fellowship

(From left to right) Second-year Fellows Shreya Mehta, Bronwyn Harris and Anura Patil; Liz McDermott, co-founder of the Ferolyn Fellowship; and first-year graduates Matt McLean and Kate Garrett

Thank you, First-Year Fellows; Hello, New Class

Just one year ago we welcomed our first class of Fellows, the inaugural recipients of the Ferolyn Fellowship. This program is designed to pay tribute to Ferolyn Powell's invaluable contributions to medical technology by helping cultivate innovators – mentoring tomorrow's rising medtech leaders who have demonstrated strong passion and aptitude to transform healthcare.

Last month we celebrated the success of these first-year graduates -- Kate Garrett, Matt McLean and Julia Fox; while introducing three new fellows -- Anura Patil; Bronwyn Harris, MD; and Shreya Mehta.

A year of growth for the first class

During the immersive 10-month program, the graduates received goal-setting assistance, personalized coaching and mentorship, exposure to diverse industry experts and leaders, and the opportunity to attend high-profile industry events -- all with the aim of accelerating their careers.

All three shared similar positive, complimentary feedback. The top benefits they identified were:

  • The importance of individualized mentoring. Each Fellow entered with a specific individual goal to advance their career and their leadership skills. They all reported achieving important milestones through connecting with mentors who could share similar experiences and talking directly to professionals who could help them address goals and challenges and give advice on moving their career forward or identifying an ideal career path.
  • Conference attendance opportunities: They attended high-profile conferences they wouldn't otherwise have had access to, such as the Wilson Sonsini Goodrich & Rosati 25th Annual Medical Device Conference and the annual Phoenix Conference for CEOs. There they met with leaders and connected with organizations to broaden their opportunities.
  • Camaraderie between the Fellows: The cohort communicated regularly regarding the program, and developed a new sounding board for sharing ideas and discussing career progression.
  • Group mentoring: Sessions in skills such as communication coaching were vital to help the graduates learn how to best present themselves and their brand.

The program made a significant impact on their careers. For example, since starting the program, Kate has sold Ciel Medical as a first-time CEO to Vyaire Medical, the healthcare industry's largest pure-play "breathing" company; Matt has identified new avenues that will help him meet his goals and Julia has moved into a new position as director of new ventures for Siemens Healthineers.

New beginnings for next year's Fellows

The graduates will continue to be involved in various capacities, including in the recent selection process of the new fellows. A diverse group of Fellows was chosen from a very talented pool based on their credentials and their current trajectory, where they are in the "sweet spot" of their career that will allow the fellowship to be most beneficial.

The new class includes Bronwyn Harris, CEO and co-founder at Tueo Health; Shreya Mehta, co-founder and CTO at Zenflow; and Anura Patil, director of marketing at Ceterix Orthopaedics.

"These new fellows are smart and passionate and have the thoughtfulness and eagerness to advance their careers and make an impact on the healthcare industry," said Liz McDermott, co-founder of the Ferolyn Fellowship.

"We are extremely pleased with the direction of the Fellowship and look forward to formalizing and building on the core parts of the program, together with the graduating class and our advisory board. I also want to express how thankful we are to the incredible pool of talented, seasoned industry veterans who are lending their expertise to help shape these careers. It is an incredible way to honor Ferolyn and make an impact."

Celebrating 10 Years!

Building Upon a Legacy of Innovation
The Fogarty Institute for Innovation is hosting its annual Wine with Heart fundraising event on Friday, September 8, celebrating the Institute's 10-year anniversary. Visit the event website and read our history of spearheading innovation.

In the News

NBC News: Three ways Virtual Reality is Transforming Medical Care (EchoPixel is a Fogarty Institute company)

Mass Device: GE Healthcare inks deal to integrate HeartFlow FFRct into CT scanners (HeartFlow is a Fogarty Institute graduate)

News Medical Life Sciences: SLUCare obstetricians examine novel device to treat postpartum hemorrhage (InPress is a Fogarty Institute graduate)