MEDICAL INNOVATION NEWS

From the CEO's Desk

"I never teach my pupils; I only provide the condition in which they can learn." - Albert Einstein

Education has been one of the pillars of the Institute since its inception. But what makes the Institute unique is HOW we go about teaching innovation: by providing the necessary tools to launch a successful and sustainable medtech startup.

Our interns, fellows and entrepreneurs learn by doing, shadowing, trial and error and perhaps most importantly, they learn from each other by sharing ideas and lessons learned. We also expose them to the best in the industry – experts who provide mentorship and help steer them in the right direction.

Our methods have proven to be successful, as exemplified by the six startups we have already successfully launched; the strong interest of educational institutions, government officials and global companies that come to the Institute to learn from our model; and the support we have been receiving from medical leaders such as Edwards Lifesciences Foundation and the Gilead Foundation.

In addition to these successes, we are excited to share that G-Tech, one of our startups, recently launched their clinical trials right here on the El Camino Hospital Campus.

We hope you enjoy this edition of our newsletter. As always, we welcome comments and ideas.

Ann Fyfe, President and Chief Executive Officer

Ann Fyfe

"Over the years, we have invested in a strong infrastructure to support our disciplined approach to quality – it has been very gratifying to see that it is yielding such good results for the patients we serve." – Tomi Ryba, president and CEO of El Camino Hospital

Thoughts from the Board

by Thomas Krummel, MD, Chairman

We wanted to update you on last month's announcement of Ann Fyfe's impending departure and our plans to potentially engage a leading search firm to ensure we find a high-caliber CEO who best fits the need of the Institute. As a follow up, we are excited to announce that we have chosen to work with Corinne Landphere Consulting.

Corinne came highly recommended as one of the best in the life sciences industry with extensive experience in medtech. Prior to launching her firm in 2000, she was an award-winning member of the Perclose sales team, which was eventually acquired by Abbott Labs after a successful IPO. Prior to that, Corinne held top-level positions at Genentech and Guidant, leading key initiatives, forging partnerships and providing leadership coaching for the executive teams. She began her career in the E.R. at Methodist Hospital's Trauma I center in Indianapolis.

Corinne knows our industry inside and out and has developed solid connections throughout the years as a self-employed professional and as a life sciences employee.

While change can be challenging, growth, innovation and opportunities often go hand in hand. We are excited about our future: Our startups are thriving; and we continue to broaden our programs and attract new investors, donors and interest in the Institute. We thank you for your support during this time of transition and will keep you apprised of our progress.

Fogarty Institute for Innovation Updates

Johnson Center for Entrepreneurship & Innovation students, a top-ranked entrepreneurial program worldwide, at the Fogarty Institute

Educational Institutions come to Fogarty Institute to learn about innovation

March was a busy and exciting month for the Fogarty Institute as they hosted students from the Johnson Center for Entrepreneurship & Innovation and the Stanford Biodesign team, among others.

Johnson Center for Entrepreneurship & Innovation

This is the second year that the Fogarty Institute for Innovation has hosted the Johnson Center for Entrepreneurship & Innovation (JCEI), one of the top-ranked entrepreneurship program worldwide and part of the Indiana University's Kelley School of Business.

Thirty of its students were in Berkley, California as part of their annual trip to Velocity, a conference for graduate-level students dedicated to the acceleration of entrepreneurial careers. During the conference, JCEI holds meetings with leading Silicon Valley innovation centers, CEOs from high-potential businesses and the venture capitalists that fund them.

The visit was coordinated thanks to the efforts of John Shoemaker, a Los Altos philanthropist and retired Sun Microsystems executive who earned a master of business administration degree from the Indiana University Kelley School of Business. Mr. Shoemaker is a strong supporter of El Camino Hospital, where the Fogarty Institute is headquartered, and of innovation and mental health services.

Mr. Shoemaker and his wife, Mrs. Donna Shoemaker, are chairing the "Fulfilling the Promise" campaign at El Camino Hospital to build a new health building and fund outpatient program.

"Coming to a place like the Fogarty Institute showcases the practical applications of a startup," said Mr. Shoemaker. "The Institute was an ideal opportunity for the JCEI student to hear first-hand from promising startup CEOs about what it takes to build a startup from concept to implementation."

Stanford Biodesign executive education participants.

Stanford Biodesign

Each year, Stanford Biodesign hosts a three-day executive education program called "Managing Innovation" for senior managers and executives from the medical technology sector. The purpose of the course is to provide these industry leaders with a fresh perspective on how to drive and sustain innovation within their organizations.

This year, the program had 70 participants representing eight companies and one academic medical center. This year's agenda included field trips to two renowned Bay Area incubators -- ExploraMed and the Fogarty Institute for Innovation. The goal of the visits was to provide these teams with the opportunity to see how these successful accelerators manage their own innovation process.

The companies in attendance at the Fogarty Institute included Johnson & Johnson, Bard, Stryker, Abbott, Verily, NEC and Texas Children's Hospital.

Our Companies

Lindsay Axelrod and Natasha Kafai, 2015 Lefteroff fund interns, are co-authors of poster abstracts for G-Tech Medical, which will be presented at the prestigious Digestive Disease Week conference in May.

G-Tech presents scientific posters at Digestive Disease Week; launches clinical study at El Camino Hospital

It's been a busy and exciting time at G-Tech Medical, a Fogarty Institute company that records the electrical signals that naturally occur in the digestive tract (also called the gastrointestinal or GI tract) and is studying the patterns of stomach and intestinal contractions in individuals following abdominal surgery.

First, the startup received the good news that the two abstracts G-Tech submitted to the Digestive Disease Week conference have been accepted for presentation. The conference, the world's largest gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, will be held in San Diego from May 21 to 24.

Presenters from G-Tech include Anand Navalgund, PhD, of G-Tech Medical, and Lindsay Axelrod. Lindsay and Natasha Kafai, two of our 2015 Lefteroff summer interns, co-authored the poster abstracts. The presentations will discuss the value of non-invasively monitoring the activity in the digestive tract and the best locations to place myoelectrical signals on the lower digestive organs to diagnose GI disorders.

G-Tech also announced that it is launching a clinical trial of its GutCheck System at El Camino Hospital. The pilot/feasibility study "Measurement of Gastrointestinal Myoelectric Activity in Patients At Risk For or Who Have a Post-Operative Ileus" uses the GutCheck System, comprised of a wireless, wearable, disposable patch and app to measure the electrical activity from the stomach, small intestine and colon.

This electrical activity is a signal of motor activity of the organs, potentially a measure of their return to function after surgery. The user interface of the app was created by Lindsay, with earlier design input from Amanda Spielman and Gabriele Cassani, two other Fogarty Institute interns.

The study will retrospectively look for differences in the patterns of patients who develop an ileus (also called an intestinal pseudo-obstruction) and those patients who have normal return of GI activity following surgery to find indications that may be used to predict who is developing ileus and determine the contributing factors.

The two-year trial is expected to enroll 80 study participants at El Camino Hospital. Nearly 60 million individuals suffer from some form of gastrointestinal disorder.

Guest Q&A — Tomi Ryba, President and CEO of El Camino Hospital

For this month's guest Q&A, we had the privilege of catching up with Tomi Ryba, president and CEO of El Camino Hospital, where the Fogarty Institute is located. Ms. Ryba has been a long-time proponent and supporter of the Fogarty Institute and strong advocate of improving patient care.

Ms. Ryba has extensive experience in hospital administration: Prior to joining El Camino Hospital, she served as president of United Hospital in St. Paul, Minnesota, and senior vice president of the hospital's parent organization Allina Hospitals & Clinics. Earlier in her career, Ms. Ryba served as chief operating officer at University of California, San Francisco Medical Center.

Q. What are some of the accomplishments you are most proud of at the hospital?

A. El Camino Hospital was recently recognized as one of the top 100 hospitals in the nation, out of nearly 3,000, by the prestigious Truven Health Analytics, which identifies the best hospitals in the nation annually.

This was a strong testament and acknowledgement of our focus on quality, which includes continually lowering mortality and complication rates, and providing the best outcome for our patients. The hospital was also recognized as one of 17 Everest Award winners, which honors hospitals that have achieved both the highest quality current performance and the fastest long-term improvement over five years.

Over the years, we have invested in a strong infrastructure to support our disciplined approach to quality – it has been very gratifying to see that it is yielding such good results for the patients we serve.

Q. What are you seeing as the most critical health issue and as the most critical unmet healthcare need?

A. This really depends on the health segment, but at El Camino Hospital we are seeing a substantial need for behavioral health, a disease and a disorder of the brain that affects people's behavior and emotional well-being. This is an area where it is critical to get the right care in the time of need. Currently, we see limited access to services, a pervasive stigma attached to the disease and challenges in holding open conversations.

During discussions with local school districts and businesses, mental health has been identified as one of the top concerns. It manifests itself in so many ways: stress and depression in the workforce; thought disorder among all school-aged children; teens at risk of suicide; mothers battling with post-partum depression; addiction and older adults struggling with acute depression. Behavioral health is impacting everyone from elementary school-aged children to seniors.

One of the challenges is that families or teachers often don't recognize the symptoms and if they do, they don't know how to best get help. While other hospitals are closing their programs, we are raising awareness, expanding our services and creating strong community partnerships to advance our efforts.

Q. What are some of the biggest challenges and opportunities that hospitals are facing today?

A. We view the aggregation and consolidation of hospitals as a critical component to the success of hospitals and patient care.

Rather than focusing on the value proposition of a potential consolidation, hospitals, payers and physicians need to be aligned on the goal to lower healthcare costs and improve the lives of those we serve.

If managed appropriately, a strong group of like-minded physicians and other health leaders could bring healthcare to a whole new level by focusing on care integration and coordination, through partners.

Q. What are the opportunities you see for El Camino Hospital moving forward?

A. We are focused on choosing effective partners; payers, employers and physicians who are willing to invest in the right approach and model of care to support the community and employers in Silicon Valley.

We are strong believers that we cannot do it alone and need strong, value-based partners to offer integrated, high-quality services. We are truly fortunate to be based in Silicon Valley where we have access to an incredible network and broad range of potential partners, as well as dedicated community members interested in advancing healthcare.

Q. What is your view on medical device innovation and how is it / will it help the hospital?

A. To us, device innovation is focusing on the discovery of a health challenge and inventing a solution that improves quality outcome and lowers costs.

There are a number of different devices that have been used at the hospital, including those that address heart care, premature infant delivery and women's health. We have hosted several clinical trials to give medtech entrepreneurs an opportunity to work hand-in-hand with our physicians, techs and nurses to receive interactive feedback through the design phases.

Q. What are the advantages and what do you like best about having the Fogarty Institute on campus?

A. We are one of the few hospitals in the country to have the advantage of hosting a medtech incubator right here on our campus. This is an opportunity for medtech startups to be involved in identifying and solving real problems, while having access to world-class nurses, technicians and physicians who work on healthcare issues on a daily basis and can provide an instantaneous response on what works and what doesn't. This creates an unparalleled synergy that will ultimately create a more effective device.

Consider us a lab, where the solutions can be tested, obtain FDA approval and then often put to good use across the globe.

Peter's Corner

Foundations' donations underscore the effectiveness of the Fogarty Institute's education program

Following on the heels of our recent grant from Edwards Lifesciences Foundation, we are excited to announce a second grant from Gilead Sciences, a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

The grant was awarded by the Gilead Foundation, a nonprofit established by the company to improve the health and well-being of underserved communities around the world. The grant will support the Institute's Lefteroff Fund, a program that was launched four years ago to teach and raise the next generation of medtech innovators. The fund was established in honor of Tracy Lefteroff, a remarkable leader and strong proponent for mentoring students who show the curiosity and desire to advance the field.

Grant monies will be used to support the program and the educational activities of the 10 college interns who are selected annually. Lefteroff interns are introduced to the extraordinary world of medical technology innovation by working on projects with, and shadowing, our startups and medical technology partners.

Donations in support of the Lefteroff internship program have come from corporations, foundation grants and individual donors. These two recent grants from the Edwards and Gilead foundations are strong proof of the effectiveness of our educational program and widespread interest from current leaders in the medical community in creating the next generation of medtech leaders.

Should you or someone you know be interested in supporting us, please contact us at infofogarty@fogartyinstitute.org.