MEDICAL INNOVATION NEWS

Message from the Chairman

"May you live every day of your life." – Jonathan Swift

It is with great sadness that we share the news that Peter Hero, our former Chief Development Officer, lost a brave battle to cancer on August 21. While Peter transformed charitable giving in Silicon Valley and beyond, closer to home he was a relentless supporter of the work of our companies-in-residence and their strong promise to improve and save patients' lives. His passion, dedication, incredible sense of humor and wisdom will be greatly missed.

Peter spent his life doing what he loved most - helping "save the world," which were often his parting words of encouragement to our startups. His passing strengthens our own goal and mission to carry on the important work we are doing - helping eradicate unmet healthcare needs that needlessly impact so many lives.

In this edition, we highlight the programs that are helping us accomplish this goal: by training the next generation of medical device innovators via our Lefteroff summer internship and by hosting team members from our corporate partners to teach them the "art" of innovation.

We also feature a Q&A with Congressman Tony Cárdenas, who recently visited the Institute, and highlight Terry and Trudy Rose, two of our generous donors who are supporting InPress with the goal to help them eliminate post-partum hemorrhage throughout the world.

On a last note, we hope you are attending Wine with Heart on September 9, one of our favorite events that supports our important work here at the Institute. As many have said, "Wine is good for the heart," and we look forward to sharing a lovely evening full of exquisite wines and food and fundraising for our organization.

As always, we welcome your feedback and thoughts.

Thomas Krummel, MD, Chairman

"Places like the Fogarty Institute are critical for the industry...the ability to walk down the hall and hear about what other small startups are working on is really inspiring for the needed creativity to keep the U.S., and especially California, ahead of everyone else in healthcare innovation." – Rep. Cárdenas

Fogarty Institute Updates

The Lefteroff interns graduate from their eight-week program. The interns are pictured with Dr. Tom Krummel, chairman; Dr. Fred St Goar, vice chairman; and Gretchen Berstler, program manager.

Third-year Lefteroff interns graduate: Group says they were impressed by broad range of hands-on experience

After an intensive eight-week program at the Fogarty Institute, our third-year Lefteroff interns emerged with a broader view of the medtech landscape and what it takes to launch a startup and take a product to market.

The intern's feedback was very rewarding as they shared their favorite moments and learning experiences during the graduation ceremony. For some, the internship validated their desire to pursue a career in healthcare; for others it ignited a passion for starting their own company; and for all, it provided invaluable hands-on experience, along with real-life lessons from the many mentors with whom they interacted and the companies/organizations they visited.

We had the pleasure of chatting with a few of the graduate to learn more about their summer experience: Aaron Katz, a recent graduate of Clemson University who is pursuing a biomedical innovation and development master's degree from Georgia Institute of Technology; Heidi Peterson, a junior at Stanford University pursuing a degree in mechanical engineering with a minor in arts; Mikelle Foster, graduating in December from Cal Poly San Louis Obispo with a degree in biology and a minor in psychology; and Ryan Palmer, a rising sophomore at USC and a human biology major.

Aaron Katz: "Meeting professionals from many backgrounds gave me an insider's perspective."

Aaron worked with Madorra, a startup aiming to improve the quality of life for breast cancer survivors and post-menopausal women. As part of his internship he was responsible for finding eco-friendly materials to build Madorra's product, prototyping a more economical product design, researching the best advertising channels, collaborating on product packaging and assisting with Device and Failure Mode Effect Analysis (DFMEA).

In addition to this broad range of experience, Aaron valued the opportunity to be exposed to many professionals with different backgrounds, from entrepreneurs to surgeons, venture capitalists, government regulators and mentors from the life sciences industry.

Heidi Peterson: "A startup needs a wide variety of skill sets."

During her internship, Heidi worked with Zebra, a startup creating the next generation of medical imaging that provides a non- invasive, real-time way to examine the skin and determine the potential presence of cancer. Her main task was to work on the optimal form and shape of the device - building models and refining the design through computer-aided design (CAD) and soliciting feedback from dermatologists. She also worked with a lawyer to write a description of the patented ideas, assisted with the design of one of the device elements and analyzed the financial data model.

Her favorite part of the internship was working on project elements she was unfamiliar with, as it underscored the value of building the diverse skill sets required to launch a startup - from marketing to design, engineering, to securing funding, and much more. Upon graduation, Heidi intends to pursue a master's degree in biomedical engineering to later work with prosthetics and neuro- prosthetics.

Mikelle Foster: "There is no set path to success."

Mikelle worked with InPress Technologies, a startup developing a simple device to stop post-partum hemorrhaging (PPH). During her time with the company, she conducted research on key opinion leaders and advocacy organizations in the global market and how to effectively get InPress' device to market in countries where PPH is most prevalent.

The most valuable part of the internship for Mikelle was learning that there is no set path to becoming a physician and medical technology entrepreneur, as most of them have diverse backgrounds. She also really enjoyed observing her first cardiac ablation and was fascinated by the personal interaction between doctors and patients. Her hope is to go to med school, following a master's in stem cell and regenerative medicine.

Ryan Palmer: "Innovation has such a positive impact."

Ryan had the opportunity to work with G-Tech, a startup 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.

In his first exposure to medical device technology, Ryan reviewed data garnered from the startup's patches and tested the device for accuracy and repeatability. He was also tasked with organizing and developing an algorithm to interpret data received from patients at El Camino Hospital, where the startup is conducting a clinical trial, and from patients suffering from Parkinson's disease. With five million data points received for each person that was tested for a period of three days, he was a very busy intern!

His most valuable take-away from the experience was learning about the different career paths in healthcare and the positive impact innovation has on patients. He has dreamed of being a surgeon since he was a young child, but is still open to exploring other options.

Our Companies

Shu Uemura of Terumo, one of our Japanese corporate partners, meets the Mayor of Mountain View, Pat Showalter, during a tour of the Fogarty Institute.

Institute's incubation program helps corporations and their employees learn how to innovate

Silicon Valley and the greater San Francisco Bay Area have long enjoyed a reputation and foothold as the epicenter of innovation, home to many of the world's most impressive startup launches and accounting for as much as 43% of venture capital funding.

But while entrepreneurs are continually focusing on what's new and next, that can lead to the question of whether larger, global companies maintain the ability and interest to invent the "next big thing."

There's no doubt that large companies continue to, or would like to, place innovation as a priority. But their very success is what can make it harder for them to innovate, when compared to nimble startups that have less to lose.

This is where the Fogarty Institute's corporate program comes into play. As a successful medtech incubator and accelerator, we provide corporate partners a unique view into the startup culture by hosting teams or team members and offering them the opportunity to be co-located with our entrepreneurs.

The Institute launched this program two years ago, when a few Japanese companies expressed interest in the Institute and learning more about its unique approach to innovation. Since then, we have hosted several teams from leading Japanese medical technology companies, including Terumo Medical, Mitsubishi and Olympus.

Thanks to positive feedback, we have now expanded the program to include companies and organizations from other markets that are interested in learning how to effectively take a product from concept to reality. The goal is to showcase the structure and culture that fosters innovation in these startups, all of which are focused on discovering new techniques and devices that will benefit patients.

An organization that has benefited from the program is the FDA, which has sent several of its reviewers to the Institute to gain a better understanding of the challenges startups face as they seek to bring innovative devices to market.

The corporate program is tailored to each company or organization's needs. Some send delegates to learn more about innovation as a process, gaining knowledge they can then share with their teams.

Others appreciate the proximity to "startup culture," from brainstorming sessions to mentors to exposure to other risk takers, as their team members focus on developing a new product they can bring to market, away from the daily pressures inherent in a larger organization. These teams share ideas and feel the "freedom to fail," in an environment that supports and understands the ups and downs of the innovation process.

No matter what their ultimate goal, the participants all benefit from the close proximity to El Camino Hospital and its physicians, as well as access to business partners and world-class mentors who can provide background on each stage of the innovation ecosystem.

As they establish new connections and learn more about innovation, we all ultimately benefit when they take these tools back to their companies and put them to work with their own efforts to introduce new lifesaving devices.

Q&A with Congressman Tony Cárdenas

Rep. Cárdenas tours the Fogarty Institute. He is pictured here (center) with Kerry Pope, executive director of mentoring; Peter David, CEO of MedicalCue; Mark Juravich, CEO of Materna; and the Lefteroff interns. (Photo courtesy of the California Life Science Association)

Raised by hard-working immigrant parents, Tony Cárdenas was brought up with simple ideals - that integrity and dedication were the keys to success. These are the qualities that he has brought to his career as a public servant, and he continues to offer today as a United States Congressman.

Rep. Cárdenas was first elected to the United States House of Representatives in 2013 for the 113th Congress (2013-2014) and has represented California's 29th district since. Now in the 114th Congress (2015-2016), Rep. Cárdenas sits on the prestigious House Committee on Energy and Commerce and its Health Subcommittee, which have jurisdiction over health-related bills, resolutions and regulatory agencies, including the Food and Drug Administration.

The California Life Science Association recently recognized the Congressman for his commitment to advancing the life sciences industry and helped facilitate a tour at the Fogarty Institute to showcase our startups and approach to medtech innovation.

We had the pleasure of talking to Rep. Cárdenas about his visit to the Bay Area, his thoughts on the opportunities and challenges in our industry and details on current legislation he is overseeing.

Q. What was the purpose of your visit to Silicon Valley, some of your favorite stops and key takeaways?

A. As a member with a seat on the Energy and Commerce Committee's Health Subcommittee, which oversees the laws and public policy that impact the health care sector, I make a point of visiting as many stakeholders in the industry throughout California as I can. Last year I had the opportunity to tour locations in Southern California, and this year I completed the tour throughout the Bay Region of California.

I thoroughly enjoyed every visit for different reasons. The health sector in California is so vast and diverse, you really can't pick one portion of it as the most interesting or the most important. Every piece has an important role to play in ensuring that the rest of the country's population has access to the most innovative and effective treatments and therapies. I also really appreciated the time that everyone took to meet with my staff and me.

Q. What are your thoughts on the role the Institute plays in the medtech innovation ecosystem and what most surprised you or made the strongest impression about the organization?

A. Places like the Fogarty Institute are critical for the industry. Most of the new treatments, therapies and technologies are discovered by smaller companies that don't necessarily have access or funds for expensive labs and instruments that larger players have. Also, the ability to walk down the hall and hear about what other small startups are working on is really inspiring for the needed creativity to keep the U.S., and especially California, ahead of everyone else in healthcare innovation.

I was able to meet with interns at the Institute from around the country on their last day of their internship. It's wonderful to see these young scientists gaining hands-on experience from the Fogarty Institute, which is a wonderful source of innovation.

Q. What are your views on the role medical technology innovation plays on fostering jobs and boosting our economy?

A. Medical technology innovation is absolutely critical to economic success in the United States. We have to do everything we can to ensure we have young, eager scientists entering their work field with innovative ideas and solutions to a lot of questions that remain unsolved like the cure for diabetes, Alzheimer's or cancer. As these technologies are created, they will lead to the creation of more jobs - and ultimately to the sustainability of the health of these workers.

Q. What challenges and opportunities are you seeing in healthcare and in advancing innovation?

A. We must continue to foster innovation in our healthcare industry, and California is a wonderful example of that. California has an ecosystem that could be a standard for the rest of the country. In California, we are able to recruit the best talent in the world from the great university system, and we have some of the largest, most innovative companies headquartered in the state. These jobs and workers need to continue to grow and be maintained in order for our continued success as a state and as a nation.

Q. Which legislation that you have worked on are you most proud of and / or what are some of the initiatives you are currently working on to promote medical innovation?

A. I am glad to have been able to work on The 21st Century Cures Act, which essentially would give our life sciences industry a competitive advantage at fostering innovation to create cures, therapies, technologies and treatments.

21st Century Cures is the kind of legislation I came to Washington to work on.

California is full of people doing amazing work to find cures for diseases that shorten the lives of too many Americans. In passing this bill out of the Energy and Commerce Committee and then the House, we give these brilliant researchers hope that America is behind them; that we will support their heroic efforts to keep our loved ones with us, living longer and healthier lives. I hope that the Senate is able to pass the bill quickly and send it to the President's desk to be signed into law.

Next year we in the Committee will begin consideration of the next reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from companies that produce certain human drug and biological products. It's a great opportunity for Congress, the FDA, industry and patients to work together towards enhancing the FDA's ability to keep pace with scientific advances in drugs, therapies, technologies and cures.

Donor Spotlight

Terry and Trudy Rose support Fogarty Institute and back InPress, with goal to help eradicate PPH globally

"Whatever you do, do it well" and "Choose your friends wisely" were two pieces of advice that Terry Rose's father gave him before he moved to Silicon Valley from the Midwest in 1965. These simple, yet wise, words proved to be invaluable in helping him launch a successful career in the real estate development business.

Terry initially became a commercial real estate broker, and three short years later, he started his own development company. While there were many up and downs in the economy and in the industry, Terry built a highly successful company with an impeccable reputation. Nearly 50 years later, his firm has developed several million square feet of commercial real estate in the Santa Clara and Livermore valleys.

Today, at age 79, Terry still puts in a full day's work, yet focuses on spending time with his wife Trudy giving back to the communities where he works and lives. "Silicon Valley has been very good to us and we feel very fortunate - that's something we want to share," he says.

When Terry and his wife were introduced to the Fogarty Institute and visited the Fog Shop, he says that they "were very impressed by what we saw. We were completely unaware of the many unmet healthcare needs that are impacting so many people worldwide."

The couple was particularly interested in the technology developed by InPress, which is creating a simple, effective device to stop postpartum hemorrhage (PPH), the leading cause of maternal death globally, which takes the life of one woman every four minutes.

The Roses made a donation to the Fogarty Institute to support its programs and invested in InPress, embracing its vision to eradicate PPH globally. "We donate and invest where we think we can make a difference," he says, adding that their goal is to help those doing important work and facilitate their path. "InPress is working on a major breakthrough, a technology that will save millions of lives, so it was an easy choice for us."

The Roses have been involved in many charities over the year including donating to San Jose State's athletic department, the Boy Scouts, the YMCA and several healthcare organizations and companies. In their spare time, they devote time to their church as well as enjoying outdoor activities such as flying Terry's airplane and playing golf. Terry and Trudy spend about four months a year at their home in Hawaii on the Big Island.

Celebrating 20 Years: Wine with Heart

One of our most popular fundraisers, Wine with Heart, is set for Friday, September 9 from 6-10 p.m. at the beautiful Thomas Fogarty Winery. For more information, please email us at infofogarty@fogartyinstitute.org