MEDICAL INNOVATION NEWS

From the CEO's Desk

"Coming together is a beginning. Keeping together is progress. Working together is success." - Henry Ford

As fall is in the air, we reflect on the summer that is coming to a close and the strong strides we have made on the innovation front.

In this edition of our newsletter, we are excited to share the news about our successful collaboration with the FDA, which has led to a first-of-its-kind educational program to help increase efficiency and advance innovation. This is a big step forward in our quest to improve the regulatory environment and establish a better understanding between startups and reviewers.

We are also thrilled by the progress of our startups, with InterVene receiving approval and funding to do early feasibility clinical trials in New Zealand. And lastly, we appreciate the knowledge, wisdom and experience Dr. Krummel shared with our Lefteroff summer interns during a recent lunch Q&A.

We hope you enjoy this edition, and as always, we appreciate any feedback on our work and e-newsletter.

Ann Fyfe
President and Chief Executive Officer

Ann Fyfe

"We believe this collaboration (with the Institute) will assist the FDA in better understanding the unique considerations of medtech startups." – Murray Sheldon, FDA Center for Devices and Radiological Health

Fogarty Institute for Innovation Updates

Dr. Fogarty, Mike Needels, COO of the Fogarty Institute, and FDA reviewers celebrate the first-of-its-kind educational program to help accelerate medical innovation in the U.S.

Institute Collaborates With FDA to Increase the Efficiency of the Medtech Approval Process

Dr. Thomas Fogarty has long worked with regulatory bodies in his quest to improve and expedite the approval process for medical devices.

His quest came to fruition when the Food & Drug Administration proposed to work with the Institute to learn more about the challenges that medtech startups face when bringing their products to market.

We are excited to announce that we recently signed an agreement with the FDA to begin a first-of-its-kind educational program. The goal of the program is to help accelerate medical device innovation by improving communication, collaboration and understanding between the FDA and early-stage medical device innovators, thereby improving the overall efficiency of the medical device approval process.

This initial pilot program is a strong step forward. The Institute recently hosted two FDA reviewers from the Office of Device Evaluation in the FDA's Center for Device and Radiological Health, the governmental body that is responsible for the program areas through which medical devices are evaluated or cleared for clinical trials and marketing. The FDA staff participated in a one-week educational program at the Institute, working closely with our startups to obtain a better understanding of what it takes to bring a device to market in the U.S., and the impact FDA policy and decisions have on startups' ability to commercialize innovative and potentially life-saving technologies.

"This is a critical step to help develop a safe and effective U.S. medical device ecosystem, with the end goal of supporting medical innovation that benefits patients," said Ann Fyfe, President and CEO of the Fogarty Institute. "The Institute provided FDA staff with access to a 'living laboratory' of medical device start-up companies, providing insight into the challenges faced by these companies; and, in turn, offering our companies-in-residence a better understanding of the positive impact the FDA can have on the development of safer medical devices."

"Our goal at the FDA is to promote innovation and efficacy in medical devices, to better serve the American public while maintaining the highest level of safety," said Murray Sheldon, MD, Associate Director for Technology and Innovation in the FDA's Center for Devices and Radiological Health. "We believe this collaboration will assist the FDA in better understanding the unique considerations of medtech startups; and the costs, time and money incurred during early-stage development to bring their innovation to doctors and patients."

We are grateful to the FDA for partnering with the Institute to improve the mutual understanding between the startups and the Agency, for the greater good of patients. We look forward to continuing our discussions and building on our pilot program.

Our Companies

The Intervene team, from left to right: Michi Garrison, VP of Research and Development; Ben Clark, engineering consultant; David Batten, Senior Research and Development engineer; and Fletcher Wilson, founder and CEO.

InterVene Sets Off to New Zealand For Early Feasibility Clinical Trials

One of our recent graduates, InterVene, is making great strides, having recently been approved and funded to do early feasibility clinical trials in New Zealand. The team, led by founder and CEO Fletcher Wilson, left right before Labor Day Weekend.

InterVene has enjoyed several accomplishments in the past several months: securing nearly $8 million in Series A funding, which underscores the significance of their new medical technologies; adding new team members; and moving to its new headquarters in South San Francisco this month.

The startup is creating a novel, minimally invasive device for the treatment of venous disease in the legs. The clinical trials will be the first catheter-based therapy to correct the underlying cause of chronic venous insufficiency (CVI). This condition is caused by improper function of the veins in the legs, which leads to blood pooling in the lower extremes, causing skin changes and painful ulcerations. CVI is not uncommon — it afflicts up to 24 percent of adults and costs the U.S. healthcare system nearly $2 billion annually.

The clinical trials are aimed at demonstrating functionality and safety. To date, CVI treatment for patients with deep vein reflux is limited to compression stockings and wound care, or in rare cases, invasive surgery.

"This is exciting news for Fletcher, his team and the millions of patients who will benefit from the technology," said Fogarty Institute President and CEO Ann Fyfe. "Here at the Institute, we judge our success based on the quality of the company we help create; the legitimacy of the medical device, as proven by its ability to secure funding; the number of patients who will potentially benefit; and the probability of the innovator to make a long-term impact on healthcare. We couldn't be more proud of InterVene and feel confident in its potential for success."

Guest Q&A — Thomas Krummel, MD, Fogarty Institute Chairman

Our interns had the opportunity to chat with Dr. Krummel, one of the foremost authorities on medtech.

Dr. Krummel is one of those rare individuals who has seen and experienced medical innovation from every front — as an academic, surgeon, writer, startup adviser and administrator. He served as Emile Holman Professor and Chair of the Department of Surgery at Stanford University School of Medicine for the past 16 years, as well as Susan B. Ford Surgeon-in-Chief at Lucille Packard Children's Hospital, and is one of the Co-Directors of the Stanford Biodesign program.

During his distinguished career, Dr. Krummel has been a pioneer in the application of information technology to simulation-based surgical training and robotics, has received countless awards for his work, and perhaps most importantly, has been a mentor and inspirational educator to numerous innovators and medical device startups.

This summer, our Lefteroff interns were treated to an informal Q&A with Dr. Krummel to discuss the secrets behind his successful career and future of the medtech industry.

Q. What would you consider failure, and how does it change or make you better?

A. Success is built on failures.

For me personally, I struggled in medical school. Medical residency is tough, and there were many days that I wanted to drop my beeper in the trashcan, but I bounced back.

And then as a surgeon, I think it's a natural tendency to think more about the patients you were not able to help, rather than those you did. But to succeed in the medical world you need to persevere and think of the greater good. And that's what I did.

When you look for solutions to a difficult problem, you have to be creative when you find that the standard answer doesn't work. Study all the attempts and failures — when you think differently, that is when a major breakthrough can happen.

Here's a perfect example: kidney transplants. It used to be unconceivable that you could transfer an organ from a dead body with a beating heart to a live person.

It was thanks to an innovative and persistent young Dutch physician named Willem Kolff, who is considered the father of dialysis, that the first successful kidney transplant took place in 1954. It took Kolff almost 20 years to see his technology come to fruition, and his path was ripe with failures and challenges, including the need to hide the progress of his work from the Nazis.

To be successful, you have to discover how something doesn't work - that's how you find out what will work. Samuel Beckett perhaps says it best in his quote: "Ever tried. Ever failed. No matter. Try Again. Fail again. Fail better."

Q. Can you share the beginning of your career path — you didn't really know what you wanted to study when you went to school, and yet ended up being so successful.

A. I believe that educational institutions should be a place for exploration. As a student, you should be surrounded by faculty who are there to help expose you to different things, to help you find your passion. The result is a graduate whose brain has been challenged and is ready for lifelong achievements.

Take Larry Page and Sergey Brin. They founded Google while they were Ph.D. students at Stanford. Their mission was to organize a seemingly infinite amount of information from the web, and their mentors encouraged them to pursue their ideas. Their first Google computer at Stanford was housed in custom-made enclosures constructed from Lego bricks. Now that's thinking outside the box.

The message is that you shouldn't be afraid to explore — or to tell people that you are exploring. That's how you are able to figure out where your strengths are, and then you can hone in on them.

Q. How do you come to terms with the responsibility surgeons have over patients and their families — is that a process or something that is learned?

A. That was my fear of pursuing medicine when I was in college. My mom thought I should go to medical school, but I thought it was too much responsibility. However, once I started, I began following the path and realized it was fun to deal with difficult problems. It was fun to get it right and help people. There's an enormous sense of satisfaction that comes from contributing to the health and well being of patients.

That's what I experienced, and what I share with my students at Stanford. You train a group to trust themselves and learn to fail better and quickly.

Q. What is the largest unmet need in the medical world right now?

A. Continuing to attract and inspire bright, talented young people to the healthcare profession. There is some pessimism around the ways that healthcare is changing. But there is no better privilege than helping someone in a moment of need. If we keep attracting bright young minds, new devices and technology will be developed and new medical solutions will be found.

Q. What is your interest in virtual reality and robotics in medicine— what role do they play in medicine and why aren't they more prevalent?

A. I have always had a strong interest in tinkering with mechanical things. With virtual reality, you can fail, and if you kill a virtual patient, it's no big deal. The freedom to fail and quickly learn from your failures is key to medical advancement.

Virtual reality has its roots in the aviation industry. In World War II, the mortality rate associated with learning how to land an airplane on a carrier was in the double digits. The pilots were very motivated to learn quickly. Thanks to Edwin Link, who invented the first aviation simulation device, 70 to 80 percent of lives were saved.

The notion of feeling comfortable failing and failing safely is at the heart of how we train the next set of physicians and surgeons. It doesn't replace learning on the human body, but it expedites the learning process. Medical device innovators use simulators and technology to train surgeons how to use their tools.

The other piece of this is the robotics side. I did a lot of work on robotic development at Penn State. Think of it as R2-D2 — robots are great at repeating the same task consistently. One of the most innovative and inspiring computer science and robotics centers is located in Strasbourg, France, the IRCAD Training Center. What they are doing is truly impressive — a surgery and computer science think tank that is now also expanding into distance learning, offering the most extensive library of surgical videos.

The key takeaway is that no one has a lock on anything. Innovation can happen anywhere. There is always someone who is worth meeting and learning from.

Q. What does the next generation of healthcare provider look like? Will there be a stronger shift towards technology, and how can this need be met?

A. The younger generation brings a lot of technology savviness. Our running joke is that electronic healthcare currently only exists thanks to interns who know how to use the system.

Technology is a great way to learn. I am here to learn from the younger generations — that's how education really becomes effective, when we learn from each other.

A recent Economist cover story, Planet on the phone, stated that by 2020, 80 percent of the population will have a supercomputer in their pocket. The implication is that someone will probably take a social media concept and develop a way to match patients with physicians globally. Sohila Zadran, founder of Igantia, one of our startups here at the Institute and former student in the Stanford Biodesign program, is looking to use social media to resolve and better understand hot flashes. I would never have thought of that. She knows how to use online tools to plumb a condition that we don't know anything about — to me this is a tremendous opportunity.

Q. You have mentored hundreds of students. Who were some of your early mentors and how did they impact you?

A. I was lucky I had high expectations set at school and at home - my parents taught me everything important before I went to school, and some of my early teachers taught me the value of hard work. If a project was done poorly, I was encouraged to "step it up."

Dr. Salzberg and John Waldhausen were strong influencers when I was at Penn State, teaching me how to become a department chair. I think of mentorship as the story of Ulysses — we only have a single spear. You have to have high expectations and devote time and energy to distinguishing casual acquaintances from those who have a meaningful impact.

Q. What is the biggest roadblock for bioscience?

A. Fifty years ago, Gordon Moore created "Moore's Law:" he made the observation that every 18 months to two years, the number of transistors that could be placed on a microprocessor would double. The law has proven to be correct.

In healthcare, we have reverse Moore's Law. Every two years, the cost of bringing technology to market doubles. This isn't a good prognosis. It stifles investment. It is up to people like us, who care about healthcare, to find and create solutions. The Fogarty Institute, for example, is very capital efficient, which allows the next generation of tools and technology to be developed despite strong challenges.

Peter's Corner

19th Annual "Wine with Heart" to Raise Funds for Patient Innovation

We all know that wine and giving are both good for our hearts so we hope you'll join us Friday, September 11, at the 19th Annual "Wine with Heart" event which will raise money for the Fogarty Institute for Innovation.

This annual, and much-anticipated event, takes place under the stars at the breathtaking Thomas Fogarty Winery and is hosted by the Santa Cruz Mountains Winegrowers Association.

The evening begins at 6 p.m. with a Santa Cruz Mountains Wine Reception and silent auction, followed by an elegant gourmet dinner prepared by Chef Mike Mashayekh of Le Papillon Restaurant and an update from our Chairman Dr. Thomas Krummel, who will highlight this year's successes.

Next is the spirited live auction, which this year features priceless items such as VIP tickets and a walk-around with senior editor Luke Sykora at the 2015 Top 100 Tasting, featuring Wine & Spirits Wineries of the Year; a private tour for four guests of Thomas Fogarty Winery with Tommy Fogarty; owner's seats at a San Francisco Giants game; and a number of wine-themed dinners, receptions and tours.

The proceeds from this year's event will be used toward supporting innovation in order to improve patient care, as well as the needs of the Institute's startup company incubation program.

To register, email us at infofogarty@fogartyinstitute.org or call us at 650.962.4560. We also still have a limited number of sponsor tables available.

We appreciate your support and look forward to seeing you for this exciting event!

Thoughts from the Board

by Thomas Krummel, MD, Chairman

All Roads Lead to Strasbourg, France

Imagine a 120,000 square-foot medical institute, equipped with state-of-the-art experimental labs, with a networked team of 800 of the best minds in the medical field dedicated to training approximately 5,000 surgeons from around the world each year. The surgeons are learning the latest techniques in minimally invasive and hybrid surgery.

This medical institute is not in Silicon Valley, not even in the United States, but in Strasbourg, France.

Meet IRCAD Laparoscopic Training Center, a nonprofit educational institute based on the campus of Strasbourg's University Hospital. The Institute was founded in 1994 by Professor Jacques Marescaux, who foresaw the shift from the industrial to computer era, and captured the opportunity to leverage technology to revolutionize healthcare. He stunned the world in 2001, when, sitting at a robotic console in New York City, he removed the diseased gallbladder of a patient located in Strasbourg, France. As I've joked with Jacques that this was the most expensive choleycystectomy, he proved his point: robotics can play a critical role in the future of medicine.

This summer, I had the privilege to visit, present and teach at IRCAD. It was my twelfth trip to the Institute, which I consider a home away from home. As always, I was astounded by the work, progress and innovation generated by the Institute. As I reflect on my trip, three lessons really stand out:

  1. Never stop learning. I have always been a huge proponent of education, and spending time at IRCAD reinforced my belief. Riding my bike to the campus from my college-like flat, with my briefcase that had become a backpack, I felt like I was back in graduate school. While the purpose of my attendance was to educate others, I took away just as much. When you have 800 plus of the top medical, engineering and research minds brainstorming ideas of how to advance image guided surgical platforms, it is formidable to see the vast array of solutions being formulated and the supporting technology developed.
  2. Technological advancements will never end. Just as you begin thinking that nothing more can possibly be invented, someone comes up with a better idea and new solution to a problem. At IRCAD, they are working to develop and perfect several devices that really caught my interest: a flexible, steerable endoscope that can track to eye movements, which would restore vision control to the surgeon, hands free; and the next generation of augmented reality technology, merging pre-op CT/MRI images with real time visual images.
  3. Never become complacent. While Silicon Valley and the U.S. have been innovation leaders, other countries in the world are not too far behind, and in some ways, may even be surpassing us. We don't have anything close to an IRCAD-like institute here in the U.S., nor the kind of private / public partnerships from which both are financially benefitting. Since its inception, IRCAD has acquired a reputation of excellence in research and teaching of new surgical techniques. Through their online teaching courses, they are training over 300,000 students and physicians on the best minimally invasive surgical techniques, free of charge, in six languages.

Innovation is in our country's DNA. By continually exposing ourselves to new concepts, new people and new technologies; by continuing to push the boundaries to seek better ways to solve critical health issues; and by forging partnerships with governmental bodies and private entities to support and facilitate our work, we can strengthen or arguably, regain, our position as global innovation leader.

Events

  • Wine with Heart, September 11
    This annual fundraising dinner and auction at the Thomas Fogarty Winery is an event not to be missed. The event benefits the Fogarty Institute and its startups.
  • Investor & Donor Open Houses, September 23, 5 to 6:30 p.m.
    Monthly donor and investor events to learn more about the Institute and the important work of its companies.

    For more information email
    infofogarty@fogartyinstitute.org