MEDICAL INNOVATION NEWS

Message from the Chairman

"Celebrate any progress. Don't wait to get perfect." – Ann McGee Cooper

As we start noticing the first signs of fall with its crisp air and early darkening skies, we have many reasons to celebrate. I personally just celebrated a milestone 65th birthday and to commemorate the occasion, I undertook a fun and very memorable challenge tackling the "Pyrenees Sea to Sea" cycling tour, which covers some of the most majestic passes in Spain and France. It's a wonderful adventure that I highly recommend to any avid cyclist.

And with this theme of "celebration," we share with you the success of our 20th anniversary of Wine with Heart, our most successful fundraiser to date. We are very thankful to all of our generous donors – we would not be where we are today without your support.

In this edition, we also celebrate the success of CyberHeart, which recently signed an agreement with the National Cancer Center in Tokyo and is aiming to expand to Europe. We also feature a Q&A with Paul Yock, MD, founder and director of the Stanford Byers Center for Biodesign with whom we have a very rewarding reciprocal relationship; and highlight Lane Melchor, one of our generous donors who both backs the Institute and invests in several of our companies.

I am also very proud to announce that, thanks to the success of our program in launching and graduating four companies in the past year alone, we have opened the application process for up to three new startups to join the Institute. Please help us share the news to find the next generation of companies that will help improve patient care.

As always, we welcome your feedback and thoughts.

Thomas Krummel, MD, Chairman

"With the challenges and pressure that today's medtech startups face to bring their products to market, it is imperative to have an organization (the Fogarty Institute) focusing on early-stage implementation and providing a strong network and mentoring." – Paul Yock, MD, Founder and Director of the Stanford Byers Center for Biodesign

Fogarty Institute for Innovation Updates

An autographed photo collage was presented to our founder, Dr. Fogarty, as a tribute to his invaluable contributions to the medical device industry.

20th Wine with Heart most successful and well-attended fundraiser to date

This year's 20th anniversary of Wine with Heart was the most successful to date, raising more than a quarter million dollars for the Fogarty Institute to advance our mission of improving patient care and lowering healthcare costs. We would like to sincerely thank our generous donors, startups, alumni, Japanese corporate partners and colleagues for attending this spectacular event at the beautiful Thomas Fogarty Winery.

Highlights of the event included honoring Dr. Fogarty for his invaluable contributions to the Institute and the medical technology industry. Dr. Fogarty has had a transformative effect on the way surgery is performed today, and been an instrumental mentor to our startups by helping them throughout the difficult steps of growing: challenging them to fail and learn from their failures; never accepting "no" or "it can't be done" as a valid answer; and assisting them in finding ways to successfully bring their products to market and ultimately to patients.

We were also excited to introduce our first-year Ferolyn Fellows: Kate Garrett, a Biodesign Innovation graduate and co-founder and CEO of Ciel Medical; Matthew McClean, senior R&D manager at Medtronic; Julia Fox, senior group manager, Upstream Innovation, at Abbott Vascular; and Liz McDermott and Marian Powell, sisters of the late Ferolyn Powell and founders of the Ferolyn Fund and Fellowship. Other new faces joining us at the event included representatives from Google, Verily, Nihon Kohden and Abbott Labs.

A special thank you also goes out to the Santa Cruz Mountains Winegrowers Association for their continued generosity and commitment toward making this event a success by showcasing some of the best wineries in the country and providing our incredible auction items. This year we offered a number of priceless items, including memorabilia from Muhammad Ali, Prince and David Bowie. And once again we appreciated having renowned celebrity chef, Mike Mashayekh, owner and chef at Le Papillon, who provided our amazing food.

There is still time to make a tax-deductible donation to the Institute in case you did not have the opportunity to do so.

We have created a Facebook album to capture the beautiful evening at the Fogarty Winery, which can be viewed here. We invite you to like our page and tag yourself if you were able to attend, and if not, we hope to see you next year when we celebrate the Fogarty Institute's 10th year anniversary.

Our Companies

Dr. Koichiro Kumagai, director of the Heart Rhythm Center and professor at the International University of Health and Welfare Graduate School, with Dr. Patrick Maguire, president and CEO of CyberHeart, in Japan.

CyberHeart signs deal with Japan's National Cancer Center; adds clinical partner

CyberHeart, a startup that is developing the first non-invasive robotic ablation treatment for cardiac arrhythmias, has recently signed an agreement with the National Cancer Center (NCC) in Tokyo to install the CyberHeart system. This makes NCC the world's first center to non-invasively treat patients with cardiac radiosurgery.

"We are excited to offer our patients the most advanced, painless and non-invasive treatment for cardiovascular conditions, and thrilled to be the first center in Asia to offer the use of this breakthrough technology," said Jun Itami, MD, PhD, and chair of the Department of Radiation Oncology, National Cancer Center. "The CyberHeart system allows patients to undergo ablation for cardiac arrhythmias and other vascular conditions as an outpatient. The personalized nature of the ablation allows the treatment to be tailored to the patient's individual anatomy."

The National Cancer Center was established in 1962 by the Japanese government as the first national hospital and research institute specializing in cancer patient management. The center offers state-of-the-art therapy in radiosurgery and a world-class R&D capability.

The agreement marks CyberHeart's initial international activity as word spreads and more physicians seek to embrace its technology to benefit patients. The company has also been in discussions with The Harley Street Clinic, one of the most prestigious and well-respected private hospitals in London, and the Hermitage Clinic in Dublin to begin initial cardiac treatments.

The startup is also making great strides here in the U.S., adding the Texas Heart Institute as a clinical partner. In addition, CyberHeart is giving a poster presentation at ASTRO's 58th Annual Meeting, the world's most important gathering for the radiation oncology community attracting 11,000 clinicians.

Lastly, CyberHeart and the Fogarty Institute would like to congratulate former intern Nik Bhatt and Dr. Tom Fogarty for their combined effort in winning the Investigational Cardiac Radiosurgery publishing competition, with their article on the cost-effectiveness of cardiac radiosurgery for atrial fibrillation. Dr. Fogarty is the co-founder of CyberHeart.

Q&A with Paul Yock, MD, Founder and Director of the Stanford Byers Center for Biodesign

A cardiologist, inventor, entrepreneur and educator, Paul Yock has played a critical role in helping shape medical technology and healthcare. And he continues to do so in his role as founder and director of the Stanford Byers Center for Biodesign, a program aimed at advancing health technology innovation and widely regarded as one of the most successful partnerships between academia and the health technology industry.

Yock's career has progressed on two concurrent paths. He began his practicing and academic career as an interventional cardiologist at UC San Francisco before moving to Stanford in 1994. There, he became founding Co-Chair of the Department of Bioengineering where he continues research related to new device technologies, and founded the world-renowned Biodesign program.

He is equally regarded for his work inventing, developing and testing new devices, including the Rapid Exchange angioplasty and stenting system, which is the primary approach used worldwide; the Smart Needle; and the strain-reduction patch for wound healing of which he is a co-inventor.

We had the privilege of catching up with Yock to discuss Stanford Biodesign, its impact on young innovators, its relationship with the Fogarty Institute and exciting trends in the medtech training space.

Q. What was the impetus for launching the Stanford Biodesign program and what are some of your favorite accomplishments?
A. A big part of the reason I started the Biodesign program was that when I was younger, I had the fortune of being trained and mentored by Dr. Fogarty, who guided me and invested in my first company. Since this experience was so transformative for me, I wanted to create a program that replicated in some way what I gained from the mentoring of Dr. Fogarty and others.

What I find most satisfying about Biodesign is the quality of the trainees who have come through the program. We now have 184 fellowship alumni and over 1,000 students who have taken at least one of our courses.

We recently did an analysis of our fellows as part of our 15th year anniversary. One way of measuring success is the technologies that are developed out of the program and the number of patients who have benefitted from them. To date, 41 companies have been formed based on work that our trainees initiated during their time with Biodesign, creating devices that have treated more than 600,000 patients. In addition, alumni of our fellowship programs have launched an additional 35 companies after graduating from Biodesign, impacting one million patients.

Equally important, a number of our alums have had major impact in their roles inside existing health technology companies, as professors of medicine and engineering, or in a range of health technology professions spanning patent law to venture capital.

Another rewarding aspect is seeing our alumni devote major time to the mentoring of younger innovators. Our survey shows that 84 percent of our alumni devote time to training and mentoring aspiring innovators, with each one helping an average of 75 people in their careers to date. Several of our alums have also gone on to develop Biodesign-like programs in other universities.

It's interesting to think back about the evolution of the program over the years. The fellowship has grown from one team of fellows per year to four teams, including our global program; we have added four new graduate and undergraduate classes reaching hundreds of students per year; and we have launched a new faculty training program led, in part, by Dr. Tom Krummel, co-director of Stanford Biodesign and chairman of the Fogarty Institute.

Our biggest challenge has been adjusting to the new economic environment of the healthcare field. We are working diligently to develop a curriculum and training approach to value-based innovation. This is driven by the fact that we now need to pay attention very early on in the innovation process to the economics of a need area, alongside the clinical characteristics of the need. In this new environment, we won't come forward with a new technology unless it brings value to the patient at a manageable cost.

Q. How do you view the partnership with the Fogarty Institute and why is it beneficial to the medtech industry and ultimately patients?
A. We have a very important relationship with the Fogarty Institute. At Biodesign, we bring fellows and students to the point where they have developed a strong need-based invention, as well as a preliminary plan for how they will implement the technology into patient care. But what happens next – the in-depth planning and execution that takes place at the Institute -- is in many ways the most difficult and essential work for bringing a technology forward.

I see the Fogarty Institute as an absolutely essential partner to the training we offer at Stanford Biodesign and a critical part of our ecosystem. Especially with the challenges and pressure that today's medtech startups face to bring their products to market, it is imperative to have an organization focusing on early-stage implementation and providing a strong network and mentoring.

We are very fortunate to have such a good synergy between the Biodesign program and the Fogarty Institute, which sequences very nicely with our overlapping goals of benefitting patients and lowering healthcare costs.

Q. What is the Fogarty Institute's role in the medtech innovation ecosystem and why do you think it is unique?
A. There are two components of mentoring that blend together at the Institute and provide a real advantage and value. The organization offers world-class mentoring from senior, experienced advisors. But the other type of "mentoring" that is equally critical comes from the young innovators from the different companies that are co-located in the same space and thus can share ideas, challenges, learning moments and connections. That type of peer-to-peer mentoring is just as important in helping move a company forward. The Institute does a really effective job with both.

Q. What are the challenges and opportunities you see in the medtech industry and what are some of the trends that excite you the most?
A. There are big challenges and opportunities presented by the new value-based healthcare environment. Most healthcare economists would say that the biggest single driver of increases in healthcare cost is the adoption of new technologies. The rate of cost escalation in the healthcare system is clearly unsustainable, so we all have a responsibility to understand what the system needs in terms of improving healthcare at a cost that is manageable.

The good news is that young innovators will find a way to solve this issue. They come from a millennial "culture" that drives them to be globally responsible and to look for ways to use resources wisely. I have been impressed by how our fellows are naturally adapting to a focus on value-based innovation; we are seeing it as a core component of all of the innovations they are developing.

What excites me too is that there are a number of Biodesign-like training programs emerging, all driven towards advancing healthcare technology. I think it's fair to say that we were the first to introduce a post-graduate interdisciplinary program of this type—though, of course, there were a number of great existing programs in biomedical engineering.

Fast forward 15 years: there are now over 120 universities in the U.S. that have developed fellowships, graduate and/or undergraduate programs, which are focused on team-based innovation in health technology. And there are some absolutely fantastic programs out there. We've been happy to see that many of these universities use our textbook and open-source video library, which makes "mini-lectures" freely available to innovators and university faculty alike.

We are also proud that Stanford has directly or indirectly helped launch programs in both Europe and Asia. There is a great camaraderie among these programs internationally and we look forward to continued collaboration as the needs and markets for medical technology become truly global.

Donor Spotlight

Lane Melchor, an executive at Melchor Corporation and board member of the El Camino Hospital Foundation, has a long family history of supporting important healthcare needs.

His philanthropic focus started early, as he follows in the footsteps of his grandparents. His grandmother, a former nurse and staunch backer of the El Camino Hospital, volunteered her time and financially supported the organization before it even had a building, and his grandfather launched the hospital's foundation. Melchor is proud to follow their legacy as a current member of the El Camino Hospital's board.

Lane Melchor with his wife Lindsey

Melchor learned about the Fogarty Institute via his association with the El Camino Hospital and was quickly impressed by its mission and the positive impact it was having on patients through its startup companies.

To complement his professional career, where he manages an investment fund that focuses on publicly traded real estate (in the form of Real Estate Investment Trust or REITs) and allocates portions of them towards venture investments, Melchor finds deep satisfaction and gratification in supporting the Institute and investing in its startups.

Alumni companies Prescient and Intervene were the first to capture his attention, based on their strong presentations, impressive boards and simple, yet effective, technologies that offer the potential to save and improve the lives of millions of patients.

Melchor continues to be involved with these startups he initially supported and has added two more -- InPress and Madorra. "Investing in medtech and life sciences is extremely rewarding," he said. "There is virtually no industry where it's harder to raise money and bring a product to market, and yet none that is more deserving."

One of the most pivotal challenges he believes entrepreneurs face is transferring from an academic environment to the "real world" of starting and growing a business. This is where the Institute plays a key role, by providing an incubator setting that offers education and mentoring, while nurturing the companies and increasing their value -- all with the ultimate goal of helping patients.

"The Fogarty Institute plays a critical role in providing a platform for these startups to grow strong enough to obtain additional funding and bring their devices to market," he said. "It's extremely fulfilling when you are able to realize a return on investment while simultaneously helping people."

Outside of business and his contributions to patient care, Melchor enjoys travel, fine wine and cooking, all passions he was able to indulge while living in France.

Supporters

The Fogarty Institute would like to thank The MedTech Strategist, a leading resource for the global medical device industry, for supporting our mission to identify the next generation of companies that will benefit patients by donating advertising space in their publication.

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