MEDICAL INNOVATION NEWS

Message from the Chairman

"I certainly wouldn't be where I am today if it wasn't for the concept of mentorship, which I believe is critically important for innovation." – Dr. Thomas Fogarty

One of our favorite times of the year is upon us with the arrival of the Lefteroff interns, who are eager to learn everything they can about the medical device industry during their eight-week stay at the Fogarty Institute. This group of bright young students will be exposed to our seasoned team of volunteer mentors, physicians and corporate partners, as well as receive hands-on experience with our entrepreneurs.

Their enthusiasm in contagious, and we are looking forward to learning just as much from them, as we have the opportunity to view our industry from a fresh perspective. We also appreciate the inside look they give us at how we can best use ever-advancing technology to positively impact healthcare.

In this edition, we profile PricewaterhouseCoopers (PwC), a firm that has been tremendous in helping co-found and financially support the Lefteroff fund; introduce EchoPixel, one of our startups that is radically changing healthcare with True 3D; and feature a Q&A with one of the most prolific medtech experts, Josh Makower.

On a final note, we are hosting our much-anticipated annual Wine with Heart on Friday, September 9. We would be honored to have you join us for this exciting event, which benefits the Fogarty Institute for Innovation and supports medical innovation for better patient care.

As always, we welcome your feedback and thoughts.

Thomas Krummel, MD, Chairman

"The Institute has been transformational in the Valley for allowing companies to potentially create life-improving devices that would otherwise likely be challenged to survive on their own." – Josh Makower, MD, General Partner, New Enterprise Associates

Fogarty Institute Updates

The 2016 Lefteroff Fund interns during a tour at El Camino Hospital's Center for Advanced Radiotherapy and CyberKnife Radiosurgery.

Summer internship program helps spark long-term interest in healthcare

Our Lefteroff summer internship program is off to a great start. Twelve college students from throughout the U.S. are already in the midst of working hand-in-hand with some of our startups and have embarked on a full schedule of presentations by industry experts, surgery observations, physician shadowing and site tours of leading-edge medtech companies and hospitals.

The program offers a unique opportunity for these young scholars to be exposed to many parts of the ecosystem that helps form and shape medical technology startups, as well as learning the skills and mindset that contribute to successful entrepreneurship.

As we continuously strive to improve our program with the goal of making a positive impact on patient care, we like to take a moment to look back at a few success stories of past interns, which can serve as inspiration for future years:

  • Sarah Avery Long, a med student at Tulane University and 2014 Lefteroff intern, compiled and presented proof of CyberHeart's successful treatment to the American College of Surgeons Clinical Congress earlier this year. During her internship, Sarah worked closely with CyberHeart, a Fogarty Institute startup that is developing the first non-invasive robotic ablation treatment for cardiac arrhythmias. This hands-on experience fueled her passion for cardiac surgery, a field she is currently pursuing.
  • Nik Bhatt, an undergraduate student at UCLA and also a 2015 CyberHeart intern, co-authored a paper addressing treatment options for patients with chronic kidney disease who may be rendered ineligible for catheter ablation, but may benefit from the startup's novel technology. The paper was recently published in the prestigious World Journal of Cardiovascular Diseases.
  • Lindsay Axelrod and Natasha Kafai, 2015 Lefteroff summer interns, co-authored two poster abstracts that were accepted for presentation at the Digestive Disease Week conference, the world's largest gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. The presentations discussed 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. Axelrod, who was one of the presenters, was also a finalist of Digestive Disease Week's Young Investigators poster competition.
  • Tiffany Chang, a 2014 Lefteroff summer intern, worked closely with nVision, a Fogarty Institute company that is developing two devices: the first will significantly advance the diagnosis of the leading cause of female infertility, fallopian tube blockage. The second device will allow gynecologists to collect cells from the fallopian tube to further explore a patient's symptoms. Following her internship, Chang joined nVision as a consultant and later as a full-time quality specialist employee.

Every time we hear of one of these success stories, we are proud of the role that the Fogarty Institute and our summer internship program plays in sparking interest and providing valuable experience to these future innovators, as we help pave the way towards building the skills and confidence they need to pursue a career in healthcare.

Our Companies

EchoPixel dramatically improves patient care with virtual reality medical imaging

EchoPixel, a startup that has developed True 3D, a medical visualization software platform, is undoubtedly one of the favorite stops when touring the Fogarty Institute.

Using 3D glasses and a special display, physicians now have the opportunity to view and interact with patients' organs as if they were real physical objects. The software offers an unprecedented way to examine patients' anatomy from every angle, thus assisting in better assessing ailments and planning medical procedures.

EchoPixel's technology has been well received by the medical community. Recently, the startup forged a partnership with computer giant Hewlett-Packard to bring the company's virtual reality display, the Zvr, into healthcare. Coupled with EchoPixel's software solution, the partners are aiming to reduce the time it takes to diagnose medical conditions and improve outcomes.

EchoPixel was also invited by GE Healthcare to showcase its technology at GE's booth at the American Society of Echocardiography's 27th Annual Scientific Sessions, which was held in June in Washington. "As the leader in medical imaging, GE is an exceptional corporate partner for EchoPixel," said Ron Schilling, CEO of EchoPixel.

One of the key differentiators contributing to EchoPixel's success, is its ability to accurately measure its impact on clinical and workflow improvements. The results have shown significant gains in patient outcomes. "True 3D allows doctors to focus directly on the clinical problem at hand, rather than having to solve a 3D problem with a 2D view," said Sergio Aguirre, CTO of EchoPixel.

A few examples of recent clinical studies show the potential for EchoPixel to change the healthcare landscape in future applications:

  • The software helped Stanford physicians find up to 90 percent more congenital heart defects in newborns in 40 percent less time.
  • The software helped Boston Scientific researchers to accurately size and dramatically reduce the sizing time of left atrial appendage occlusion devices. The testing, conducted at Boston Scientific, showed sizing time reduced from 40 minutes to two.
  • Clinical testing from Lahey Hospital and Medical Center showed neurosurgeons were able to more accurately size a stent for a patient undergoing brain aneurysm embolization surgery. The 2D flat screens were off by 4.5 millimeters, which is significant considering the delicate anatomy in this part of the body.
  • A trial done at Stanford for evaluating brain arteriovenous malformations (AVM) showed that True 3D provides equal or better results than angiography, which is more invasive and exposes patients to radiation.

EchoPixel's True 3D is FDA 510K cleared for diagnosis and surgical planning using CT and MRI image data. Some current clinical customers include Lahey Hospital and Medical Center in Burlington, Massachusetts; Nicklaus Children's Hospital in Miami; the Hospital for Sick Children and Toronto General Hospital in Toronto, Ontario, Canada; the Penn State Hershey Medical Center in Pennsylvania; and Deborah Heart and Lung Center in Browns Mills, New Jersey.

Q&A with Josh Makower, MD, General Partner, New Enterprise Associates

Josh Makower is one of the most accomplished, varied and prolific innovators, entrepreneurs, inventors and venture capitalists in the medical technology community. He is currently a general partner at New Enterprise Associates (NEA), a global venture capital firm, leading its medtech and healthtech practice. Makower is also the founder and chairman of ExploraMed, a medical device incubator that has created notable companies such as Acclarent, EndoMatrix and TransVascular; and founder of several other healthcare-related companies.

When he is not creating companies, he serves as a consulting professor at Stanford University School of Medicine and as mentor to the Fogarty Institute startups. Makower is also the co-founder of Stanford's Biodesign Innovation program and holds over 300 patents and patent applications for various medical devices.

We had the privilege to catch up with Makower to discuss his career, his thoughts and tips for startups, the challenges and opportunities he sees in medtech and medical trends that excite him the most.

Q. How did you first become involved in healthcare and medical technology?

A. Since I was a young boy, I have always been fascinated by the wonder and complexity of the human body and finding ways to help people live healthy lives, with less suffering. I found my way into engineering and bioengineering at MIT to learn how technology could enhance and improve people's lives. I then went to medical school to learn more about the body and its physiology, and to help play a role in helping shape the future of healthcare.

Immediately after medical school I joined Pfizer, where I had an opportunity to partake in the development of the next generation of medical devices and in identifying the best process for innovating new medical technologies. In 1995, I used that same process to create the incubator ExploraMed and, a couple of years later, to train medical students at Stanford. The Stanford program led to the co-creation of Stanford Biodesign, with Paul Yock, where that process is still taught.

Q. How did you get involved with the Fogarty Institute and what are your thoughts on the role the organization plays in advancing medical technology?

I have always had a very high regard for Dr. Fogarty, a medical pioneer and entrepreneur who helped lead the way with high methodical standards for improving innovation.

Dr. Fogarty was also a pioneer in creating a space (the Fogarty Institute) where early-stage startups could grow "strong" enough to convert to a bigger platform. The Institute essentially creates more runway for these startups to advance and potentially thrive, and, similarly to Y Combinator, offers a good transition for early innovators before they are ready for full investment.

Many of our Biodesign fellows have joined the Institute, which is a natural next step in the innovation process for these young entrepreneurs. The Institute has been transformational in the Valley for allowing companies to potentially create life-improving devices that would otherwise likely be challenged to survive on their own.

Q. What do you look for in a startups when you are considering an investment?

A. NEA manages fairly large funds and we have our own criteria. We are still dedicated to medtech; however, the companies need to be of substantial size. We look at how big the opportunity is – there are many great opportunities that unfortunately are rather small – and the technology needs to be "needle moving" for a firm of our size and scope. We also look at the impact a company makes on medicine and if it is transformational. We will likely be less excited about a company developing a device that is following a market rather then leading it. We also like to back strong leaders and extremely experienced management teams.

Q. What are your top tips for early-stage startups to best position themselves to secure funding?

A. First, they have to have an amazing team. The more experienced, the better. If the CEO has a strong track record, that goes a long way. Second, you need to have a sizable and significant opportunity you are addressing, and be able to describe it in a clear and concise way. Third, make sure you have good patent protection. Finally, you need to have a strong regulatory and financial strategy in place.

Q. What are the challenges and opportunities you see in medtech?

A. The challenge: The number of financial backers has dramatically decreased in the past years due to FDA regulations and the global financial crisis. The fact is that things are taking longer and it is getting more expensive to get a product to market. There is a lack of dollars available and there are fewer acquirers. Also, it's a significant challenge to stay private longer, and it's very expensive.

Because an environment exists where it takes longer and longer to gain market approval by regulators, an increasing number of investors are walking away from this innovative field.

The opportunity: There has never been a better time to go after improving people's lives. It's a tremendous dream and there are still many opportunities to make a positive impact.

Q. What are some of the trends you are most excited about?

A. I am particularly excited about the consumer healthtech space. Consumers are becoming increasingly aware of finding health solutions online, and they are much more active in seeking answers.

Technology embedded in phones, sensory technology and cloud-based products will enhance people's quality of life and ability to find solutions directly without having to go to a physician's office. This opens a whole new guild of device technology that is more accessible and will allow people to stay healthier and improve outcomes while reducing the cost of care.

Donor Spotlight

Adrian Beamish and Peter Claude, partners at PwC, have been strong backers and proponents of the Lefteroff Fund

PricewaterhouseCoopers instrumental in supporting the next generation of life science innovators and companies

The medtech world experienced a huge void when Tracy Lefteroff passed three years ago. He displayed an unequaled passion and dedication to advancing the field of life science, regardless of economic forces.

Fortunately, thanks to a collaborative effort involving the PricewaterhouseCoopers (PwC) Charitable Foundation, the California Healthcare Institute (CHI, now the California Life Sciences Association) and the Fogarty Institute for Innovation, his legacy has continued. Lefteroff was a Fogarty Institute and CHI board member.

The three organizations created a fund in his name, which mirrors Lefteroff's goals and ambitions to invest in individuals or early-stage ideas that will create the next generation of life science companies. The fund, which is housed at the Fogarty Institute, supports educational scholarships, programs and medical innovation projects that advance entrepreneurship in healthcare.

PwC and several of its members, including PwC partners Adrian Beamish and Peter Claude, have been instrumental in the fund's development – ensuring its longevity through their efforts to launch it and determine its mission and scope.

"Tracy was a poster child for giving yourself completely to something you believe in and value, in this case the medical technology industry," said Claude. "Establishing a program that supports the people who create the next generation of life science companies is something he stood for, which also aligns with the scope of the firm and our PwC Charitable Foundation, which provided the initial seed grant to honor his legacy."

PwC and the Institute are currently working towards enhancing and potentially expanding one of the cornerstone programs of the Lefteroff Fund, the Institute's successful summer internship program.

"Talent presents itself at a young age and is an ideal time to pique the interest of potential healthcare entrepreneurs," said Beamish. "Advancing the life sciences industry and ensuring its longevity is critical for us, which is why we support the work of the Institute. We all benefit when we ensure that innovative products, which will improve patients' lives, reach the market."

Claude and Beamish are both veterans of the healthcare and medical device industry and currently consult with leading-edge companies through their work at PwC. The mission of its healthcare practice is to help clients solve an array of emerging complex problems facing pharmaceutical and life science clients, service providers and new market entrants in the New Health Economy – a commitment that dovetails well with the Institute's life-saving work.

Others participants involved in the creation of the Lefteroff Fund include Hank Plain, general partner, Lightstone Ventures; Mike Mussallem, CEO of Edwards Lifesciences; Allan Will, founder of the Foundry; Casey McGlynn, partner at Wilson Sonsini Goodrich & Rosati; and Dr. Fogarty.

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

In the News

Nurse Barb's daily dose: When Every Second Counts (MedicalCue is a Fogarty company)

Samsung Insights: Five Ways Virtual Reality Will Transform Healthcare (EchoPixel is a Fogarty company)

ABC7 News: Stanford Researchers Use Camera to Peer into Human Muscles in Real Time (Zebra Medical Technologies is a Fogarty company)