MEDICAL INNOVATION NEWS

From the CEO's Desk

"Talent wins games, but teamwork wins championships." – Michael Jordan

Sometimes you feel like you have a little extra spring in your step, an added feeling of excitement and a stronger sense of passion and purpose. That's how I have been feeling since joining the Institute in early January.

As I have been meeting with our entrepreneurs, staff and partners over the past few weeks, I feel even more positive about our growth opportunities and potential to build on past successes.

For me, one of the biggest honors of this experience will be working with Dr. Fogarty, whose contributions I have long admired. With his unwavering vision and life-long mission to continuously seek better ways to improve patient care, I know that together with the board, we are on a solid course to shape the future of the Institute to best support our innovators, expand our education programs and strengthen our partnerships.

But we can't do this alone. We need to work together to create an organization that will have a lasting impact on our industry and continue to generate the breakthroughs that will improve the lives of people worldwide.

In this edition, we highlight how partnerships have helped advance our mission, our startups and fellows. Whether it is through our collaboration with Stanford Biodesign "From the Innovator's Workbench" series, or our relationship with El Camino Hospital, we have an incredible opportunity to partner with some of the top medical institutions to enhance the work we do and impact we are making.

Read on for a Q&A with El Camino Hospital's Dr. Singhal on why it's vital for physicians to work closely with entrepreneurs; a look into EchoPixel's involvement in the successful separation of conjoined twins; and early feedback from Matt McLean, a member of our Ferolyn fellowship program who is already seeing the benefits of the mentorship he is receiving from a broad range of industry leaders.

Lastly, we would like to share that we are now accepting applications for our Lefteroff summer internship program. This is an incredible opportunity for undergraduate and graduate students to learn every facet of the medtech industry first-hand from our entrepreneurs and mentors.

We have exciting times ahead of us and look forward to sharing our progress.

As always, we welcome your feedback and thoughts.

Andrew Cleeland, CEO of the Fogarty Institute

"Playing a role in developing therapies that improve someone's quality of life and seeing a patient improve as a result of technology that you helped design is one of the most rewarding aspects of my job." – Matt McLean, Ferolyn Fellow

Fogarty Institute Updates

From left to right: Gordon Saul, executive director of Stanford Biodesign; Dr. Fogarty; Dr. Krummel; Dr. Peter C. Farrell, founder of ResMed; and David Cassak, managing partner of Innovation in Medtech at Stanford Biodesign's "From the Innovator's Workbench" series. (Photo courtesy of Stanford Biodesign)

Institute's Lefteroff Fund sponsors discussion on sleep-disordered breathing, a "monster public health problem"

To honor the legacy and contributions of Tracy Lefteroff, each year the Lefteroff Fund, one of the programs at the Institute, sponsors a session of the Stanford Byers Center Biodesign's "From the Innovator's Workbench" speakers series.

This year, Dr. Peter C. Farrell, founder and executive chairman of ResMed, shared his insight on a prevalent, chronic health condition that often goes undiagnosed or untreated: sleep-disordered breathing (SDB). This condition, which he termed "a monster of a public health problem," includes a broad range of sleep-related conditions, the most prevalent being obstructive sleep apnea.

Approximately 50 percent of men and 23 percent of women suffer from SDB, which is associated with a broad range of health issues, including hypertension, strokes, heart arrhythmia, diabetes, work-place accidents, metabolic syndrome, depression and many more. "Unless your sleep is healthy, you can't be healthy," noted Dr. Farrell.

Dr. Farrell founded ResMed in 1989 to commercialize a device for treating obstructive sleep apnea. Today, the company is a global leader in respiratory management, developing award-winning medical devices and cutting-edge cloud-based software applications that better diagnose, treat and manage sleep apnea, chronic obstructive pulmonary disease and other chronic diseases.

Stanford Biodesign launched the "From the Innovator's Workbench" speaker's series in 2003 to provide an opportunity for members of its community and the public to learn from leading health technology innovators. The Fogarty Institute is a strong supporter of the series, which reflects our Lefteroff Fund's mission to invest in individuals and programs that will help launch the next generation of life science companies.

Our Companies

Thanks to the effectiveness of its technology, EchoPixel's true 3D software is being used in complex surgeries throughout the country.

EchoPixel's technology plays critical role in success of conjoined twins surgery

"There is a better way" is a common mantra heard frequently in discussions between Fogarty Institute mentors and its entrepreneurs. It's what drives us each day to devise and create new technologies that will transform patient care. And while the process is not always easy, there is nothing more rewarding than seeing a successful patient outcome as a result of a device that was created right here, in our own "family."

That's why we felt great pride the day that one of our companies-in-residence played a critical role in a complex surgery that redefined the lives of two toddlers and their family.

In early December 2016, two-year-old conjoined twin sisters Eva and Erika Sandoval were successfully separated during a 17-hour surgery that took place at Lucile Packard Children's Hospital Stanford.

It took a team of 50 people, which included some of the best physicians in the world, to perform this very complex surgery, since the twins shared numerous organs. Led by Gary Hartman, MD, a clinical professor of surgery at the School of Medicine, it marked the fifth separation he conducted at Stanford, but the first time his team used a true 3D interactive virtual reality imaging system to help plan the surgery and address unexpected complications.

By using 3D glasses and a special display, the software, developed by Fogarty Institute startup EchoPixel, allows physicians to view and interact with organs as if they were physical objects, offering an unprecedented way to examine patients' anatomy from every angle.

Frandics Chan, MD, Stanford cardiac radiologist and associate professor of radiology at the Stanford University Medical Center, worked with EchoPixel to develop the virtual reality tool and has used it to help physicians better visualize complex congenital heart cases in both adults and children.

He also used EchoPixel's technology to help the conjoined twin's surgical team prior to and during the surgery. Most notably, he used the VR tool to assist the surgeons visualize the complex pelvic anatomy of the conjoined twins, who between them shared three legs, one of which was not functional. The imaging played a critical role in allowing them to plan the best way to separate the sisters without major vessels bleeding out.

During the surgery, Dr. Chan was called in four times to answer questions on how to best approach unexpected complications, all of which were addressed with the help of the VR system. Specifically, EchoPixel's technology helped confirm the orientation of the twins and the location of blood vessels going through the liver; determined which girl owned the single colon; and provided solutions for how to use the leg that wasn't functional.

"EchoPixel's technology was indispensable during the planning process and the surgery itself," said Dr. Chan. "In complex cases, which are ripe for complications, the software allows physicians to familiarize with the abnormal anatomy just before they open the body. This can give them insight into the best way to proceed during the surgery, minimizing unexpected situations."

The twins slept in separate beds for the first time following the surgery and one of them has already been discharged. There could not have been a more storybook ending for these two young girls.

For EchoPixel, it's one more rewarding success story for the startup. In addition to situations like the conjoined twins, the technology has promising applications to solve a broad range of complex cases, including diagnosing and treating complicated cardiac conditions.

"Our True 3D Viewer has demonstrated significant results in a range of applications, from device sizing to virtual colonoscopy, but we're particularly excited about our progress in pediatric cardiology," said Ron Schilling, CEO of EchoPixel. "We're honored to play a role in the success of these difficult operations, and to assist physicians in understanding and working with patient anatomy."

Q&A with Shyamali Singhal, MD, Medical Director, Cancer Center, El Camino Hospital

A Bay Area native, Dr. Shyamali Singhal has played a key role in assembling a team of highly skilled cancer experts at El Camino Hospital. Thanks to her strong belief and passion for combining the latest treatment and technologies with compassionate, empathetic cancer care, she has enabled El Camino Hospital to exceed national averages in curing patients or extending their lives.

In addition to spearheading the hospital's cancer program and managing her own private practice, Dr. Singhal has been actively involved with the Fogarty Institute. She has worked closely with several entrepreneurs during their clinical trials at El Camino Hospital, helping them refine and test their technologies, and has mentored our summer Lefteroff interns.

We had the privilege of catching up with Dr. Singhal to discuss the benefits of working closely with innovators to develop an effective medical device, the importance of clinical trials and the value of mentorship.

Q. How did you first get involved with the Fogarty Institute?
A. I have always had a strong interest in research and I pay close attention to creating new ways to improve and cure diseases. I am constantly listening to fresh ideas coming through in our industry.

My passion for finding ways to advance the field I specialize in – cancer – as well as others, led me to work with several innovators at the Fogarty Institute to help them develop better products that are more useful in treating patients.

I am also a firm supporter of what Dr. Fogarty was trying to achieve when founding the Institute – innovation is critical to our industry and I believe that every professional should join in the effort to promote and encourage those on the front lines.

Why is it beneficial for physicians to work closely with medtech entrepreneurs?
A. It's critical for physicians to work with medtech innovators so they can better understand the end customer and tackle a clinical problem with an effective solution.

As an example, recently a startup (not from the Fogarty Institute) showed me a device they had developed. While their concept was interesting, the technology was not effective because it could not be utilized appropriately when conducting the procedure.

This startup understood the clinical need but had failed to deliver a product that we could practically use. If their engineers worked with a physician in the early phases of their design, this problem may have not occurred and could have saved the company time and money.

When developing a product, it's imperative to get the experts together and vet the ideas. So much innovation is designed without knowing what the customer, who in this case is the physician, needs or does, and it is simply not effective.

Q. What is the value of mentorship in innovation?
A. Mentorship is invaluable in helping entrepreneurs avoid common mistakes when developing their devices and to help get their products to market -- and ultimately to the physicians and patients -- faster.

I feel fortunate to be a contributor to the Fogarty Institute. There aren't many women surgeons in the field, so I provide a different perspective and can be a "test case" on what devices work and don't work for women in the medical field.

Also, being able to mentor students early on to help them identify their passions, as I do with the Lefteroff summer interns, is invaluable in shaping their future careers.

Q. Why are clinical trials so important?
A. Clinical trials are important in helping discover and test new treatment methods. Having the Fogarty Institute right here on our campus is very beneficial to both the innovators and our hospital: We provide the expertise of the physicians and nurses, and the entrepreneurs allow us to learn firsthand of new technologies that may help our patients.

For example, we have had a constructive experience with G-Tech Medical, the Fogarty Institute startup that is undergoing a two-year trial at the hospital to study their proprietary technology's ability to record the electrical signals that naturally occur in the digestive tract and patterns of intestinal contractions and movements in individuals who undergo abdominal surgery.

The patches are non-invasive, and while the trial is currently only collecting data, the technology may help make better clinical decisions, including how to better assess when bowel function will be restored so we can set appropriate expectations with the patient in terms of feeding and discharge.

Clinical trials are also an important step of the regulatory approval process, without which the companies cannot get funding, which of course would stump medical advancements.

Our job as physicians is to help the entrepreneurs test and improve their technologies in a real-life scenario. Based on the success I've experienced with the new devices that I've been able to test from the start, compared to the bumps that occur when devices do not receive early intervention, the importance of collaboration is clear.

Monthly Spotlight: Matt McLean, Ferolyn Fund Fellow

Matt McLean with his wife at our annual Wine with Heart event.

Knowledgeable, articulate and already on a solid career path, it's easy to understand why Matt McLean, senior engineering manager at Medtronic, was selected to be part of the first group of Ferolyn Fund fellows.

Matt received his BS in Mechanical Engineering from Stanford University, which is where he started considering how he could best apply his background to an industry that would benefit people in a direct and tangible way. Medical devices seemed like a natural fit.

What started as the glimmer of an interest expanded to becoming a path to a life-long career. "Playing a role in developing therapies that improve someone's quality of life and seeing a patient improve as a result of technology that you helped design is one of the most rewarding aspects of my job, and has really solidified my passion for this industry," he said.

Matt launched his medtech career at NeoTract, a company that develops minimally invasive solutions to address unmet needs in the field of urology, where he worked for nearly six years. This was an impressive first experience in medtech for Matt as he had the opportunity to work on the design and refinement of the company's signature product, the UroLift® System treatment for men suffering from enlarged prostate, which is on the market today.

He later moved on to The Foundry as R&D manager and became director of R&D at Twelve, which was acquired by Medtronic last year. At Twelve he had the opportunity to follow a device from concept through the entire lifecycle up to the first-in-human experience. This well-rounded experience involved all aspects of device development, including R&D, clinical studies and physician training.

The Ferolyn fellowship has been a natural segue for his career progression. What has impressed him the most so far is the number of leaders and entrepreneurs in the medtech industry who have volunteered their time to share their expertise as mentors.

He has had the opportunity to tap into a large network, receiving input and advice on diverse areas that include R&D, VC best practices, finance and branding. The mentorship he has received so far will help accelerate his career as he has been offered perspective and insight that would otherwise likely take years to obtain.

"It's been a great honor to be part of this first year fellowship, and I hope I am able to contribute to helping shape the future of the program, and therefore give back as much as I am receiving from it," he noted.

Matt has also greatly benefited from the relationships he has formed with the other fellows, as they experience the camaraderie that comes from discussing professional challenges and share what each is learning from the program.

In his spare time, he loves kiteboarding and playing music, but most of all spending time with the new addition to his family, his five-month old son.

The Fellowship was created as a tribute to the late Ferolyn Powell, an invaluable contributor to the medical device industry, with the goal to improve patient care by supporting promising entrepreneurs with strong leadership skills, passion and aptitude to transform healthcare.

Fogarty Institute Lefteroff Summer Internship Program

The Fogarty Institute for Innovation is now accepting applications from undergraduate and graduate students for its summer internship program. Deadline to apply is Friday, March 3.

[APPLY TODAY]