MEDICAL INNOVATION NEWS

From the CEO's Desk

Medical technology is at the heart of medical advancements and at the core of finding new ways to lower healthcare costs and increase patients' quality of life. But, while the power of technology can be life changing, as American author Helen Keller said: "Alone we can do so little; together we can do so much."

Without forging partnerships with entities that have similar goals and aspirations, we would not be where we are today. And without sharing our collective high-level expertise in entrepreneurship, there wouldn't be a next generation of innovators.

It is with this spirit of collaboration and of strengthening our partnerships that we have been welcoming many visitors to the Institute. In the past month, we were proud to once again host two FDA fellows, a team from Okayama University and young entrepreneurs from Arizona State University.

In this edition, we also highlight the incredible progress of one of our newest companies-in-residence, Marz, and the generous donation of $1 million by Bill Bowes, a long-time supporter and friend of the Institute.

Lastly, the time has come for me to offer my good wishes to the Fogarty Institute and all of our incredible supporters, partners and donors. My last day at the Institute is April 30. It's been a great six years at the Institute, and I could not be more proud of our accomplishments and pleased with our current financial strength, our present executive team and our incredibly talented entrepreneurs.

I wish you all the best and am looking forward to following the progress of the Institute for years to come.

Ann Fyfe, President and Chief Executive Officer

Ann Fyfe

"Our staff was really impressed by the skills and quality of the development community....We entered as potential 'opponents' and came out as colleagues." – Murray Sheldon, MD, Associate Director of Technology and Innovation at FDA

Thoughts from the Board

by Thomas Krummel, MD, Chairman

We often hear from outsiders how impressed they are by the work of our startups and the innovative environment at the Fogarty Institute. That message is now being echoed by an exceptionally talented pool of candidates, whom we are interviewing as part of our process to select the next CEO of the Institute.

The interviews have really validated our mission, and the number and quality of professionals who have expressed interest in the Institute is truly humbling. Most of the interviewees are in the medtech innovation industry, have led illustrious careers, understand the core values and culture of the Institute, and the innovative mindset of Silicon Valley.

We are completing our first round of interviews and are feeling very optimistic that we will have identified our ideal candidate by this summer, with the goal of a September starting date.

In the mean time, I have full confidence in our executive leadership team and our board to provide high-caliber support to our companies-in-residence and continue our strong relationships with partners, donors and investors.

We have exciting times ahead of us, with the prospect of new startups joining the Institute, young talent coming this summer as part of our Lefteroff Fund internship program, very positive discussions with El Camino Hospital on new space opportunities, and the outlook of a dynamic CEO setting the stage for the Institute as we approach our 10 year anniversary.

We wish Ann all the best in her future endeavors. Her passion, enthusiasm and wisdom will surely be missed. Please know I am available to answer any questions and we thank you for your continued support during this period of transition.

Fogarty Institute for Innovation Updates

Mike Needels, COO of the Fogarty Institute, and FDA reviewers shaking hands to celebrate the continuation of a strong partnership to help accelerate medical innovation in the U.S.

FDA, Okayama University and Arizona State University come to Institute to learn about medtech startups and innovation

Last September, we launched a first-of-its-kind educational program with the FDA with the goal to help accelerate medical device innovation by improving communication, collaboration and understanding between the FDA and early-stage medical device innovators. The program was so successful that we are continuing the partnership with eight staff that will attend four different fellowship sessions.

The first two fellows for the 2016 program were at the Institute in April, working with Zebra Technologies and G-Tech, to gain a better understanding of the challenges that medtech companies face when bringing their products to market.

Members of Okayama University during their visit at Fogarty Institute. The team met with Kerry Pope, the Institute's executive director of mentoring.

Okayama University researching robotic system to reduce radiation

The Fogarty Institute has enjoyed ongoing partnerships with several Japanese companies, which place teams at the Institute to learn about innovation that can further benefit patients, and Japanese universities and hospitals, as part of our effort to help improve healthcare globally.

A team from Okayama University, led by Yasutomo Nasu, professor at the Center for Innovative Clinical Medicine at Okayama University Hospital and chief of medical research, came to the Institute to explore team placement to develop a robotic system to remotely reduce radiation exposure in labs.

Last November, the Okayama University opened a campus in Silicon Valley to focus on international medical device development, and help link startups to Okayama University Hospital to conduct clinical trials and clinical research, among others goals.

ASU entrepreneurs at the Fogarty Institute during one of their tour stops in Silicon Valley.

Arizona State University entrepreneurs come to Silicon Valley

As more and more universities are embracing the concept of entrepreneurship, we are seeing an increasing number of young students coming to the capital of innovation – Silicon Valley. Recently, a group of entrepreneurs from Arizona State University came to Silicon Valley as part of the eSeed Challenge, a competition open to all ASU's student-led startups, to meet with top professionals, startup companies and innovators.

The Fogarty Institute for Innovation was one of the few stops they made in the Valley, along with meeting with Tim Draper, founder of Draper University, and YCombinator, a company that provides seed funding for startups.

This is the second year the Fogarty Institute has hosted students from ASU, thanks to Tom Prescott, former President and CEO at Align Technology and a graduate of the university's civil engineering program, who facilitated the tour stop. Mr. Prescott has been a long-time proponent and contributor to the Institute's Lefteroff Fund, which supports educational scholarships, programs and medical innovation projects that advance entrepreneurship in the life sciences.

Our Companies

Marz Medical making strong progress

Since joining the Fogarty Institute less than a year ago with its U.S. FDA 510(k) clearance in hand, Marz Medical has received two patents and identified a novel plan to raise money and develop its product. The startup, which is developing a technology intended to shorten recovery time for patients undergoing breast reconstruction, is aiming to be market ready in the next 18 months with just three people on the team.

Tissue expansion for breast reconstruction currently takes from two to six months and is essentially a race between scar tissue formation and tissue expansion. By automating the process, Marz's FDA-cleared BlossomTM technology can shorten tissue expansion to just seven to 10 days, in addition to significantly reducing the number of physician visits required. One in eight women are diagnosed with cancer each year, and about 100,000 of them undergo mastectomy in the U.S.

The technology offers a new approach to tissue expansion by automating the process of administrating saline to breast expanders used in reconstruction via a smart controller. Blossom monitors pressure and adds saline in small amounts, being available to act 24/7 in the comfort of a patient's own home in lieu of the physician's WEEKLY visits. Patient can also self-adjust saline flow based on comfort.

Marz will soon be undergoing its second round of clinical trials at Stanford University. The first round resulted in 100 percent of the cases being successfully completed in seven to 10 days.

The technology was developed by plastic surgeon Josh Korman, MD, who also practices at El Camino Hospital, has taught at Stanford University for 20 years and is currently Adjunct Clinical Associate Professor. The company is spearheaded by CEO Kerry Pope, who is also the executive director of mentoring at the Fogarty Institute. Marz has partnered with Nottingham Spirk, a business innovation and product design firm with a proven vertically integrated development capability that includes fund raising for their clients.

Guest Q&A – Murray Sheldon, MD, Associate Director of Technology and Innovation at FDA

On the heels of our continued partnership with the FDA, we had the privilege to catch up with Murray Sheldon, MD, Associate Director of Technology and Innovation at the FDA, Center for Devices and Radiological Health. Dr. Sheldon shares his views on the organization's role in advancing medical technology, recent successes, and future challenges and opportunities.

Dr. Sheldon is uniquely positioned to help bring medical technology safely and quickly to patients. Prior to joining the FDA in late 2012, Dr. Sheldon served for 10 yeas as medical director of several cardiovascular medical device companies, including BioVentrix, Solinas Medical and Arbor Surgical Technologies, which was sold to Medtronic. Before working in the medtech industry, he was in private practice for 20 years, serving as a staff surgeon in several medical centers in Northern California, performing cardiac, thoracic and vascular surgery.

Q. How do you view the FDA's role in advancing new medical technology, and how has it evolved over the years?

A. Since joining the FDA three-and-a-half years ago, I have been looking forward to helping improve the landscape of medtech development. Although we at the FDA are a regulatory entity, we believe that we can play a supporting role in significantly advancing medical technology.

In the past, we had been viewed, to a certain extent, as an obstacle for the industry, driving products to be developed outside of the U.S., which is not good for those who need the life-saving devices that could be optimized in our country.

As part of my role at the FDA, we have identified protecting and promoting health, and ensuring that innovative technology gets to patients, as priorities. We are achieving this by playing a more active role: by improving our regulatory pathways, customizing decisions based on individuals' needs and by working more closely with developers to craft high-quality approaches to developing and regulating products that have a significant likelihood of getting to market and patients quickly.

Q. What has been the feedback of the steps you have taken to streamline the approval process?

A. When you are going to develop a new medical device, where you conduct the earliest feasibility studies is also where you usually market those devices first. In 2013, we set a priority to increase the number of early feasibility/first-in-human-trials here in the U.S. We created a new guidance document, outlining how we would encourage early feasibility trials in all of our pre-market divisions. The result: we doubled the number of studies submitted to be conducted in our country.

As an example, prior to my joining the FDA, a lot of early clinical studies were done in Europe. Today, we are seeing more European companies come to the U.S. for their development. We are successfully stemming the tide of development leaving the U.S., positioning us as the country of choice to conduct trials - a strong indicator that we are heading in the right direction.

Q. What initially attracted you to partner with the Fogarty Institute and what led you to continue the partnership?

A. I cut my teeth with medical device development with Dr. Fogarty, someone I have known and respected for a long time. After six months of my tenure at the FDA, we brought in a group of outside expert stakeholders, including Dr. Fogarty, to help us understand the barriers to device development, real and perceived, and to suggest ways to improve our processes.

What we realized is that although highly skilled in medicine and biomedical engineering, many of the FDA staff had not worked in the medtech development community, and because of that, there was a limited understanding of the challenges startup companies are facing when bringing their products to market.

Dr. Fogarty reached out to us, offering the Fogarty Institute as a test bed to link FDA staff and startups. We conducted a pilot program at the Institute last year, which was so successful, that in 2016 we are continuing and expanding the partnership with eight staff who will attend four different sessions.

Q. How did choose the staff going to the Institute?

A. We wanted to make sure that whomever we chose, would not be someone who would interact with the startup for a regulatory submission in the future. But we also wanted to choose staff whose decision-making would be impactful and who could implement and share the gained knowledge. The first year, we chose two representatives from our early feasibility representatives in our Office of Device Evaluation. This year, we have representatives from four different Offices participating. In the end, it would be ideal if all our staff was exposed to this type of experience.

Q. What are some of the key lessons learned from the partnership with the Institute and how will it help the FDA with its approval process moving forward?

A. Our staff was really impressed by the skills and quality of the development community. They were impressed that medtech entrepreneurs are not "fly by night cowboys," but truly hold patient care as their primary motivation.

They were also surprised by how little they actually understood about the many of the challenges faced by startups, including raising capital, establishing a supply chain of materials they need, setting up animal labs, conducting clinical trials and putting all the pieces together.

Our staff went in with their eyes wide open and came out as a different kind of reviewer. For the companies that FDA staff interacted with, breaking the barriers of being viewed solely as a regulator, and learning that the FDA shares in common the same motivations for device development, (improved patient care), was a critical step forward. We entered as potential "opponents" and came out as colleagues.

Q. What are your top tips for medtech startups that are in their inception phases?

A. Our recommendations include:

  1. Have a good sense of what it is you are developing.
  2. Determine who needs your product, what is the landscape and what are the improvements needed over potential existing products.
  3. Develop a value proposition for the patients and products you are targeting.
  4. Confirm that what you are developing is feasible.
  5. Determine if your business development plan will be sustainable.
  6. Research existing patents to determine if your product is likely to win one.
  7. Assess if you can identify the right people/team members to get your product to market.
  8. Learn about the regulatory hurdles you are going to face, and the insurance coverage and reimbursement landscape.

Q. When is the most beneficial time for a startup to engage with the FDA?

A. We highly recommend early and often. When you develop a prototype, you should have an initial discussion with the FDA to benefit from early feedback on regulatory requirements to get the product to market and the likely best regulatory pathway to pursue. Without knowing, you may risk going down the wrong path and/or developing the wrong kind of evidence.

Q. What are the challenges and the opportunities you see for the FDA moving forward, within the medtech industry?

A. The challenge is the rapid pace of device development in the U.S. and around the world, especially with IT and software. Innovation is exploding around us, the pace of development is quicker than ever, and it is a challenge to keep up and guide companies in the right direction so they can create usable medtech devices.

The opportunity is for the FDA to learn and grow with the development ecosystem and to be part of this rapidly changing world we are living in together.

Innovation will continue and the only guarantee is that everything will always change. The best course of action is to embrace both the challenges and the opportunities, as a team.

Donor Spotlight – Bill Bowes, co-founder of U.S. Venture Partner and founding shareholder of Amgen

Perhaps one of the most accomplished VCs and medical investors, Bill Bowes was also an early donor and backer of the Fogarty Institute. Mr. Bowes recently re-invested in the Institute by donating $1 million, bringing his total gift to $3.5 million. His donations were critical in helping support the launch of the Institute, and his latest gift will fund our programs and startups.

Mr. Bowes has been a long-time friend of Dr. Thomas Fogarty, someone he deeply admires for his ability to not only succeed as a surgeon, but also as an effective and prolific innovator.

"What attracted me to the Institute is the innovative work of its startups and the strong likelihood that these young innovators will develop life-saving and life-improving devices," said Mr. Bowes. "I am a strong believer in investing where you can achieve tangible results."

Mr. Bowes' interest in medicine stemmed from his mother, who was a doctor and one of the first women to graduate from the Stanford School of Medicine. He almost became a doctor himself. Instead, he co-founded U.S. Venture Partners (USVP), a VC firm that invests in innovation, and was the founding shareholder of Amgen, one of the world's leading biotechnology companies, where he also served as its first Chairman and Treasurer.

At USVP, Mr. Bowes also led the firm's investments in Advanced Cardiovascular Systems, Applied Biosystems, Devices for Vascular Intervention, Glycomed, Sun Microsystems and Ventritex. USVP is also an investor of HeartFlow, a Fogarty Institute startup.

His proudest moment was founding a company that has very tangible results – Amgen. Last year he attended the company's 35-year anniversary, a celebration of the company's scientific advancements that have helped disrupt the course of many life-interrupting illnesses.

Today, Mr. Bowes dedicates much of his time to medical and environmental research and projects. He is a strong backer of the Environmental Defense Fund, based in New York, to bring back the fishing population. He also continues to be a strong proponent for breakthrough drugs.

Through his foundation, he supports nonprofit organizations in several areas including medical research, access to college, the arts and higher education.

We are extraordinarily thankful for Mr. Bowes' long-time support, which has enabled us to grow our organization into one of the most well-respected medical technology innovation centers in the nation.

Save the Date: 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