Photo credit of Prof. Sankai, University of Tsukuba / CYBERDYNE Inc.

From the CEO's Desk

"There's no good idea that cannot be improved on." – Michael Eisner

In the past month, I have had the opportunity to attend several medtech innovation events, including speaking on a panel on the future of our industry at the Medical Device Manufacturers Association Annual Meeting. While we undoubtedly face challenges, I am very optimistic about our industry. I continue to see a tremendous drive and passion coming from all corners – regulatory bodies, entrepreneurs, educators and veteran companies – all wishing to advance our field. By uniting our innovation ecosystem, we have an opportunity to accelerate the process and vastly improve how we take technologies to market.

In this edition, we highlight the efforts of these different types of groups. In the veteran company arena, Mitsubishi set up a meeting with entrepreneur CYBERDYNE, whose technology promises to greatly assist those with mobility challenges. We also have features on one of our newest innovators, Healyx, which is on a mission to transform chronic, non-healing wound therapy globally; and our CFO, Starr McNamara, who is playing a critical role as a mentor to our entrepreneurs in addition to heading finance.

Finally, in order to continue our work with our partners and innovators, please save the date for our signature event, Wine with Heart, taking place on September 8 at the Thomas Fogarty Winery. This year's theme "Building Upon a Legacy of Innovation," speaks to our desire to celebrate our 10-year anniversary by looking back, as well as forward.

As always, we appreciate your support and welcome your feedback and thoughts.

Andrew Cleeland, CEO of the Fogarty Institute

"The mentorship and education (at the Fogarty Institute) that comes from being with others who ask thoughtful questions and help connect us with the right people has been invaluable." – Cam Hutton, co-founder and CEO of Healyx

Fogarty Institute for Innovation Updates

Yoshiyuki Sankai, president and CEO of CYBERDYNE; and Dr. Fogarty at a recent meeting at the Institute coordinated by Mitsubishi Corporation.

CYBERDYNE visits Fogarty Institute to showcase its innovative technology and discuss potential ways to collaborate

"We are looking at the future of medicine," said Dr. Fogarty after seeing a presentation and demonstration of the world's first cyborg-type robot, HAL (Hybrid Assistive Limb) at a recent meeting organized by Mitsubishi Corporation.

Driven by neural connections and moved by command signals sent from the wearer's brain, the medical application HAL (the "Medical HAL") improves and regenerates the brain-nerve-physical functions of individuals with mobility challenges, such as stroke victims, the disabled and the elderly, so that they can walk and participate in day-to-day activities.

HAL is the brainchild of Yoshiyuki Sankai, a professor at the University of Tsukuba, who founded CYBERDYNE in 2004 to further develop his initial concept of a robot suit.

HAL works by facilitating the connection between the nerves and sensory system to help the brain send bioelectrical signals to move specific muscles. The suit senses the neural command signals and immediately provides the patient's intended movement, such as raising an arm, extending a leg or walking.

By using the Medical HAL, patients have the potential to promote functional improvement and regeneration, strengthening the neural pathways and essentially allowing the brain to move the body smoothly. Many of the patients who use the Medical HAL for several hours or on a regular basis, depending on their physical need, have been able to actually reconstruct the connections to/of the brain, allowing them to eventually successfully walk on their own, without the assistance of the robot suit.

The CYBERDYNE and Mitsubishi Corporation teams at a recent meeting at the Fogarty Institute. From left to right: Hideaki Miyata, manager at Mitsubishi Corporation (Americas); Yoshihiro Yasunaga, business planning director of CYBERDYNE; Yoshiyuki Sankai, founder, president and CEO of CYBERDYNE; Dr. Fogarty; Andrew Cleeland; Noboru Ohrui, team leader of Mitsubishi Corporation's healthcare business; and Shin Kosuga, director of Healthcare Business for Mitsubishi Corporation (Americas).

CYBERDYNE is also combining robotics with regenerative medicine to help patients with severe or complete spinal cord injuries regain mobility. In one of their studies, with HAL treatment after cell transplantation, a patient was able to walk 200 meters unaided after using HAL for eight months.

Since its inception, CYBERDYNE has gone public and refined its technology to serve a broader market. While the Medical HAL has been recognized as a medical device in both Japan and Europe, different types of HAL were developed for other fields, such as living support – devices that support the independent movement of elderly people and those with disabilities – and labor.

For example, HAL for Labor Support (Lumbar Type), provides lumbar support to workers in factories, airports and construction sites to help mitigate the risk of back injuries when they lift heavy objects. HAL for Care Support (Lumbar Type) reduces the load on caregivers' lumbar during assistance activities, such as transferring the elderly or disabled.

This will be particularly impactful in Japan, as approximately 80 percent of the caregivers suffer from lower back pain, according to studies.

The company is now eager to apply its technology to the U.S. market where it could make a tremendous impact on stroke victims, veterans and others who wear prosthetics, the elderly, and those who are paralyzed or have suffered spinal injuries. They have communicated with the FDA and are interested in exploring ways to work with the Fogarty Institute to further leverage their technology to benefit patients.

"Our focus is always on patients first," said Dr. Sankai, underscoring just one of the many areas that CYBERDYNE and the Fogarty Institute have in common.

"This technology is truly ground-breaking," said Andrew Cleeland. "We are looking forward to continuing to explore ways that we can leverage our ecosystem to mutually work together and learn from one another."

Our Companies

Healyx co-founders Madeline Sides, product lead; and Cam Hutton, CEO; visiting patients at Popular Medical College and Hospital in Dhaka, Bangladesh.

Healyx on a mission to transform acute and chronic wound therapy globally

"We believe the best therapies should be accessible to the people who need them," says Healyx co-founder Madeline Sides. "We've realized there is a problem with unequal global access to advanced therapies. We wanted to design specifically for these developing countries to enable doctors to heal their patients faster."

One of these needs is the treatment of severe, non-healing wounds resulting from trauma, diabetes, burns and surgery, which are on the rise due to an aging population and a rapid increase in diseases that cause chronic wounds. Experts have labeled acute wounds as a "public health and economic threat," affecting more than 110 million people worldwide and imposing a significant opportunity cost to stakeholders.

In developing countries, where resources are scarce and there is little to no access to high-quality healthcare, long-term hospital stays can be financially devastating for patients and their families who live on only a few dollars a day. Extended stays also cause a significant burden on already overcrowded hospitals.

Healyx, one of the Fogarty Institute's newest companies-in-residence, is set to meet this need by developing an innovative, cost-effective solution that improves upon negative pressure wound therapy (NPWT), a proven and leading method to treat chronic wounds.

Identifying a need; honing the solution

Healyx was formed in 2015 out of a program at Stanford, Design for Extreme Affordability, a unique social innovation course that pairs teams of graduate students with organizations operating in the developing world to tackle social challenges.

The project-based program provides an environment in which students learn to design products and services that will change the lives of the world's poorest citizens, working on real-life world problems and culminating in solutions that can be implemented to provide real change.

Healyx partnered with ReSurge International, a Sunnyvale-based nonprofit that provides people in developing countries with access to life-changing reconstructive surgical care that is safe, timely and affordable. The organization trains the next generation of reconstructive surgeons in Africa, Asia and Latin America; works with them to create a sustainable business model; and together, they provide high-quality reconstructive surgical care to people living in poverty and in remote areas.

The group first went to Bangladesh as part of a class project to work with research plastic surgeons to identify areas where better solutions were needed, and the treatment of chronic wounds emerged as a priority.

After identifying the need, Healyx next worked on discovering how to innovate and redesign a proven technology to make this therapy more cost-effective and accessible to meet the realities of low-resource settings.

Following its first prototype at the end of the program, the Healyx team secured grant funding totaling $200,000 to continue its market research in Bangladesh and Nepal. The next step was to define its price point and seek feedback from patients, clinicians, plastic surgeons and hospital procurement officers to improve the design of the device.

Advancing the therapy through the resources of the Fogarty Institute

Healyx reached three key milestones before applying to be part of the Fogarty Institute's incubator program: low-volume manufacturing of 15 functional prototypes; a run usability validation study in Bangladesh with feedback on the design and usability from 37 local physicians; and a business plan on how to implement in India, their target market, in the private hospital infrastructure.

Their desire to join the Fogarty Institute stemmed from a need to move from an academic setting to one where they could learn the practical elements of how to build a medtech company. Healyx was also keen on becoming part of an entrepreneurial community where they could learn and grow.

"The first two months have been incredible," said Healyx's Cam Hutton. "The mentorship and education that comes from being with others who ask thoughtful questions and help connect us with the right people has been invaluable. Given our youth, it's imperative to be surrounded by seasoned experts."

An entrepreneurial team focused on its mission

Cam was the first Healyx member to join the company full time, as CEO. Cam earned an undergraduate and graduate degree in mechanical engineering from Stanford and had experience in medtech in both the academic world and working as an intern for J&J Development Corporation. He developed an early interest in how to apply his background to benefit the industry and make an impact on patients.

Madeline Sides also joined the team full time as head of product, leading the technology. Madeline studied bioengineering as a Stanford undergraduate and will receive her master's in mechanical engineering in June. She is also a teacher at the Stanford Product Realization Lab, where she brings extensive experience in manufacturing and machining.

Other co-founders include Tiffany Kung and Cassie Ludwig, two medical students with strong clinical backgrounds; and Matias Rivera, a Stanford MBA graduate and current part-time advisor who brings substantial expertise in starting companies and raising grant money, having launched four startups in Chile.

Looking to the future

Major upcoming milestones for Healyx include running a clinical trial in the first quarter of 2018 with a goal of receiving an FDA 510(k) prior to commercialization. They are currently raising $1 million in seed funding to achieve those targets.

Healyx will initially bring its technology to India where it sees an untapped market with more than 20 million potential users and where the team has established solid on-the-ground partnerships. After proving its ability to commercialize and scale, Healyx will seek to expand into more developed markets to generate alternative sources to its impact-driven revenue.

Monthly Spotlight: Starr McNamara, Fogarty Institute CFO

Sharp. Intuitive. Inquisitive. Fast learner. With those qualities as her foundation, it's no surprise that Starr McNamara quickly advanced in her professional career.

Starr parlayed her background in accounting and finance to a starting position in the manufacturing industry, but was soon lured to the biotech space: A friend invited her to join a Sunnyvale-based startup, Scios, a biotechnology company developing a drug for congestive heart failure which was later acquired by Johnson & Johnson for $2.4 billion.

Starr joined the startup just as they were starting to file their first new drug application (NDA) with the FDA, an exciting time to be part of the small startup as it began to ramp up its clinical operations and medical affairs team.

Upon NDA approval, Starr was invited to join the clinical operations team, and within a few short years was leading the heart failure registry – one of the largest at the time with more than 160,000 patients.

As with most small startup environments, she had the opportunity to work on multiple aspects of the business in addition to finance, including marketing, site and clinical research organization (CRO) management, and electronic data capture (EDC) systems, even earning multiple certifications in clinical trial management to get up to speed on clinical regulations.

While overseeing the transition following the acquisition, Starr realized her heart and passion lay in the startup world, as it allowed her to continue to use her business and finance background while applying it to clinical programs in innovative ways.

She segued to senior positions in clinical research at two other startup biotechnology companies targeting different therapeutic areas, Affymax and XenoPort, before she began consulting in clinical program management.

In 2011, she was recruited to the Fogarty Institute as the director of business and finance of its newly formed clinical research program, which perfectly mirrored her background in finance and clinical research.

Though moving from industry to a nonprofit was a different career path, she viewed it as an exciting step to have the opportunity to work with Dr. Fogarty, whom she highly respected. "In many ways it was like creating a startup, a vehicle to foster clinical research for the Institute's innovator companies, El Camino Hospital and ultimately the community," she says.

She soon was also asked to oversee the Institute's finance department and handled both until the organization spun off its clinical research to El Camino Hospital. "I felt I had the opportunity to make a real impact on the community for the first time," she says. "I loved the idea of building on Dr. Fogarty's legacy and being part of shaping an educational-based program that brings together the innovation ecosystem to develop devices that create more value in healthcare."

Starr has a strong respect for El Camino Hospital for having the foresight to embrace and invest in research and innovation by hosting the Fogarty Institute on its campus, especially considering the current constraints placed on hospitals. "Having that direct interaction between physicians and entrepreneurs in this partnership has had a tangible impact on the community we serve," she says.

Starr has thoroughly enjoyed being part of building the Institute to its current success and sees great potential for the future. "We have assembled a high-caliber team and it's inspiring to have them as co-workers," Starr said. "I am looking forward to continuing to be part of this exciting process as we raise the bar on the value we deliver to the community and our startups. Finally, I am very excited to be part of the mentoring team for clinical research and clinical operations, in addition to my role in finance."

One constant throughout Starr's career climb has been her close relationship with her daughter – the two traveled together as she built her career, and still find time to go camping and enjoy the outdoors.

A long-time student of Kenpo karate, Starr participated in international fighting competitions in her teens and twenties. At that time, not many females were participating so she was often paired with males and she still enjoys pulling out her sparring equipment today.

"Martial arts was a formative experience that taught me to channel my energy in a focused way, and helped me learn to be thoughtful, observant and adaptive, which has greatly helped me throughout my career."

Save the Date!

Building Upon a Legacy of Innovation
The Fogarty Institute for Innovation is hosting its annual Wine with Heart fundraising event on Friday, September 8, celebrating the Institute's 10-year anniversary.

In the News

The MedTech Conference Blog: Incubators could help medtech innovators hatch new products...and get them to market

Medtech Conference, June 1: An unparalled gathering of the leading innovators, investors and executives; featuring Andrew Cleeland as a speaker

Portland Business Journal: Women's health startup wins big at Angel Oregon (Madorra is a former Fogarty Institute company)

BBC News: The new 3D image tool for surgeons (EchoPixel is a Fogarty Institute company)