MEDICAL INNOVATION NEWS

From the CEO's Desk

"Feeling gratitude and not expressing it is like wrapping a present and not giving it." – William Arthur Ward

As we enter into the season of thanksgiving, closely followed by the season of gift giving, that quote seemed particularly apt. Here at the Fogarty Institute, we place a high priority on thanking the many, many groups that make our organization successful. From our partners to our donors, from the board to our staff, each and every person associated with the Institute plays a vital role in helping us advance our mission. And, we feel especially grateful to our entrepreneurs, who have devoted this segment of their lives to tackling daily challenges and roadblocks in their quest to improve patient care.

Speaking of advances in patient care, this month we had the immense pleasure of hearing about an ambitious current project at our lecture series, which we cosponsored with Stanford Biodesign. Jessica Mega, MD, chief medical officer at Verily Life Sciences, gave a dynamic presentation about the convergence of engineering and health, as demonstrated in a new initiative called Project Baseline.

We caught up with one of this year's Ferolyn Fellows, Bronwyn Harris, CEO and co-founder of Tueo Health, who is also exploring the integration of medicine and innovation. This month she shares her fascinating career path and tells us more about the device that is helping manage asthma, a common pediatric ailment.

Another chronic condition is being addressed by Radial Medical, one of our newer companies in residence, which is developing an effective compression therapy system designed to replace the current cumbersome methods of treating venous insufficiency.

And lest today's professionals believe that hard technological skills are all they need for success in medtech, I had the pleasure of moderating a recent panel discussion where several experts covered the importance of soft skills, and gave solid advice on how to measure and build these traits.

We hope you enjoy these stories, possibly while you're relaxing with family and friends this season. All of us at the Fogarty Institute wish our valued partners, donors and friends a wonderful Thanksgiving.

Andrew Cleeland, CEO of the Fogarty Institute

"Soft skills help you build trust. I strongly believe that being good at what you do only matters if you are also passionate and really care about the people you serve, whether it's a customer, a patient or your team." – Mike Welch, vice president of market development for EBR Systems

Fogarty Institute for Innovation Updates

Dr. Mega shares a moment with Dr. Fogarty. She was the featured speaker at the 19th annual Thomas J. Fogarty, MD, lecture.

Breaking New Health Ground With Project Baseline

How much more fruitful would our lives be if we could find a way to predict, and therefore prevent, disease?

That was the topic explored by chief medical officer of Verily Sciences, an Alphabet company, Jessica, L. Mega, MD, who presented to a group of 300 — representing the entire medtech ecosystem, including physicians, entrepreneurs, students and professors — at the 19th annual Thomas J. Fogarty, MD, Lecture sponsored by the Fogarty Institute and our partner, Stanford Biodesign.

Dr. Mega's lecture, titled "Surfacing Human Signals – The Convergence of Engineering and Health," left attendees with an inspirational message that provided a glimpse into the state of engineering and health, as she shared details of Verily's quest to create meaningful tools that will lead to earlier disease detection and ultimately help people lead healthier lives via Project Baseline.

This initiative was launched in April 2017 with the goal of creating a comprehensive "human map," as a multi-dimensional baseline that will provide a clearer understanding of patients' health. The intent of the study is to uncover new information about health and disease by analyzing how genes, lifestyle and other factors influence health and determine individuals' "normal" measures of health, which can be used to identify warning signs or predict future onset of disease.

The first step is collecting information from a diverse group of people across the country and then monitoring how their health changes over time. The ambitious four-year study is already well underway, with thousands of people of different ages and backgrounds from all 50 states volunteering to participate. The goal is to enroll 10,000 patients.

The company partnered with Stanford University and Duke University to create the "gold standard" in data, tools and technologies that can be used to research the next generation of "signals" and aim to proactively prevent diseases.

"The challenge lies in discovering how to engage people in their own health and determine what might get them excited about their well-being, as everyone is going to be motivated differently," said Dr. Mega. "We then need to surface these insights, determine what is meaningful, build the infrastructure and determine which platform is needed to integrate all the information."

While Dr. Mega acknowledges that there is currently a lot of hype about artificial intelligence in healthcare, there is also deep value. In her view, using deep-learning algorithms to analyze and read the data and surface relevant information, could prove to be an invaluable tool for physicians and the healthcare system.

"The convergence of engineering and clinical medicine is where I see the future," said Dr. Mega. "What gets me going in the morning is determining what problem we can solve today and which signals we need to act on now. But let's keep our feet on the ground while simultaneously putting our head in the sky because there are still people suffering from disease, and it is our obligation to create and deploy the right tools that will allow them to live healthier lives."

About Jessica Mega, MD
As CMO, Jessica Mega, MD, leads the company's healthcare team, which informs and studies Verily's products, creates health platforms and translates them into systems that improve outcomes. A cardiologist, faculty member at Harvard Medical School (on leave), senior investigator with TIMI Study Group, a recipient of numerous awards and honors, author of multiple peer-reviewed publications and sought-after lecturer, she brings a wealth of knowledge and experience to the healthcare field.

About the series
The lecture series, sponsored by the Fogarty Institute and Stanford Biodesign, was established to discuss, debate and promote medical innovation and entrepreneurship.

The forum also provides an opportunity to look back and celebrate the remarkable progress of biomedical advances, thanks in large part to an increasingly robust innovation ecosystem, strong partnerships, including the one we enjoy with Stanford Biodesign, and from passionate and innovative inventors such as Dr. Fogarty, whose countless contributions helped shape our industry and inspire future generations of inventors.

Our Companies

Eric Johnson, co-founder of Radial Medical, a startup that is aiming to treat venous ulcers.

Forty percent of adults suffer from some degree of venous insufficiency, or inadequate flow of blood through the veins, which, if left untreated, can lead to varicose veins or worse, severe venous ulcers. Radial Medical, one of the newer Fogarty Institute startups, is addressing this condition by developing a comfortable, easy-to-use smart compression therapy system. The treatment will initially target venous ulcers, which affect approximately three percent of the population over the age of 65, a total of 1.5 million cases a year, making it a $3 billion market.

The system delivers precise compression therapy, tailored to each patient. It monitors in real-time, allowing for adjustment as needed with the assistance of a physician. This is a revolutionary approach in a space where until today, venous ulcers have been primarily treated by wraps and compression stockings, which are uncomfortable and difficult to put on. In fact, up to 70 percent of patients don't wear them, even if prescribed.

Flexing for success

The device acts like the calf is flexing, which improves circulation back to the heart and helps heal the ulcers. Radial's therapy can be used in the comfort of one's home for two hours a day for approximately a month. Patients are reminded to use the therapy by text, and progress is monitored by the physicians.

Data supports that wearing this active compression for two hours a day drastically reduces the time to reduce ulcers, reduces time-consuming visits to wound care clinics and lowers costs and pain. Comparative data shows that with current therapies, half of ulcers were unhealed at four months.

The system is the brainchild of co-founders Dr. James Wall, Stanford surgeon and Stanford Biodesign assistant director; and Eric Johnson, a serial entrepreneur who most recently founded Crux Biomedical, which was acquired by Volcano Corporation.

Targeting an underserved market

The idea behind the device came to James and Eric as they surveyed greatly underserved conditions, noting ones where other companies had tried to solve the technical, clinical and regulatory challenges unsuccessfully, but where the market remained viable. Their goal was to learn from previous experiences, and then add in current technical advances in non-medical fields, such as materials science, AI and sensors, to improve efficacy.

In true Silicon Valley fashion, the team worked out of Eric's garage for the first year until they secured seed funding in November 2016 and were accepted as a company-in-residence in May 2017 by the Fogarty Institute, where they are now based.

"I have had the privilege of working with Dr. Fogarty in the past and it is a true honor to be part of his vision of advancing medical technology and helping patients," said Eric. "The Institute is the ideal startup ecosystem as it brings together physicians, a diverse group of entrepreneurs, and veteran medical device mentors just a few steps away from each other, which allows us all to seek one another's expertise. The setting fosters creativity, while also providing the lab and materials that would otherwise be difficult to procure as an early-stage startup."

Radial is currently developing and testing its compression technology in anticipation for regulatory submission in 2017 and planning for clinical studies and market launches in 2018.

Charm School: Why Soft Skills Are The "New Black"

Chances are good you've recently heard a lot about the importance of soft skills as a factor for workplace success. But you might think those are mostly applicable to fields likes sales or project management, rather than for those planning to form and advance a company in the medical space, which requires specific technical experience.

While that is true, as technological advances such as artificial intelligence promise to take over many of the hard skills sets that employees have, soft skills are the new hard skills, says Claudia Carasso, the founder and managing partner of Elastic Minds, a strategic communications and branding firm, and mentor for the Ferolyn Fellowship.

Studies back her up, showing that senior executives express concern that a gap in soft skills is a detriment to a well-rounded workforce. Shockingly, nearly 65 percent fear that a lack of soft skills will threaten the U.S. economy as companies will move to foreign countries where those skills are more prevalent, and 34 percent believe a lack of soft skills is a threat to R&D. Even more worrisome is the hit to retention that companies can take if they hire a manager who doesn't have the right soft skills.

Claudia spoke at a recent educational seminar at the Fogarty Institute to share the newest thinking on how to develop the soft skills needed in today's work setting.

Joining her in a panel discussion moderated by the Institute's Andrew Cleeland and Greg Bakan were industry leaders who included Mike Welch, vice president of market development for EBR Systems; Kara Liebig, partner at The Foundry; and Corinne Landphere, principal of Corinne Landphere Consulting.

Here is a recap of their engaging conversation, with food for thought for any entrepreneur.

Q. What's the difference between hard and soft skills and why are the latter important?

A. Claudia: Hard skills are predictable, systematic and logical; the rules of engagement are clear and reproducible, thus reducing variables for consistent outcomes. They are easy to "celebrate," as "wins" show as hard data and provide a feeling of satisfaction. For example, you know when the code is correct because the program works.

Soft skills, on the other hand, are hard to define or even measure. Think about things like authenticity, collaboration, problem solving, critical thinking, teamwork skills, empathy, cultural awareness and negotiation. These things vary by culture. They can be subjective. Some people see them as attributes, while others see them as skills. They are all of the above!

While employers used to hire specifically for hard skills, there is a growing body of data showing that soft skills rival academic and technical skills, especially when as a predictor of workplace advancement and compensation. A recent study by Stanford University showed that 75 percent of employees report that long-term job success depends on soft skills. That same study showed that 72 percent of employees felt they did not have those skills when they started working. Soft skills are also hard to replicate, which is a huge factor considering that the growth of Al will increasingly replace hard skill jobs.

Mike: Soft skills help you build trust. I strongly believe that being good at what you do only matters if you are also passionate and really care about the people you serve, whether it's a customer, a patient or your team. When you have other people's interest at heart, it earns you a lot of credibility and it builds trust, which is a key soft skill in corporate culture. Ultimately, people do business with people they trust and enjoy. You have to be capable, but you also have to be authentic and show you care.

Q. If soft skills are hard to quantify, how do you know if you have them?

Kara: You need a foundation of self-awareness to really know where you stand on this spectrum. Be honest with yourself; be aware of how you are perceived, and be open to taking feedback.

Corinne: I agree it is important to build self-awareness. I have an exercise I like to do with clients where I ask them to reflect on a time of their life that they enjoyed, and then compare that with tougher times. How did they feel and how did they react? We all move so fast that we don't always stop to process how we feel and subsequently see the effect our actions may have on others.

Q. What are some tools to build soft skills?

A. Claudia: It's important to understand your own value system and build your own approach to developing and refining soft skills. It starts with self-awareness and an understanding of how you learn things. For example, you can assess your emotional intelligence with what assessment what are called personality assessment tools. You can start on your own or you can work with psychologists trained in this area of development. But, I would say, especially to our community of scientists, clinicians and engineers, proceed with caution! Some approaches are better than others. Some will resonate with you and some won't. There is no "one size fits all" approach. Another lifelong practice you can develop is to ask trusted peers, mentors and managers about how they perceive you.

Mike: To prioritize and practice the use of my soft skills I broke down my core values into tangible daily tasks and keep them in my daily planner. It's easy to spend all our time focusing on urgent daily work tasks, but to build effective relationships, you need to prioritize things that are important, but not always urgent, such as family, faith, work, learning and health. Breaking these into daily tasks insures they won't get forgotten in the busyness of life. As an example, I have been fortunate to build a healthy marriage, which doesn't just happen; you need to work on it on a daily basis and putting activities in my daily planner makes sure I keep it a priority.

Q. Are soft skills innate or can they be learned?

A. Mike: I am a firm believer that they can and need to be learned. For me, it wasn't until my sophomore year in college that I learned some of these critical skills by selling books door-to-door. It taught me that you have a choice in how you respond to events, whether you choose to be positive or negative. You have to navigate through a lot of little decisions but by practicing, you realize you can change the outcome, and that ultimately you are the only person who can choose how you react.

A. Claudia: Absolutely! We all have the ability to be empathetic, to learn how to listen, to develop critical thinking skills. It's just like being a better parent, spouse or sibling. You have to become open to the process and begin to see where you need to develop and then work on how to develop those important skills. When I teach and coach presentation development and skills, I always start with one important message: love your audience, care about their experience and chances are they will love you back! When you start to think about how to create a better experience for your customers, your audience and your colleagues, you're already well on the way to developing a great foundation of soft skills.

Q. Empathy and cultural awareness are two very important soft skills. How do you adapt when conducting business in different countries?

A. Mike: There are several skills that come into play when you do business abroad. Certainly, it helps to have a sense of adventure and humor and the ability to become a chameleon by adapting to different customs and circumstances.

Before visiting a country, I do a lot of reading to learn about the culture and the history. I also take the time to learn about each team member I meet and show a genuine interest in what they do, what they like and their culture. The best and most long-lasting relationships occur when you learn from one another.

Q. The importance of building strong relationships is a constant theme. How do you do that?

A. Corinne: You need to have empathy to have a solid relationship. If not, you won't ask the right questions and you will be challenged to make a good first impression and then provide ongoing value.

Kara: Strong working relationships are an essential component in early-stage company development and success. You need to invest the time to have one-on-one meetings with your team members and foster a sense of community. In turn, this will cultivate a "safe" environment where employees can constructively give and receive feedback – and in turn, learn and grow.

Monthly Spotlight: Bronwyn Harris, Second-Year Ferolyn Fellow

Now in its second year, the Ferolyn Fellowship once again attracted a class with incredible talent. This month, we introduce you to Bronwyn Harris, CEO and co-founder of Tueo Health, a company that is empowering families with a digital health solution to better monitor and manage their child's asthma.

With a father who was an electrical engineer in the medical device field, Bronwyn was destined to follow in his footsteps. "When I was young, I was always challenged to answer questions about how and why things worked. And as kids, we had to write a proposal if we wanted something, which gave me a head start on thinking about the business case for everything," she says.

She went on to study biomedical engineering, as she had always been drawn to medicine, and knew from the start it was a great fit. However, she quickly realized during graduate school that she did not want to spend all her time in the lab, far from clinical care. Rather, she found she most enjoyed meeting with physicians and reviewing data as part of her clinical decision support research. Bronwyn realized it fed her curiosity about the other side, as in, the care being delivered to patients. In her dual role, she also was privy to what she recognized as a sizable disconnect between what the physicians needed and what the engineers were developing. In fact, some of her engineering peers were working on devices before ever having talked to a physician or seen a patient to gather their insight.

Bronwyn felt she was uniquely positioned with the ability and desire to bridge that gap between engineers and physicians to help unite their efforts. Therefore, she decided to enroll in medical school at Vanderbilt University School of Medicine. Upon completion, she came to Stanford for her residency and fellowship, where she simultaneously joined the Stanford Biodesign program to unite her two passions of engineering and medicine.

"The ability to combine medicine and innovation crystalized my path," she says. "Thinking about all the different aspects of the problem and then making sure I understood the clinical need allowed me to determine the next best steps for delivering the right solution."

Launching a startup

One of the key roles of Stanford Biodesign fellows is looking at clinical needs. During her fellowship, Bronwyn's Biodesign team discovered that asthma was a major problem – seven million children and 26 million adults in the U.S. alone suffer from it, and yet there isn't a good measure of control, like there is for other conditions, such as diabetes. This can be a handicap when trying to care for patients who are relying exclusively on their symptoms for diagnosis. Her team set up to solve and better manage asthma by using tools, initially focusing on pediatrics to help prompt families to engage in their children's asthma care.

The asthma solution her team worked on during the fellowship really took off, and after finishing clinical training, she became the full-time CEO of Tueo Health. In order to stay connected to clinical medicine, she still maintains a part-time position as a clinical instructor at Stanford Children's Health.

Tueo Health takes the technology used in off-the-shelf sleep sensors that measure movement, heart rate, heart rate variability and respiratory rate. The company then uses proprietary analytics to determine individualized baselines so it can alert parents when changes occur, thus engaging the family to gain additional context and information before providing educational guidance that has been shown to make a difference. A Tueo Health asthma educator can also reach out proactively or parents can request one through its service.

Tueo Health has finalized their product development and analytics. They are now enrolling for a clinical study, partnering with Evidation Health, to run a randomized virtual study that can recruit anywhere in the lower 48 states. Enrolled participants randomized to the intervention arm are shipped a device to participate in the study, with the goal of showing that asthma control can be improved through data-driven alerts to engage families and targeted educational guidance. (For more information on the study and to check your eligibility, please click here.)

While similar off-the-shelf technology is available and used for sleep tracking, it is not currently tied to chronic disease management. The company is able to transform available data through analytics to engage families and provide targeted education and guidance.

Tueo Health is not only looking at expanding its use to adults but also other conditions that would benefit from similar solutions. A limited launch of its current device is planned for 2018.

Finding benefits through participating in the Ferolyn Fellowship

Bronwyn learned about the Fellowship through one of the Institute's partners, Stanford Biodesign, after hearing about Ferolyn's inspirational work in medtech.

While it's still early in the program, she has already seen benefits, such as meeting many new and accomplished people, including current and past fellows who convene on a consistent basis to share knowledge and tackle work challenges. She has also been introduced to outside experts whom she otherwise would not have had the opportunity to meet in casual settings, which to her is one of the most critical advantages as she works to determine her company's next steps.

While she feels confident that she can launch the product itself, the nuances of running a business is new territory, and expert sources of guidance will be essential to help her accomplish her goals.

The Ferolyn Fellowship was established in 2016 to pay tribute to Ferolyn Powell's invaluable contributions to medical technology by helping cultivate innovators – mentoring tomorrow's rising medtech leaders who have demonstrated strong passion and aptitude to transform healthcare.

In the News

The MedTech Strategist: Fireside Chat with Andrew Cleeland, "Being the Change," Wed., Nov. 29th

Cardiovascular Business: Noninvasive FFRct imaging a better predictor of outcomes than CT angiography (Heartflow is a Fogarty Institute graduate)

VRFocus: VR Medical Imaging Firm EchoPixel Secures Funding (EchoPixel is a Fogarty Institute company)