From the CEO's Desk

"The greatest glory in living lies not in never falling, but in rising every time we fall." – Nelson Mandela

This fall has brought some dark days, as many regions in the country have been ravaged by catastrophes, including the devastating fires here in Northern California that have destroyed thousands of homes, businesses and lives, and displaced countless families. Our hearts go out to all those affected. But tragedies like these are when we see humanity at its best, as communities come together to help those impacted rebuild their lives.

I think you'll be heartened to hear how this indomitable spirit can be found within all of us, as we profile James Doty, MD, a man who knows better than most about the effect of resiliency and the value of compassion.

In this edition, we also highlight how the Fogarty Institute continues to advance medical technology innovation, as we share the story of MedicalCue, a startup that is addressing the critical needs of newborns.

We'll introduce you to our newest board member, Stacy Enxing Seng, whose extensive experience in the medical technology industry will be invaluable in helping advance our mission; and we report on our fourth lecture series, which discussed the crucial role that quality management systems play in early-stage startups looking to transform the healthcare industry.

Lastly, a reminder about the 19th annual Thomas J. Fogarty lecture on November 3 at Stanford University: "Surfacing Human Signals – The Convergence of Engineering and Health," will feature the chief medical officer of Verily Life Sciences (Google) Jessica L. Mega, MD.

We hope you enjoy this edition and as always, welcome feedback and comments.

Andrew Cleeland, CEO of the Fogarty Institute

"When you understand yourself and your strengths and open yourself to listen to others, you establish an environment of trust and create a situation where everyone is on the same team. Trust has a profound effect that leads to success." – Dr. James Doty

Fogarty Institute for Innovation Updates

Dr. James Doty (center, pictured with Dr. Fogarty and Andrew Cleeland) was one of the featured speakers at a recent Fogarty Institute educational seminar.

Mindfulness and Compassion: Two Oft-Missing Ingredients That Would Bolster the Success of Teams and Companies

In today's fast-moving, technology-driven, high-achieving society, it is easy to overlook the toll that our personal and business "successes" have on our health, relationships and lives. Many modern workplaces have created a high-pressure culture that de-emphasizes the value of human interaction. Unfortunately, this has led to an astonishing 50 percent increase in healthcare costs for employers and higher human resources costs due to increasing job dissatisfaction.

What is often overlooked is how using a different leadership style – one of compassion and leading from the heart rather than our typical intensity – can actually improve not only your health and personal life, but also your business.

No one is more aware of this possibility than James Doty, MD, whom the Fogarty Institute had the pleasure of hosting during one of its recent educational seminars on building successful teams.

An accomplished neurosurgeon and entrepreneur, Dr. Doty is the founder and director of the Center for Compassion and Altruism Research and Education at Stanford University School of Medicine (CCARE), of which the Dalai Lama was the founding benefactor; a clinical professor in the department of neurosurgery at Stanford University; and author of New York Times bestseller "Into the Magic Shop: A Neurosurgeon's Quest to Discover the Mysteries of the Brain and the Secrets of the Heart."

To each of these many diverse roles he brings his authentic self, drawing from his personal experiences to share his insight.

Dr. Doty first learned about the value of mindful and compassionate leadership at the age of 12. He grew up in poverty, raised by an alcoholic father who was in and out of jail, and a mother who suffered from depression and attempted suicide on several occasions. His life changed in 1968 when he happened to walk into a magic shop and met Ruth, who changed the course of his life by re-training his mind and heart.

First and foremost, Dr. Doty was able to use mindfulness to combat his stressful adverse childhood experience, which can have a devastating impact on a child's health and ability to succeed in life, at a time when the mind wasn't thought to have neuroplasticity.

Over the years he has found a number of mindfulness lessons that are applicable to business success. Here are a few he shared.

  1. Demonstrate authenticity and transparency to truly connect with others.

    Trust is always an issue in any relationship due to the nature of interactions in modern society, particularly in competitive environments. We always want to put our best foot forward, which ultimately separates us from others because whether we like it or not, we all have that less-impressive side that we prefer not to show.

    But to be truly self-actualized, we need to accept both parts and realize that it is only by showing your weaknesses and failures that you can ultimately connect to others, which is key to fulfillment in life. The ability to develop the type of long-lasting, trusting relationships that successful leaders desire is by being open to criticism, showing empathy and acting with kindness.
  2. Stay in the present to increase your focus.

    When we are stressed, we cannot focus because we are not present. Studies have shown that 75 percent of us are consistently thinking about the past or the future, instead of being in the moment. When you are not present, you lose focus, which prevents you from connecting with others – a critical element to success.
  3. Turn off the "internal DJ."

    We all have an internal dialogue in our heads, and unfortunately most of it is negative. The challenge is that when you tell yourself something negative, you are building a "jail" – you are defining what is possible and what is not. Ruth taught Dr. Doty that our dialogues are self-created, and the key to success is to avoid an emotional response to that dialogue. By engaging with a negative response, your body has a physiological reaction ("fight or flight" syndrome), causing an increase in heart rate, release of proteins that cause inflammation and a suppression of the immune system.

    Anxiety also negatively affects the executive control function, which you need to be thoughtful in decision making. By staying calm and mindful, you reach maximum potential for creativity and productivity.
  4. Realize that long-term success and self-actualization is driven by kindness and compassion.

    Considerable research has shown that self-compassion and the ability to replace negative internal dialogue with positive self-affirmations, kindness and acceptance are critical to success. To connect authentically with others, you must first be kind to yourself. This is particularly important in Western cultures, where connecting with others without fear is especially difficult to find.
  5. Don't judge.

    Between a stimulus (an event) and a response, there is a gap. In that gap, there is a choice of what you are going to do and how you are going to respond. In that pause is your greatest freedom and opportunity for growth.

    But often we fill in that pause with a negative narrative – assuming, for example, that the person scowling is rude or angry with you, when really they just had a fight with a family member or learned some sad news.

    In that gap, don't jump to conclusions and rush to judgment as the latter taints every action and decision. Events are just events and don't have power – we are the ones who define them and give them power as being positive or negative. When we stop judging, we stop reacting, and it changes how the world interacts with us. You never know the potential someone may have and how connecting with that person may positively impact everyone around you.
  6. Establish an environment of trust for true leadership.

    When you understand yourself and your strengths and open yourself to listen to others, you establish an environment of trust and create a situation where everyone is on the same team. Trust has a profound effect that leads to success.

Thanks to Ruth's teachings, Dr. Doty went from a childhood with little hope for any future to touching countless lives -- attending college and medical school to become a successful and empathetic neurosurgeon; becoming CEO of a medical technology startup that helped change how radiation therapy is delivered, which went public for $1.3 billion; founding CCARE and inspiring millions of people worldwide to embrace a world of compassion and pursue a life of meaning and connection.

As he shares these ideas with others, he plants the seed that he hopes his audience will nurture in their own lives, just as he did.

Our Companies

MedicalCue is set to change newborn healthcare.

Every Breath You Take: MedicalCue's Device Makes a Critical Difference to Newborns

Each day, more than 1,100 babies born in the United States require assistance breathing, and in these cases, a few seconds can make the difference between a healthy child and one with irreversible brain injury. Meet MedicalCue, which has developed NeoCue, a bedside device that guides clinicians step-by-step through neonatal resuscitation to help ensure they are providing the care that is needed in those few crucial seconds.

Every Step You Take: Full documentation to support nurses

Much like a "GPS for care," MedicalCue's technology provides dynamic, real-time reference information needed during the complex steps of newborn resuscitation. To make the process easier, the system offers both visual and audio information to clinicians and automates tasks, such as documentation and time keeping.

As MedicalCue continues to improve and expand its device, it also is growing its team and adding educational components, as an ambassador to educate healthcare providers and mothers regarding vital, but little-known, issues in childbirth.

Every Single Day: Ongoing testing leads to device improvements

Since MedicalCue launched NeoCue in late 2015, the startup has steadily improved the device with additional features. This year it released its second major software revision that supports the 2017 national standard of care by the American Academy of Pediatrics' Neonatal Resuscitation Program.

Another new tool helps nurses and obstetricians in monitoring umbilical cord clamping by helping determine the timing of the procedure. The current practice is to immediately cut the umbilical cord, but recent guidance from the American College of Obstetricians and Gynecologists (ACOG) recommends delaying, as babies gain 50 percent of additional blood in just two to three minutes.

This extra supply is important because when the baby takes a breath, it inflates the lungs, which takes a significant volume of blood. If the cord is clamped too soon, there isn't as much blood to go around; the newborn's body struggles to get enough to the brain, and the baby can have trouble breathing. Healthcare providers can make a significant difference in the baby's life by waiting to perform this procedure, and NeoCue can help document the appropriate care.

The startup is now preparing to launch pilot programs in four hospitals across California.

Knowledge is power

MedicalCue has also been working to raise awareness for both mothers and healthcare providers on the importance of getting a newborn to breathe during the critical "golden minute" to avoid brain injury, and why neonatal resuscitation should be treated as a time-critical emergency.

In addition, MedicalCue is developing an informational piece with five questions for expectant mothers that includes data on why a health practitioner should delay umbilical cord clamping. "Most new mothers wouldn't have any reason to understand the importance of a delay, so this helps educate them and empower them," said Peter David, MedicalCue CEO.

Building the Team

To supplement its growth, MedicalCue recently hired Marie Alexander as chief operating officer. "Marie is a very talented, seasoned technology executive whose experience will be pivotal in helping advance our mission and build our company," Peter said.

With nearly 30 years of experience in the technology sector, Marie's area of expertise has been coming into organizations that need to build up a company to support an existing product.

She has helped build companies in a wide range of industries that include electronic data interchange, customer relationship management, IT intelligence and location services. Most recently, she served as CEO of Avaago, a gaming company, and has acted as a CEO and an advisor to a healthcare company.

In addition to her corporate work, Marie sits on the Forbes Technology Council, an invitation-only organization comprised of elite CIOs, CTOs and technology executives.

Marie was immediately drawn to the startup for two reasons. From an intellectual point of view, she saw the potential for how the device can evolve to improve upon the processes at hospitals and be used as a meaningful resource for research to improve the quality of care. And, she appreciated it from an emotional stand point, when learning how those first 60 seconds in a baby's life can be crucial for lifetime overall health.

"I am truly honored to part of this team because of our potential to save lives," said Marie. "I am looking forward to taking my experience in using technology to build companies and apply it to something that is meaningful and intellectually stimulating in a field that has long appealed to me."

Monthly Spotlight: Stacy Enxing Seng

Stacy Enxing Seng Joins the Fogarty Institute's Board of Directors

At the Fogarty Institute we depend on our board of seasoned professionals to help us continue to grow and adapt to the medtech market. That's why we were delighted to add another elite name to our esteemed group, with Stacy Enxing Seng joining as our newest member. With nearly 30 years of experience in the medtech industry, she has successfully led multiple technologies and companies from early concept and development through global market leadership.

"I am honored and excited to have joined this board and to be able to work with such a reputable group of directors, an accomplished management team and an impressive portfolio of startups," said Stacy. "Andrew's style of leadership and drive to expand the capability of the Institute, coupled with Dr. Fogarty's vision for education and innovation to keep the entrepreneurial community robust, was a big draw to join the organization. The Institute has a very promising future, and I am excited to be part of it."

Personal relationships enhance professional success

Stacy knows the value inherent in relationships and believes her successful career in medical technology is largely the result of the people who inspired and supported her work along the way.

After graduating from Michigan State University with a degree in public policy, Stacy was not specifically targeting medtech, however, after interviewing with the team from American Hospital Supply, she was drawn to the combination of their "esprit de corps" and focus on the customer.

As her career with American Hospital Supply and then Baxter progressed, she realized that she eventually wanted to build and run a business, so she enrolled in Harvard Business School to bolster her business acumen. After earning her MBA, she joined Scimed, a small interventional cardiology company that was eventually acquired by Boston Scientific. She held a variety of sales and marketing roles, ultimately becoming vice president of global cardiovascular marketing.

During her time at Scimed/Boston Scientific, she had the good fortune of being mentored by the late Dale Spencer, a pioneer in the medical technology industry, who envisioned starting a new company focused on areas of endovascular medicine that the larger cardiovascular strategic companies weren't targeting – namely peripheral and neurovascular interventional devices. In 2000, she joined him to start ev3 as president of the peripheral vascular division, taking the company public in 2004 and then selling ev3 to Covidien in 2010.

"It was an incredible experience to build the company from the ground up – from zero to approximately half a billion in revenue when it was sold to Covidien," she says, noting that the revenue was generated both organically and through acquisition, which included a number of household interventional names, many of which stemmed from the Bay Area.

She considered moving to other endeavors after the acquisition, but stayed on with the company due to her commitment to her ev3 colleagues, as well as the vision set forth by Joe Almeida, CEO of Covidien. She took the position of president of the vascular division to play a key role in both ev3's successful integration, as well as growing the overall Covidien vascular business.

"Along the way, I've been grateful for the chance I've had to work with and lead so many impressive people," she says. "I've also derived great satisfaction from building companies and therapies that started in clinical experience and now are making a difference in patients. The technological improvements that have been pioneered have made a real difference across vascular disease and stroke."

A new chapter

Stacy stayed with Covidien until it was acquired by Medtronic, a point when she realized it was time to put a "bow" around her 25 years of driving a daily business and turn her attention to the next frontier.

In addition to pursuing opportunities as in independent director on the boards of both small entrepreneurial and mid-size public companies, she set her sights on the venture capital sector, given her awareness of how essential VC is to medtech innovation.

While VC work is quite different from building and running a business, she greatly enjoys the excitement of working with entrepreneurs and the satisfaction of investing in innovation, which allows improved health care around the world and a vibrant growth pipeline for the larger strategic medical device companies.

And, as throughout her career, the people she works with play a key role in her fulfillment. At Lightstone Ventures, she now has the chance to work alongside the team behind FIRE1, a group she met while working at Covidien, whom she deeply respects and thoroughly enjoys working with.

"My current work in the VC space and on boards such as the Fogarty Institute, allows me to stay engaged in an industry I'm passionate about, while working with amazing people and giving back to the healthcare community," she says.

Vision and advice on medtech

Despite the decrease in investments and what she calls the "resetting of the table" due to the elevated and necessary demands brought forth by value-based healthcare and a more rigorous reimbursement path, Stacy is optimistic about the future of medtech.

The elements she sees contributing to its growth include demographic factors that will lead to increased therapeutic device demand worldwide; innovation stemming from such trends as digitalization, artificial intelligence and smart devices; the consumerization/retail possibility of medicine; and the continued excitement created by drug/device combinations.

As she sees it, innovation needs to be more "disciplined," in terms of considering earlier how the device is expected to improve the value and delivery efficiency of healthcare, while at the same time "expansive" in considering the potential value of new delivery models and ways in which a device can work to enable both patients and their caregivers.

Stacy has a favorite saying, repeated to her by her father growing up, that encapsulates her belief that the sky is the limit: "Your attitude determines your altitude."

There will always be road blocks, she says, but when addressed with the right attitude and the right team, most of the time everything will fall into place. "Entrepreneurs tend to succeed when they get it right by their customers, employees and shareholders, and demonstrate the persistence and the attitude that they are in it for the long haul."

Fogarty Lecture Series: Quality Management Systems

The Institute's fourth lecture series focused on quality management systems and featured speakers (from left to right): Maureen Bensing, consultant; Windi Hary, HeartFlow; Scott Wilson, Cala Health; and Denise Zarins, Fogarty Institute

Startups are besieged by demands on their time and resources, both of which are in short supply. That's why they may be tempted to postpone developing and establishing a quality management system, in order to focus on what might be considered more pressing needs.

But that would be a mistake. First, of course, it is required by regulatory bodies. But besides that, it's smart business to do it correctly. Failure to establish these systems at the start can prove to be extremely expensive down the line, hampering eventual success if the device ends up not meeting the user's need or doesn't perform as expected.

It's not a question of "if" the company should create a quality system, but rather how to best to develop an effective system.

The Institute's fourth lecture series covered this topic from a wide range of angles, moderated by Fogarty Institute chief technical officer Denise Zarins and featuring input from seasoned professionals that included Scott Wilson, vice president of regulatory affairs and quality assurance for Cala Health; Windi Hary, vice president of clinical, quality and regulatory for HeartFlow; and Maureen Bensing, an experienced consultant for medical device startups in Silicon Valley.

The startups and entrepreneurs in attendance learned the nuances of quality systems from a big-picture view of their importance down to an in-depth look at how to create one and why design controls are crucial for startups. In addition, Healyx, one of the Institute's startups, shared an insider's look at its recent journey into creating a quality management system, sharing best practices and lessons learned.

The Ins and Outs of Quality Management Systems

The first step may seem obvious, but can be easily overlooked. Before a company does anything, it has to start with a basic question: Is my device a medical device?

This is important because the answer helps determine regulatory pathways and the United States and European Union have different tools that determine classifications. Domestically, a good place to start is the FDA's website, which offers insights into everything from the definition of a medical device to post-market requirements.

The European Union has a comparable process with a clear-cut classification system that defines medical devices.

And then, everything flows from that:

  • How you approach the depth of your quality system
  • The type of technical files or design dossier you need to put together
  • Necessary proof to outline and solve the potential risk of your medical device

Why should you care about your quality system?

Well, first off, it's the law. In California, for example, you need to have a manufacturing license in place even to ship devices for clinical studies.

But meeting regulatory requirements is just the first reason that a quality system is key. Its most value-added purpose is to provide a business advantage: A simple, easy-to-understand system can provide a common understanding and structure that your company will coalesce around – and later, that strategic partners will appreciate when they value your efforts.

Given the rapid pace of development and the myriad individuals who are working on your innovation, from different team members to consultants, a quality system provides a consistent common language for elements from user needs to evaluating risks to labeling to distribution across multiple markets.

It provides a mechanism to make sure that team members can work interchangeably as needed, but also establishes cross-functional approval, ensuring that that no one single person can make a significant change unless the remainder of the team buys in.

A quality system can complement and strengthen your intellectual property strategy, and can help outside entities evaluate your company through the insight it provides. A quality system:

  • Serves as an outside indicator that you are simultaneously being deliberate and creative.
  • Demonstrates how transferable your work is and if your efforts are repeatable.
  • Creates a common understanding with vendors, who have quality systems of their own, thus improving your interaction.
  • Reduces business liability and risk.

While there is a common expectation for quality systems, that doesn't mean that one size fits all. "Plug and play" doesn't work: The system needs to be appropriate to your company, customized for scalability and evolution in a way that makes sense for your company specifically.

In whichever way you approach your quality system, the most important principle is: Your team is going to go create value through its precise, creative and unique efforts – use your quality system to capture that important work in a systematic and efficient way, so that you and others know what you have done.

Transitioning into your quality systems – When and how to implement

There is no substitute for implementing a simple quality system early. Creating that structure forces companies to get the documents in place that will be later required for submissions, and it also helps create a common culture where everyone is on the same page and understands the road map, so you are not changing how you do business on a whim.

Your system will evolve as your company does; implementing a quality system is a process where you tackle the parts that are pertinent to your current stage.

For example, in the research phase a quality plan will help you:

  • Understand the unmet need.
  • Give insight into your cost structure.
  • Identify your end user.
  • Detail your competitive advantage.
  • Determine the market size.
  • Formalize your need for initial filings, patentability and regulatory and clinical requirements.
  • Ensure design verification, validation and risk analysis.

In other words, it will be a living document that states your intentions and implementation timeline.

Then to phase in the rest of your system, work backward from your regulatory milestones, considering the size of your company and the risk of your medical devices. The higher risk the device, the sooner the quality system should be implemented.

Current trends are pointing towards implementing quality systems early in the process. In Europe for example, you need to have a quality system qualified before you receive your CE marking. The FDA also is now assessing which quality indicators should be in place in earlier phases as they aim to reduce recalls and adverse events.

A Focus on Design Control

While just one aspect of the quality system, design control deserves special attention because of its import.

While the product idea is the first step, it is just as important to envision the end product and how it will be used. Design controls are required for medical device companies: Regulatory bodies emphasize the need for knowing your device so you can understand and control any potential risk.

The time spent developing it upfront is paramount and will pay off in the long term. That's because an effective design control will:

  • Create a repeatable and hopefully predictable process for developing your product.
  • Show you are in control of your product development.
  • Provide a means for supporting risk assessment/risk control of your product.
  • Establish appropriate identification and traceability of the product.
  • Demonstrate the product is effective, which can save a lot of work in the long term. After all, you don't want to get too far and realize the design is not meeting user needs.
  • And ultimately, it will ensure you receive regulatory approvals to allow you to get your product to market

Healyx Labs Case Study

As Fogarty startup Healyx develops its device for wound care, it is currently in the process of implementing its quality system evolution.

Healyx had already completed some of the foundation for establishing a quality system. They had conducted extensive research in Bangladesh to determine the need and built out their prototypes to guide the understanding of how the device would fit the users' need. They were very sophisticated in their documentation with users from the start, which eased their process.

When they joined the Institute, they developed a quality system that enabled them to advance their device. While their initial documentation was helpful in starting the process because it was so detailed, it lacked compliance requirements, as well as cross-functional review, which is a critical component of the process.

Healyx developed a basic system in a lean, cost-effective manner. Thanks to the system now in place, the product development milestones seem more approachable in terms of design control phases. While it forced them to make design decisions earlier, it gives them leeway to change things later if needed without being penalized and gives them confidence they are designing the right product for the end user.

The 19th Annual Thomas J. Fogarty, MD, Lecture: Focus on Innovation

Jessica L. Mega, MD, MPH
Chief Medical Officer
Verily Life Sciences (Google)

When: Friday, November 3, 2017, from 4 to 5 p.m.
Where: Berg Hall, Li Ka Shing Learning & Knowledge Center, Stanford University

The lecture is free. Please RSVP here.