From the CEO's Desk

"The visionary starts with a clean sheet of paper, and re-imagines the world." – Malcolm Gladwell

At the Institute, we have the privilege of working with visionaries each and every day. As we continue to actively participate in industry events, meet new innovators and expand our partnerships, I am continuously impressed by the caliber and quality of the entrepreneurs who are shaping the future of our industry – a few of whom you will read about in this edition.

Up first is Josh Makower and his engaging discussion we enjoyed at the Stanford Biodesign "From the Innovator's Workbench" speaker series; you'll also get to know industry expert Mike Regan, whom we are proud to announce has joined the Institute as chief innovation officer, supporting us in a range of activities including mentoring, operations and the organization's collaborations; we highlight progress made by Zebra Medical Technologies, whose device is poised to be a game changer in physicians' ability to better detect and monitor skin cancer; and lastly, we wish Tom Fogarty a very happy 84th birthday, as we share his wisdom in an insightful Q&A.

We also invite you to join us in congratulating EchoPixel, our ninth startup to graduate following a successful round of funding; and Shreya Mehta, our Ferolyn Fellow whose startup, Zenflow, just raised an impressive $31M in Series A.

In wrapping up, if you have the opportunity, we hope you attend The MedTech Strategist's annual Dublin conference April 17 through 19, 2018. This prominent investment and networking event has been recognized as the best-in-class medtech investment conference in Europe.

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

Andrew Cleeland
CEO of the Fogarty Institute

Fogarty Institute for Innovation Updates

The Stanford Biodesign speaker series featured the ExploraMed team. The event was co-sponsored by the Fogarty Institute. Photo courtesy of Stanford Biodesign.

A Special "Workbench" Session Honors Medtech Innovation's Past and Present

When you think of medtech innovation, there are few individuals who were as influential and inspiring as Tracy Lefteroff, which was why it was so fitting that the recent Stanford Biodesign "From the Innovator's Workbench" honored his legacy. Continuing the theme, it also featured accomplished innovator Josh Makower and panelists from his team at ExploraMed, a prolific medical and health technology incubator.

The session had special meaning given the ties to both: The Workbench series, Makower's brainchild, was launched by Stanford Biodesign in 2003, with Dr. Fogarty as the first guest. Its goal is to enable the Stanford Biodesign community and the public to learn from some of the greatest health technology innovators, and the Fogarty Institute has co-sponsored one event a year as part of its Lefteroff Fund.

Participating panelists included the architects behind Acclarent, a pioneer in minimally invasive treatment for ear, nose and throat (ENT) conditions that was acquired by Johnson & Johnson for $820M; NeoTract, a minimally invasive treatment for urinary tract symptoms due to benign prostatic hypertrophy (BPH) that was acquired by Teleflex for $1.1B; and Willow, the first all-in-one breast pump that easily fits inside a bra and recently was honored as CES' Best Healthcare Innovation of 2018.

The event was moderated by David Cassak, managing partner, Innovation in Medtech LLC, publishers of The MedTech Strategist.

Makower founded ExploraMed following a stint at Pfizer, where he had the opportunity to play a role developing the next generation of medical devices and in identifying the best process for innovating new medical technologies. Eager to make stronger headway with this newly developed process, especially with more disruptive technologies, he formed the incubator ExploraMed with limited funding, as the first and only employee in 1995. To date, the firm has touched countless lives through the creation of eight companies and four funding rounds.

One of the key ingredients behind the development of successful technologies is identifying a significant clinical need and focusing on areas where there hasn't already been a lot of innovation or investment. "We focused on needs where no one really wanted to be and took a holistic approach," explained Makower. "When developing our technologies, we take into consideration the feelings of the people we are trying to help, which raises new ways of thinking about the problem and often forces us down a path that tends to be more minimally invasive and more sensitive to how a body can heal on its own."

One of their most recent companies, Willow, embodies this philosophy. Despite the proven benefits to babies and the mother, more than 35 percent of U.S. women stop breastfeeding after six months because of work or other obligations, according to the Centers for Disease Control and Prevention.

ExploraMed set to create a company that would address this problem. The field was ripe for innovation, given the clinical need, the vast audience and the fact that the last innovation was nearly 30 years ago. "Our goal was to help moms pump anywhere, anytime, with dignity, by developing a device that was mobile and discreet and emulated the natural mechanism of breast feeding," said John Chang, founder and CTO, Willow and ExploraMed. "We were inspired in part by a New York Times article that said, 'Why can't my breast pump be as quiet as a Prius and as elegant as an iPhone?'"

Among the many pieces of advice that were passed on during the evening, the panel concluded with a summary of the ingredients that help make a company successful: "The central theme is focusing on important needs and trying to find that space that is not already filled with solutions. And, we wouldn't be here without our incredibly talented team with their broad range of skillsets and expertise, drive and passion," Makower said.

A copy of the recording of the event will be available on the Stanford Biodesign website as soon as it is available. Upcoming Workbench events will feature Joe Almeida, CEO of Baxter International on Tues., March 20; and Yoh-Chie Lu, founder of Biosensors International Group Ltd., who will give a perspective on medtech in China on Wed., April 25.

Our Companies

Zebra Medical Technologies' Device Provides an Answer to Deluge of Skin Cancer Screenings

American dermatologists experienced 7.5 million office visits for suspected non-melanoma skin cancer in 2017, and a number of factors are indicating these numbers are liable to increase. First, scientific concerns mount continuously over global warming and a decrease in ozone levels, which have magnified the attention over the potential impact on skin cancer rates and solidified the importance of screening for both physicians and the general population. And, an increasing array of at-home self-diagnostic devices and apps are causing more people to visit medical offices for further testing.

But this wise, proactive response can have unintended consequences. Each year, patients endure 15 million biopsies for suspected skin cancers, and more than half of these prove negative, which results in a significant burden and costs to the healthcare system.

The situation makes the need for Zebra Medical Technologies' (ZMT) device more crucial than ever. The company has made great strides to provide a solution with the creation of the first non-invasive, real-time cellular imaging system aimed at reducing the need for traditional biopsies. This one-of-a-kind technology provides a view of skin cellular pathology without a biopsy in real time, allowing physicians to painlessly and quickly inspect a larger number of patients.

Just by touching the skin, the company's handheld microscope, the EagleCyte, immediately shows images that replicate the colored stained slides pathologists and physicians use to identify cancerous cells.

Recently, the National Cancer Institute provided the first phase of funding for a pilot study that uses the company's clinical prototype, and ZMT is now enrolling patients at El Camino Hospital to gather its first clinical data. The aim of the study is to compare biopsy results with real-time images from the EagleCyte to test its efficacy.

"We are very fortunate to be able to leverage our proximity with El Camino Hospital and enroll patients right in our own backyard," said Gabriel Sanchez, co-founder and CEO of Zebra Medical Technologies. "We are looking forward to working with Dr. Menkes to test our technology with patients who are coming in for suspected skin cancer, and show how this solution can save physicians and patients time and unnecessary worry."

ZMT's technology has already proven to be very successful when testing healthy volunteers. The startup is also experimenting with artificial intelligence that may help clinicians quickly determine whether tissue is cancerous or healthy based on features in the images. If cancer is suspected, ZMT's technology can help guide physicians where to look more closely, within minutes, without cutting.

"EagleCyte provides three distinct advantages: early detection, monitoring and pre-treatment planning, which greatly simplifies the current process and empowers physicians to make decisions accurately and in a more expeditious manner," said Gabriel.

ZMT's Zebrascope technology, the predecessor of the EagleCyte system that is designed to image skeletal muscle microstructure, is also receiving attention. Northwestern University just kicked off a three-year study on the effects of stroke and subsequent brain damage on muscle impairment and is using Zebrascope as part of the study.

Q&A with Dr. Thomas Fogarty

Dr. Fogarty Continues His Legacy at Age 84, With No Signs of Slowing Down

With age, comes wisdom, and although no one who knows Dr. Fogarty would call him "old," there's no doubt his wisdom benefits us all.

Dr. Fogarty, who celebrated his 84th birthday on February 25, is an inspiration to us all. Most of us know his many accomplishments, but for those who don't, he is one of the most notable cardiovascular surgeons and innovators of all time and recipient of the prestigious Presidential National Medal of Technology and Innovation, among many other honors.

And he continues to make his mark as a pioneer in the medtech industry. Every day he visits the Fogarty Institute's Fog Shop, where the companies-in-residence are located, to check in with each of the startups and offer his invaluable advice for whatever challenge they might be currently encountering.

"As a surgeon, you make the rounds every day to visit your patients and see how they are doing, and I like to do the same with our companies-in-residence," he says. "The energy I get from these young people and their innovative ideas inspires me and keeps me abreast of new advances."

In addition to his mentorship role at the Institute, Dr. Fogarty keeps up to date with the latest technology trends in other ways: He is an active board member of several medtech companies, including a recent board of director's appointment for Pulse Biosciences; he invests in companies committed to changing healthcare, such as EBR Systems; and he advises numerous other companies that he either co-founded or helped form, such as CyberHeart and Radial Medical.

We recently had the privilege of catching up with Dr. Fogarty to get his insight on the direction of the Institute and the medtech industry, as well as advice and wisdom he has garnered over his illustrious career.

Q. The Fogarty Institute has made a lot of progress in the past year. What stands out to you as one of the most notable accomplishments?

I am very excited about the new team that has been put in place to lead the organization, all seasoned professionals in the field of medical devices and medical technology, who clearly enjoy what they are doing. Collectively, they bring a host of experiences, wisdom and insight that benefit our entrepreneurs.

I am also very impressed with the quality of applicants, and the exciting prospects they bring – and progress they have made already – for creating new technologies that will address critical needs and treat a broad spectrum of patients. This is a strong reflection and a tribute to what the Institute and its team have accomplished, and highlights the organization's reputation for successfully helping early-stage companies develop, receive funding and eventually get to market.

The Institute has a bright future ahead – we have a solid team and companies, and we are expanding our relationships with other entities that complement what we do. I am looking forward to seeing the continued impact we will have on our industry.

Q. What are your thoughts on the state of the medtech industry?

I am very optimistic. In the past six months, we have seen real progress in the number of devices and drugs that have gotten to market, in a kind of resurgence.

While, undoubtedly, the industry has been challenged by long incubation periods for early-stage medtech startups and dwindling funding, we are seeing things steadily improving as the FDA has made tremendous progress in accelerating and smoothening the path to get devices to market, and most importantly, to patients. We now need to encourage the Centers for Medicare & Medicaid Services (CMS) to collaborate more closely with the FDA, so the path to reimbursement is accelerated once a company's device receives approval. The Institute hopes to help with this collaboration. Our direct insight into the struggles of startup companies will help both agencies.

Q. What is the best advice you ever received?

First, listen: It's important to keep an open mind and not immediately discount anyone's comments, even if you initially disagree. Instead, reflect and make observations that would document whether what was said is reflective of the actuality before making a snap judgement. And then, retain what you learn.

Q. What was your best career move and who helped influence your career?

My mom was my best mentor growing up. A single mother raising three kids after my dad died, she always provided valuable wisdom on how to best channel my childhood "energy," let's call it.

Also, because we had little means, I had to find ways to earn money, from mowing lawns to delivering papers. I also discovered a talent for tinkering with things, and started building race cars and model airplanes for the neighborhood kids.

Before long, I got a position at the local hospital, where they let me work part-time, but get paid as a full-time employee. There I had the fortune of being mentored by Dr. Jack Cranley, who mentored me all the way into medical school and helped me start my career as a surgeon.

Best career move? Becoming a surgeon and entrepreneur instead of a boxer, which as a kid, seemed like a potential avenue.

Q. What kind of mindset / traits do you need to be a successful medtech entrepreneur?

You need to be persistent and have passion. You also need to have the capacity to listen and recognize that you are young and don't have a lot of experience and therefore you should seek others who do and learn from them. Remember that you don't have to make all the mistakes yourself, but can learn from those who are willing to share what helped them and what to avoid. And then, when do you make the inevitable mistake, make sure you learn from it.

Q. What advice would you give someone who is just entering the medtech industry?

You must be patient, as this is not an easy path, particularly in this day and age. But the benefits are unmatched: When you are successful, you can know that you developed something to save a patient or to relieve pain and suffering. And this holds true no matter what position you have or contribution you make. Healthcare is a "team sport," and every single person plays an important role.

Q. How do you get into the "innovation"/creative mindset?

The freedom to imagine is critically important, and I believe we start by encouraging kids to imagine or day dream. You also need to have the ability to ask the question "what if we do something different?" The process of creation, these days, is a team effort and requires input from many people with different backgrounds.

While technology can numb some of that ability to freely imagine -- as we deal with information constantly coming at us, versus having more free time to be creative -- it also helps develop the curiosity that is needed to innovate.

And I think reading helps with this too. I like reading biographies and history books and learning from other successful people's experiences and careers, or delving into the stories of notable companies like Nike.

Q. Let's leave with some inspiration: What is your favorite quote or motto?

Never give up...but have the flexibility to change path or direction when you need to.

Monthly Spotlight: Mike Regan, Fogarty Institute Chief Innovation Officer

Mike Regan Joins the Fogarty Institute as Chief Innovation Officer

As the Fogarty Institute continues to expand and strengthen its services and broaden its relationships, it has hired medtech industry professional Michael (Mike) Regan as chief innovation officer.

Mike comes to the Institute with 35 years of industry experience, spanning a broad range of positions in general management, product development, operations, sales and marketing, clinical, regulatory and engineering. He mostly recently served as chief operating officer at Minerva Surgical, a medical technology company focused on women's healthcare. Prior to that, he was vice president of operations at Emphasys Medical (now Pulmonx), a company that develops therapeutic solutions for patients with emphysema. He was also chief operating officer of Cardeon Inc., which focused on innovative approaches for coronary artery bypass grafting surgery.

Mike's passion for healthcare stems from his childhood, when he would hear exciting life-saving tales from his mother and grandmother, who were both nurses. He was also intrigued by the prospect of new ways to help people using biomedical technology, as showcased in the popular television series The Six Million Dollar Man and The Bionic Woman.

At the time he attended college, bioengineering was not available as an undergraduate course, so he pursued a degree in industrial engineering at California Polytechnic State University, San Luis Obispo.

But his most formative experiences came through a broad range of internships and full-time positions as he began his career. During his college summers, he worked as an electrical mechanic and machinist helper, where he found that working on the floor and with a team sparked a desire for building things and seeing them come to fruition. He later joined Walt Disney Imagineering, helping build Tokyo Disneyland and the Epcot Center, which gave him great insight into how to start with a blank piece of paper and come up with something very creative.

His first job out of school was where he was initially exposed to the medical field. He joined American Hospital Supply, whose management training program allowed him to rotate into different assignments, fueling his passion for taking on cross-functional positions that tied together different roles and experiences.

Despite the great experience and solid job, he decided it was time to leave Los Angeles and headed to Colorado, where he became a short-order cook, bar tender and "ski bum," working at Copper Mountain. This was another foundational experience for him, as he learned that he could take risks, try something different, and still land on his feet.

Before long, he knew it was time to rejoin the "real world," and he fulfilled a desire to return to the medical field with a position at Advanced Cardiovascular Systems. He undertook a variety of assignments, and his career grew with the company, which was eventually spun into Guidant.

When he was invited to join the Fogarty Institute, it was an ideal time and position for him. He has long known and admired Dr. Fogarty and several on the executive team at the organization. "Working with entrepreneurs who have great ideas, combined with a talented team committed to helping them bring their ideas to fruition, is a dream come true for me," Mike said.

"I think this is a golden time -- a renaissance period -- for medical technology," he continued. "When I started in the field, we had great ideas, but were limited by the understanding of the physiology, computing power and materials, among others. Today, there are so many facets and tools, such as artificial intelligence, advanced imaging and nanotechnology, which we can use to bring new solutions to clinical problems. We live in a very exciting time for medtech."

Outside of the office, Mike enjoys skiing, tennis, hiking and traveling with his wife, who is a nurse at Stanford. He has two daughters who reside in New York and Boston.

From our Partners

The two-and-a-half-day DUBLIN 2018 event, recognized by the medical device industry as the leading medical technology investment forum in Europe, will be held at the centrally located historic Shelbourne Hotel, Dublin, overlooking St. Stephen's Green.

This exceptional investment and networking event will feature presentations by more than 40 early-stage medical device companies from around the world, along with thought-leading guest speakers, on-stage interviews with key device executives and VCs, and insightful and timely panel discussions. DUBLIN 2018 will also feature the popular and exciting MedTech Innovator startup competition, hosted by Paul Grand, CEO of MedTech Innovator.


In the News

Wall Street Journal: HeartFlow Valuation Tops $1.5 Billion for Disease Detection Software (HeartFlow is a Fogarty Institute graduate)

Digital Journal: Global Plastic Wound Retractors Market Outlook, Share, Growth, Trends, and Forecast 2017-2025 (Prescient Surgical is a Fogarty Institute graduate)

Equity Insider: Connected Wearable Patches Market 2018 by its Clinical Application (G-Tech is a Fogarty Institute company)