Derek Herrera, founder and CEO of Bright Uro, grew up in a military family with a curious mind and a skill for building things. After graduating, he entered the Naval Academy, studied systems engineering and robotics, and became a Special Operations Marine Raider. When an injury left him paralyzed from the waist down, he launched a new career to improve the lives of spinal cord injury patients through medical innovation. Herrera speaks with podcast host Geoff Pardo about his extensive military career and the leadership skills fostered during that time. He also talks about his first entrepreneurial pursuit creating a fully internal and remotely controlled device for chronic urinary retention, a common issue for spinal cord injury patients. Herrera discusses his new business, Bright Uro, which leverages advanced technology to create urological diagnostic devices. He says, “Not only will we offer a superior patient and customer user experience, a more comfortable technology, and improve clinical efficiency, we’re unlocking data that’s never been obtained before because there’s never been the capability to do so.” Links from this episode: Gilde Healthcare Bright Uro UroDev Medical

Growing up in Austria as the daughter of two physicians, Lisa Anderson, co-founder and CEO of Paragonix Technologies, spent many evenings around the dinner table discussing patient care with her parents. After pursuing advanced studies in biomedical sciences and medical genetics, Anderson ventured back into patient care and launched a donor organ preservation and transport company to dramatically improve the standard of care for many donor recipients. In this episode, Anderson speaks with host Geoff Pardo about the current issues in organ transport and how their first device—the Paragonix SherpaPak Cardiac Transport System—significantly decreases the number of adverse events less than 24 hours after heart transplant surgery. She also talks about the company’s transition to a service-based business with the development of the Paragonix app, their expansion into transporting lungs, livers, and kidneys, and the strategies used to develop a straightforward and high-performing device. She says, “We wanted to provide a simple device that provides superior clinical outcomes, is easy to us, and has an intuitive user profile when [organ recoveries] occur. We provide [surgical teams] with superior organ preservation.” Links from this episode: Gilde Healthcare Paragonix Technologies Paragonix SherpaPak Cardiac Transport System

Fred Khosravi, chairman and CEO of Imperative Care, returns to the podcast for another engaging conversation with host Geoff Pardo about his personal and professional experiences in the medtech space. He speaks about the elements of preparedness that help entrepreneurs seize new opportunities, the importance of maintaining intellectual honesty in one’s work, and why a “market-first” mentality leads to industry success. He says, “It’s not a great medical innovation unless it ends up helping a lot of patients. Otherwise, it’s just a great invention.” Khosravi generously shares three decades worth of entrepreneurial wisdom and recounts stories of the people who profoundly impacted his career. He talks about viewing investors as partners not parents, the attributes that spur venture capitalists to invest in a CEO, the lessons learned from developing the number one intravascular filter in the global market, and his work at Imperative Care—a stand-alone comprehensive stroke and thrombectomy company. He also explains why he believes “freedom and innovation” set the American medtech industry apart and the path forward to make it even better. Links from this episode: Gilde Healthcare Imperative Care Incept Medical Incubator (Axtria, Ostial, Neurolutions, Instylla, Tulavi Therapeutics)

This month host Geoff Pardo speaks with one of the most prolific entrepreneurs in the medtech industry, Fred Khosravi, chairman and CEO of Imperative Care, about the path that led him to start over 24 healthtech startups. Khosravi recounts leaving Iran at 17 and studying mechanical engineering at Tennessee Tech. He talks about his first experiences with medical device manufacturing and how he designed a fully automated process for making cataract lenses. Khosravi also shares his pioneering work in developing cardiac stents, how serendipity is really “opportunity meets preparedness,” and why every entrepreneur needs a board of directors. He clarifies, “Not your company’s board of directors, but your own personal board of directors: people who care about you to be skeptical about you and tell it to you like it is.” Links from this episode: Gilde Healthcare Imperative Care

As a trained neurosurgeon, Dr. Chris Mansi is familiar with the challenges patients face in accessing lifesaving treatments. After earning an MBA from Stanford and enrolling in their Biodesign Medical Innovation track, he learned to develop multifaceted and technology-based solutions to improve healthcare workflows. In this episode, host Geoff Pardo speaks with Mansi about Viz.ai, a revolutionary application that increases patient access to life-saving treatments in over 1,200 hospitals. Every minute an ischemic stroke patient waits for treatment equates to approximately 2 million neurons lost and a week of disability. Viz.ai abbreviates the sometimes five-hour-long process of securing a specialist to merely minutes, changing the course of patients’ lives. Mansi also discusses how to address naivety in entrepreneurship, the value of an interdisciplinary mindset in improving patient outcomes, and the importance of creating a value-based company with mission-driven employees. Links from this episode: Viz.ai

Dr. Josh Makower is one of the few multidisciplinary leaders making a tremendous and broad-reaching impact on the medical device and consumer product industries. As an inventor, professor, CEO, and venture capitalist with experiences in medicine, bioengineering, business, and big pharma, Makower has led the charge in creating some of the most unique and practical designs. In this episode, host Geoff Pardo speaks with Makower about his interests in science and technology at an early age, his college transition from music to engineering, and what he believes is the future of biodesign. Makower details the mechanics of his inventions for incontinence, chronic sinusitis, benign prostatic hyperplasia, and women’s health as part of the nine companies he created in the past 25 years. Finally, he speaks about the joy of teaching and offers sage advice to up-and-coming medtech innovators: “My classic piece of advice for anyone getting into any health-related field is you really have to be perseverant. You have to never give up because there are so many reasons to turn away and give up, but if you have a dream and believe in what you’re doing and are willing to listen and adapt, that’s key. I think anyone can win, and it’s just about believing in yourself and your vision.” Links from this episode: Stanford University Stanford University School of Medicine ExploraMed, a medical device incubator Coravin Willow

Before he began his Ph.D. program in biomedical engineering, Andy Doraiswamy bought a one-way ticket to Southeast Asia to explore and “find himself.” He was successful: discovering a love for mountain climbing’s physical and mental challenges and developing a practice of meditation that has proven helpful in both climbing and commerce. Since leaving academia, he’s been involved in startups at Advanced Vision Science, Oculeve, and now Koya Medical. Doraiswamy has a huge bias and love for eye care, he says, particularly intrigued by its complexity. He and host Geoff Pardo discuss how medical devices fare in academia, letting go of promising technology in an acquisition, and the shifts required when transitioning from COO to CEO. Links from this episode: Koya Medical

Host Geoff Pardo talks with Adam Berman, CEO of Alleviant Medical, about the groundbreaking device treating heart failure without hardware or permanent implants. The Alleviant device mitigates shortness of breath in patients with diastolic heart failure by leaving behind a shunt cut from interatrial septum tissue. The shunt moves blood from the left atrium to the right, diminishing pressure on the lungs. Berman speaks about his start in biomedical engineering, gaining invaluable experience in the operating room, developing sales tactics and industry knowledge as a medical device field representative, and switching gears to create novel devices for cardiac care. Links from this episode: Alleviant Medical

Geoff Pardo and three successful medtech CEOs who exited their companies through a different pathway— M&A, IPO, and SPAC—discuss the pros and cons of each. While market volatility is a given, Bruce Shook, Former President & CEO, Intact Vascular and Vesper Medical; Clint Carnell, Co-Founder & Chairman, OrangeTwist; Former CEO, BeautyHealth; and Leslie Trigg, CEO, Outset Medical agreed that successful CEOs keep their focus on delivering returns for their investors—whether private or public. If your company is solving a really important problem and is creating value for patients, you’ll ultimately succeed, Shook said. From there, Trigg pointed out, exit vehicles are simply different modes of transportation to the same place. GUESTS: Bruce Shook, Former President & CEO, Intact Vascular and Vesper Medical Clint Carnell, Co-Founder & Chairman, OrangeTwist; Former CEO, BeautyHealth Leslie Trigg, CEO, Outset Medical, Inc. HOST: Geoff Pardo, General Partner, Gilde Healthcare; Host, Medtech Talk podcast LINKS: Cambridge Healthtech Institute   Medtech Talk  Gilde Healthcare  OrangeTwist Outset Medical

Nicole J. Walker brings far more diversity than just her race and gender to her role as managing partner at Arboretum Ventures. Her background was in operations and engineering, and she knows her perspective has given her valuable insight into the businesses she works with. Walker also credits her team with asking hard questions, applying different experiences, and bringing an historical perspective—together keeping each other disciplined and objective. Walker knows that “fullness of diversity” will be equally successful for the healthcare venture space as a whole. “It’s really important that we keep pushing the envelope on the people around the table,” she says, having honest conversations about who are the decision-makers, how we compensate people for their work, and how our pools and pipelines may be influencing our candidate choice.

Dr. Aaron Kaplan has several startups and many years of cardiology practice under his belt, and he is uniquely positioned to give a physician’s perspective on the medical device startup space and how big ideas actually impact the clinic. As a practicing interventional cardiologist and Director of Clinical Research, Heart & Vascular Center, at Dartmouth-Hitchcock Medical Center, Kaplan is intimately aware of the challenges facing cardiology today and the needs facing both patients and their care providers. And as an entrepreneur and inventor, he’s learned to maximize his role in the startup arena. “The role of the doc is not to design the device, but to define the problem,” Kaplan told Medtech Talk. Kaplan says he brings ideas to the table “that often violate one if not two of Newton’s laws”, but he has learned to hand them over to creative engineers and others with diverse perspectives. While, as a physician, he alone answers for all the care decisions that were made for a patient, as an entrepreneur, he instead builds multidisciplinary teams with competencies that are divorced from medicine. One of the biggest differences between the two roles, Kaplan says, is that entrepreneurs must learn to accept failure. In speaking with Geoff Pardo, Kaplan employs a physician’s traditional habit of postmortem assessment of one of his previous startups, candidly breaking down the problems in the market approach, the trial strategy, and the leadership structure—valuable lessons for him—and others—to apply to future projects. Dr. Kaplan is a practicing interventional/structural cardiologist and a medical device entrepreneur. Aaron supervises cardiology fellows and lectures regularly at the Tuck School. In addition, he directs the Clinician-MBA Scholars Program at Dartmouth. Prior to Dartmouth, he was Director of Interventional Cardiology at the Palo Alto VA/Stanford University. Dr. Kaplan has authored >75 peer-reviewed papers and serves on the Editorial Board of Cardiac Catheterization & Intervention and J Soc Cardiovascular Angiography & Interventions. Aaron is an active entrepreneur who has been on the founding team of a number of companies including Conformal Medical, Tryton Medical, LocalMed and Perclose (acquired by Abbott). Dr. Kaplan is on the Board of Cairn Surgical and was an Entrepreneur-In-Residence at Three Arch Partners. Aaron has authored 60 U.S. Patents and was inducted into the National Academy of Inventors (Class of 2015). He received a BS in Engineering Sciences (Cum Laude) from Tufts University, MD from Wake Forest University, medical training at Northwestern University and cardiology training at Stanford University.

Kurt Azarbarzin grew up valuing discipline, hard work and a can-do attitude, and he credits much of his success to continuing to work and live by those principles. Having moved to the United States from Tehran, Iran in late 1970's as a senior in High School, Kurt was fortunate to live with an American family who knew his own family well. He enjoyed math and science, so he studied manufacturing engineering in college and had his first exposure to the medical device industry from a professor who was then consulting at U.S. Surgical. This professor helped Kurt obtain a part-time job there, and although he was not initially interested in medtech, Kurt quickly became fascinated with surgery as he worked with surgeons in the OR. He learned that if he truly aimed to help the surgeons achieve better outcomes, and not just pitch them products, then a mutually beneficial partnership could develop. After 21 years at U.S. Surgical, the company was acquired by Tyco, and Kurt decided to continue his passion for innovation by first becoming a consultant and then an entrepreneur. In this interview with host Geoff Pardo, Kurt shares how his family values and early learnings at U.S. Surgical helped shape his success as a founder and leader, including starting and exiting SurgiQuest, leading Verb Surgical, and now overseeing ColubrisMX Robotics. Tune in to hear these stories and insights, plus the three most pressing questions you need to be able to answer if you’re considering surgical robotics. BIO Kurt Azarbarzin is a 39-year medtech industry veteran, having led the development of over 90 new products representing over $910 million of annual sales at companies including U.S. Surgical, Tyco Healthcare (now Medtronic), Spine Wave, Respimetrix, SurgiQuest, Verb Surgical, and J&J. He has experience in surgical, robotic, cardiovascular, interventional, orthopedic and urological markets. Kurt founded SurgiQuest in 2005 and sold it to Conmed, and the company’s lead technology AirSeal became the standard of care for advanced Lap and Robotic Surgery. He then became CEO of Verb Surgical, a Joint Venture between Google and J&J consisting of over 550 employees, that was acquired by J&J in January 2020. After that, Kurt became and is currently the CEO of ColubrisMX Robotics, which is developing the first endoluminal robotic platform in the world, thus truly enabling scarless surgery through existing lumens. Kurt currently lives in Greenwich, CT and is a funding member of the MIS Revolution.

The pandemic has certainly affected many aspects of life, but what about the medtech industry? Specifically for this audience, did COVID impact medtech investment strategy? As part of the recent Medtech MVP conference, host Geoff Pardo moderated a panel interview with four medtech investors to tackle that question and many more: Carter McNabb, Managing Director, River Cities Capital Funds; Darshana Zaveri, Managing Partner, Catalyst Health Ventures; Justin Klein, MD, JD, Co-Founder & Managing Partner, Vensana Capital; and Tara Butler, MD, Managing Director, Ascension Ventures. The panel also discussed aspects of the virtual world that are likely to remain in the entrepreneur/VC ecosystem, the latest drama around coverage and MCIT, the rise of consumerism and patient payment, the funding gap for early-stage companies, and the investment appetite for AI/data-driven diagnostics and devices. Listen now to catch these valuable insights! Panelists: Carter McNabb, Managing Director, River Cities Capital Funds Darshana Zaveri, Managing Partner, Catalyst Health Ventures Justin Klein, MD, JD, Co-Founder & Managing Partner, Vensana Capital Tara Butler, MD, Managing Director, Ascension Ventures

Bernie Haffey started his career as a high school physics teacher, then decided to go to business school. He remained interested in science and technology though, so he started working in the medtech industry at Hewlett-Packard’s Medical Products Group before transferring to Mentor Corp. After rising in the ranks at Mentor, Bernie then joined Summit Technology, where he was first exposed to the concept of high-performance management systems. He learned about the importance of a clear vision (and vision statement), the value of a mission statement and how it differs from a vision, and the benefit of narrowing a multitude of initiatives down to the vital few that focus on true breakthrough opportunities. After over two decades of experience as a senior leader at Summit, Intralase, NDO Surgical, and Nexis Vision, Bernie decided to return to his roots, found a consulting firm focused on high-performance management systems, and start teaching management science. In this interview with host Geoff Pardo, Bernie shares many of the critical aspects, decision points, and challenges of high-performance management systems, including how to balance voices of the customer, shareholder, and employee; the importance of a strong operational team who can carry out a new vision; the need for effective systems in addition to brilliant staff; and many of the watchouts when leading change in an organization.

Now a seasoned medtech entrepreneur and leader, Amar Sawhney first became interested in the industry starting in graduate school. He was studying chemical engineering and developing biodegradable polymers for adhesion prevention and hydrogels for light-activated polymerization within the body. He and his advisor were then approached by Mayfield Fund to spin out the technology into the startup Focal. Amar was fortunate to learn a lot from then CEO Mark Levin, including some hard lessons that drove him and Fred Khosravi to found Incept, an IP holding company for creating operating companies based on field of use. As CEO/Founder of Confluent Surgical, AccessClosure, Augmenix, Ocular Therapeutix, and now Instylla, Amar learned how to transition from scientist to executive and is truly a medtech influencer. In this interview with host Geoff Pardo, Amar shares many of the valuable lessons he’s learned founding and managing various startups, including how to find the right application for a technology, when a platform solution really makes sense, how to effectively lead and build successful teams, the value of a diverse workforce, and tips for overcoming the funding gap for early-stage companies, plus his candid thoughts on the differences in funding/entrepreneurship between the East and West coasts. Amarpreet (Amar) Sawhney, Ph.D., is the Founder, Chief Executive Officer and Chairman of the Board of Directors of Instylla. He is also the CEO of Pramand LLC, and Rejoni, Inc. Prior to this Dr. Sawhney served as CEO and Chairman of Augmenix (acquired by Boston Scientific) and Ocular Therapeutix (NASDAQ: OCUL). In addition, he is a general partner of Incept, LLC, an intellectual property holding company. Previously, Dr. Sawhney founded Confluent Surgical and served as its President and CEO prior to its acquisition by Covidien plc. He also was a technology founder of Focal, Inc., a biopharmaceutical company acquired by Genzyme Corporation, and a founder of AccessClosure, Inc., acquired by Cardinal Health. Dr. Sawhney’s innovations are the subject of over 120 issued and pending patents. He holds M.S. and Ph.D. degrees in chemical engineering from the University of Texas at Austin, as well as a B.Tech. in chemical engineering from the Indian Institute of Technology, Delhi India.

Navigating the ever-changing sea of medtech reimbursement is never easy, particularly with the recent swings in policies pertaining to breakthrough devices. As part of the continued Medtech Talk Digital Discussion Series, host Geoff Pardo moderates a panel interview with three medtech reimbursement experts to look at strategies for obtaining reimbursement coding, coverage, and payment: Mary Hailey, CCM, CDMS, Vice President Health Economics and Reimbursement, Relievant Medsystems, Inc.; DeChane Dorsey, JD, Executive Director of AdvaMed Accel, AdvaMed; and David Gregory, Principal, Healthcare & Life Sciences Consulting Leader, Baker Tilly. The panel discusses coding and payment issues that are particularly pertinent to small/mid-sized companies; the impact of recent changes to accommodate breakthrough devices, including MCIT, Add-On payment, NTAP, and TPT; CMS’s approach to handling issues/questions and how to best work with the agency; thinking wholistically about bringing your product to market (more than just FDA approval); and the influence of advocacy efforts by physician specialty societies on coding and payments. Listen now to catch these valuable insights! Mary Hailey, CCM, CDMS, Vice President Health Economics and Reimbursement, Relievant Medsystems, Inc. DeChane Dorsey, JD, Executive Director of AdvaMed Accel, AdvaMed David Gregory, Principal, Healthcare & Life Sciences Consulting Leader, Baker Tilly

There’s nothing like those pivotal moments of a startup that lead to it becoming wildly successful. The excitement as the company’s first product begins to earn market share and attention from additional investors or acquirers. This month’s podcast guest Joe Mandato has been in that situation with several successful startups turned corporations, including Guidant Corporation, Origin Medical Systems (predecessor of Intuitive Surgical), and Align Technology (maker of InvisAlign), as well as leading Tear Science and iOptics Research. Joe has learned a lot about leadership throughout these endeavors and his doctoral research on the effectiveness of corporate governance. He’s seen firsthand the importance of understanding where leaders can contribute and where they need help; switching from the “wrong” application to the “right” one; having technological innovation at root, but the right business model innovation and culture to achieve to success; and maximizing boards of directors. After many decades in the industry, Joe is truly a medtech mentor. In this interview with host Geoff Pardo, Joe shares many of the valuable lessons he’s learned working with various startups, how to shift from being an operator to an investor, how to best leverage boards and board meetings, and his suggestions for changes in the healthcare system and opportunities coming out of COVID. Joe Mandato holds a Doctor of Business Administration degree from Case Western Reserve University, where his research focused on the evolving role of boards in ensuring effective corporate governance. He was a 2011-2012 Fellow of Harvard University’s Advanced Leadership Initiative and served as Co-Chair of Harvard’s Advanced Leadership Coalition. He is a Managing Director at DeNovo Ventures, Senior Advisor at Apercen Partners and Sonder Capital and Lecturer at Stanford University. He has served on more than 20 public and private boards of directors focused on technology and the life sciences. He also serves on the boards of Case Western Reserve University, Headstart and Save the Children. He was an investor, board member and advisor to the founders of Align Technologies (Invisalign) and has served as CEO of five life sciences companies, which created significant shareholder value. He was a member of the founding management committee of Guidant Corporation (NYSE) and was an entrepreneur-in-residence at Mayfield Fund, a Silicon Valley venture fund. He has authored or co-authored numerous articles on healthcare and governance and the book The Entrepreneur’s Journey.

Like many entrepreneurs, Christian Gormsen admits he didn’t start his career with a passion for his current field. Instead, he backed into the hearing industry from his work in investment banking and consulting, and eventually wound up working at the world's 4th largest hearing aid company. Christian realized just how stigmatized hearing aids are and became determined to address this. In 2012, he was first connected to Eargo while doing advisory work. Unlike other traditional hearing aids, Eargo’s products are basically invisible, comfortable, rechargeable, removable, and sold directly to consumers rather than via physicians. After being a board member for about 3 years, Christian was asked to lead Eargo as CEO through a challenging time in 2016, and by the end of 2017, he had achieved a four-fold increase in sales and the company has since gone public. In this interview with host Geoff Pardo, Christian shares his story of entering the hearing industry and then joining Eargo, various unique aspects about the company compared to traditional hearing aid manufacturers that have led to their success, achieving cognitive diversity via cultural diversity, and the effect on the company’s personnel after its recent transition to being public.

After passing out from extremely painful complex ovarian cists at age 13, Surbhi Sarna became all too familiar with the challenges and lack of adequate solutions for women’s health. Benefiting from intelligent and entrepreneurial parents, she became so determined to start a company to tackle women’s health issues someday that she wrote it in her college application personal statement. After graduating from UC Berkely, she went to Abbott Vascular to work on some of their most innovative products before transitioning to BioCardia for more of a startup culture. While at both places, she continued to read papers about women’s health, and after she lost her grandmother to breast cancer, she decided to take her leap of faith and start nVision Medical. In this interview with host Geoff Pardo, Surbhi shares her story of founding and leading nVision, including securing a very challenging first funding round, transitioning from being an engineer to a woman CEO, negotiating the company’s eventual exit, and staying onboard to support the product’s further development as part of Boston Scientific. Here all this plus Surbhi’s thoughts on the changing landscape of women’s health and what’s next for her.

Despite the pandemic, 2020 was a successful year for medtech. The industry reaped the fruits of over a decade of concerted effort to reduce regulatory hurdles, work better with hospitals and diagnostic companies, and increase innovation. As part of the continued Medtech Talk Digital Discussion Series, host Geoff Pardo teams up with Justin Klein to co-moderate a panel interview with three medtech investment experts to recap 2020 and look to strategies for 2021: Scott Whitaker, President and CEO, AdvaMed; Mark Deem, Venture Partner, Lightstone Ventures; Managing Partner, The Foundry, LLC; and Rachel Jonas, Vice President and Investment Analyst, T. Rowe Price. The panel discusses challenges, watchouts, and opportunities for 2021; the continually evolving reimbursement landscape; the need to and how to encourage more early stage investing; public funding and whether the medtech IPO window will persist; where to invest next; and what new administration and policy issues to watch out for. Listen now to catch these valuable insights!