Newport Beach Speakers

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  Stanton J. Rowe

  Founder & CEO, NXT Biomedical Incubator - Former Chief Scientific Officer and Corporate Vice President of Advanced Technology of Edwards Lifesciences Corp.

  Mr. Stanton J. Rowe, also known as Stan, is CEO of the NXT Biomedical Incubator He is a former Chief Scientific Officer and Corporate Vice President of Advanced Technology at Edwards Lifesciences Corp. Mr. Rowe served as a Scientific Advisor at Ascent Biomedical Ventures. He Founded Percutaneous Valve Technologies (sold to Edwards).

  Mr. Rowe served as the President and Chief Executive Officer of Percutaneous Valve Technologies Inc. (PVT). He served as the Corporate Vice President of Business Development and Strategic Planning at Datascope Corp. Prior to this, Mr. Rowe served as a Vice President of Business Development at Johnson & Johnson’s Interventional Systems Division (JJIS), responsible for Johnson & Johnson’s coronary stent development efforts. At JJIS and the related Cordis Corporation, he held a variety of positions with increasing levels of responsibility, including heading Johnson & Johnson’s Business Development, Advanced Technology, Worldwide Clinical Research and Marketing groups. Mr. Rowe joined Cordis after having held several positions in product management for various medical device companies.

  He serves as a Director of InSeal Medical Ltd. Mr. Rowe also serves as Director of Remon Medical Ltd. He serves as a Board Member of NeuralAnalytics and the Discovery Science Center in Orange County. He serves as a Director of Zift Medical, LLC. He served as a Director of Biomerix Corporation. He holds a Bachelor’s Degree from the University of Alabama.

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  Lessons Learned from the Birth of TAVR

  I love the idea of the big, hard problems

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  Paul Lovoi, PhD.

  Co-Founder and CTO, MindRhythm Inc. - Serial entrepreneur of eight companies

  A serial entrepreneur, Paul has founded and funded eight companies in diverse fields including flat panel displays, laser paint stripping, oncology, cardiology, and stroke triage. With 43 years of experience inventing solutions to significant problems in technology and medicine, Paul is backed by a demonstrated track record of translating those solutions into the clinic. He is dedicated to guiding teams in new product development and working around solutions to make significant shifts in technology and markets.

  Following the death of his wife due to a stroke, Paul was determined to prevent this from happening to others. In discovering the Headpulse algorithm, he found a way to accurately diagnose stroke in a non-invasive manner leading him to form MindRhythm.

  “The device technology is a groundbreaking effect of the innovative product development and clinical proficiency from a team dedicated to lifesaving, diagnostic treatments. Seeing that solutions are made and brought into the marketplace in preventing stroke complications is at the utmost importance."

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  The Purpose Driven Medtech Startup – Turning Life Experience into Successful Medtech

  Applying tech industry lessons to medtech

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  Deepika A. Lakhani Ph.D.

  Vice President of Regulatory & Quality, PAVmed Inc. - Former FDA Team Leader and Corporate Regulatory Affairs Expert

  Deepika A. Lakhani serves as the Vice President of Regulatory & Quality, at PAVmed Inc. Prior to her current role, Deepika was at AstraZeneca Pharmaceuticals in Global Regulatory Affairs and has also spent nearly 11 years at the FDA where she started as a reviewer in Center for Drugs Evaluation and Research (CDER) and subsequently served in multiple positions in CDER and Center for Devices and Radiological Health (CDRH) involved with the review of medical devices, drugs, biologics, and combination products. Deepika considers regulatory affairs to be a creative process that enables innovation. She has multiple peer-reviewed publications and received many awards for excellence and leadership while at the FDA. She holds a Ph.D. in Pharmaceutics from Virginia Commonwealth University.

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  Effective Communications with Regulators

  Insights and tips from a former FDA team leader

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  Gregg Homer, JSD (PhD) - Chairman and Chief Science Officer at Strōma Medical Corporation

  Invented instant coffee bags at age 12, patented “subscription on demand”, leader in permanent eye color change

  Gregg Homer grew up in Los Angeles, California. He began inventing at age 12, when he put espresso grind coffee in a tea bag for instant steeped coffee and sold the invention to Hills Bros. Coffee in San Francisco for $2,000.

  While in high school, Dr. Homer worked as a studio musician (piano and guitar) for Epic Records, as a close-up magician at the Magic Castle, and as an understudy in the LA cast of “Hair.” At 16, two years before graduation, Dr. Homer dropped out of high school to attend Immaculate Heart College in Los Angeles. He graduated with a BA in English and spent his final year in the graduate creative writing program. Dr. Homer then attended Stanford Law School, where he graduated at the top of his class and served as a senior editor of the Stanford Law Review.

  Dr. Homer practiced entertainment law in Los Angeles for two decades, served as an arbitrator for the Screen Actor’s Guild, and taught the entertainment law curriculum at Stanford Law School for several years. While at Stanford, Dr. Homer completed an interdisciplinary doctorate in evolutionary neurology and economic game theory, writing his dissertation on the co-evolution of the neural system and social order.

  Dr. Homer’s time at Stanford also reignited his early passion for invention and innovation. His first patent claimed a method for monitoring internet packets, now known as “deep packet inspection.” His next patent claimed the on-demand distribution of media files over the internet on a subscription basis, now know as “subscription on demand” and reflected in such delivery platforms as Netflix, Spotify, Hulu, Apple Music, and Amazon Prime. Dr. Homer’s third invention was laser eye color change, which has been developed for commercialization by Strōma Medical Corporation. Dr. Homer continues to invent, primarily in the fields of medical devices, media and communications, and enterprise software applications.

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  From Entertainment Law to Eye Color Change:

  What a Long Strange Trip It’s Been

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  Earl Slee, Board Member or Advisor to Six Medtech Organizations

  (Retired) Vice President, Technology, Strategy and Business Development, Medtronic Brain Therapies

  Earl brings over 35 years of experience as an engineering and business innovator in the medical device space. His innovations are the standard of care for treating stroke endovascularly – aneurysms, arterio-venous malformations, and acute ischemic stroke. He has earned 28 U.S. patents. Annual revenue for the Neurovascular business that Earl was involved in has grown from a zero-revenue start-up in 1998, to a business in excess of $1B annual revenue (now residing within Medtronic). Most recently, Earl led the Technology, Strategy and Business Development (M&A) group for Medtronic Brain Therapies - a developer, manufacturer, and commercial organization focused on endovascular therapies for hemorrhagic and ischemic stroke, electrical brain stimulation therapies for movement disorders, and neurosurgical enabling tools and therapies. In his role, Earl was responsible for portfolio management, business strategy and external technology and company acquisition and licensing.

  Earl joined Micro Therapeutics Inc. (MTI) in 1998 as Vice President, R&D, and led the development of Onyx liquid embolic and delivery systems for treatment of AVMs (MTI was acquired by ev3 in 2006). At ev3 (VP of R&D), Earl led the development of Axium embolic coils for aneurysm treatment and invented the first stent-retriever for acute ischemic stroke (Solitaire FR) (ev3 was acquired by Covidien in 2010). At Covidien, serving as VP R&D and Business Development, Earl was integrally involved in acquiring and launching Pipeline Flow Diverter (Covidien was acquired by Medtronic in 2015). At Medtronic, Earl also served as interim VP/General Manager of the Enabling Technology business (>$1B in annual revenue), earned the 2017 Patent of Distinction award, and was inducted as a Bakken Fellow in 2016 (Medtronic’s highest technical award). Earl retired from Medtronic in October, 2020.

  From 1995 until 1998, Earl was Vice President of R&D with Aequitron Medical, Inc., a manufacturer of portable respiratory care devices (acquired by Nellcor Puritan Bennett in 1997). From 1992 until 1995, he was Director of Engineering with Instromedix, a manufacturer of portable ECG monitors. From 1983 to 1992, Earl held various engineering and management positions with Pfizer, Welch Allyn and Hughes Aircraft Co.

  Earl holds a bachelor’s degree in Physics with a minor in Mechanical Engineering from the University of California, San Diego. He also holds an MBA from the Tuck School of Business, Dartmouth College and an MSEE from San Diego State University.

  Earl serves on the boards of a pediatric interventional cardiology company, a surgical robotics company, and a mechanical thrombectomy company; he also serves as an advisor to start-ups in the brain-computer-interface and neurovascular catheter spaces; and serves as an advisor to Octane and chair of Octane’s CEO Peer Leadership Group.

  Earl recently celebrated his 39th wedding anniversary with his wife, Elisa (a consultant who provides STEM professional development). They have two children, one working in education in Los Angeles, and one in a PhD program in Sociology and Social Policy at Princeton.

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  How strategic acquirers determine value

  Case Studies in Strategic Exits

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  Ramgopal Rao

  Chief Executive Officer, LensGen, Inc. - serial entrepreneur with 25 years of experience in the ophthalmic pharmaceutical and devices

  Ram is a serial entrepreneur with 25 years of experience in the ophthalmic pharmaceutical and device industry. Ramgopal is inventor, founder and chief executive officer of LensGen, Inc., a clinical stage medical device company that is developing a novel intraocular lens for presbyopia. The Company has received support from one of the largest medical device companies in the world. LensGen closed a $28.0 million Series A Financing in May 2018.
  Currently he is also Chairman of the Board of 2C Tech Corporation, Inc., an emerging medical device company that is developing a novel nanotechnology application for preservation of vision for patients with degenerative retinal diseases. 2C Tech Completed Series B Financing in 2016 and 2019.

  Ram co-developed an innovative corneal implant device for presbyopia and licensed the technology to (venture funded) Acufocus, Inc. The company is now commercializing the product on a global scale. Prior to that, Ram founded Tomey Technology Inc., that pioneered the corneal topography imaging technology that is now a standard of care in eye care for LASIK and cataract surgery. This joint venture company was acquired by Tomey Corporation of Japan.
  He was Chief Operating Officer and Director of Vitreoretinal Technologies, Inc., a venture funded ophthalmic pharmaceutical company that developed a drug for diabetic retinopathy.

  Ram was President of Ophthalmic Group at Premier Laser Systems, Inc.; a publicly held company that developed the first laser assisted cataract surgery technology. He also held various executive positions at Biorad Laboratories, Inc.

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  Going after the Holy Grail of Ophthalmology - The LensGen story

  How it happened and lessons learned.

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  Bill Walker Ph.D.

  Director of Entrepreneurship, Duke Engineering - Inventor, serial entrepreneur, and educator

  Bill Walker is an inventor, serial entrepreneur, and educator. He has repeatedly invented solutions to unmet clinical needs and built companies to deliver those solutions. PocketSonics, acquired in 2014, developed the Sonic WindowTM, a compact, low-cost imaging platform to guide peripheral vascular access. HemoSonics, acquired in 2017, developed a comprehensive point of care in vitro diagnostic to determine the cause of critical bleeding and enable rapid, directed treatment. Over a 12 year period as a professor of Biomedical Engineering at the University of Virginia, he built a world-class ultrasound research lab and co-created UVA’s undergraduate major in Biomedical Engineering. In 2016 he was named the Mattson Family Director of Entrepreneurship at Duke Engineering. In this role he coaches innovators and entrepreneurs, leads two major research projects, directs the A. James Clark Scholars Program, and is actively building new programs in education and entrepreneurship. Dr. Walker holds BSE and PhD degrees in Biomedical Engineering from Duke.

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  Ultrasound Entrepreneurship:

  Perspectives as a Player and a Coach

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  Yiorgos Polizos

  VP of Sales and Marketing, Life Science Outsourcing (LSO)

  Yiorgos Polizos is the VP of Sales and Marketing at Life Science Outsourcing (LSO) since January 2023.
  Prior to joining LSO, Yiorgos has held various leaderships roles across multiple industry segments.
  His career started in the Cardiovascular sector, where he led a Cardiac Rehab and Non-Invasive Cardiology unit, later expanding into the invasive space with leadership roles in the Cath Lab and Electrophysiology. He has been a published author and research director on multiple journals in the cardiac Electrophysiology space, currently being an active reviewer for the American Journal of Cardiology.
  Leveraging his clinical expertise, Yiorgos took on roles of increasing responsibility with various Blue Chip companies like Medtronic and 3M.
  His tenure includes VP roles with multiple cardiac and infection control start ups, which he led to a successful exit.
  Most recently, Yiorgos served as the Global Sales Director at Integer, having an intimate view and engagement of the supply chain, operations and commercialization.
  He holds a Bachelor’s of Science in Exercise Science with an emphasis in Cardiovascular Physiology and an Executive MBA in Healthcare Economics, Policy and Polotics from the Merage School of Business at the University of California, Irvine.
  On the personal front, he has been a member of the Greek National swim team, world master’s swim champion and Div I collegiate Water Polo Player.
  He continues to stay active and compete and resides with his wife and daughter in Orange County, CA.

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  Yoav Raiter, Chief Executive Officer and Director of Scryb and Cybeats

  Developer of innovative software and medical device products

  Yoav is the current Chief Executive Officer of Scryb and Cybeats, which is a position he has held for the last two years. Prior to that, he held the position of Director of Product Development. His career has focused on developing innovative software and medical device products mainly for start-ups and fast-growing companies. He has developed processes to ensure delivery against clients needs at a high-quality standard, has improved operations, and business strategy. Prior to joining Scryb, he was project manager for strategic accounts at StarFish Medical and director of project management and business development at Kangaroo Group. He has also held several prominent positions managing large scale ERP product development and implementation projects for broadcasters in Canada and the US for Pilat Media and SintecMedia. Yoav was the co-founder and Co-CEO of Panta-Rhei, a software development and consulting firm. He received an MBA, specialized in High Tech Innovation Strategy, from Haifa University in Israel in 1997 and a B.Sc. in Industrial Engineering in 1993.

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  Why SBOM are Critical to Managing Medical Device Software Supply Chain

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  Ryan Kelly, PhD, MBA

  General Manager, Innovation Lab

  Ryan operates in the frontlines of health innovation at the intersection of biomedical research, innovation, commercialization, and transformation. His work spans the entire landscape of product and service innovation, from translating unmet needs into products in market, to helping hospital systems foster a culture of innovation. Ryan brings over 20 years of experience in research, innovation, and commercialization to his role as General Manager at Innovation Lab. At the Lab, he leads a talented team of professionals across the country, and together they manage partnerships with seven major hospital systems and alliance partnerships with industry and academia. They collaborate with 200,000 medical professionals affiliated across those seven systems to develop, commercialize, and bring new products and solutions to patients and the market at scale. Ryan has amassed a long list of accolades including closed deals, strategic partnerships (industry, academia, venture), grants and fellowships, guest speaker at national and regional industry groups, and published many peer-reviewed articles. Ryan blends his health, tech, and business mindsets to not only translate unmet needs into implemented solutions at scale, but also advise organizations and their leaders on how to identify and monetize often overlooked clinical and operational know how. Prior to joining the Lab in 2015, Ryan held executive positions within the commercialization teams at Cleveland Clinic, City of Hope National Medical Center, and Scripps Research Institute where he was responsible for commercializing breakthrough drugs and diagnostics. He earned his PhD in immunology from the University of Minnesota, BS in biochemistry from Cal Poly San Luis Obispo, and MBA from the University of Southern California. When Ryan isn’t working to improve healthcare across the US, he can be found enjoying the sun and surf with his wife and children in Orange County, CA.

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  Getting Value from strategic Health System Partners

  Industry Panel

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  Pablo Avalos

  Associate Director of Translational Medicine, Regenerative Medicine Institute

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  Getting Value from strategic Health System Partners

  Industry Panel

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  Matt Mitcho

  Co-Founder & CEO, Gemelli Biotech

  Matt Mitcho brings twenty three years of experience in the life sciences, pharmaceutical and laboratory industries to his chief executive position at Gemelli Biotech. Prior to joining Gemelli, Matt served as a strategic consultant for Exact Sciences and as a brand director in the gastroenterology space at Salix Pharmaceuticals, leading successful brands like Xifaxan. He also held positions at GlaxoSmithKline including ones in sales, sales training, and marketing. Matt received his MBA from Kenan-Flagler Business School at the University of North Carolina and his B.S. degree in public affairs from Indiana University.

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  Getting Value from strategic Health System Partners

  Industry Panel

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  Michael Hill

  Managing Director of Octane Capital Markets, Octane Capital & Growth

  Michael Hill is the Managing Director of Octane Capital Markets, as a part of the Octane Capital & Growth division. “Mike is the ideal person to serve in this new capacity”, said Bill Carpou, CEO of Octane. “He has walked in the shoes of the entrepreneurs we serve and understands the obstacles companies face to raise capital as they start their journey. Mike is client focused and has delivered results since joining Octane.” Michael is an experienced entrepreneur and angel investor with a deep passion for helping startup technology and medical technology companies advance their business models. He has co-founded, grown, and created liquidity for investors at two startup software companies and a professional services business which he ran for 25 years. Prior to leading his own ventures, he worked for Merrill Lynch, Xerox, and Orco Block Company. He also worked with the Small Business Development Center (SBDC) hosted at California State University, Fullerton where his teams helped the owners of small businesses secure more than $100 million in funding solutions.

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  Nick Allan, Bio Services Manager at StarFish Medical

  Designed, Facilitated and Executed more than 500 Unique Research Protocols and Medical Device 510(k) Antimicrobial Support packages

  Nick has over 19 years of regulatory and product development experience in the field of microbiology and assay development. Over his career, Nick has provided innovative solutions to issues ranging from proof-of-concept studies for rapid detection point of care assays, to full scale regulatory submission studies. At StarFish Medical, he applies this skill set to product development and currently manages the Bio Services division, formed in 2015 to support novel infectious disease detection platforms and gene and cell therapy products. Through the Bio Services department, Nick oversees advanced equipment, BSL2 facilities and personnel with advanced degrees and training in Bio Services focus areas.

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  Developing the World’s First Ingestible Digital Fluorometric Laboratory: From First Principles to First In Human

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  Scott Phillips

  CEO and Founder, StarFish Medical

  Scott Phillips is CEO and Founder of StarFish Medical. Scott holds a degree in Engineering Physics from the University of British Columbia. Prior to starting StarFish, he worked in diverse areas such as lithium battery development and manufacturing, UV spectroscopy instrumentation and hi-fi audio speakers. Under his leadership StarFish has grown into a diverse professional organization with clients around the world and 100% focus on medical devices. Scott is a Fellow of The Canadian Academy of Engineering, winner of the EY Entrepreneur Of The Year™ 2017 Pacific Awards Technology category, 2017 recipient of the VIATEC Technology Champion award, member of the LifeSciences British Columbia board, and volunteers with Junior Achievement, Entrepreneurs Organization, and University of British Columbia.

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  Studies in Lean Medtech Startups. 

  Development and Investor Milestones for an efficient startup.