MedTech Innovator LIVE

Paul Fasolo has 20 years of medical device experience in mechanical design engineering, systems engineering, R&D project management, and R&D functional management. He spent 14 years working at startup companies with less than 50 employees. Paul specializes in non-invasive image guided therapies including ultrasound and radiotherapy.

As the Director of Research and Strategy at Ximedica, Elizabeth is responsible for informing product design through end user insights, and for ensuring that products comply with the Human Factors expectations of regulated bodies. She is passionate about ensuring that products are not only safe to use, but that they are also enjoyable and compelling. Elizabeth’s work extends from physical devices to apps, websites, connected experiences and voice user interfaces. To this end, she leverages a range of Human Factors and Design Research methods including contextual inquiry, heuristic evaluations, participatory design, task analysis, cognitive walk-throughs, and usability studies. Elizabeth has over 20 years of experience conducting research and Human Factors work in the US, Europe and in emerging markets in the space of both consumer and medical products. Elizabeth previously worked at the Munich office of frog Design as the Principal Director of Design Research, at Siemens as a Usability Engineer, and at Sprint as a User Experience Design Manager. She holds a Bachelor of Arts in Psychology and German, magna cum laude, from Vanderbilt University and a Master of Science in Cognitive Psychology (Psychologie Diplom) from the University of Regensburg, Germany. Elizabeth is a co-inventor on 13 patents, and regularly holds workshops and gives presentations on Human Factors and Research.

Chris Wilson is the Director of Human Centered Industrial Design in the San Francisco office of Ximedica. With over 15 years designing products in the medical and biotech spaces, he leads multi-disciplinary teams through projects ranging in scale and complexity. He takes pride in providing hands-on design leadership with evidence-based design thinking resulting in solutions that meet client needs while improving the lives of end users and those whose lives they impact. He has won numerous design honors including those awarded by Medical Design Excellence Awards, Businessweek International Design Excellence Awards, Good Design, Spark, and Core77.

Phil Halbert is a product development leader with proven experience in medical devices, team leadership, concept generation, CAD, mechanism development and design for manufacturability. His work has resulted in over 20 US patent applications and multiple IDSA and MDEA awards.

He has been managing projects in medical and biotech at Bridge Design since 2006 and directing the engineering department since 2008. Bridge Design merged into Ximedica in 2015 and he directed site operations for the first year of transition and now directs the engineering team in San Francisco.

Clients while at Ximedica/Bridge have included Second Sight Medical Products, Arthrex, Medtronic, Accelerate Diagnostics, Oraya Therapeutics, Abbott Diabetes Care, Glaukos, Spectranetics, Intellicyt, LI-COR, and more.

He began working as a mechanical engineer in the year 2000. His early experience was in developing consumer electronics at Foundation Design for clients such as Kodak, Palm, and Netgear. Phil graduated from UC Berkeley with a B.S. in mechanical engineering in 1999.

Marc Chaput brings over twenty years of experience in investment banking and investment management, primarily in the emerging growth health care / medical device sector, and is currently a Partner at Gravitas Healthcare, LLC. Before Gravitas, he was a Director in Cowen & Co.’s health care group and was a senior member of the medical technology investment banking team responsible for originating and executing financing and M&A advisory assignments. He was based in San Francisco and was the senior member of Cowen’s health care group on the west coast. He joined Cowen from Deutsche Bank, where he spent over six years in the health care group in San Francisco. Prior to joining Deutsche Bank, he worked in equity research at Pell, Rudman & Co., an investment management firm in Boston. He also serves on the boards of Fe3 Medical and Procyrion and is on the Advisory Committee of Sweetwater Capital Partners. He holds a B.A. from Bates College and an M.B.A. from the J.L. Kellogg Graduate School of Management at Northwestern University. He is based in San Francisco, CA.

Ben is currently the national leader of SVB’s Early Stage Life Science Practice, which represents the interests of pre-Series A life science start-ups. In addition to spending time with early stage companies, Ben also focuses upon building relationships with key centers for life science technology development, such as accelerators, academic & corporate tech transfer, and business professionals who specialize in helping early stage life science companies. Ben is also a frequent speaker on relevant issues affecting innovative life science companies, and is active in the life science innovation ecosystem.

Ben joined SVB in 2007 to lead the technology and life science effort in the State of Minnesota, and in 2010 began focusing exclusively upon life science companies across the Central United States, and led SVB’s effort in this region through 2017.

In concert with his broader leadership responsibilities at SVB, Ben has successfully deployed over $1 billion of strategic debt capital to growth-oriented life science companies that are either pre-cash flow or pre-revenue, and has specific expertise in the craft of venture debt. Additionally, over the years Ben has developed influence/expertise in the medical device sector and is active nationally in representing SVB’s brand in this sector. Prior to joining SVB, Ben spent 11 years in various roles in both commercial and private banking at US Bank and Wells Fargo, respectively.

Scott is Vice President – Global Access, Value & Economics at Intuitive Surgical. He has held similar positions at Baxter International, Johnson & Johnson. He has a wealth of expertise in health economics and market access.

David Uffer is the Vice President and senior partner of Alira Health, leading their global Medtech practice in management consulting and investment banking advisory.  David is a 30 year veteran of healthcare having spent the majority of his career in various management roles at leading large cap medical device and diagnostic companies. He has directed strategy development, strategic planning and business development activities in these fields in order to accelerate adoption and growth of existing and newly introduced technologies and solutions. David has led business development deals ranging from M&A, licensing, distribution and co-development for numerous companies since he began his career in in vitro diagnostics, with Abbott Labs’ $3B Diagnostic Division. He then helped create and execute a newly formed Oncology Division at Boston Scientific in a strategy and Bus Dev role leading new market assessments, strategic clinical and market access initiatives, and executed acquisitions. Afterwards, David joined Hologic, Inc. in corporate development completing numerous licensing, distribution and acquisition deals augmenting and reformulating the women’s health portfolio across molecular diagnostics, breast health and gyn surgery. Most recently he led the Business Development function for the $5B Medtronic (legacy Covidien) patient care, respiratory and monitoring business in which he was responsible for acquisitions, licensing and distribution agreements and multiple minority equity investing in areas of strategic growth. David has also held management roles at Integra Lifesciences and Bovie Medical in areas of new product development, downstream marketing management and commercial introduction of new technologies. David has a BA from Clark University,Worcester, MA and an MBA from Thunderbird, School of Global Management.

Deirdre Baggot, PhD, is one of the nation’s most respected voices on healthcare payment reform. She pioneered development of bundled payments as the leader of the CMS Acute Care Episode (ACE) bundled payment demonstration at Exempla Healthcare in Denver. Drawing upon this work and her experience as a clinician and hospital executive, she has designed and implemented new payment models with employers, commercial payers, and Medicaid and Medicare in over 200 hospitals. These care model transformation initiatives have led to reduced costs, improved quality, and better patient experiences.

In addition to being a trusted advisor to health system boards and senior leadership, she has served as an expert reviewer to CMS for the Bundled Payments for Care Improvement Initiative and an advisor to the New York Medicaid bundled payment pilots. She is a noted author and frequently presents to national audiences on healthcare payment reform.

Jo Carol Hiatt, MD, MBA, FACS, is chair of the National Product Council for Kaiser Permanente and also chairs KP’s Inter-Regional New Technologies Committee. She is a partner in Southern California Permanente Medical Group (SCPMG) and is currently Assistant Medical Director, SCPMG Business Management. Jo chairs Southern California’s Technology Deployment Strategy Team as well as the Oversight Committee for Integrated Medical Imaging. She joined Kaiser Permanente as a general surgeon at Panorama City, later serving as Chief of Surgery at that location and member of the SCPMG Board of Directors. Jo received her undergraduate degree from Stanford University and her medical degree from Duke University. She trained in general surgery at UCLA. In addition to her clinical degree, Jo received an M.B.A from UCLA’s Anderson School of Management. She was designated an American College of Surgeons Health Policy Scholar in 2013.

Dr. William “Billy” Cohn, MD is one of the most renowned medical device inventors today. He is the Vice President for Johnson & Johnson Medical Devices Companies and the Executive Director of the new Center for Device Innovation and Director of Minimally Invasive Surgical Technology and Co-Director of the Cullen Cardiovascular Research Lab at the famed Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston, TX. He has over 15 years of experience in cardiothoracic surgery and over 90 active or pending patents for medical devices, several of which have revolutionized heart surgery techniques. He is the founder or co-founder of five venture-backed life science startups. In addition, Dr. Cohn is a venture partner at Santé Health Ventures, a venture capital firm focused on capitalizing early-stage life science technology.

Dr. Jaye Thompson has over 30 years of experience in clinical research and currently serves as Co-Founder and Chief Operating Officer of Proxima Clinical Research, Inc., a firm assisting emerging companies in development of medical devices and drugs. Dr. Thompson was President and Founder of SYNERGOS, Inc, a contract research organization based in The Woodlands, Texas which was acquired by inVentiv Health (VTIV) in 2006. Later, Dr. Thompson was Director and Senior Vice President of Clinical and Regulatory Affairs for Repros Therapeutics Inc (RPRX) and Opexa Therapeutics, Inc. (OPXA). Throughout her industry and consulting experience, Dr. Thompson has advised a large number of life science companies on strategic planning, clinical product development and regulatory affairs. Dr. Thompson holds a B.S. degree in Applied Mathematics from Texas A&M University and MS and PhD degrees in Biostatistics from the University of Texas Health Science Center in Houston. She served on the Governor’s Texas Emerging Technology Fund Advisory Committee.

Matt Wagener is the Vice President of Clinical Operations at Proxima Clinical Research, Inc., a contract research organization that serves the emerging drug and medical device industries. Matt has over 15 years of industry experience working across multiple life science businesses in key areas including clinical operations, business operations, and business development. Prior to joining the Proxima team, Matt was the Sr. Director of Corporate Operations at the CRO MedSource and held several management positions at McKesson/US Oncology. While at MedSource, Matt successfully managed corporate operations and business development through high growth period building operations to support growth. At US Oncology Matt led clinical and business operations for launch of their oncology CRO through start-up, full service clinical trial operations, and business acquisition. Prior to managing the CRO business unit at US Oncology, he led clinical development for the Lung, GI, Hematology, and Radiation Oncology research programs. He also held other research positions at the University of Texas Medical Branch in Galveston in the department of Orthopedic Surgery and MD Anderson Cancer Center in the department of Radiation Oncology. He received his degree in biomedical science from Texas A&M University. Since starting his career in research, he has worked in key sections of basic and clinical research from bench to bedside to management.

Isabella Schmitt is a Regulatory Affairs Consultant at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. At Proxima, she has worked on various medical device and drug product consulting projects and submissions across all stages of development. Prior to joining the Proxima team, Isabella served as the Senior Regulatory and Quality Manager at a medical device company, where she was charged with outlining the regulatory strategy and putting together design controls and design history documentation, and as the Director of CMC and Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US. She has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications. Isabella graduated from the University of New Orleans with honors in Chemistry. During her undergraduate career, she managed her own research projects, which involved the modification of nanoparticles for applications in the medical and energy fields and presented at a number of chemistry and materials science research conferences. She is also RAC certified. She has written content for multiple companies to help with their marketing reach. Isabella is passionate about engaging with startups and is eager to assist with the advancement of innovative technologies in health care.

Dr. Murray Sheldon, MD received his medical degree from the University of Michigan Medical School in 1975 and his cardiovascular fellowship at the Montefiore Hospital and Medical Center in New York. After practicing cardiac, thoracic and vascular surgery in Northern California for over 20 years, he entered the medical device industry, leading device development projects and providing expert consultative services to numerous start-up innovative medical device development firms. Dr. Sheldon joined the FDA in 2013 as the Associate Director for Technology and Innovation overseeing the Center’s initiative to proactively facilitate medical device innovation to address unmet public health needs and to align what is traditionally done at FDA with what is required to support the US medical device ecosystem. His primary focus is working with FDA staff, the medical device industry, the clinical community and other stakeholders on ways to facilitate bringing innovative medical devices to the patients in the US first in the world. Dr. Sheldon currently leads the Medical Device Payer Communication Task Force, identifying methods to streamline the path from FDA approval to reimbursement.

Nada joined Experien Group in 2017 after working 12 years at FDA’s Center for Devices and Radiological Health (CDRH). Since 2010, she had been a CDRH Senior Science Health Advisor, serving as an expert consultant and senior advisor in the Center Director’s office. Nada combines her deep institutional knowledge with innovative approaches to help companies successfully communicate product information to FDA throughout the total product life cycle. Leveraging her years of reviewer experience and broad FDA exposure, she develops actionable premarket strategies to guide programs through successful submission. She also orchestrates compliance activity. While at FDA, Nada led postmarket investigations for ob-gyn devices, wrinkle fillers, tanning devices, breast implants, negative pressure wound therapy (NPWT) devices and metal-on-metal hip implants and she applies this knowledge to help companies effectively manage postmarket requirements.

At Experien Group, Nada helps medical device and combination product manufacturers generate regulatory/clinical roadmaps for success. Building upon her strong engineering background, she helps companies devise and position product performance testing and/or clinical studies to achieve major milestones. Nada’s primary functions include:
• Product information review and strategic regulatory/clinical assessment to devise long term program and actionable milestones towards U.S. commercialization
• Pre-submission support and FDA communication, including product positioning for device testing and clinical studies, including patient preference testing
• U.S. regulatory submissions (e.g., IDEs, 510(k)s, PMAs, de novos, HUD/HDEs, 513(g)s, etc.)
• Postmarket compliance advisory services
• Experien Group and client company representative at industry meetings and symposia, presenting as speaker or panelist to societies, universities and public/private consortiums

Past Companies and Experience

Nada initiated her career at Biomat Sciences as an R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation (ODE) in 2004 and led FDA review teams for first-of-kind (and sometimes controversial) devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE and two novel neurological stent HDEs for the treatment of atherosclerotic disease. As a Senior Science Health Advisor at CDRH, Nada led cross-Center and Agency programs for the advancement of FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She collaborated with the Center for Tobacco and the National Institutes of Health (NIH) to improve regulatory efficiency and to strengthen data collection and she was the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH).

Education

Nada holds an MS in Biomaterials and a BE in Biomedical Materials Science & Engineering from Queen Mary College, University of London. She earned her MPH from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).

Kwame Ulmer is a MedTech executive with nearly 20 years of government and private sector experience. He integrates his time working as an operating company executive, evaluating over 1,000 technologies at the FDA, advising early stage companies, and formal business education to help clients set a clear regulatory strategy and deliver on key milestones. Kwame is based in Southern California with his wife and two children.

Josh joined FDA in the Office of Device Evaluation (ODE) in 2002 in the Gastroenterology and Renal Devices Branch, where he primarily reviewed hemodialysis, obesity, and endoscopic devices. Josh moved to the Division of Radiological Health in OIR in 2010, where he reviewed ultrasound devices, medical imaging software, and other medical imaging devices. Beginning in 2013, he took on the role as branch chief of the General Surgery Devices Branch 2 in the Division of Surgical Devices, which focused on laparoscopic, electrosurgical, ablative energy, and robotic assisted surgical devices. Josh started as the Director of the PMA staff in January of 2016. Josh received his Bachelor’s degree in Biomedical Engineering in 2000 from Vanderbilt University and his Master’s degree from the University of Florida in 2002.

Responsible for leveraging the technical expertise and market leadership of Fujikura in semiconductor manufacturing, miniaturization, fiber optics and CMOS for a diverse number of applications within the medical device and medical diagnostic fields

Pradnya has over 10 years of medical device manufacturing experience and currently works as the Global Vice President for Business Development at RAUMEDIC INC (Mills River, North Carolina), the sister facility to RAUMEDIC AG (in Germany). RAUMEDIC INC specializes in providing complete contract manufacturing services and specialize in silicone, thermoplastic, molding, extrusion and assembly.

She holds degrees in Engineering, Finance and Public Policy.

Lilli Zakarija is Co-Founder and President of EdgeOne Medical Inc and has over 20 years of experience in the medical device industry. Her expertise includes development and global launch of various single-use, disposable medical devices and combination products, strategic/technical development of device platforms and IP management. Throughout her career she has held management roles in engineering and project management, and prior to founding EdgeOne Medical Lilli established and led the global engineering function supporting all device and combination product related needs for the BioScience division of Baxter Healthcare (now Baxalta a Shire company).

Lilli has a Bachelor of Science in Biomedical Engineering and a Master in Engineering Management from Northwestern University, and an Executive MBA from Kellogg School of Management. In addition, Lilli serves on the Board of Directors for Women in Bio – Chicago Chapter, Board of Advisors for Biomedical Engineering Dept at Northwestern University, is a Chicago Innovation Mentor (CIM), and is a speaker on device development and combination products.

Ajay is Director of Venture Investments at Johnson & Johnson Innovation – JJDC, Inc. (JJDC) and is based at the Johnson & Johnson Innovation Center in California. Ajay focuses on Medical Device investments on the West Coast that are in areas of strategic interest to Johnson & Johnson.

Ajay previously held roles multiple financial based roles at JJDC, Ethicon, Advanced Sterilization Products and Janssen Business Development.

Ajay has a B.A. in economics from the University of Illinois at Urbana-Champaign.

John Kim is the Principal at Aphelion Capital and has a history of working as a medical consultant in biogenetics. He graduated from Harvard with a Bachelors in Biochemistry, and has since earned an M.D. and an MBA from Duke University.

Casey McGlynn is a partner at Wilson Sonsini Goodrich & Rosati. In 1990, Casey McGlynn formed the life sciences practice at the firm, and today, it has one of the largest practices focused on medtech, healthtech, and biotech companies in the country.

Casey has formed, represented, sold, and taken public many of the most important medical device companies founded over the last 30 years.

Casey has extensive hands-on experience in helping entrepreneurs form, build, fund, and sell their companies. He has formed, participated with the boards of, and invested in companies in all of the major medical device fields. Over the last 30 years, he has built close-working relationships with an unparalleled list of entrepreneurs, doctors, investors, engineers, and managers in this industry. Through his portfolio of companies, he has met with and negotiated with the leaders of all of the major medtech acquirers.

Over much of his career, Casey has participated in forming and managing several small funds, all of which have been top quartile performers. In 2005, he founded Life Science Angels (LSA), an angel organization focused on investing in medtech, healthtech, and biotech companies. Since its formation, LSA has invested over $50 million in more than 40 companies that have received an additional $600+ million in follow-on funding from VCs.

John Weiser serves as President First Run Production, Sony Pictures Television. He previously was President, U.S. distribution for Sony Pictures Television (SPT) where he oversaw all domestic sales operations for SPT, including sales of feature films produced by Sony Pictures, first-run and off-network syndicated programs and Sony Pictures library titles to U.S. broadcast networks, cable networks and television station groups along with SVOD, AVOD and domestic pay television.

Weiser also managed the personnel and operations of four regional offices located in Los Angeles, New York, Chicago, and Atlanta.

Joining the company in 1990 as account executive, west coast, Weiser became division manager in 1992. In 1995, he was promoted to vice president, west coast, managing all sales activities for the regional office. In 1999, Weiser was named senior vice president, sales for Columbia TriStar Television Distribution, expanding his duties to include sales of SPE’s vast library. With more than 500 television series and 4,000 films, it is the largest catalogue of its kind. Weiser became executive vice president, US distribution for Sony Pictures Television in 2002.

Before joining the studio, Weiser served as senior vice president, Guber-Peters Entertainment and head of sales for Chuck Barris Entertainment. His television career began at Tribune Broadcasting, where he oversaw its northeast and Midwest sales offices.

Weiser served on the board of directors of the Television Bureau of Advertising from 2004-2012. In 2006, he served on the board for the Broadcaster’s Foundation charity event. From 2003-2006, Weiser was the co-chairman of the National Association of Television Program Executives (NATPE), and from 2003-2005, he served on the fundraising steering committee board for the Cedars-Sinai Prostate Cancer Center. Weiser also served on the board of the Southern California chapter of UNICEF.

Weiser currently serves on the board of Props for Tots. For the past two years, he has served as co-Executive sponsor for SPE’s Emerging Professionals as well as a committee member for the SPE Council for Inclusion.

Paul is the founder and CEO of MedTech Innovator. He created and managed MedTech Innovator as a program within RCT Ventures from 2013 – 2016. In 2016, with the financial support of RCT and other sponsors, Paul left to run MedTech Innovator as a stand-alone company. He spent 11 years as Director and Managing Director at RCT Ventures, the investment arm of Research Corporation Technologies, Inc. Prior to RCT, Paul was co-founder and CEO of startups in the medtech, pharma, and tech sectors.