MedTech Innovator LIVE

Wendy Dowd combines organization, executive and leadership development to initiate positive change for improved business outcomes. She has over 20 years of experience leading strategic transformation for Fortune 100 companies. She has a passion for making positive impact in people’s lives, business and communities.

Wendy has been with Humana for ten years and is currently leading Consumer Experience Best Practices, responsible for the Perfect Experience Pivot and building Consumer Experience Internal Capabilities. In her time with Humana she has led Associate and Consumer Engagement, Succession Management, Performance Management, Associate Well-being and served as the HRBL for PPNO, Small Business, Specialty and Humana One.

Before joining Humana , she led the Learning Organization for Manpower for ten years in Milwaukee, was the top sales agent for Adams Laboratories in pharmaceutical sales, placed Physicians and Nurses across the nation with US Medical Search and led the call center for the Frantz Group.

Wendy holds a Bachelor of Arts degree in both Communication and Political Science from The University of Wisconsin – Milwaukee and studied at the University of London. She serves on board for Neighborhood House through the Humana Foundation.

At BD, Albert Lauritano was responsible for identifying, negotiating and establishing global, external relationships that support BD’s strategic innovation, technology and capability needs. He also directed BD’s technology accelerator and incubator programs as alternative business model partnerships for the entrepreneurial, investor, university and startup communities. He was responsble for establishing the unique technology partnerships for BD within the State of Israel, establishing the BD-Microsoft Healthcare Accelerator and becoming a corporate partner with the Office of the Chief Scientist to fund new technology R&D.

Al joined BD in 2003 and has over 35 years of experience in the pharmaceutical, biotechnology and medical technology industries. Prior to joining BD, he held executive business development positions at Amylin Pharmaceuticals, Icagen and D-Pharm Ltd after starting his career at Novo Nordisk Pharmaceuticals where he served in senior clinical, marketing and business development positions in the US, Canada, Europe and Japan. He has a BS in Biology from Fairleigh Dickinson University and an MS in Pharmacology from Rutgers University; he has published widely in the field of diabetes. He received his Certified Licensing Professional credential in 2007 from the Licensing Executive Society and is also a member of the Association of University Technology Managers.

David Uffer joined Alira Health with over 25 years of management experience in the medical device, products and clinical diagnostics field. He has lead strategy development, strategic planning and business development activities in these fields for mid and large cap public companies. David has directed business development deals ranging from M&A, licensing, distribution and co-development for companies such as Medtronic (legacy Covidien) in their respiratory and medical products business, as well as Hologic and Boston Scientific. He has held management roles at Integra Lifesciences and Abbott Labs. David has a BA from Clark University, Worcester, MA and an MBA from Thunderbird, School of Global Management, Glendale, AZ.

David Cassak has more than 30 years of experience in the health care industry. Prior to co-founding Innovation In Medtech, LLC, he served as Vice President, Content, and Managing Director, Medical Devices for Elsevier Business Intelligence, a Reed Elsevier Company, including the publications The Gray Sheet and The Pink Sheet. He also wrote extensively on the medical device industry for Windhover Information’s monthly publications, IN VIVO, START-UP, and MEDTECH INSIGHT. He is a frequent speaker before various companies and trade groups within the medical device industry.

Prior to joining Elsevier, Cassak worked for nearly 20 years at Windhover Information Inc., a company he founded with his partner, Roger Longman, which spun out the publications business of The Wilkerson Group, a leading management consulting firm at the time. Long known for publishing IN VIVO, widely recognized as the premier provider of business intelligence in the health care industry, Windhover launched a number of other successful publications, including START-UP: Emerging Medical Ventures, and The RPM Report: Regulation • Policy • Market Access. In 2004, Windhover acquired Medtech Insight, Inc., which published the MEDTECH INSIGHT: Medical Technology Market Intelligence newsletter. While at Windhover/EBI, David also organized and produced numerous conferences around the world, including the Investment in Innovation (In3) medical device partnering conference series, as well as such pharma-focused conferences as Pharmaceutical Strategic Alliances, Euro-Biotech and BIO-Windhover. In 2008, Windhover was acquired by Elsevier, which formed Elsevier Business Intelligence, combining the products of Windhover and F-D-C Reports, publishers of The Gray Sheet and The Pink Sheet, among other industry newsletters.

Brian has worked in the business of healthcare for over 20 years. He has an MPA in Healthcare Policy and Management and an MBA in Marketing. He began his career working in the Managed Care industry in the area of Medical Delivery Systems, managing relationships with physicians/ ancillary providers of all types and leading a Team responsible for hospital and health systems contracting. Since joining Johnson and Johnson (ETHICON Inc.) in 1999, Brian has worked in all aspects of health economics, outcomes research, reimbursement and market access. He has worked extensively in the US and Globally in support of new product development and new business development, lead ETHICON’s first field-based Reimbursement Team, worked on policy and reimbursement issues for multiple ETHICON products, lead the ETHICON and Global Surgery Group Health Economics & Outcomes Research Group and most recently, was named the Leader of the ETHICON Global Center for Excellence for Health Economics & Market Access.

Chandra Branham, J.D., joined the Advanced Medical Technology Association (AdvaMed) as Vice President, Payment and Health Care Delivery Policy, in 2011. She leads AdvaMed’s policy work in a number of areas, including diagnostics payment, coverage issues, and comparative effectiveness. Prior to joining AdvaMed, Chandra was an associate with Arnold & Porter where she focused on healthcare regulatory and legislative issues involving Medicare coverage, coding, reimbursement and quality for providers and suppliers of Medicare items and services. In that role she regularly interacted with representatives of the Centers for Medicare & Medicaid Services (CMS).

Chandra has served as a consultant with a small Washington, DC consulting firm, providing legislative and regulatory strategy and guidance to companies and trade associations on a variety of Medicare and health care issues; a senior legislative analyst in the CMS Office of Legislation; and early in her career, served as associate director of regulatory affairs at the National Association for Home Care. Chandra has a Bachelor of Science from Drexel University and a J.D. from the George Mason University School of Law.

Leslie Wise is Vice President of Global Healthcare Economics for AngioDynamics where she is responsible for US and OUS reimbursement, health economics and market access. Prior to joining AngioDynamics, Leslie was the Global Director of Reimbursement Biologics at Biomet.

Leslie possesses deep and broad based knowledge on US and OUS countries HTA, reimbursement and tendering processes. She also has experience with clinical strategy, protocol development, regulatory and reimbursement alignment, value proposition development, health economic outcomes research, coding requirement, patient engagement, professional clinical guidelines, patient care pathways, care delivery efficiency and quality metrics.

Mary McNamara-Cullinane is a regulatory expert bringing over 25 years of regulatory experience to Alira Health. Prior to joining Alira Health, Mary has had her own consulting firm since 2011 (MMC Regulatory Consulting). Mary worked as Senior Regulatory Consultant to MEDIcept, as Senior Director of Regulatory Affairs for Intrinsic Therapeutics, and held executive positions in Regulatory Affairs for Echo Therapeutics, Z-Medica Corporation, Molecular Biometrics, and Medical Device Consultants. Earlier in her career, she was a scientist at Hygeia Sciences (acquired by Carter-Wallace). Mary McNamara-Cullinane has over 25 years of regulatory experience in the medical device, diagnostics, combination product and biotech industries. She has successfully authored over 175 510(k)s, multiple PMAs, denovo submissions, requests for classification and designations submissions as well as been responsible for several clinical trials.

Mary has focused on helping emerging companies navigate challenges during development while establishing appropriate clinical, regulatory, and compliance pathways. Mary has a BA in Biology from Mass College of Liberal Arts, with concentrations in Molecular Biology and Medical Technology. She did post graduate studies at Northeastern University in Cardiovascular Health and Exercise Science. She is Regulatory Affairs Certified and has written extensively for various industry journals and newsletters on a broad range of topics related to regulatory affairs.

For the last 15 years, Patterson Shafer has supported R&D and supply chain clients in pharma, med device and biologics companies. His domain expertise includes performance measurement, business process reengineering, product life cycle management, quality management, knowledge management, contract management, change management and business continuity planning.

During Pat’s career, he has led scores of strategic and tactical projects including operating model development global road maps and capability maturity assessments. His projects have also included industry benchmarking, organizational design and the development of global governance models. Pat has led or supported projects in regulatory affairs, pharmacovigilance, clinical, medical affairs, quality and supply chain functional areas. He is a member of the Medical Device Industry Consortium’s Case for Quality initiative, working in partnership with the FDA.

Anna Libman joined Experien Group in 2010 and has developed a specific focus in Digital Health. She primarily supports companies with powered technologies, mobile platform enabled devices and Software as a Medical Device (SaMD). Product areas with notable experience include surgical robotics, wearable devices, Artificial Intelligence/Machine Learning based applications, mobile app operated medical devices, radiation therapy, hospital data aggregation software, and diagnostic devices. Anna works with Digital Health companies to scope technology features and use cases that are not regulated by FDA as well as develop a stepwise approach from a non-regulated technology to regulated as a medical device.

At Experien Group, Anna supports clients with regulatory strategies, submissions, device testing and QMS Design Controls as the design team’s regulatory representative. Her regulatory work includes the development of effective documentation and testing requirements for regulatory approvals.

James joined Santé Ventures in 2010. Previously, James served in the Air Force and was the medical director and Vice-Chair of Emergency Medicine at Wilford Hall Medical Center, an academic level-one trauma center in San Antonio. He completed two tours in Iraq as a critical care transport team chief and as the emergency department commander. He separated honorably as a Major in 2008. James received his MBA from the University of Texas McCombs School Of Business, his MD from Harvard Medical School, and a BS in bioengineering, Summa Cum Laude, from the University of Michigan. He is board certified in emergency medicine and completed his residency at Massachusetts General Hospital and Brigham and Women’s Hospital.

Thomas is the head of health care investing at Qualcomm Ventures where he focuses on digital health care companies. Thomas is also a General Partner at dRx Capital, which is a joint venture investment company launched by Novartis and Qualcomm with a capital commitment up to $100M. As part of these roles, Thomas strives to catalyze the success of digital medicine products, services and business models by investing in high-growth, technology companies.

Prior to Qualcomm Ventures, Thomas was an investment professional at Providence Ventures, the venture capital arm at one of the nation’s leading healthcare delivery networks, Providence St. Joseph Health. Prior to Providence Ventures, Thomas was part of the strategic finance / strategic investing team at Cambia Health Solutions, the private equity sponsor for Regence Blue Cross Blue Shield, a nationally recognized health insurer committed to transforming healthcare. As part of his role at Cambia, Thomas had an observer seat on the Fund Management Team (FMT), the formal governing body established by the company to approve all VC, PE and M&A deals. Thomas was also a direct investment professional at Adams Street Partners where he supported the partnership on venture capital and growth equity opportunities.

Thomas holds his Master of Science in Medical Informatics and a Bachelor of Science in Biomedical Engineering from Northwestern University where he is a published author in the Journal of Surgical Oncology.

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.

Samantha brings extensive operating, business development and investing experience in the life science industry. Prior to joining Locust Walk Partners, Samantha was Director, Commercial Operations for Confluent Medical Technologies where she led Corporate Development, Commercial Operations and Marketing to drive strategic advantage and long-term revenue growth.

While at Medtronic, Samantha led the Latin America launch of a novel cardiovascular device therapy, tackling reimbursement, pricing, referral and sales channel issues in addition to developing regional KOLs. She gained investment experience across medical devices, biotech and diagnostics at Lighthouse Capital Partners, a venture debt firm providing growth capital to early stage companies. During her tenure, she co-sponsored more than $200M in investments. Samantha also formerly served as an auditor with PricewaterhouseCoopers and KPMG.

Samantha holds an MBA in Healthcare Management from The Wharton School and a BS in Accounting from the University of Oregon. She also serves on the screening committee of HealthTech Capital, an angel investing group focused on digital health.

Tom is a urologist and was formerly the Chief Medical Officer at UCLA. His accomplishments included substantial growth in the clinical program, achieving competitive NIH funding for clinical trials in transplantation to UCLA, and ultimately achieving significant research funding. Tom also started UCLA’s Value Analysis Committee, and ran it for nearly 20 years. He received his M.D. from Duke in 1974 and completed his residency at the Lahey Clinic. He previously served as Program Director in Urology at UCLA, Vice-Chair for Clinical Affairs and Executive Vice-Chair in the Department of Surgery at UCLA, and Director of the UCLA Medical Group before assuming his current roles. He is a past officer in a number of transplant societies.

Barbara directs the value management program which collaborates with physicians, nurses and staff across the care continuum providing the tools and infrastructure to standardize products and reduce practice variation. Employing a team of VA nurses and analysts their data driven results approach to manage resource utilization produces $6M of savings annually.`

A veteran of the healthcare, medical device, and technology industry, Austin Dirks founded GreenLight Medical with a vision: to create a software platform that helps hospitals and physicians get the medical technology they need to advance surgical outcomes and patient care. Austin developed GreenLight Medical’s cloud software to streamline new product introduction workflow, project management, product research, and decision-support needs for hospital value analysis committees and medical device companies alike. Before founding GreenLight Medical, Austin worked as a cardiac medical device sales representative for St. Jude Medical, as well as for Thoratec Corp.

Doug Portnow is a partner in the Palo Alto office of Wilson Sonsini Goodrich & Rosati, where he focuses his practice on patent prosecution and counseling. He regularly works with inventors to prepare new patent applications, and to draft amendments in response to office actions from the U.S. Patent and Trademark Office. Doug is also experienced in patentability, validity, and freedom-to-operate studies. He has worked extensively in the medical device and surgical sectors, including interventional cardiology, vascular surgery, and orthopedics, as well as with more traditional mechanical inventions.

Doug has worked actively with a number of start-up companies to help develop their intellectual property portfolios as well. He has performed due diligence work for numerous clients during venture financing and M&A activities, with many of these companies successfully raising capital or being acquired by public companies.

Prior to joining the firm, Doug was an associate in the mechanical and medical device group at Townsend and Townsend and Crew LLP (now Kilpatrick Townsend & Stockton). Before entering the legal profession, he worked for more than a decade in the medical device industry. He also held positions in engineering and senior management at start-up companies and well-established medical manufacturers located both within the U.S. and overseas.

Uri Greenwald, M.D., is an associate in the San Diego office of Wilson Sonsini Goodrich & Rosati, where he leverages his background and expertise as a trained physician and general surgeon to build strong, valuable patent portfolios for medical device, pharmaceutical, and life science companies at all stages of growth and development.

Uri has trained at some of the country’s busiest hospitals, including Bellevue Hospital, Kings County Hospital, and the Interim Charity Hospital of New Orleans. In addition, he has conducted clinical and bench research with leading physician scientists in the medicine and surgery departments of the New York University School of Medicine.

Doug Limbach is a partner at Shay Glenn LLP where he counsels technology companies and investors, primarily in the medical device industry. Doug entered the field of intellectual property law in 1991 as a patent agent and later an associate at Limbach & Limbach, LLP where he was trained in patent preparation, prosecution, opinion writing, licensing, litigation, mediation and strategic portfolio management. In 2001, he founded Synchroscan Corporation, which developed a line of wireless telecommunications products. Doug later served as Director of Intellectual Property at medical device company TheraSense / Abbott Diabetes Care, and Senior Counsel at microelectromechanical systems company Form Factor. He returned to private practice as Of Counsel, first at general practice law firm Greenberg Traurig and then at life sciences IP firm Bozicevic, Field & Francis. Prior to entering the legal profession, Doug was a design engineer for six years in the fields of automated machinery, precision mechanisms and medical equipment development.

Doug received a Bachelors of Science in Mechanical Engineering with an emphasis in robotics from the University of Colorado, and holds a Professional Engineers License in California. Doug earned his J.D. degree from Golden Gate University School of Law, where he was a judicial extern in U.S. District Court for Chief Magistrate Judge F. Steele Langford. He is admitted to practice in California and before the U.S. Patent and Trademark Office.

Doug was the 83rd President of the San Francisco Intellectual Property Law Association and served on its Board of Directors from 2005 to 2010.