CBSA Annual Medical Device Symposium
Annual Medical Device Symposium
Innovative medical technologies are transforming patient care around the world and Medtech in Colorado is growing strong with more than 2,200 devices in development or distribution. Many of the most promising innovations are being developed at the intersection of devices, drugs, diagnostics and digital health.
Gather with Colorado Medtech leaders at the annual Colorado BioScience Association Medical Device Symposium to discover emerging and cutting-edge trends in medical breakthroughs, gain insights on the pulse of the industry as MedTech adjusts to a new post-pandemic landscape, and take an in-depth look at public policy shaping the U.S. Medtech sector.
Speakers and panelists will provide their perspectives on developing and launching new products and the convergence of digital health and medical technology in the state during the symposium.
Complimentary for CBSA Members | $100 for Non Members
Questions: Email Francisca (Francis) Bermea, Member Success Specialist firstname.lastname@example.org
1-1:30 p.m. Registration
1:30-1:45 p.m. Welcome & Introductions
1:45-2:30 p.m. Keynote
Antoinette Gawin, President & CEO, Terumo Blood and Cell Technologies
2:30-3:00 p.m. State & Federal Policy Updates impacting the MedTech sector
State policy overview – Amy Berenbaum Goodman, Vice President and Counsel, Policy + Advocacy, CBSA
Federal policy and national trends – Roxy Kozyckyj, Director, State Government & Regional Affairs, AdvaMed
3:00-3:15 p.m. Break
3:15 – 3:45 p.m. EY MedTech Report
John Heinbigner, Partner, EY
3:45-5:00 p.m. Panel Discussion: Intersections in Medical Device Innovation
Frank Chan, President, Patient Monitoring. Medtronic
James Mault, MD, FACS CEO & Chairman, BioIntelliSense
Kimberly Muller, Executive Director, CU Innovations, University of Colorado Anschutz Medical Campus
Natasha Bond, President, ERI Group
William Jaworski, Sales Director, Mikron Corporation Denver
5:00-6:30 p.m. Happy Hour + Networking
Sponsored by CSA Group
Thank you to our booth sponsors:
Thank you to our event sponsors:
Thank you to our sustaining sponsor:
Dan Wittenberg’s practice is concentrated on representing manufacturers and distributors of products across a vast array of industry sectors including: life sciences, medical technologies, pharmaceutical, consumer products, appliances, fall protection, food, cosmetics, dietary supplements, healthcare products, heavy equipment, oral and personal care products, power generation and timber. He regularly defends these companies in product liability litigation as well as counsels these businesses on agreements, risk avoidance/management strategies, labeling and marketing materials, instructions for use, as well as recalls and regulatory matters, including those involving the FDA and CPSC. Dan has served as national counsel for major medical device manufacturing concerns and regional as well as local counsel in mass tort cases. He has attained certification as a Global Regulatory Affairs Compliance Professional (GRACP). Dan also works with entities in technology transfer and intellectual property matters including university technology commercialization, litigation, licensing and agreement negotiations. He also represents individuals and companies in commercial litigation. Representative clients also include renewable/clean energy companies, such as a leading manufacturer of solar cells, panels, inverters and imaging detectors, as well as one of North America’s largest wind energy companies.
Dan is a Co-Chair of the firm’s Pharmaceuticals and Medical Devices Industry Group, is listed in The Best Lawyers in America®, Product Liability Litigation – Defendants and named by LMG as a Life Sciences Star. He is Peer Review Rated AV Preeminent in Martindale-Hubble and currently assisting clients throughout the Western United States including Arizona, California, Colorado, Nevada and Utah.
Antoinette Gawin is the president and chief executive officer of Terumo Blood and Cell Technologies, a $1 billion mission-driven medical technology company that is focused on unlocking the potential of blood and cell-based therapies. The innovative medical technology company strives to advance healthcare, broaden treatment options and improve patient outcomes through its technologies within the sectors of blood banking, transfusion medicine and regenerative medicine.
Gawin focuses on how Terumo Blood and Cell Technologies will continue to evolve with healthcare’s rapid changes to meet more patients’ needs globally. She believes medical device manufacturers must change and go beyond equipment to think about services, data management and new geographies where people do not yet have access to the technologies that can advance their health and lives. She is ensuring that Terumo Blood and Cell Technologies continues to focus on service and helping our customers solve problems—enabling them to better serve patients.
Gawin has been recently appointed to serve as Group Managing Executive Officer (GMEO) for Terumo Corporation focusing on shaping strategy across all Terumo operating entities. Gawin is the only female and only non-Japanese leader ever to serve in this capacity. She is also part of Terumo’s Executive Management Meeting (EMM) as a core member.
Gawin is a member of the AdvaMed Board of Directors, leading the AdvaMed Ethics & Compliance Committee chair.
Roxy has ten years of experience working in government affairs and advocacy at the state and federal level, for nonprofits, trade associations, and in Congress. Currently, she is the Director of State Government and Regional Affairs at AdvaMed, the largest national trade association representing the medical technology industry. In this role, Roxy is responsible for developing and executing the advocacy strategy for over 25 states, working with members to form policy positions on critical issues facing the industry, building relationships with legislators and key stakeholders, and working with consultants in state capitals. She works with Congressional offices occasionally as some priority legislative issues cross over to the federal level. Before coming to AdvaMed, Roxy was the Director of State Government Affairs at the Healthcare Distribution Alliance. She was responsible for representing HDA members on priority legislative and regulatory issues in twelve states, covering the Midwest and part of the Eastern region of the U.S., representing members on key issues in pharmaceutical distribution.
Prior to joining HDA, Roxy worked for the U.S. House Committee on Energy and Commerce, and before moving to Washington, D.C. she was a policy analyst and lobbyist for Illinois Association for Rehabilitation Facilities in Springfield, IL. She holds a degree in International Studies with a minor in Russian, Eastern European, and Central Asian Studies from University of Wisconsin-Madison and a Master’s in Economic Policy Analysis from DePaul University in Chicago.
In her spare time, Roxy volunteers with N St. Village, an organization in Washington, D.C. serving women experiencing homelessness. She is also an avid cook and loves to spend time trying new recipes, restaurants, reading, hiking, catching an occasional concert, and traveling to new destinations to experience other cultures.
Amy Berenbaum Goodman
Amy Berenbaum Goodman leads Policy + Advocacy for Colorado BioScience Association. An attorney who holds a Master of Bioethics (M.B.E.), Amy develops strategies to support a pro-business environment for health innovation in Colorado. Working with the President & CEO and CBSA Board of Directors, she advances state and federal policies that support the companies and organizations in our ecosystem and the patients they serve.
Amy draws on her background in healthcare law and policy, regulatory compliance, and member-based organizations to advocate for policies that support the health and growth of life sciences in Colorado. She champions issues critical to the ecosystem, including Capital + Growth, workforce cultivation, favorable tax and regulatory policies, incentives for innovation, and patient access to healthcare innovation.
Before joining CBSA, Amy advocated for physicians, residents, and medical students as the Senior Director of Policy at Colorado Medical Society. Previously, she served as Senior Manager of Corporate Compliance at DaVita Kidney Care and as an Associate Attorney focused on healthcare law at Hall, Render, Killian, Heath & Lyman.
Amy earned a J.D. from the University of Denver Sturm College of Law, where she was a Chancellor’s Scholar and graduated Order of the Coif. She holds an M.B.E. (Master of Bioethics) from the University of Pennsylvania Perelman School of Medicine and a B.A. in health & societies from the University of Pennsylvania, graduating magna cum laude.
John is a Partner and MedTech sector lead at EY and focused on buy and sell-side transactions. He has over 15 years of experience in the Med Tech industry, spanning M&A, financial performance improvement and optimization, and in Corporate Finance at Medtronic. John has worked with a variety of MedTech deals, including cardiovascular, orthopedics, diabetes, neurovascular, structural heart, robotics and advanced technology, dental, wound care, diagnostics, ENT, CRO, CMO, and capital equipment.
Tony Caldwell is a partner in Snell & Wilmer’s corporate group who helps clients navigate complex issues related to law and technology. His day-to-day practice focuses on corporate, technology and life sciences transactions, with an emphasis on licensing, manufacturing and supply chain, clinical trials, data use, cybersecurity, and mergers and acquisitions.
Tony advises biotechnology, pharmaceutical, medical device, and diagnostics companies with commercial contracting and clinical matters, and he is a member of the firm’s life science and medical technology industry group. He has a comprehensive understanding of the legal needs of the life sciences industry, including its regulatory framework, risks and opportunities, rapidly changing technologies, and competitive landscape. He has extensive experience negotiating pre-clinical and clinical trial agreements, material transfer agreements, and domestic and international supply chain agreements. He has also represented several life sciences companies in connection with M&A transactions and IPOs.
From business associate agreements to electronic medical records compliance, Tony has extensive experience counseling healthcare providers on business and legal issues. He regularly represents various healthcare organizations, including hospitals, physician groups, pharmacists, chiropractors, surgery centers, assisted living facilities, home health agencies, clinical laboratories, and commercial insurers, as well as digital health and telehealth companies looking to innovate the healthcare industry. Prior to joining Snell & Wilmer, Tony represented one of the nation’s largest nonprofit healthcare systems as deputized in-house technology counsel.
Frank is the President of the Patient Monitoring Operating Unit in Medtronic’s Medical Surgical Portfolio. The Patient Monitoring business includes technologies that provide insights and intelligence to help clinicians reduce dangerous and costly patient complications in acute care.
Frank is known for driving engagement by aligning organizations to a common vision, developing meaningful strategies, and driving execution across stakeholder groups.
Since 2004, Frank has held diverse leadership roles in R&D, program management, business transformation, medical affairs, and general management in the Respiratory Therapies Group (RTG) and the Minimally Invasive Therapies Group (MITG). Previously, Frank was the Vice President and General Manager of the Patient Monitoring business in MITG. Originally an orthopedic bioengineer, Frank has over 100 peer-reviewed publications and was named the 2019 Champion for Change by Medtronic Women’s Network.
James Mault, MD, FACS, is the Founder and Chief Executive Officer of BioIntelliSense, a Data-as-a-Service (DaaS) platform company, delivering breakthrough medical-grade biosensor technology with unique clinical intelligence for scalable remote patient monitoring. Prior to BioIntelliSense, Dr. Mault served as Senior Vice President and Chief Medical Officer of Qualcomm Life for over five years, where his leadership responsibilities included Strategic Planning and Business Development, Mergers and Acquisitions, New Product Innovation, Clinical Program and Regulatory Oversight, Health Policy and Government Affairs, Global Spokesperson and Public Relations. Dr. Mault came to Qualcomm Life through its 2013 acquisition of HealthyCircles, a Care Coordination and Remote Patient Monitoring Platform Company founded and led by Dr. Mault in 2009. Prior to starting HealthyCircles, he was the Medical Director of the Health Solutions Group at Microsoft as well as the CEO of Microlife.
Dr. Mault has more than 35 years of experience in senior executive positions in the Health IT and Medical Device industry as well as clinical medicine. He has founded five Health IT and medical device companies, raising over $150 million in working capital and leading these companies to develop novel devices and software technologies, FDA approvals, strategic partnerships with Fortune 500 companies, culminating in M&A or IPO exit transactions. He is the named inventor of over 80 issued and pending patents for a variety of novel health IT and medical device innovations. He has been board-certified in both General Surgery and Cardiothoracic Surgery, having specialized in heart and lung transplantation, thoracic oncology and critical care. He has conducted academic medical research under grant awards from the NIH, American Cancer Society, and others. He is the author of more than 60 scientific articles, chapters and books in the published medical literature. Dr. Mault received his B.S. in Biology and Medical Degree from the University of Michigan and conducted his General Surgery and Cardiothoracic Surgery residency training at Duke University Medical Center. Dr. Mault provides global thought-leadership on the future of technology and healthcare delivery, serving on numerous Boards and leadership positions, and is a member of the Board of Industry Leaders for the Consumer Technology Association’s (CTA) and Chairman Emeritus of the CTA Health & Fitness Technology Board.
Kimberly Muller is the Executive Director of CU Innovations where she leads innovation for the University of Colorado Anschutz Medical Campus. Kimberly’s business development responsibilities include investing, company creation, innovation management, forming key strategic industry partnerships, and licensing. Large-scale industry collaborations have been established in areas such as AI and drug development. She also manages several investment funds, including a $10 million innovation grant fund, a $50 million early stage venture fund, a $75 million follow-on fund, and partners with UCHealth on a $100 million growth stage fund.
Kimberly joined the University of Colorado from Yale University where she was formerly the Deputy Director of the Yale Entrepreneurial Institute (YEI), and managed New Ventures in the Office of Cooperative Research. During Kimberly’s tenure, Yale’s Office of Cooperative Research started more than 70 new ventures that have raised over $5 billion in investor capital.
Previously, Kimberly started and sold companies in the biotech, tech, and clean energy fields, companies included Curagen Corporation (acquired by Celldex Therapeutics), 454 Life Science (acquired by Roche), and Arbor Fuel, a biofuel company that utilized recombinant microorganisms for the production of ethanol and butanol. Kimberly began her career in New York as a patent attorney for Chadbourne and Parke, LLP.
Kimberly has a graduate degree in Genetics and received her law degree with highest honors from the University of Connecticut School of Law.
Tasha is a proven leader in medical device program delivery, with over 20 years’ experience integrating technical and commercial teams. Tasha provides enterprise leadership for ERI Group, ensuring that the team at ERI Group can successfully deliver on partnerships with clients.
Tasha has focused on enabling small, often venture-funded, medical device companies to proceed to commercialization efficiently and effectively. Her experience spans New Product Development and Commercialization, Risk-Based development strategies, and implementation of least-burdensome approached to accelerate development lifecycles across a variety of medical devices including Vascular, Venous, Respiratory, Gynecological, Analytical testing and diagnosis, Drug Delivery, Wearables. She also has deep experience in Regulatory Strategy & submissions, including PMA, 510(k), EC Tech File, Canada, Japan, FDA pre-submission and communication management including multiple successful Breakthrough Device Designations.
Prior to ERI, Tasha has held various leadership positions in start-ups, with multiple successful exits to J&J, Abbott etc., most recently holding COO position at Sana Health, a novel wearable for pain and mental health management. Tasha has considerable depth of engineering and regulatory consulting experience, across 5 organizations, including Vention, who exited to Nordson in 2018 after sustained double-digit growth under her leadership. Tasha is a Chartered Mechanical Engineer and PMP.
William (“Bill”) Jaworski has held a variety of strategic roles at the intersection of healthcare, medical device, and manufacturing technology. For 20+ years Bill has explored market needs and developed solutions to meet those needs as Product Manager, Segment Marketing Manager, Global Marketing Director with GE Healthcare; Business Development Director at ATS – Life Science; and currently as Sales Director at Mikron Automation – Denver.
As a member of the executive leadership team at Mikron, Bill is enabling the success and positive experience of Mikron’s partners in North and Central America. This currently includes building out product development support consultative services to “de-risk” complex programs and developing new manufacturing technologies to ensure that Mikron continues to be a trusted partner in assembly solutions for the rapidly evolving pharma, life science and medical device ecosystem.
Bill holds a BS in Mechanical Engineering, earned graduate degrees (MS in Mechatronics Engineering and a MS in Global Engineering Management) from the Northern Institute of Technology of Hamburg-Harburg, Germany, as well as an MBA from Marquette University. In his spare time, Bill enjoys cooking, traveling, watching his sons play soccer and unplugging from the grid during extensive backpacking trips.