Thursday, February 16, 2023 (9:00 AM - 12:30 PM) (EST)
Join us for our virtual Regulatory Roundup, designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry. The agenda includes comprehensive presentations by CDRH, industry representatives and regulatory experts.
We are thrilled to welcome our keynote speaker, Dr. Suzanne Schwartz, Director of the Office of Strategic Partnerships and Technology Innovation, CDRH. Dr. Schwartz's team is tasked with providing our industry with leadership and strategic direction on medical device cybersecurity, software, and digital health.
|9:00 – 9:45 AM||Destination, Switzerland? The Impact of the Recent Decision of the Swiss Parliament on Medical Devices with FDA Authorization|
|9:45 – 10:30 AM||Navigating MDR Today and Tomorrow|
This interactive presentation will provide you with an overview of the latest updates on MDR in the EU, including the impact to global medical device regulatory developments due to the proposed transition period for compliance. Join us to hear what will happen next for MDR and how you can best navigate the evolving global regulatory environment.
|10:30 – 11:00 AM||FDA Priorities for 2023|
Rhonda Mecl, Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, FDA will join us to provide an overview of FDA priorities for the coming year from a local investigator’s perspective.
|11:00 – 11:20 AM||Recent Developments on the “Fraud on the FDA” Theory of False Claim Liability|
Rick Ball and Coleen Hill from Duane Morris will provide an overview of a theory of liability for pleading claims under the False Claims Act commonly referred to as “Fraud on the FDA.” They will discuss what risks such a theory might pose and delve into how various federal courts have recently accepted or rejected claims based on this theory.
|11:20 - 11:25 AM||Mass CyberCenter Overview|
|11:25 – 11:45 AM||Cybersecurity Best Practices for Regulated Medical Devices|
|11:45 AM – 12:30 PM||Keynote Presentation & Q&A - Dr. Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA |
This session will provide an overview of the latest updates from CDRH’s Office of Strategic Partnerships and Technology, with a specific focus on digital health and cybersecurity. This briefing will be followed by a moderated Q&A session led by Amra Racic of Veeva Systems where you will get the chance to ask your questions directly to Dr. Schwartz!
|Dr. Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA |
Dr. Suzanne Schwartz MD, MBA, is the Director of the Office of Strategic Partnerships and Technology Innovation at FDA’s Center for Devices and Radiological Health (CDRH). Schwartz’s work in medical device cybersecurity includes raising awareness, educating, outreach, policy development, partnering and coalition-building within the healthcare and public health sector (HPH) as well as fostering collaborations across other government agencies and the private sector. Schwartz has been recognized for Excellence in Innovation at FDA’s Women’s History Month for her work in medical device cybersecurity. Schwartz chairs CDRH’s Cybersecurity Working Group. She also co-chairs the Government Coordinating Council for the HPH Critical Infrastructure Sector, focusing on the sector’s healthcare cyber-initiatives.
|Fredrick Ball, Partner, Duane Morris |
Frederick (Rick) R. Ball focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences and Medical Technologies industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.
Joe Dawson, Principal Software Security Analyst, Intertek EWA-Canada
Joe Dawson is a Principal Software Security Analyst for Intertek EWA-Canada based in St. John's, Newfoundland. Joe has more than 30 years' experience in Software Development, Data Communications, and Information Security, in both the public and private sectors. He currently sits on the Standards Technical Panels for all the UL 2900 family of standards and sits on one of the IEC 62443 standards committees.
|Ainoa Forteza, Associate Director, Regulatory Affairs, Aliria Health|
Ainoa is the leader of the Regulatory Medtech Group of Alira Health. She has over eight years of experience in Regulatory Affairs consultancy. As part of these years, Ainoa worked at Drug Development and Regulation S.L. (DDR), currently Veristat, where she was in charge of DDR’s team responsible for Medical Devices and In Vitro Diagnostics, contributing to these products’ strategy to obtain the CE mark while making sure the manufacturer complies with the Medical Devices and In Vitro Diagnostics Regulation (MDR and IVDR). Ainoa is a Human Biologist (Pompeu Fabra University) who also holds a Master on Pharmaceutical and Biotechnology Industry (Pompeu Fabra University) and a Postgradute on Expert on Medical Devices (University of Barcelona).
|Mercè Guerra, Manager, Regulatory Affairs, Alira Health|
Mercè Guerra is a Regulatory Affairs Manager at Alira Health. In his Manager role, she supervises the development and regulatory activities for Medical Devices (MD) and In Vitro Diagnostics (IVDs) in the EU and US contributing to these products’ strategy to obtain the CE mark and FDA clearance.
Mercè Guerra joined Alira Health in 2021 after several years of experience in regulatory affairs in Medical Devices and In Vitro Diagnostics as part of Drug Development and Regulation S.L. (DDR, now Veristat).
Mercè has a bachelor degree in Human Biology and a Master’s Degree in Pharmaceutical and Biotechnology Industry, both from Universitat Pompeu Fabra (UPF). Mercè expertise lies in MD/IVD strategy and regulatory activities, including CE Mark, CER, pre-RFD, 510(k), PreSubs, BDD, 513 (g), De Novo request, among others. Mercè has also been involved in the development of drugs for a wide range of indications and has expertise on EMA-related activities such as Scientific Advice, Orphan Drug Designation and Briefing Meetings.
|Coleen Hill, Associate, Duane Morris|
Coleen Hill is a trial attorney representing clients in the life sciences industry in complex commercial disputes. She holds a leadership role in Duane Morris’ Life Sciences and Medical Technologies Industry Group. In addition, she helps pharmaceutical companies, biologics manufacturers, medical device manufacturers and pharmacies navigate the complex challenges faced by state and federal regulation for their industries.
|Benjamin Linville-Engler, Chief Investment Strategist and Program Executive, MassTech|
Ben Linville-Engler is the Chief Investment Strategist and Program Executive at MassTech where he works across the agency’s programs and funds to manage strategic investments into emerging technologies, align investments with growth strategies, and identify new opportunities for growth to ensure maximum impact on the Commonwealth’s tech and innovation economy. Ben also provides program oversight for the agency’s Center for Advanced Manufacturing (CAM), MassCyberCenter, and the Massachusetts eHealth Institute (MeHI).
Previously, Linville-Engler served as the Industry and Certificate Co-Director for MIT System Design and Management (SDM) where he first joined as a Fellow in 2016. SDM is jointly offered by MIT’s School of Engineering and Sloan School of Management; focusing on solving complex socio-technical challenges by taking a systems thinking approach to multi-stakeholder management, multi-disciplinary problem solving, model-driven engineering, design, and strategic decision throughout the entire product/system lifecycle. In this role, he established strategic industry partnerships and collaborations, identified industry trends, and taught medical device and project-based courses to help partner companies and students develop new technologies, products, and leaders.
Prior to MIT, Ben worked for over a decade in medical device product, team, and organization development. This experience included serving as Vice President in technology and product development, as well as engineering at Applied Medical, a global, vertically-integrated, company that develops innovative products that improve patient outcomes. Ben has also leveraged this experience working and consulting with digital health and other tough tech start-ups.
During the COVID-19 Pandemic, Ben was an integral part of the Massachusetts Manufacturing Emergency Response Team (MA M-ERT) that was established to mobilize, organize, and operationalize critical path work streams necessary for Massachusetts manufacturers to pivot their operations to produce needed FDA compliant medical devices and supplies at scale. For these efforts, Ben was awarded MIT's 2021 Collier Medal, an annual award given in memory Officer Sean Collier to honor passionate curiosity, genuine kindness, and dedication to service.
He holds a B.S. in Mechanical Engineering from the University of Colorado – Boulder with and emphasis in Biomedical Engineering and a Minor in Biochemistry. Additionally, he received a Master of Science degree in Engineering and Management from MIT through SDM.
|Rhonda Mecl, Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, FDA |
Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office.
Amra Racic, Senior Director, Government Strategy, Veeva Systems
As Senior Director of Government Affairs at Veeva Systems, Amra is responsible for understanding the challenges and opportunities of medtech companies as well as representing the company in major industry associations to help foster industry progression. She has more than 23 years of experience in the Healthcare Industry, most of which were in large Medical Device companies in a variety of regulatory roles. Most recently, Amra led Regulatory Intelligence activities for Abbott’s Medical Device Division where her team was responsible for receiving, analyzing, and interpreting regulations that had the potential of impacting Abbott or wider industry. Prior to Abbott, Amra held leadership roles across regulatory, clinical, and quality at Bayer and Medtronic. She has also represented the medical device industry in various association working groups include Advamed, RAPS, WHO, IMDRF, and the FDA.
|Sandra Rickenbacher-Lächli, Head of Public Affairs & Legal Counsel, Member of the Executive Board, Swiss Medtech|
Sandra Rickenbacher studied law at the University of Zurich, Switzerland, is a attorney-at-law and holds an LL.M. in European Law from the College of Europe in Brugge, Belgium. Sandra Rickenbacher has been working in the position as Head of Public Affairs and Legal Counsel, Member of the Executive Board, for Swiss Medtech, the association of Swiss medical technology, since September 2021. Before, she had worked for the Federal Department of Economic Affairs and subsequently for the Federal Department of the Environment, Transport, Energy and Communica-tions for more than ten years – in both Departments (“Ministries”) in the position as personal advisor to the respective member of the Swiss government. In previous functions, she held positions in the energy and the financial sectors.
George Strom, Business Development Director of IOT, Intertek
George Strom is Business Development Director of IOT at Intertek, a FTSE 100 Company. George has worked with medical device manufacturers around the world to help them meet all of their assurance, testing, inspection, and certification needs. George’s 20+ years in the Quality Assurance & Safety arena bring insight into the unique challenges of launching a product in today’s Connected World. Prior to Intertek, George worked in Sales and Marketing within the Computer & Office Automation Industry. He is a proud alumnus of U-Mass Lowell and lives in the Greater Boston Area.