Why Medtech - Stories of Diverse Female Leaders

Thursday, March 23, 2023 (2:00 PM - 3:00 PM) (EDT)

Description

Join this interactive conversation with Medtech Color and MassMEDIC during Women's History Month to learn from female leaders in the industry about why they chose Medtech and their career journeys. Speakers will share the importance of advocating for better representation of historically underrepresented and marginalized groups. While the industry is essential and growing, we must continue to consider diversity, equity, and inclusion (DE&I) in all areas of medtech to support ongoing innovation.

 

This collaboration is a continuation of the Why MedTech Campaign, where through sharing positive stories from our industry, we will inspire a new generation of diverse individuals to join us in our pursuit to make the world a healthier place for all, especially for those underserved populations.


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Moderator


Vernessa Pollard

Vernessa T. Pollard is co-leader of McDermott Will & Emery’s FDA practice. She provides strategic business and regulatory advice to FDA-regulated companies on complex issues related to the development, manufacture, marketing, post-market safety and compliance for FDA-regulated products, including drugs, medical devices and digital health technology. Vernessa counsels companies on product development and premarket strategy, good manufacturing practice and quality system requirements, advertising and promotion, adverse event reporting, FDA warning letters, FDA inspections, recalls, import detentions, corporate compliance programs and regulatory due diligence in mergers and acquisitions. Vernessa is a former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel. She received the LMG Life Sciences, Regulatory Attorney of the Year: FDA Medical Devices, 2018 and has been recognized in numerous Law and Life Sciences publications, including Chambers USA 2014 to 2018, Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia). Vernessa received her B.A. in Communications from Howard University and her Juris Doctor from Temple University School of Law.
Speakers


DeChane Dorsey

DeChane Dorsey is executive director of AdvaMed Accel, the division within AdvaMed dedicated to the needs of smaller medical technology manufacturers. The vision of AdvaMed Accel is to be the leader in advancing medical technology by bolstering the industry’s emerging and early-growth enterprises – the drivers of disruptive innovation, job creation, and economic expansion. The division is committed to ensuring the voice of small pioneering and entrepreneurial companies is always heard by policymakers. 


DeChane is also team lead on AdvaMed’s heath equity workstream, spearheading the creation and execution of AdvaMed’s Principles on Health Equity. Previously, as AdvaMed’s Vice President of Payment and Health Care Delivery Policy, DeChane provided analysis and guidance to association members on Medicare payment, coding, and coverage issues; and developed the association’s policy positions for improved payment and coding infrastructure. 


Before joining AdvaMed, DeChane served as Director of Health Policy for the American Academy of Ophthalmology and as Senior Counsel in the Office of Counsel to the Inspector General within the U.S. Department of Health and Human Services. DeChane started her career as a Westwood Fellow at the Neighborhood Legal Services Program in Washington, D.C. 


DeChane received a Bachelor of Arts in Political Science from Syracuse University and a Juris Doctor from Georgetown University Law Center. 

Nada Hanafi


Nada joined Veranex (previously Experian Group), in 2017 after working 12 years at FDA’s Center for Devices and Radiological Health (CDRH). Since 2010, she has 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 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).



Manisha Shah-Bugaj

Manisha Shah-Bugaj has a long-standing track record as a successful global medtech executive, key influencer and transformational leader, both globally and domestically, with a core strength in developing and protecting team culture founded in transparency, recognition, and acknowledgment of areas of improvement, with identified countermeasures. She joined Activ Surgical in January 2022 as Chief Operating Officer, she now serves as the Chief Executive Officer. Manisha is responsible for overseeing all business operations for the company, including oversight of the commercialization of its ActivSight™ enhanced visualization imaging module and the implementation of its surgical visualization technology at established pilot hospital sites in 2022. Prior to Activ Surgical, Shah-Bugaj architected the gynecology unit at Olympus from the ground up in the U.S., ultimately serving as General Manager and Global Vice President for the company and played an integral role in expanding the gynecology business internationally. She has more than two decades of experience, including building and implementing corporate business plans, directing regional and global businesses aligned to financial and operational targets, hiring and establishing new teams, and managing product portfolios.

Kimberly Sterling

Dr. Kimberly L. Sterling is the Vice President of Global Value and Access at ResMed. Kimberly serves as a key leader within the Medical Affairs organization, responsible for the development of scientific evidence that demonstrates the value of ResMed devices and digital solutions, with a significant focus on research that supports gaining, maintaining, and expanding patient and provider access. Prior to joining ResMed in 2019, Kimberly held a variety of positions at Eli Lilly & Company and Sanofi, focused on HEOR strategy; implementation, scientific communication to payers and engagement with health technology assessment organizations. She has 20 years of HEOR experience within the pharmaceutical and medical device industries. Kimberly received her Doctor of Pharmacy degree from Butler University then went on to receive her Master of Science degree in Pharmaceutical Economics and Policy at the University of Southern California. In addition to her current sleep and respiratory medicine research at ResMed, she has published HEOR studies for multiple other diseases including bipolar disorder, cardiovascular diseases, diabetes, and autoimmune diseases in peer-reviewed journals.



Thursday, March 23, 2023 (2:00 PM - 3:00 PM) (EDT)
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