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Clinical Challenges Under the EU MDR

Online Event

With the EU Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the MDR, and introducing new products. Although the Medical Device Coordination Group (MDCG) guidance has been forthcoming, there remain significant gaps in guidance and interpretation of requirements, and varying interpretations of expectations. In addition with the limited number of Notified Bodies designated under the MDR, there is substantial pressure to make MDR submissions as soon as possible to avoid the “cliff edge” of May 2024. NAMSA invites you to join this upcoming webinar as our team of regulatory experts discuss practical insights to address these challenges.

The Need for Transitional Coverage for Emerging Technologies (TCET)

Online Event

For patients on Medicare, the majority of whom are over age 65, time matters. However, newly published research from the Stanford Byers Center for Biodesign shows that patients can wait up to 5 years after FDA authorization to access new medical technologies. Instead, a well-designed transitional coverage program could greatly accelerate patients’ access to care, while reducing the overall cost burden on our healthcare system. This program would also encourage innovation in areas of critically important unmet clinical needs. The Duke-Margolis Center for Health Policy has recommended the addition of several key elements to a transitional coverage pathway, highlighting the need for early engagement between stakeholders to inform and guide evidence development and appropriate use of novel technologies. Please join us to explore these findings and hear the perspectives of physicians, innovators and CMS stakeholders on this important initiative to advance patient care.

Transitioning from EUA to 510(k) for IVD Products: Planning to Execution

Online Event

In 2020, NAMSA hosted, “Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect?,” which focused on necessary regulatory, clinical and quality steps required to move from EUA to 510(k) approval. Two years later, we all have a stronger understanding of the expiration timeline for the Emergency Use Authorization (EUA) and a clearer picture of how to prepare for the upcoming changes. NAMSA invites you to attend this webinar where we will unpack the U.S. FDA draft guidance and discuss best practices for identifying gaps and maximizing your on-market product for a successful 510(k) submission, including an execution plan to achieve a quick and timely 510(k) approval.

MedCon Conference 2022

Online Event

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Health’s legacy of delivering the MedCon Conference.

Virtual Medtech Happy Hour

Online Event

Innovation: Setting your Company Up for Success in Commercialization, Adoption, and Further Investment. Presented by Project Medtech, this online event features speaker Kipum (Kip) Lee, a designer, scholar, and healthcare executive. Currently, he serves as Vice President of Innovation & Product Strategy at University Hospitals (UH) in Cleveland, OH where he leads a team of innovators within UH Ventures – the innovation and commercialization arm of health system. His day-to-day work involves managing the innovation portfolio and "living lab" that supports University Hospitals’ strategic initiatives and partnerships through product innovation and human-centered design. Earlier in his career, he was part of the team at frog design that produced a mobile service around HIV awareness and self-testing in South Africa that was hailed by The Economist as “the world’s largest field trial in mobile health technology.” He also helped plan and lead the design of Marriott Mobile, which debuted at number four in the iTunes App Store and shortly went on to become the third-largest in mCommerce after Amazon and Apple.

14th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistics Issues Conference

Online Event

This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. In an effort to provide quality programming in the safest and most effective manner possible, the Conference will once again be held virtually this year. Dates: Wednesday, May 11th - Friday, May 13th

The Basics of IVDR Clinical Studies, a NAMSA webinar

Online Event

Join NAMSA for this webinar as we walk through the key differences between EU’s In Vitro Diagnostic Directive (IVDD) and IVDR and the clinical study requirements outlined within these regulations. We will also examine ISO 20916:2019 as the Good Clinical Practice (GCP) guidance for IVD clinical performance.

BIO International Convention 2022

San Diego Convention Center San Diego

Mark your calendar for the BIO International Convention, June 13-16, 2022, in San Diego, held by BioOhio national partner, BIO! More information about the 2022 event will be made available in the coming months. Sign up for notifications about this event at BIO.org.

Medtech Startup Symposium

Rev1 Ventures 1275 Kinnear Road, Columbus

Project Medtech and its Network of industry thought leaders have organized an interactive event to help founders build a successful medical technology company. The Symposium will include 1:1 time with subject matter experts, industry networking events, educational presentations, and thought leader panel discussions.

Virtual Medtech Happy Hour: Preparing for the Valley of Death

Online Event

Grab your favorite drink (or just a drink), come learn and interact with industry experts while they discuss hot topics in Medtech. Speaker: Dr. Wessels founded LiquidSMARTS℠. He leads the global practice and is a member of the leadership team. He is passionate and dedicated to the improvement of human performance and ethical business practices in sales and marketing. His expertise comes from more than 25 years in the healthcare industry, including 14 years as a consultant to global and local marketing and sales teams. His clients gain rapid performance improvement through analysis, design, implementation of market approach, and commercial operations execution. He leads the field in providing micro-learning for business professionals. His micro-learning approach teaches people essential soft-skills and influencing and leadership behaviors in a few minutes per day.