Join JumpStart on Wednesday, March 23, for the next Founders Unfiltered featuring Dr. Dan German, founder of orthobrain. An award-winning orthodontist, Dr. German is well known throughout the dental world. Now he’s helping dentists seamlessly integrate orthodontics into their practice by providing education and real-time support through orthobrain’s innovative platform. Tune in to find out how Dr. German set out to resolve the unmet demand for orthodontics and hear more about how he went from dental practitioner to tech founder.

This event is presented by Project Medtech. Grab your favorite drink (or just a drink), come learn and interact with industry experts while they discuss hot topics in Medtech. Dr. Ashley Mooneyham is President and Director of Grants at Superior Medical Experts, a medical writing and research support company. As Director of Grants, she has helped small businesses in the healthcare innovation space secure over $14 million in non-dilutive seed funding through the SBIR/STTR grant program. Superior Medical Experts provides comprehensive grant assistance that spans company registrations, grant strategy consulting, full research and compliance drafting, and submission in as little as 12 weeks.

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.

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.

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.

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.

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.

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

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.

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.