Learn about impactful innovations as well as new startup companies generated from Abigail Wexner Research Institute at Nationwide Children’s Hospital. Join us for talks highlighting novel interventions from Nationwide Children’s researchers.
Every third Friday of the month, G2G hosts this online event to give bioscience companies (i.e. therapeutics, diagnostics, medical device, digital health, etc.) the chance to learn about non-dilutive funding opportunities, such as grants and BAAs that could accelerate company growth. We will share insights from our research and provide some Q&A during the first half hour. We then take a deeper dive on non-dilutive federal government funding sources and related priorities with consultation during the second half hour for our customers.
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.
The surge in digital healthcare technologies has reshaped the healthcare experience for consumers. Consumers are looking for more personalized health experiences where they are in control of their health but they are also more aware of the risks and benefits of sharing their data. Now more than ever, it’s important organizations understand how to use technology to deliver value while addressing consumer concerns around data, consent and security.
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.
Join JumpStart for the next episode of Founders Unfiltered featuring Afif Ghannoum, co-founder of BIOHM Health. Afif, a biotechnology attorney by training, co-founded BIOHM with his father Dr. Mahmoud Ghannoum, a global leader in medical mycology and Case Western Reserve University Professor. The father and son duo launched BIOHM in 2016 to help bring Dr. Ghannoum’s science to consumers, commercializing probiotics and microbiome testing kits to target fungi and bacteria in the digestive tract. JumpStart will talk to Afif about BIOHM’s recent funding round, the results of their groundbreaking clinical trials and his work commercializing healthcare innovation.
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.