Healthmark presents an informative webinar on quality in medical device manufacturing. Medical device manufacturers are required to follow stringent standards, policies and procedures to ensure they are delivering a safe and quality product to their customers. This presentation will highlight some of the most significant practices in the manufacturing process of medical devices.
Today, healthcare innovation centers on advancing breakthrough treatments to improve patient outcomes. Focused Ultrasound is a revolutionary, noninvasive therapy that can treat multiple diseases and has the potential to address many more with further R&D funding. Join us to learn how, for many patients, this noninvasive, non-pharmacological treatment is a significant improvement over conventional therapies and reduces overall costs. This briefing will educate about the established benefits of focused ultrasound, its potential in other areas of healthcare, and the value of additional research investment to advance this field of medicine.
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.
This event is presented by Project Medtech. Early-stage Medtech companies are expected to navigate the complex process of bringing an idea into reality, but very seldom do they have the expertise, experience, or resources to ensure success. If you are founder faced with this dilemma, this is for you. Project Medtech and our 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.
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.