Join us on the waterfront in historic Annapolis, Maryland for three days of networking and education as we explore the global regulatory landscape in Digital Health.
WHEN: Tuesday, April 22- Thursday, April 24
WHERE: Annapolis, Maryland
REGISTRATION: Log in to the Member Site to access the registration link.
HOTEL: A discounted hotel rate of $259 has been reserved for meeting attendees. Log into the member site to access the hotel block link.
SUBMIT SPEAKER QUESTIONS TO: mpc@osma.net
AGENDA: Log into the Member Site to access the full agenda.
OVERVIEW:
Tuesday, April 22– Please join us for an evening Networking Reception at the Annapolis Waterfront Hotel. This is a great chance to reconnect with other OSMA members!
Wednesday, April 23– We will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on the global digital health regulatory landscape:
- Digital Health Revolutions:
- Discover how key trends including care dispersion, cost pressures, and digitalization are reshaping the MedTech landscape
- Learn strategies for building a digital core and leveraging digital capabilities to navigate industry challenges
- Explore evolving reimbursement models and partnership strategies, with insights applicable to orthopedics
- Understand the emerging impact of AI and agentic AI technologies on orthopedic innovation and patient care
- AI/ML Lifecycle: PCCPs, Updated regulatory guidance, and more!
- Precision in Practice: Navigating Regulatory Requirements for Patient-Specific Implants & Surgical Planning Software-
- Regulatory Pathways: Navigating FDA submissions and recent guidance updates.
- Testing & Validation: FDA expectations for mechanical testing, biocompatibility, and software validation, including AI/ML-based applications.
- SaMD vs. Integrated Submissions: Evaluating the benefits and challenges of separating pre-operative planning software as SaMD.
Later that evening, take a stroll down to the Choptank Annapolis for our private event in the Commodore’s Room.
Thursday, April 24– The final day of the meeting is packed with education sessions that include even more digital health topics:
- European Regulatory Trends in Medical Devices: Navigating the AI/ML Act, Cybersecurity Essentials
- Revolutionizing Orthopedic Device Testing: In Silico Trials- Future Digital Methods to Reduce Cost and Time to Market, Digital Twins
- Smart Implants, Sensor Technology, Wearable Sensors
- Digitalization in Regulatory, Quality, and Clinical Documentation
We can’t wait to see you in Annapolis!