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 Waterfront Hotel, Annapolis, Maryland
REGISTRATION: Update: Registration has ended.
- Members- please choose the “member” ticket type
- Strategic Partners- please choose the “strategic partner” ticket type
HOTEL: Update: The hotel block has closed.
SUBMIT SPEAKER QUESTIONS TO: mpc@osma.net
PRESENTATIONS:
Track One: Digital Health Revolution- Key Trends Shaping the MedTech Evolution
Track 1- Oliver Richards and Jens Lauber
Track Two: Digitalization in Regulatory, Quality, and Clinical Documentation
Track Three: Unlocking AI Innovations- Navigating FDA’s Guidance Documents for AI/ML Enabled Devices.
Track 3 – Manan Hathi, Ganesh Saiprasad, Diane Johnson, Anupama Govindarajan
Track Four: Precision in Practice: Navigating Regulatory Requirements for Patient-Specific Implants & Surgical Planning Software.
Track 4 – Dave McGurl and Nima Akhlaghi
Track Five: Emerging European Regulatory Trends for AI/ML Medical Devices.
Track Six: Revolutionizing Orthopedic Device Evaluation with In-Silico Evidence
Track Seven: Smart Implants: New Generational Implants, Devices, and Sensor Technology
Track 7 – Garrett O’Lochlainn and Andrew Fields
Track Eight: Post-Market Surveillance and Real World Evidence: Challenges and Opportunities in an Era of Regulatory Change and Technological Advancement
AGENDA: Agenda for the OSMA 2025 Spring Meeting
OVERVIEW:
Tuesday April 22– Please join us at 7pm 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 Revolution:
- 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.
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Digitalization in Regulatory, Quality, and Clinical Documentation
- Methods applied by the medical device industry to increase efficiency.
- From application to certification, the value of digital methods.
- Current practices and future opportunities.
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Unlocking AI Innovations- Navigating FDA’s Guidance Documents for AI/ML Enabled Devices.
- Regulatory Insights on Lifecycle Management of AI-enabled Devices
- Introduction of AI-DSF into Clinical Workflows
- R&D of AI-enabled Devices – Development, Data, and Interoperability
- PCCP – Background and Expectations
- 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 EU AI/ML Act
- Cybersecurity/QMS Integration
- Cybersecurity Essentials- Requirements and Security by Design & Testing
- 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
- Introduction to sensor technology/smart implants and the regulatory challenges
- Considerations for active implantable medical devices (radio, battery, software, hazardous substances etc.)
- Regulatory considerations for sensors in medical devices; wearable sensors in the orthopedic space
- Post-Market Surveillance: Challenges and Opportunities in an Era of Regulatory Change and Technological Advancement
- Regulatory landscape and trends (MDR & IVDR Challenges, Active surveillance program from FDA/NEST, IMDRF’s Global Harmonization Efforts)
- Digital Transformation & Automation (AI & Machine Learning in PMS, Automating Complaint Handling & Signal Detection, Natural Language Processing (NLP) for PMS)
- Real-World Data (RWD) & Post-Market Evidence Generation (Leveraging RWD for PMS, Predictive Risk Management, Data Quality based on Standardization and Interoperability)
- Surveillance Beyond Compliance – Closed Quality Loop & Patient Outcomes (Proactive vs. Reactive PMS Strategies, Customer Feedback Loops, Patient-Centric Surveillance)
We can’t wait to see you in Annapolis!