Medical Device Innovation Consortium (MDIC)

Attention MDIC Members, Your Voice Matters! ?? Join us on April 1 for our MDIC Member Listening Session, moderated by Board of Directors members Ami Simunovich (BD) and Rob Lyles (Cook Group, Inc.). This interactive session is your opportunity to share your insights, participate in live polls and chat surveys, and engage directly with fellow members on common challenges our industry is facing. Your input will help shape critical discussions around navigating uncertainty, the value of public-private partnerships, enhancing MDIC’s value to our member community, and our evolution toward even greater innovation and patient impact. Check your inbox for your invitation! If you are an MDIC Member and didn’t receive one, reach out to us at [email protected]. Don’t miss this chance to make your voice heard and shape our collective path forward! Learn more about MDIC Membership at mdic.org/membership

MDIC’s Advanced Manufacturing Clearing House (AMCH) is proud to support Nanopath, an early-stage molecular diagnostics company revolutionizing point-of-care testing for pelvic and gynecologic infections. Through collaboration with MDIC’s AMCH, Nanopath successfully integrated simulation-aided design early in their product development, enhancing sensitivity, efficiency, and cost-effectiveness. By optimizing manufacturing processes within the U.S. before FDA clearance, Nanopath is demonstrating how #advancedmanufacturing can accelerate regulatory pathways and improve #patientaccess to high-quality diagnostics. Read more at https://lnkd.in/etwSgG_V

Traditional compliance efforts often focus on patching specific issues. But what if we approached compliance differently—by strengthening the entire quality ecosystem? The Accelerate Sustainable Capability pilot study, developed by MDIC in collaboration with ISACA and FDA, took this challenge head-on. Through structured appraisals, action planning, and ongoing performance monitoring, ASC participants achieved measurable improvements in product quality, risk management, and operational efficiency. This wasn’t about just checking the box of compliance—it was about building a foundation for lasting success. Download the report at https://hubs.li/Q03cyMJZ0 #medicaldevice #quality #qualitysystems #patientsafety #qualitymatters #CaseforQuality

How can recall modernization improve field responses and drive better #patientoutcomes? MDIC’s Paul Sumner joins industry experts at the Veeva MedTech Summit to explore best practices and innovations shaping the future of patient safety. See the full agenda here: https://lnkd.in/erzZKT7J

Sustainable compliance isn’t just about fixing gaps—it’s about building a culture of quality that drives continuous improvement. The Accelerate Sustainable Capability (ASC) pilot study provided participating medical device manufacturers with a structured, data-driven pathway to enhance their quality systems, address compliance concerns, and achieve lasting operational excellence. Through tailored appraisals, action planning, and ongoing assessments, participating manufacturers successfully improved their quality processes and resolved open advisory actions. Read the full report: https://hubs.li/Q03bxLHB0 #MedTech #QualityImprovement #Compliance #MedicalDevices

The 2025 MDIC Symposium on Computational Modeling & Simulation is the premier event for industry experts, regulatory professionals, and innovators advancing Modeling and Simulation in #medicaldevice development. Join us in person November 4-6 to explore cutting-edge insights on model credibility assessment, computational evidence for regulatory submissions, and AI’s transformative role in CM&S. Featuring keynote talks, expert-led panels, real-world case studies, and selected podium and poster presentations, the Symposium will highlight recent innovations in physics-based modeling, novel simulation applications, and AI-driven advancements. Don’t miss this opportunity to connect, collaborate, and advance regulatory-grade in silico evidence. Register now: https://lnkd.in/e9cMHicq #ModSim2025 #ComputationalModeling #MedTech #Simulation #RegulatoryScience #AI

The latest Final Pilot Report from MDIC takes a deep dive into the MedAccred Sterilization Audit and Accreditation Program, analyzing its alignment with industry standards and potential role in regulatory oversight. The study looked at: ? Audit depth – MedAccred goes beyond routine compliance checks, assessing both sterilization processes and Quality Management Systems (QMS) ? Potential efficiencies – Findings suggest the program could help reduce redundant audits and improve oversight without compromising safety ? Program impact – The report explores how a standardized accreditation approach could enhance quality assurance across the industry FDA representatives involved in the study noted that the audits provided thorough, well-organized assessments of key sterilization processes. The report offers new insights into how audit data can strengthen industry-wide quality efforts and informs FDA considerations for future regulatory oversight. More information and the report here: https://hubs.li/Q03b9HRQ0 #RegulatoryAffairs #QualityAssurance #HealthcareInnovation

The Open Hand Initiative highlighted key challenges and opportunities in using real-world data (RWD) to generate real-world evidence (RWE) for regulatory submissions. By fostering transparency between the FDA and medical device manufacturers, this collaboration uncovered critical insights on data quality, study design, and regulatory expectations. What did we learn? The importance of early engagement, standardized data collection, and clear pathways for regulatory use of #RWE. Explore the full findings: https://hubs.li/Q03956pd0

MDIC is headed to #PatientsasPartners2025! Jonah Golder, MDIC's Project Manager in Science of Patient Input, will lead a critical discussion at the 12th Annual Patients as Partners in Clinical Research Conference on early-phase #patientengagement strategies for biotech and medical device development. Join him on Monday, March 17, 2025, at 1:05 PM for an interactive roundtable exploring a cutting-edge tool that helps companies assess and enhance patient engagement efforts from the start. This session will provide tailored evaluations and actionable recommendations to ensure patient-centered innovation in medical technology. Learn more at https://lnkd.in/gPtx4mkr #MedTech #PatientEngagement #Innovation

From product development to manufacturing, supply chain, and clinical studies—quality touches everything. In this MDIC Studio Session, Joseph Sapiente leads a conversation with Al Crouse, VP of Quality at CVRx | Barostim, and George J. Serafin, President & CEO at NanoDx, Inc., on actionable strategies to unify QA across your enterprise. Discover insights on building a culture of quality, optimizing risk management, and balancing speed, cost, and quality. A must-watch for #MedTech leaders committed to operational excellence. https://lnkd.in/gCQEn6XD #medicaldevice #manufacturing #supplychain #qualityassurance #medtechquality #QA #riskmanagement