1、Sponsored byChris DeVany,Pinnacle Performance Improvement WorldwideThe Keys to Cost-Effective Project ManagementObjectivesDetailed information addressing:Regulatory requirements Understanding regulations like EU MDR Working on cross-functional teams Cost-efficient design Design For Manufacturability
2、 Supply chain management FDA Quality Management System Regulation Gaining feedback Securing adequate funding Developing a comprehensive marketing and market access strategy Collecting real-world dataThe 10 Keys To Cost-Effective Project Management1.Strategic Planning and Project Scoping2.Regulatory
3、Concerns3.Cross-Functional Teams and Collaboration4.Innovation and Cost-Efficient Design5.Supply Chain Management6.Quality Assurance and Risk Management7.Patient and Practitioner Engagement8.Funding and Financial Management9.Marketing and Market Access Strategy10.Continuous Improvement and Post-Mark
4、et SurveillanceImageStrategic Planning And Project ScopingBefore embarking on the development of orthopedic products,perform a thorough market analysis to identify target demographics and understandregulatory requirements.These steps define project goals,budgets and expenses for research,development
5、,regulations,manufacturing and marketing.Detailed project scoping identifies financial risks early in the process,allowing you to implement mitigation strategies.ImageRegulatory RequirementsReferencing from BONEZONE a helpful article by Dan Cook,titled:OSMA Sets its Sights on OMTEC,which describes t
6、he efforts by the OrthopaedicSurgical Manufacturers Association(OSMA)to expand its reach and influence in the device development process.https:/ ConcernsRegulatory strategy and compliance are not just legal obligations.They should be a key part of your strategic plan.Early and continuous engagement