Changes In Strategic Thinking

Because there are now two separate medical products under investigation which may have different life cycles, companies involved in co-development are facing new challenges and may have to create complex arrangements that allow for regulatory and business issues to be addressed. FDA is committed to approaching products being submitted as part of a co-development paradigm to assuring that good science and appropriate regulatory thresholds be met but also bringing to bear a regulatory framework that is as flexible as possible.

Companies may either wish to rethink their business models, shift strategies to accommodate new types of products, and change administrative structures to allow drugs and devices to be developed either in parallel or at least in a scientifically streamlined manner. Moreover, companies may be inclined to develop business alliances, seek out business partners and financial solutions to developmental costs that will encourage product development, and demonstrate the proper premium on testing so that value-based reimbursement becomes possible. Some authors have called for health system reforms that promote value-based, flexible reimbursement for innovative diagnostics and therapeutic products, and others have highlighted potential value to creating stronger economic incentives for the development of personalize medicine [7]. As health care costs continue to skyrocket, the role of FDA regulation appears to be a less important barrier to development of product than obtaining reimbursement or widespread clinical acceptance. Increasingly, both third- party payers and health care gatekeepers are demanding studies grounded in evidence-based medicine before making coverage decisions or before choosing to order new tests. There is also heightened interest among third- party payers to performing complex cost-effectiveness analysis to help make payment determinations.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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