Despite rapid advances in life science research, the bioindustry has been plagued by a slowdown in new drug, biologic, and medical device applications. Indeed, the FDA addressed this issue two years ago with the release of a white paper entitled Challenge and Opportunity on the Critical Path to New Medical Products.
Meanwhile, the cost of developing novel products has increased significantly. There is a concern that the development of new products and therapies could stagnate altogether, rather than delivering a biomedical revolution, as some expected.
According to the FDA, the problem is The applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences. The new science is not being used to guide the technology development process in the same way that it is accelerating the technology discovery process.
For medical technology, performance is measured in terms of product safety and effectiveness. Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness off new products can be demonstrated.
The research community is beginning to respond to the FDAs call with creative technologies for stem cell research, particularly in the area of devices, commercially scalable methods, assays, delivery methods, and industrial and manufacturing applications.