This session will highlight intellectual property positions, FDA regulatory pathways and funding considerations that affect the near-term prospects for medical products combining nanostructured materials with microelectronic or cellular components. In this fashion we look to provide pragmatic insight on legal, regulatory and business issues just over the horizon for this particular area of combination products.



Objectives:

Highlight the promising new technologies at the convergence of nanotech, microelectronics and regenerative medicine (using these categories broadly).

Consider concerns over the divergence between the regulatory and legal paths for combination products.

Focus on the practicalities, including: 1) how companies will get their products to market and secure funding; 2) what needs to be addressed to allow for medical and economic advancement; and 3) unmet needs of current products.