Development and early HTA of novel microfluidic systems for bio-analytical and drug delivery applications

This research work is in the field of Biomedical Robotics, and it is concerned with the development of mechatronic technologies for biomedical applications. More in detail, in this work the development of novel microfluidic solutions and systems both for molecular diagnostics, through on-chip analysis, and for therapy, through targeted drug delivery, is presented. The main aims of the work can be summarized as follows: 1. Proposing a novel approach for research activity, combining together a biomechatronic design approach, that is typical of bioengineering, with several "in progress" health technology assessment (HTA) procedures, that are typical of other scientific fields, such as health economics. 2. Defining roadmaps of technological innovation for microfluidic systems, especially concerning systems for bioanalytical and drug delivery applications. 3. Performing an experimental research activity, from the very early concepts to in vitro tests on the prototype, on one of the mentioned technologies (i.e. applications for drug delivery). 4. Validating the chosen research approach on other technological applications. In this dissertation all the mentioned activities are presented, together with the main results. In the first part, after a critical investigation on the state-of-the-art in the field of microfluidic applications to biomolecular analysis and drug delivery, two feasibility studies are presented, on possible novel microfluidic solutions for motion, manipulation and dispensing of biological samples for bioassays. In particular, these two case studies relate to two different kinds of technological innovation: the first one is an example of "incremental" innovation, that mainly consisted in improving an existing technology; the second one is an example of thorough innovation, that investigates the feasibility of a bioanalytical system based on a novel approach. Then, the development of a novel biomechatronic system for direct drug delivery into a tricky anatomic compartment, such as the brain, is presented, starting from a model of interaction of the system with the anatomic location of interest, to the fabrication of an early prototype and of a hardware simulator of the cerebral dynamics for in vitro tests. The second part of the dissertation relates to the application of different early HTA procedures to the afore mentioned technologies, in order to test the novel approach adopted for technology development. As a matter of fact, health technology assessment (HTA) is an existing discipline, that usually is used for performing analysis and evaluations on well-established medical technologies. However, sometimes it is too late to perform such evaluations on an already-on-the-market technology, especially in the biomedical field. Several technologies may result ineffective, not user-acceptable, or even harmful, thus leading to a waste of resources and time, that could be avoided by performing such evaluations at every step of development of a certain technology. Eventually, in the second part of the dissertation, another HTA case study is also presented, on a further emerging biomedical technology currently in use at the Biorobotics & Biomicrosystems Lab at University Campus Bio-Medico. This is done for showing that there are several ways of performing HTA, especially when dealing with technologies that are in their investigational/experimental stage of development. For this reason, for each technology that is assessed, a proper analysis level is kept, in order to provide conclusions and evaluations that are suitable and well-timed with regard to the degree of progress of each technology field.