||As the first step in the translation pathway, ideation relates to the inception of a new device, therapy, optimization method, approach or protocol. Topics may include parametric studies and disease modelling, design optimization methods, the role of computational modeling in concept generation, addressing customer needs, and technology scouting. This track is ideal to highlight case studies of products, devices and technologies and the role of computer modelling in ideation. In some cases, computational analyses themselves result in discoveries leading to ideation of new technologies or products - such studies would be ideal for this track.
||Prior to testing in human subjects, preclinical studies provide a critical step toward translation to the clinic. This track includes topics from the role of computational modeling in the design and maximizing of efficiency of animal studies, developing the animal to human transfer function, model validation, and test development. Studies implementing combined or paired computational-experimental approaches would fit well into this track.
| Product Development
||Product development involves the translation of early concepts to commercializable products. Computational modeling is taking an increasing role in product development, and topics for this track include predictive modeling, business modeling, robust design processes, and use of modeling to enhance pre-submission communication with regulators. Use of modeling to facilitate lean, rapid manufacturing of products would be of interest for this track as well.
| Clinical Study
||Clinical studies are designed to generate evidence that demonstrates suitability of a technology, device, protocol, and or product for use in humans. Computational modeling provides unique data in this regard. It can also be used to enhance the interpretation of experimental data in different clinical contexts and among different patient cohorts. Topics for this track may include virtual patients, design and optimization of clinical protocols, simulation as therapy, clinical study design, and statistical modeling. Other topics may include how to address challenges related to differences in patient cohorts such as gender, age, or disease state.
| Market release and post-market
||The Market release and post-market track follows products into the field and will highlight the challenges and advances that occur during the lifecycle of a product as well as in context of post hoc studies. Oftentimes the knowledge gained after market release is a key input into the ideation of the next design cycle. Topics may include regulatory marketing approval, post-market surveillance, failure analysis, and product recall. R&D based studies comparing products and clinical performance between manufacturers and/or clinical centers would be particularly welcome.