This question is part of the following Ask The Expert session:
Job Title: Biomedical Automation Application Engineer
Yes, of course there are, as with any new technology. Though dispensing methods might not be new, the applications we are seeing haven’t been done until now. Printing with live cells and biological reagents definitely requires not only a lot of caution on the part of the researcher, but it opens doors to regulatory questions (is 3D printed tissue going to be considered a drug? a medical device? a Cell Therapy application? does the FDA need to be involved in particular applications?) and potential ethical questions as well (some people have referred to these as “playing God” type questions: should we even be printing organs at all? should we enhance the function of an organ if we figure out how? will this lead to us engineering better humans, and if so, at what cost? where will we ever stop?).
Even in pharmaceutical development, there will be looming questions. 3D cell culture models are still being researched and tweaked, and there is not one standard model being used. Comparing the data from a 3D assay to a 2D assay could prove difficult, even though I’m thoroughly convinced 3D-derived data is far superior. One big hurdle is that, as the industry has been standardized around a 2D system thus far, validating the results around a 3D model will not be the most straightforward task. However, I believe it is an imperative that companies jump on board, as those that do will ultimately be bringing large efficiency improvements to their processes. This will pay off in due time, and allow more of a streamlined process.