Biosensors have been popping up in academic papers for some time, and they all cite the same aspect: it's going to be the next big thing, next big thing, etc. Biosensors research focuses mostly on validating the new device against a standard available protocol. I have seen biosensors that validate against HPLC, ELISAs, spectrophotometry etc. However, a lot of biosensors target the same analyte, and they provide different transducers, materials, pathways and recognition techniques to sample those analytes in a complex media. Some 'projects' of biosensors are more attractive than others. Some are more 'novel', others are more 'proven'. If I were to commercialize biosensors on a large scale, let's say in an over-the-counter fashion, my materials would need to be cheap and disposable, environmentally-friendly; if they were to be in a lab, otherwise, the biosensor would have to be able to run multiple times. My question is (and it's a little philosophical), how do you choose, from a entrepreneurial point of view, that a biosensor that just has the 'it's gonna sell a lot' feature among so many available options to sense something? I wish I knew how the guys at the diabetes/glucose biosensor had the idea to put their invention into the market, in an era where no one would expect a little strip with a blood drop to measure their sugar levels. Are there any similar ones on their way?
Having created the term „biosensor“ already in 1977 (Fresenius Z. anal. Chem. 287, 1-9 (1977)) I must agree to your statements that many biosensors described in the literature are too often academic toys lacking any strict validation according international quality standards. The glucose sensor is an exception due to the abnormal high stability of glucose-oxidase. I think the most difficult problem is a long lasting reliable calibration made by the sensor producer with respect to the fragile biological recognition elements. Also the definition limits their applicability: the bio receptor in close contact with the transducer prevents the rejuvenation of the sensing area by new and working biological receptors. But even with the most prominent biosensors, the glucose sensors, sensor trials with different manufacturers deliver not such an agreement which an Analytical Chemist (trained in the field of standard reference materials analysis) would tolerate. With the exception of glucose sensors, how will they be stored and how will their calibration be guaranteed? Those problems have limited a wider use of biosensors or have rendered them into semi-quantitative devices. See also attached paper.
I found myself sometimes wondering if I were hired by an entrepreneur seeking to enter the biosensors market and I am asked to build a sensor for a specific application our clients need, what sorts of figure of merits I would go through? I think of:
- Scale: can it be built using traditional large scale manufacturing techniques, like roll-to-roll printing, inkjet printing, screen printing?
- Cost: is the unit cost viable? would it be disposable or reusable? should it need a rewash buffer if it's reusable?
- Platform: is there any platform that reads my data or would I need to develop a specific electronics just for this sensor?
- Market: is there already a traditional analytical technique for this biological specimen I'm trying to sort out in a mixture? is my product more appealing? would it need a learning curve? is it steep or is it flat?
I don't know if that's the way, but it seems like it.
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