(Invited) Industrialization Trial of a Biosensor Technology
Authors: Ohashi Keishi , Osaka Tetsuya 
Published: February 2020

Sensor network systems using mobile phones with several physical sensors can collect big data related to human health. The addition of low-cost chemical sensors to the sensor system increases the scientific prescription based on contemporary medicine. The authors examine the commercialization of a system based on the concept of physiological balance sensing. Individuals and animals possess biological barrier systems against various stressors. This study offers a system that constantly monitors biological barrier functions on the epithelial layers by using an ion sensitive field-effect transistor (ISFET) sensor and feedback recommendations and precipitations through a smart phone [1].
The initial business trial of the ISFET sensor was developed jointly with Horiba, Ltd. to provide a micro-pH meter with no reference electrodes. The sensor chip consisted of two ISFETs, namely a chip that detected the hydrogen ion concentration [H3O+] and another chip that was unaffected by [H3O+]. The differential signal between both the chips is converted to a pH value without using a reference electrode [2]. This holds tremendous potential from a research viewpoint. However, the expected market size did not meet the expectations of a large company.
The next business trial involved establishing two approaches to commercialization. The first approach involved a public finance start-up with an existing large company. This approach is usually effective when a technological breakthrough is required. Universities were expected to play a key role in organizing a joint venture by combining several existing enterprises, and thus this was included in the objectives of the Radical Innovation and Entrepreneurship Program (COI STREAM) of the Center of Innovation Science and Technology that was launched by the Japanese Ministry of Education, Culture, Sports, Science and Technology (MEXT). A wireless multi-target ISFET system that detected, analyzed, and provided feedback on physiological substances in biological barriers was developed. This program involved a collaboration between the Waseda University and two private enterprises (Riken Genesis Co., Ltd. and Toppan Printing Co. Ltd). Certain key molecules for monitoring the balance sensing such as cortisol do not possess electric polarization. Hence, the role of aptamers that deformed to change the charge distribution within a Debye length was investigated for the detection of these non-polarized molecules by ISFET. This entailed a collaboration with another government program (the Adaptible and Seamless Technology transfer Program through target driven R&D (A-STEP)) to develop artificial nucleotides with NEC Solution Innovators, Ltd. and to develop the aptamers with high sensitivity and high selectivity with Gunma University.
Another approach included a small startup from Waseda University in the Enhancing Development of Global Entrepreneur (EDGE) program of MEXT. The first trial of the startups was a pet business, which served a skin monitoring system by using an ISFET sensor for pets. A wireless ISFET system was developed for animal skin care and it included a simple and quick skin pH measurement method applicable to both humans and dogs. As part of the first stage in customer discovery, students interviewed several dog-owners and their pets who participated in a dog run at a big park by showing a prototype as the minimum viable product (MVP) [3]. None of the dog-owners were interested in the MVP, as all the pets were young and healthy. Since there were no true customers, alternative areas were explored. The next target entailed animal hospitals with unhealthy dogs. However, veterinary doctors did not want to purchase the products as they believed in the accuracies of their diagnoses. The next area explored was dog-grooming services. In these services, there were constant complaints that customers did not accept their suggestions despite being informed about symptoms of a cutaneous disease. Hence, the dog-grooming services could be the early adapters of the first product.
At this stage, it is difficult to determine the approach that leads to industrialization success. Hence, further explorations are required in order to “embrace the struggle” [4].
References:
[1] K. Ohashi, S. Kuroiwa, S. Hideshima, T. Nakanishi, A. Matsuzaka, and T. Osaka, IEEE RFID-TA 2015, P2-8 (2015).
[2] S. Kuroiwa, J. Wang, D. Satake, S. Nomura, and T. Osaka, J. Electrochem. Soc., 156 (4), J67¬J72 (2009).
[3] Steve Blank and Bob Dorf, The Startup Owner’s Manual, K&S Ranch (2012).
[4] Ben Horowitz, The Hard Thing About Hard Things: Building a Business When There Are No Easy Answers, Harper Business (2014).