# BME100 f2017:Group12 W0800 L2

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# OUR TEAM

 Name: Jason Zhang Name: Priscilla Han Name: Amy Nystrom Name: Aimee Stryker Name: Vishnu Karthigeyan

# LAB 2 WRITE-UP

## Device Image and Description

The device being created is a strip that is four inches long, an inch wide and an eighth of an inch thick. On the posterior side, it contains a adhesive that will adhere to surgical, general and medical masks, and on the anterior side, it contains nanotechnology that will bind and change color when it comes into contact with bacteria. The healthcare issue being addressed is healthcare workers in the us and other countries being able to know when they are in contact with bacteria.

## Value Creation

The ability to rapidly detect contact with a specific bacterium in the field can save the lives of the workers using them. It can save money for the companies by avoiding paying for workers compensation and having to hire new employees to replace one's that were infected.

## Technical Feasibility

The technologies that will be require include nanotechnology that interacts with a bacterium as well as a secondary chemical that causes a change in color that detects the binding of the nanotechnology and bacterium.

Existing methods to detect whole pathogens typically focus on identifying proteins on the surface of the organism. For example, there is a nanotechnological device that detects the flu virus from exhaled breath, it chemically links the antigen to its surface using chemicals (1). Another proposed nanotechnolocial device is the carbon nanotube thin film biosensor (2). These carbon biosensors supposedly bind to specific antibodies on the intact virus to chemically determine the presence of the virus. According to the research done, this method appears to be cost effective (as the carbon is acquired from alcohol vapor and the fabrication of "reproducible sensors" is described) and claims to be more accurate in comparison to "electrical impedance sensors with identical microelectrode dimensions".
An existing method to create a change color in a material is using biomimetic virus-based colourimetric sensors (3). These genetically engineered viruses (M13 phages) change their structural formation in response to a chemical trigger. This method is primarily focused on detecting harmful volatile chemicals, but while implementing the detection of pathogens was considered, this biomimetic sensor has a limited affinity for specificity. In other words, the sensor had difficulty distinguishing between similar chemical structures.

Taking these two methods into consideration, the most obvious challenge that we will face would be to find a way to connect these techniques together and make it applicable to bacteria rather than viruses. We will need to attempt to fnd a specific nanotechnology that will bind to bacterial surface proteins instead of virus antigens, and we may also need to engineer a different chemical that changes color upon activation. Our group will also have to be cautious in terms of making a chemical receptor that is specific to one type of antigen; otherwise, the mask may give false readings of the environment.

### References:

(1) Michael Berger. “Nanowerk.” Nanowerk Nanotechnology portal, Nanowerk, www.nanowerk.com/spotlight/spotid=25762.php. Accessed 13 Sept. 2017.
(2) Oh, J.-W. et al. Biomimetic virus-based colourimetric sensors. Nat. Commun. 5:3043 doi: 10.1038/ncomms4043 (2014). Available from https://www.nature.com/articles/ncomms4043?wptouch_preview_theme=enabled
(3) Mandal HS, Su Z, Ward A, Tang XS. Carbon Nanotube Thin Film Biosensors for Sensitive and Reproducible Whole Virus Detection. Theranostics 2012; 2(3):251-257. doi:10.7150/thno.3726. Available from http://www.thno.org/v02p0251.htm

## Clinical Feasibility

In a clinic this will be applied to a surgical mask before a physician goes around patients. It will also be used in field settings where humanitarian doctors are exposed to deadly infectious bacterial diseases. a risk with this technology is that the strip is not exposed to a dose large enough to change its color and the physician is unaware.

There were clinical trials conducted to detect and diagnose Tuberculosis in patients that were somewhat similar to our product. These trials were conducted for the purpose of improving the detection of Tuberculosis and although the methods were different to our own potential trials, the clinical risks would be similar. This study started in May 2016 and was completed in December 2017 and had an estimated enrollment of 1000 people. One other challenge that this study encountered that we would probably also find is that many patients who have tuberculosis are also people that are in hard-to-reach groups, meaning that these people have backgrounds that prevent them from readily coming to the hospital or participating in a study.

An issue in the clinical success of our product is that our product relies on physicians using them in interactions with patients rather than something that the patients directly use. In foreign countries where tuberculosis and other airborne bacterial diseases are most common, this process will depend on doctors visiting patients where they live and this can create a lot of external factors that we cannot control in a trial. These factors could affect our research.

Example Clinical Trial-

Southern, J. (2015, July 27). Improving the Detection of Active Tuberculosis in Accident and Emergency Departments. Retrieved September 13, 2017, from https://clinicaltrials.gov/ct2/show/NCT02512484

## Market Analysis

#### Cost to Manufacture

• Band of cloth with adhesive: $0.025 • Incorporated nano-tech and chemicals for detection:$0.11
• Labor per strip: $0.005 • Packaging:$0.01

## Fundability Discussion

##### Discussion:

After working through the fundability worksheet, it has been decided that the product should not be funded. The overall score that was found for our product is lower than that which was proposed as a base-level fundable score. It has also been decided that there are many variables that cannot be controlled, some in the marketability and clinical feasibility of the product. The uses and benefits of the product, in theory, do not outweigh the monetary cost to hospitals and individuals.