Team:Bielefeld-CeBiTec/Implementation

Bielefeld-Cebitec-2020-Implementation

-->
Implementation

Introduction

At first, we asked ourselves why iGEM requires an implementation page. Arent all iGEM projects constructed to solve real world problems? We as synbio researchers spend most of the time imagining the coolest theoretical constructs, but unfortunately, we tend to loose track of what is working for the people who are impacted by our research and about what is safe enough to be “released” to the real world.
In our project we started with an issue several team members faced – insufficient choice of contraception methods-, and our first step was to find out wether this is a problem for the broader public. So, we decided to design a questionnaire. We conducted a survey about common contraception methods and how necessary it would be to look for alternatives. This survey encouraged us in our goal to revolutionize contraception and finally deliver a method that is safe and healthy.
iGEM want’s us to design projects that can be implemented in the real world and for us that means that we need to think beyond our labbench.
One of the most important requirements is thorough human practice work. Human practice means to analyze how the world influences our project and how our project influences the world. This is something one can only achieve by establishing a dialogue with the people we identified to be affected by our work and implementing their feedback to improve our project.

So who would use wavy sense? Get to know our target group!

The majority of participants of our survey are interested in new and alternative methods of contraception such as our product WavySense. Our target group consists therefore mainly of women who have already had negative experiences with other contraceptives. This includes above all persons with uterus who are dissatisfied with hormonal contraception or women who were not interested in taking hormones for contraception from the very beginning.
The alternatives most women turn to are copper IUDs or condoms. Unfortunately, some are uncomfortable about having a foreign object inserted into their uterus and others feel that condoms are too unsafe. Ultimately, this group of people who do not feel comfortable using existing contraceptives, whether hormonal or not, is our target group. It is important that our product can not only be used for contraception: by just measuring the hormone concentrations in the body, WavySense allows the user to decide at any time whether she wants to use this information for contraception or for optimal odds at a pregnancy. Because the hormones are measured regularly over long periods of time, it is easier to detect fertile days than currently possible with already available methods. Tracking one's own menstrual cycle also leads to positive side effects, as has been reported by women who have tried natural contraception by measuring their body temperature or by using a conventional calendar to track their cycle.

We decided to design a new method of contraception:
"The healthy way"

The curiosity for a balanced healthy life and also the interest for this topic is currently taking over humanity. That’s why we wanted to create a different way to prevent pregnancy. With WavySense we want to offer a method which does not affect your body directly, like many other contraceptives for people with a menstrual cycle.
Our way of contraception is through knowing what happens within your body. By that we mean to measure the hormones which are responsible for the changes in the fertility and define the time when you could get pregnant.
It is our will to create a situation in which you can decide, wether health or comfort is more important, when it comes to contraception. We recommend to chose health of course.
Till today there is no choice for this, but times change with WavySense.It should be noted that our proposed solution has some requirements for the users, as not everyone may be suitable for the use of WavySense. For optimal use, the measurements must be taken regularly at the same time of day over a period of several months, with each individual measurement taking at least five minutes to complete.

The Device

We talked to users of contraception via a survey and found out that a hormone free, surgery free and natural method is desired. Therefore, we developed and tested a concept of a handhold device for easy hormone concentration measurement. With the associated app this concentration can be correlated with the natural female cycle whereby a statement about fertility can be made. Due to the low hormone concentration a sensitive and specific detection method was needed. Therefore, we decided to introduce the surface acoustic wave (SAW) technique to iGEM. This innovative method is characterized by a high sensitivity and specificity and can be used to detect a broad range of molecules. This makes SAW biosensors the next generation biosensors.

Figure 1 SAW sensor components. Quartz piezoelectric crystal, IDTs (interdigital transducer) are built on the crystal, the sensing film is located between the IDTs, the SAW Chip is inserted in a chip case which establish the connection to the electronics, the electronics are connected to the app to evaluate the data.

Safety

To design research projects that are responsible and good for the world, it is necessary to identify all possible risks and establish proper precautions. On our safety page, we listed all biosafety risks, biosecurity risks and ethical considerations related to our project. It is also mentioned how we changed our project to prevent these risks.
In short, we decided to construct a cell-free biosensor, this means that the biosafety risks are rather low, because our real-world application wouldn’t require to release GMOs into the wild. The biggest concern regarding safety and security would be the data security of the collected data by our device.
Securing the safety of personal data, especially nowadays is important. Therefor our App saves the data locally ensuring that only the user has access. It is possible to export your data, so that you can save it on a separate device, not losing the information if your phone gets damaged. We wanted to keep the information in the hand of the user, therefor we abstained to use a server with an account system. We as the developers have no access to the collected data. Ideally the communication between the measuring devices and app as well as the data saved on the device could be encrypted.
The predictions of our app need a lot of data to get to a level of providing trustworthy predictions, we worked on ideas to create a learning algorithm, that understands the female cycle. With the time and amount of data we were not able to create such an algorithm, but we think this is an interesting field that should be explored further. For the safety of the user´s predictions that the app provide should have a high quality as getting pregnant has drastic consequences. For commercial use studies should be performed, that provide evidence for the method. The chip itself is not a source of safety issues. Every chip gets used only ones so that no germs can establish on the chip, the chip works on a low voltage so that even if the device would be damaged, there would be no serios thread of electronic shock.
In case that in a later stage of development a reusable ship would be developed, safety measures as densification should be moved in place.

The Reliability

In addition to health, reliability is an important criterion in the field of contraception. Of course, our aim is to fulfill this criterion as far as possible. Wavysense could therefore offer excellent possibilities for measuring your hormone status. These possibilities apply to both contraception and pregnancy planning. Furthermore, the general interest in hormone status offers opportunities in medicine.
For the assumption of reliability, studies will be necessary to test and evaluate the functionality of this method in comparison to conventional methods. In our interest, the medical approval is an important milestone that we intend to achieve. A major challenge is to ensure that Wavysense is available to the public in pharmacies.
Before Wavysense is considered reliable to a certain standard, user-oriented studies will be necessary. These studies require medical monitoring as we intend to achieve medical approval. The various aspects of contraception, child planning and general hormone concentration measurement must be tested extensively to identify possible sources of uncertainty. However, experience reports alone cannot provide information on reliability, which is why data and facts must be used for this purpose, and these must be recorded during the study phase.
In addition, the reliability of the various components is also an important aspect, since in addition to the measurement technology, the developed app must perform at its optimum in terms of its function and data storage.
Our ambition at Wavysense is to achieve a certain standard with the overall concept. Reliability plays an important role in this standard.


Our Vision

The WavySense set for the measurement and tracking of the sex hormone concentrations of luteinizing hormone (LH), progesterone and estrogen in urine, includes three components: the measuring device, several measuring chips, and our app. Tracking the hormonal cycle can be used as non-invasive and at the same time safe conception method, being an option to established contraception methods targeting 11.7 million possible users solely in Germany. Starting as an iGEM project, our WavySense measuring set has the potential as realizable application in the ‘real world’. Therefore, the prototype has to be completed and comprehensive testing has to be performed. In the end of this process, clinical testing and medical approval are most important, before the market launch in cooperation with medical experts, the German ministry of health and widely know official information platforms. We are aware of the long journey from an iGEM project to an approved and distributed product, but it is not impossible.