Businessplan

Introduction

We are the iGEM Bielefeld-CeBiTec 2020 team and consist of 14 people who are divided into sub-topics of the project with different focuses. Our project has been running since November 2019 and we are currently developing a new method of contraception that does not challenge the body with any hormones and does not require any physical intervention. We develop our product for people with a uterus who want to use alternative methods of contraception compared to hormonal or interventional methods. Therefor, we focus on natural contraception. As the demand for alternative contraceptive methods continues to grow, we see great potential to meet this demand with our product. This business plan is written in connection with the iGEM competition and shows a possible marketing strategy for our product WavySense, considering the current status of our project.

Figure 1 Hardware components

Product information

WavySense is a new kind of contraceptive that does not interfere with the hormonal balance and therefore avoids the risks associated with hormonal contraceptives, for example increased risk of suffering strokes, thrombosis, and certain forms of cancer, as well as the risks of IUDs like infertility or bacterial infections. The user would receive the WavySense set including a measuring device, several measuring chips and an app. With this set, the user can monitor the hormonal cycle and easily identify the fertile days which are calculated and visualized by the app. The measuring chips are single use products that can be purchased, whereas the measuring device itself and the app can be reused. Like the temperature method for contraception, our project reflects the course of the female cycle. However the temperature method is based on vague secondary factors mainly the temperature and cervical mucus, while the WavySense analysis is based on primary factors, measuring the concentration of the sex hormones progesterone, estrogen and luteinizing hormone (LH) in urine. This makes WavySense an easy applicable, reliable, and non-invasive conception method.

Figure 2 Case of the hardware

The WavySense measurement is based on the innovative surface acoustic wave (SAW) method, enabling high sensitivity measurement. The (SAW-) chip, carries immobilized antibodies which can specifically bind the sex hormones. The SAW technique enables the device to measure slight weight differences which occur when the sex hormones bind to the SAW-chip. This is achieved by the usage of the piezoelectric effect, where an electric charge is created upon mechanical force. Due to the change in pressure, caused by the weight of the bound antibodies, the electric charge is changed. WavySense detects this change and correlates it with hormonal standards to identify the precise hormone concentration. The measuring chip contains a seperate measurement channel and a reference channel for each hormone detection. The chip is connected to a handy measuring device, which sends the measured data to the self-created WavySense-app, where it is displayed to the user. The app can also record important additional information like the time and duration of the menstruation.

Further improvements

Currently, the app is functional, but additional functions and improvements will continue to be implemented at regular intervals. A prototype of the measuring device was designed but, due to the corona virus pandemic, ccould not be fully assembled at this point in time. An initial production of the recombinant antibodies for the binding of the hormones on the chip is currently taking place and will be further optimized. A fully functioning prototype, including chips and app, is estimated to be completed by the beginning of 2021. In the future, the reusability and durability of the chips and the other components will be investigated to further safety and reliability of our product.

Market analysis

Our product is basically aimed at all people with a uterus. Since there are no statistics in which they are recorded, the market analysis refers to women, which implies a potential customer base of 42,1 million in Germany (as of 2019)[1].

With WavySense, we want to address the women who want to prevent pregnancy. That is why we have defined the age of our target group to be of 16 to 40 years of age. Especially the younger potential users rarely deal with alternative contraceptive methods and rely on common variants such as the pill or the condom. Approximately 90 % [2][3] of sexually active people use these variants, whereby the condom is often used in addition to another method of contraception. On average, the menopause occurs in the age of 40 years or older. Since our method is based on hormones that are subject to fluctuations during this time, our solution loses in accuracy and reliability. Using these restrictions we estimate our target group to be about 11.7 million women in Germany. Regardless of age and sexual activity, our product can give important insights into the users hormone cycle.

Young women in particular have become increasingly aware of the severe and risky side effects of the pill and want to switch to hormone-free contraception methods. In the age group of 18-29 years, the use of the pill decreased by16 % within the past seven years [3]. This shows a clear trend towards alternatives. The fraction of women who use alternatives to the pill contraceptive is 23%, of which 2% are sterilized [2]. Transferred to our target group, this results in a market of 2.16 million potential WavySense customers, and the trend is rising.

As an alternative to the pill, women most often use the IUD (copper or hormone) or copper chain, which, is inserted in the uterus in a medical procedure and has to be removed in the same way. The average costs for the use of the IUD are between € 200 and € 400 [5][6], with an effective life span of of 3-5 years.However this does not include additionoal examinations, furthermore, the financial cost is often an obstacle, especially for young women.

This leads to other alternatives such as the vaginal ring or the three-month injection. These, in turn, are also hormonal contraception methods, which are therefore also subject to the same severe side effects as the pill. These include the highly increased risks of thrombosis and strokes, but also headaches, a feeling of tension in the breasts, nervousness, nausea, dizziness, sexual aversion, depression, negative effects on bone density and acne. The costs here are € 46-50 every 3 months[7][8].

The temperature method and the calendar method, which are preferred by 2 % and 3 % of women , respectively, are on the rise[2]. These methods do not have a hormonal or medical intervention, nor can side effects occur.[9] However, these methods are relatively inprecise. In the event of illness or stress, the results and thus the effectiveness of the contraceptive method can decrease rapidly.

The Future

Figure 3 Milestones for the project

. The exact production costs have yet to be deteremined, as volume discounts can impact the prize significantly. The cost of the current prototype also includes components especially fabricated for us. However, the price will decrease once the level of massproduction is reached. The current research and development costs are covered by sponsors and are therefore not precisely defined.

Market Entry Strategy

We are already represented with our product and project on Twitter, Facebook and Instagram through our participation in iGEM. Since iGEM is an international competition in the field of synthetic biology, our project is already known to some people around the world. But this is a fairly limited user base.

Therefore, we plan that our product will be included with additional information on official websites such as Familienplanung.de and profamilia, which are well known informative platforms in Germany for intimate topics like contraception methods. Therefore we will aim to seek the dialoge with the Federal Ministry of Health - Bundesgesundheitsministerium and the organizations. In this context, we will also seek contact with gynaecologists and these organizations to provide them with information about our WavySense method and use their feedback to further improve our product. Thereby, we inform potential users about the expanded possibilities of contraception via medical experts to ensure the medical background information and thereby strengthen the trust in WavySense. If our project is recommended by gynecologists and included on the information pages on contraception, it will also be included in sex education classes in schools, which are mostly based on these official websites in Germany. Thereby, we will reach a new generation of potential users.

First of all, we are planning a market launch in Germany, since the calculations for potential users was based on the statistics in Germany. Furthermore we have focused on the research of theGerman regulations to ensure the safety and marketability of WavySense at this stage of our project developement. This also minimizes the risks of a failed implementation. After the product has been established in the German market, we would also expand into other countries and market the product worldwide.

Corporate form

For the realization of the WavySense launch, the formation of a company is necessary. The corporate form, we have selected is a limited liability company (GmbH). This decision is based on the form of our project. First of all, we have to carry out the research, develop the scientific basis and test the product. Only when we have achieved this, we can market the product. We are counting on a resounding success and want to limit the risk with the limited liability company. In addition, each team member can draw a salary, so that ultimately there are no disputes about profit sharing and the annual surplus remains in the company.

Investment planning

As part of the project, we are currently using the university's premises and materials and are receiving funds and other materials from sponsors. Due to this fact, a detailed liquidity and financial planning cannot be drawn up at the current time.

Sources

[1] https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoelkerung/Bevoelkerungsstand/_inhalt.html
[2] https://de.statista.com/statistik/daten/studie/2353/umfrage/genutzte-verhuetungsmittel-und--methoden/
[3] https://www.bzga.de/aktuelles/2019-09-19-neue-bzga-studiendaten-verhuetungsverhalten-erwachsener/
[4] http://www.sozialpolitik-aktuell.de/tl_files/sozialpolitik-aktuell/_Politikfelder/Bevoelkerung/Datensammlung/PDF-Dateien/abbVIII3.pdf
[5] https://www.profamilia.de/themen/verhuetung/kupferkette.html
[6] https://www.profamilia.de/themen/verhuetung/spirale.html
[7] https://www.profamilia.de/themen/verhuetung/depot-spritze.html
[8] https://www.profamilia.de/themen/verhuetung/vaginalring.html
[9] https://www.profamilia.de/themen/verhuetung/fruchtbarkeitswahrnehmung.html

Team:Bielefeld-CeBiTec/Entrepreneurship