Entrepreneurship

Abstract

   This year，the ultimate goal of our team，iGEM_BIT is to achieve the commercialization of the biomarkers detection module type (JACOB)，we need our project go into people‘s daily life，that's why we need entrepreneurship.

   Starting with markets and businesses:
   Through the market, we clarify the characteristics of JACOB and discard unnecessary factors.
   Through the company, we optimized the design of JACOB in laboratory to make the project more consistent with the actual situation.

Market Analysis

   In terms of market, our market is IVD, we has carried on the SWOT analysis to project the market, which seriously analyzes the project's strengths, weaknesses, opportunities and competition (see links). In addition, we conducted interviews with our future users and, through interviews with people of different ages, got further feedback on the project. we conducted SWOT analysis of the project，including strengths, weaknesses, opportunities and competition（Hyperlink）.In addition, we interviewed with our users of different ages,getting more information for our project.

SWOT

Strength

1. Convenience
2. Adaptability
3. High Cost/Performance Ratio
4. Inelastic to change in test conditions

Weakness

1. Technology Barrier
2. Branding Barrier
3. Strict Market Admittance Criteria
4. Distribution Barrier

Opportunity

1. Favorable national economic condition
2. Positive national policies
3. Uprising Health-consciousness

Threats

1. Well-established industries control the high-end markets with related products
2. Industrial chain is currently complete
3. Technological applications are matured

Comments

   Comparing to technology equipped by clinics and hospitals, The use of adjustable aptamer and genetic modified microbes made JACOB more economical, adaptable, and stable. The integration of automated proceeding made JACOB more user-friendly and portable. JACOB does not need professional physicians reading results, behaving like glucose meter but less risky. In China it is likely to be deployed in units of household or local communities. Similarly, for United States the Food and Drug Administration classified the core mechanism of JACOB as Class I medical device (if designed to not detecting cancer biomarkers), means no premarketing control is required. It is worth noting though, Chinese in vitro diagnostic market is relatively new and have few competitors. Those few players can no longer support the concrete increasing demand for medical cares. Chinese government had ratified a great number of acts as well as guidelines and simplified documents examining and approval process to encourage innovation in the field of medical devices, which offers our team a great market environment.

Customer Study

   We performed two types of investigations: on different age groups, and on people who participated traditional health examination.

   Survey on Different Age Groups
   We surveyed to people of different ages in the science museum,asking questions about the awareness of the disease.

   Survey on Participants of Traditional Health Examination
   To better understand student body’s attitude and knowledge about medical examination, our team interviewed staff and students participated in medical examination at BIT School Hospital on 7 September 2017. （Hyperlink）

Results

   The result confirm that no one is willing to take bad health, but they simply are not informed. A “stimulus” is needed to warn them potential health issues and prompt patients to visit healthcare. This again reinforce that our main market role is to warn patients and help diagnosis, not to compete for decisive diagnosis. Therefore we came down to build up JACOB’s convenience, efficiency, and affordability instead of optimizing sensitive and specificity.

Industry Research

   In market analysis we had solved many issues regarding our project background, but also generated more questions about operability. To obtain a better answer, we had visited LinfinPort Biotechnology Corporation Ltd and CapitalBio Corporation.
   We asked BluePHA mainly on how to construct a viable procedure to industrialize JACOB. Our plan for JACOB after the iGEM jamboree is divided into developments, commercialization, and resource transformation. For development we currently divided it into small, medium, large scale trial. Based on our current knowledge, small and medium trial is planned as below.

Small Scale Trial

   1. Duration: About half year.
   2. We will choose the production method for JACOB, e.g. as we learned from Biotechnology Corporation Ltd, the “filtration” of aptamers are still expensive, but aptamers synthesis is more economical. Nine sets of known aptamer (90np, 15 microliter, 100nmol/L) costs only about $135, and every set is sufficient for 250 microfluidic chips.
   3. During this phase we also need to rule out unknown influences on the device caused by switching to new assembly conditions, such as switching to fermentation flask instead of tightly controlled experiment chamber.
   4. During this phase preserving microbes will greatly affect the cost of production, and affordability is one of the most important characteristics of JACOB.

Medium Scale Tria

   1. Duration: 4-5 months
   2. When the production of microfluidic chip is resolved, how to prepare it for using will be on the agenda. Currently the chip we used for final packaging needs to be soaked in ethyl alcohol and acetone for about one hour, which pose a question for mass production.

   We asked CapitalBio Corporation mainly on how to control the cost of microfluidic chip production¬. From their experience we found that chips cost much more in the early development, but its cost diminishes quickly in later stages when mass production is reached, ranging from $0.1 to few dollars. However, there exist a conflict of material. In the iGEM version we picked optical cement instead of PMDS for its advantages of adequate solidification speed, feasibility, bio-inertia, and precision of altitude. However, PMDS production industries are much more matured. There is currently no companies offering mass production of optical cement microfluidic chips. Thus, we must decide the better material.