Entrepreneurship

Lambert iGEM developed CADlock, a breakthrough testing kit to provide to researchers and doctors who are working with coronary artery disease (CAD). Here, we outline our business plan to bring our testing kit to the market (see Fig. 1). Although anyone can purchase our kit, we intend to target labs and research centers with limited access to online data and expensive lab equipment. Because we will include frugal devices and built-in testing kits and protocols, we can increase the accessibility of the kit.

Value Proposition Canvas

The Value Proposition Canvas explains the specific advantages for each stakeholder in CADlock (see Fig. 2). Doctors, patients, scientists, and researchers receive distinct benefits from our kit.

Business Model Canvas

The Business Model Canvas outlines our strategy to develop and expand our business (see Fig. 3). CADlock provides unique utility to various parties, and we delineate the methods through which we will produce, finance, and sell our kit. By understanding the relationship between our product and customers, we can maximize our value in the market.

SOM/SAM/TAM

SOM/SAM/TAM, or serviceable obtainable market/serviceable available market/total addressable market, describes the population subsets our business is marketing to (see Fig. 4 & 5). The SOM details the realistic minimum outreach of our product, while the SAM shows the total possible market. With minor improvements and alterations to our business model, we could expand our company to a broader target market, pushing us closer to reaching our TAM.

Legal

CADlock will be organized and run as a Limited Liability Company (LLC). To learn more about business organization and the legal nuances of establishing a biotech company, our team consulted the Georgia Secretary of State Department. An LLC formation allows for benefits such as reduced liability (in the case of litigation) and greater tax flexibility. The company will operate taxes under a partnership to prevent double taxation and create an organized tax structure. Our Entrepreneurship Committee Lead will serve as the required agent. Additionally, CADlock will file an Articles of Organization and Transmittal Form and submit all necessary documents to obtain a business license. Lastly, the Georgia Secretary of State requires LLCs to pay a $50 annual billing and registration fee, which we have factored into our financials.

Investor

To receive feedback on our business plan and learn more about creating a successful business model that would appeal to investors, Lambert iGEM spoke to various industry experts. Before curating our business plan, our team talked to Dr. Kulkarni, a retired San Diego State University professor, who helped educate us about basic business model structures. In addition, she verified that our customizable kit approach guaranteed greater inclusivity and a broader customer base. With further guidance from Dr. Kulkarni on effective ways to conduct market research, our team put together the initial draft of our business plan. Furthermore, we contacted experienced investors for feedback on our business plan for CADlock. We primarily sought advice to improve our approach to market entry, product description, and promotion methods.

The first investor we talked to was Dr. Alawad (see Fig. 6). Dr. Alawad served as the business development manager for the Middle Eastern and North Africa (MENA) region for Johnson and Johnson and co-founder of a multi-million international start-up, Medway Inc. He spoke to us in person about several areas of improvement. Firstly, he recommended initially sending our kit to established research institutions to test a prototype. He explained that this third-party testing was essential to developing CADlock’s credibility. As a result, our team prioritized third-party testing as part of the quality control process before any partnerships or marketing of our product was attempted. Specifically, we hope to send CADlock to local universities such as Emory and Georgia Tech, where microRNA (miRNA) research is currently being conducted, for preliminary testing. Secondly, as a start-up founder, Dr. Alawad stated that new companies often need excess capital for miscellaneous costs. This “buffer” was added to our financial plan and allocated for in our cash flow sheets. Finally, he warned that research should be done on every individual investor we plan to reach out to. More specifically, Dr. Alawad recommended that our team err against angel investors as part of our initial seed funding. This is because when an angel investor brings money to a start-up, they expect a share of equity and revenue in return. He explained that different equity demands and potential predatory strategies of angel investors could unnecessarily drive up costs, cut into income, and reduce capital available for research and development. Taking this advice, our team chose to rely on grant money from accredited organizations for funding rather than angel investors, in contrast to our initial plan.

The second investor we spoke to was Mr. John Nahas, an investor and business owner in Los Angeles, California (see Fig. 7). He founded U.C. Berkeley's Venture Capital Club, led numerous micro-investment deals, graduated from Berkeley HAAS Business School, and founded a public speaking education startup that made six figures in revenue within its first year of operation. Mr. Nahas provided extensive feedback on an online video call. Firstly, he critiqued our analysis of the industry's history, adding that it needed to be more focused on the developments of early miRNA research and institutions that led up to our project, in addition to the work being done with miRNAs that continues today. Providing further historical context helped investors feel more secure about potentially high-risk investments such as bioengineered products since they could verify that the method had not already been tested and failed. Furthermore, Mr. Nahas emphasized the importance of knowing an industry's past and how it can affect a consumer’s feelings toward a specific product. For example, a particular scandal or public event could cause a safe, quality product to become unmarketable. He further suggested that we compare our product to competitors in an industry analysis and use this information to identify how we can differentiate ourselves from our competitors. To implement this advice, we added a section analyzing current and future competitors in the miRNA diagnostic industry alone, with a comparative explanation of how CADlock was unique to the market. Lastly, we were advised to improve our marketing strategy by changing our positioning statement and using an emotional appeal when describing our product. This helped influence our marketing materials and social media strategy.

Generally, entering a new market is not as easy as entering a new region with various cultural, linguistic, and economic factors. This includes new age demographics which contributes to long-term struggles in communication with patients. Moreover, healthcare is extremely competitive due to the number of corporations within the market, which are increasing legal actions as it becomes difficult for new businesses to enter the market when existing businesses own licenses, exclusivity contracts, and patents.

The healthcare industry demands time-consuming medical tests, but they expand the longevity of medical tests. Evolving drug price control regulations and pricing disparities between generic drugs and its producer can limit the credibility of the drugs and the overall price margins, especially in developing nations. In industrialized countries, the increase of successful companies has become a major barrier to market entry due to the increased start-up prices and advancements necessary to sustain competitive advantage. Additionally, successful companies in the industry make it more difficult for new businesses to enter the market and exert some control over consumers’ purchasing decisions since larger businesses are actively pursuing consolidation. The control of larger businesses effectively strengthens their negotiating position and sets upper limits on their market share while limiting the market shares of other businesses. Keeping track of changing payment schemes and economic programs, such as Medicare and Medicaid, for each person can limit a patient’s accessibility to resources. Different countries use different currencies, impacting payments from the variance in the exchange rate of certain currencies and other foreign currencies. Therefore, the variance in payments may affect the use of different diagnostic testing procedures since these procedures are cheaper in one country compared to another. Also, there is difficulty in contacting investors in the healthcare industry because some may be barred by a contract with some companies or be incentivized to be a part of a specific company. Therefore, these conditions present challenges in implementing the product to customers or patients in a clinical context.

Lambert iGEM’s long-term goals are centered on selling the screening kit into the hands of cardiologists and clinics that could utilize it as an early screening tool for CAD. Doctors could use the product for a reliable indication of CAD using an extensive database of miRNA data collected by researchers across the globe without having to use expensive echocardiograms. Additionally, we want to communicate with markets outside of the southeastern region: in order for our product to be successful on a national level, there must be alterations to the market plan and competitor analysis. By tailoring our product to dissimilar testing facilities, a more streamlined plan can enable widespread access to the kits.

Year 1

1. Develop CADlock, Micro-Q, and kit contents.
2. Communicate to miRNA researchers for critiques of the database
3. Gain preliminary opinions from cardiologists and interview patients about their experience with CAD

Year 2

1. Distribute kits to researchers in Georgia, predominantly at research institutions and universities
2. Create database website
3. Gain feedback for the database website and make needed changes to instructions.

Year 3

1. Start shipping kits nationally and target under-resourced labs and gain feedback.
2. Add keyword function to database website for ease of navigation
3. Seek investment options and pitch to potential sponsors

Year 4

1. Start distributing kits to international researchers and local cardiologists.
2. Add different languages to the database website.
3. Gain feedback from cardiologists on the point of care and start collecting patient data.

Year 5

1. Focus on patient satisfaction and slowly introduce kits for independent patient use.

Download our business plan below, which includes our company descriptions, industry and market analyses, operational and marketing plans, goals, and financials.