Team:Manchester/Entrepreneurship
UriGel's Business Plan
- Urigel’s main features are that of a hydrogel catheter coating with engineered live bacteria that is antifouling and antibacterial and reduces catheter blockage and encrustation.
- Our market analysis has shown there is a market need for UriGel as many catheter coatings are still infection prone, increase risks of antibiotic resistance in bacteria, and need to be frequently reapplied causing patient discomfort.
- It will be entering a rapidly expanding market in biomedical polymer-coatings, this market is set to rise in market value at a Compound Annual Growth Rate of 6.7% between 2021 and 2026.
- UriGel’s primary customers will be healthcare and point-of-care institutions. UriGel plans to infiltrate the market through the NHS Supply Chain, granting it access to over 240 trust customers.
- In our project, PESTLE analysis has shown significant economic and legal external environment developments that will impact UriGel. The UK government may change medical device regulation based on a recent consultation with the British public and, as of April 2021, the NHS offers funding for novel medical devices through the Medtech Funding Mandate for devices that demonstrates its fulfilment of the NICE guidelines.
- An analysis of catheter and hydrogel-based coatings using Espacenet has shown UriGel’s potential to apply for a patent, if it develops its technologies and diversifies its product into a new use.
We decided early in the process that we were interested in pursuing the realisation of our iGEM project in industry. Hence, we approached Entrepreneurship with a longer-term vision, allowing us to reflect on the values, strategies, and motivations that we want to encapsulate later as a company. This spurred us into action: we conducted detailed competitor analysis; strategised appropriate branding; agonised over our value proposition and strongly considered our impact on a local, regional and global scale.
Market Analysis
UriGel is at the intersection of two significant market considerations: the catheter market and the catheter coating materials market. Both were considered in UriGel’s market analysis, presenting a rapidly increasing demand for catheters with a market value of over $48 billion in 2021, of which $2 billion belonged to urinary catheters (1, 2). With a Compound Annual Growth Rate (a measure used to show return investment over a yearly period) of 6.4%, the catheter market is projected to rise to $74 billion and the urological catheter market to $7 billion by 2028 (1,2). Figures 1 and 2, adapted from Grandviewresearch.com (1,2), show that there is a clear demand for catheters and, thus, for coatings which can prevent infection. Despite the seemingly small proportion of the market size that urinary catheters hold, there are sociocultural factors that support the continued necessity for urinary catheters and market opportunity. These sociocultural factors include the increasing demand for complex surgical procedures that required postoperative catheterisation, surging levels of urinary incontinence and a growing geriatric population(3). Some of the fastest growing regions include APAC (Asia-Pacific) and Latin America.
Catheter coatings are projected to increase in value from $900 million in 2021 to $1.5 billion in 2026 (4). Their main aims are to minimise the colonisation of the urinary tract, the urethra, kidney and bladder, by pathogenic bacteria. There are two main types: metal-based and polymer-based, of which polymer-based coatings are the increasingly preferred choice. Polymer-based coatings are expected to grow at a CAGR of 6.7% between 2021 and 2026 (5, 6). Their ease of use and biocompatibility make them ideal for use in the human body. Current commercial catheter coatings are pre-applied onto catheters saving patients the need to go through that step, this is a manufacturing strategy UriGel might consider if partnership with a catheter manufacturer can be established. The fastest growing catheter coatings are hydrophilic ones with a CAGR growth of 7.2% between 2021 and 2026, partly due to their durability in usage (5). Hydrogel and antimicrobial coatings are becoming increasingly more popular and there is a clear problem with catheter encrustation that current catheter coatings do not fulfil.
In sum, there is an economic argument for entering the catheter coating market and UriGel can prepare itself to fulfil its customers’ criteria. Our initial customers would be point-of-care institutions, hospitals, and other healthcare centres. To streamline our supply distribution, UriGel plans to apply to the NHS Supply Chain. This would grant UriGel the ability to reach over 240 NHS centres across the UK to supply its product (7). UriGel plans to initially enter and become stable within the UK and European markets before branching out into Latin America.
SWOT and PESTLE Analysis
A PESTLE analysis is a good method of analysing the external environment a business will operate in. It can be helpful to reflect on the unexpected or expected ways outside influences will impact the business. PESTLE stands for political, economic, social, technological, legal and environmental factors that change. UriGel conducted a PESTLE analysis and found two important factors that will change how they will be accepted in the market in the future:
- From April 2021, the NHS offers funding for novel medical devices if they prove to be effective and affordable.
- This scheme is called the Medtech Funding mandate (8).
- It offers an easier route to market for medical device innovations if they fulfil NICE guidelines (9). UriGel could make use of this streamlining process.
- Legal regulatory changes in the upcoming two to five years:
- November 2021 is the deadline for the UK government’s open consultation on rules on genetically modified organisms. The UK is planning to change the laws on GM organisms and their use in medical devices and is offering stakeholders the chance to provide their own perspectives.
- The UK’s Bioeconomy Strategy of 2018-2030 aims to foster the UK’s growing Biotechnology industry(10). The increase in funding and attention on biotechnological products is important, especially as UriGel is potentially looking to enter industry in the next decade.
Value Proposition
We used a Value Proposition Canvas, established by Dr Alexander Osterwalder, to improve our understanding of how our potential product can fulfil our customers wants and needs (11). On the canvas below, you will find a customer segment on the right and a value proposition segment on the left. The customer segment is all about customer's gain, pains and jobs. Customer 'jobs' can be functional or emotional and they are what the customer wants from a product. An example of a functional job is a catheter that manages urinary incontinence without catheter blockage. Gains are what pulls the customer in, what they would ideally like to have, what they could benefit from such as a catheter that acts as an extra lubricant when inserted. The customer's pains are the problems they experience such as frequent visits to the hospital between appointments due to catheter-related(12). For references for icons used in the graphic, go to the numbers listed here (13, 14).
You can find a PDF copy of the Value Proposition here.
Competitive advantage
The design of UriGel is its main selling point. The synthetic biology mechanisms of the engineered cell-laden hydrogel are specific features which are UriGel competitive advantages. They:
- Rely on a secretion system that diffuses antibiofilm compounds into the urinary tract to prevent the build-up of bad bacteria.
- Offer a potential replacement of metal-alloy coatings and create a potential to prevent silver-resistant microbes, and
- Contain a kill switch mechanism that is activated when the environment is not right, preventing the release of engineered bacteria into the environment.
Key Competitors
Primary direct competitors
Two of UriGel's most significant competitors are Manchester BioGel (15) and Kanebiotech (16).
- Manchester BioGel is a Manchester University science spin-off with decades of experience with biomaterials. The company produces two main products as the moment: Peptigels (17) and Peptilinks (18). The products are all peptide-based hydrogel structures for multiple purposes such as tissue engineering, production of organoids, bioprinting, stem cells and, finally, drug delivery (19). Their competitive advantages include their scientific expertise; their quality control and their products’ versatility of usage (spraying, injecting and printing). Manchester BioGels have chosen to keep their methodologies private, allowing them to apply for patents for every new application of their technology. We spoke with their CEO, Aline Miller, who advised us on funding and start-up structure. From this company, UriGel can learn to ensure that, in the future, we diversify our range of products based on our budding technology.
- Kane Biotech is a Canadian company, specialising in the development of technology to fight biofilms through inhibiting the attachment of bacteria. Kane Biotech’s products rely on two developed technologies called ‘coactiv+’ and Dispersin B (20). Coactiv+ uses its binding agent, EDTA (ethylenediaminetetraacetic acid) to interact with the metal ions in wounds and function as a wound healing mechanism (21). Kane Biotech uses its Dispersin B technology to function as a wound healing spray when in formulation with the antibiotic gentamicin (22). The company has a track record of partnering with other businesses to develop new technologies. Some of the most prominent partnerships include that with Animalcare Group in commercialising Kane Biotech’s animal oral care products (23).
Large-scale Competition
Below is a table presenting how UriGel compares to the current commercialised coated catheters in critical features of importance to a potential customer.
| Properties | UriGel | Bard Care USA | Covidien Medtronic UK | 180 Medical, Rusch Catheters | Teleflex, Medical Europe Ltd | Tyco Healthcare |
|---|---|---|---|---|---|---|
| Antifouling | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Antibacterial | ✓ | ✓ | ||||
| Minimise catheter blockage | ✓ | ✓ | ✓ | ✓ | ||
| Hydrogel-based | ✓ | ✓ | ✓ | ✓ | ||
| Hydrophillic | ✓ | ✓ | ||||
| Biocompatible | ✓ | ✓ | ||||
| Latex-free | ✓ | ✓ | ✓ | ✓ | ||
| Free of metal alloys | ✓ |
Business Model Canvas
A business model canvas gives companies an effective overview of the key areas and functions of the company(15). It is composed of nine parts. Below you can find a list of the component parts of a business model canvas and an explanation of what they entail.
- Key Partners are the firms, organisations, networks that your company will need to infiltrate and build trust with to deliver what your company strives to do. These could be manufacturers, material suppliers, research faculties amongst others.
- Key Activities aspect of the business model canvas are all about what your company
does . What does your company do to fulfil what it wants to do? - Key resources are the materials and assets your business will require to fulfil your goals. These could be intellectual propeerty or laboratory equipment and many more.
- Value proposition is what your business wants to provide the customer to persuade them to use and buy your product over other products.
- Customer relationships are all about building trust with customers over both short and long-term.
- Channels are how you plan to reach your customer whether that is through raising awareness about your companies vision to helping your customers evaluate the options available to them.
- Customer segmentation are the categories of the different types of customers you may serve. Not every customer comes with the same needs, requirements and preferences. Hence, it is why it is good to group customers to get a better idea of how to specifically tailor your product to their needs.
- Cost structure comes in two types: fixed and variable.
- Revenue streams are the ways in which your business will make profit, usually from the sales of your product or your intellectual property.
You can find a PDF copy of the Business Model Canvas here.
Intellectual Property
Intellectual Property is one of the most important things to consider from an entrepreneurial standpoint as it determines the protective status of an invention. Patents are generally country-specific and last for up to 20 years and gives its holder(s) the right to prevent others from benefiting from an invention commercially.
To understand UriGel’s standing in the wider world from an intellectual property standpoint, we consulted with Dr. Paul Misselbrook from the Mewburn Ellis IP Law Firm based in Manchester, United Kingdom. Dr. Misselbrook offered to lead a session for Team:Manchester that encompassed the various aspects of intellectual property and IP rights. We discussed the various types of IP, the typical timescales, and requirements for them, and concluded the session by deconstructing an existing patent application to understand what is needed for a successful patent application and what is not.
Based on this session, we developed our strategy for Intellectual Property, as summarised below.
We used the European Patent Office’s Espacenet search engine to analyse the patent landscape of hydrogel coatings and living therapeutics. Our primary objective of this analysis was to gain a better understanding of where our idea stood from an intellectual property standpoint, i.e., whether we could patent it. Our secondary objective was to ensure that our idea (or parts of it) were not infringing on any existing patents.
While we found numerous patents for hydrogel coatings, we noticed that most of them were patents that fell in two categories:
- Utility patents that described a method of hydrogel manufacturing, or
- Hydrogel coatings for medical devices that dealt with wound healing.
We were unable to find information that indicated a patent was filed for a UriGel-like product, or a living therapeutic coating for catheters that prevented CAUTIs. As such, we found that there was potential to apply for a patent for UriGel.
Our Potential Patent
From our conversation with Dr. Misselbrook, we found that it is possible to buy a ‘second application’ in the field of medicine. This implies that we could continue developing our technologies and file for a second application patent in the future if we create an innovative enough application. For UriGel’s potential future patent, we decided to opt for a two-pronged approach for our intellectual property strategy; the first print would enable us to protect our novel idea and its design via a patent, while the second prong would protect assets such as our logos, brand name and identity, etc. via a trademark application.
The Trademark
Dr Misselbrook raised important questions revolving around the importance of building trust with the customers and using a brand name and style that can resonate with them. The iGEM competition has given us ample opportunity to experiment with the design and tone of our future start-up. We went through multiple logo designs, colour palette and brand name ideas. This has allowed us to better understand the customers perspectives and how we might approach building rapport through the use of a strong brand trademark.
Financial 101: Getting Funding
Funding for UriGel can be broadly divided into three milestones, defined by the progression of the project and its associated research activities.
Phase 1: Validation
The refinement & validation phase is characterised by the research into, development, and validation of the first prototype of UriGel. Acquisition of funding in this stage will likely come from our network and crowdfunding to build our initial prototype. However, we will additionally apply for grant funding from relevant bodies and the institution we work with.
Phase 2: Pre-Clinical
Pre-clinical testing is the stage that checks whether the medical device proposed and the biomaterials it is composed of fulfil biocompatibility standards. These studies are crucial to finding out whether the medical device can be tested on humans and must be checked by a regulating body as part of Good Laboratory Practice (16).It will be necessary to apply for larger and more ambitious grant funding opportunities under the UK Research and Innovation funding body, a UK government body that directly manages funding for research and innovation. After speaking to Jon Ball, an entrepreneur, we gained insights on how to make connections with potential investors to get funding for UriGel.
Phase 3: Clinical Trials and Launch
Prior to entering phase 3, we expect to have gathered the necessary safety data to assess and validate the relative safety of introducing engineered bacteria into the uterine climate and assess their efficacy in preventing CAUTIs. Clinical trials are long-term studies of new treatments and/or tests that evaluate their effects on human health outcomes. As UriGel’s application is in humans, clinical trials are required before the product can be approved by a regulator for wider consumption.
As clinical trials are built off preclinical data, we will divide resources at this stage for the following objectives:
- a. Assessing and analysing preclinical data
- b. Liaising with regulators (FDA, MHRA, EMA, etc.) to gather necessary approvals and licenses to push UriGel into the next phase of R&D.
- c. Begin the process of designing a clinical trial from this collected data.
Clinical trials are an expensive affair that require a significant amount of funding to successfully meet its objectives. Historically, very few start-ups have managed to obtain the money needed to develop, manage, and successfully execute a standard three-phase clinical trial. As such, we expect our exit strategy to come into play here. As we assess our preclinical data, we will begin to actively explore our options of merging with a company that has the resources to execute a clinical trial.
Viability of solution
There are many risks and pitfalls when it comes to launching a biomedical startup such as government regulations, failure of clinical trials, insufficient funding, and more. More importantly, it takes great foresight to determine whether a product should be used developed for indusry use. It is our hope that by thoroughly researching catheter coating trends and demands, making connections with key people, and progressively improving Urigel it can become viable in the market. We may never get to the stage of branding or gaining profit from Urigel, but perhaps launching the invention itself we can influence catheter coatings on the market to be safer and expand the use of genetically modified organisms in biomedical use.
Sustainability
- The team have reflected on the impacts of climate change on the current and future generations. In moving forward as a potential start-up, we would like to do what we can as a company to minimise our impact on climate change in the most effective way.
- After reflection and research, our team came across the concept called the ‘circular economy', an idea that products should go ‘from cradle-to-cradle’ instead of ‘from cradle-to-grave’ (). This is the whereby the materials used within products should be reused and remanufactured instead of ending up in landfill or becoming unusable; companies must ensure that the product materials that they use remain within their manufacturing, supply and distribution systems.
- The team considered multiple avenues to contribute to the building of a circular economy. We researched using waste to create our project idea. In our initial design, we planned to incorporate shrimp waste and using our chassis as a bio-factory in the procedure, making it both an economical and sustainable design. However, we decided to opt for a hydrogel design, making it far more difficult to disassemble and remanufacture.
- We have explored the avenue of working with future teams or companies to disassemble the hydrogel component of the finished product. Future teams or our team in the future could work on creating a non-permanent bond between the catheter and coating. This could ensure that the hydrogel could be more easily disassembled and used for other applications such as biofuels.UriGel plans to incorporate the circular economy concept into its potential future activities as a start-up.
Complementary activities
EPIC Summer Bootcamp
Attending the summer EPIC bootcamp has given Team:Manchester a fantastic starting point for developing our business model canvas and curating our business report. The bootcamp raised significant questions surrounding prioritising our stakeholders and visualising how to scale our product. The EPIC bootcamp prompted our team to use the extended business model canvas to expand our ideas about moving forward into industry.
Team:Stockholm Entrepreneurship Workshop
In May, we attended the interactive workshop ‘From iGEM to Entrepreneur’, run by the 2021 Stockholm team. The workshop supported us in considering internal and external stakeholders in our future company and the channels with which we can reach our customers. Moreover, it prompted important questions about data gathering and capital resources that we discussed as a team and fed back into our business report.
Business Report
You can find a PDF copy of the report here.
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