Team:UCopenhagen/Entrepreneurship
Introduction
We consider the entrepreneurial part of iGEM to be crucial because no idea can become reality without a business perspective. Thus we started our entrepreneurship by joining a Start-up Incubator Program early on in the project. Through our work, we have focused on navigating the regulatory landscape of MedTech devices. Our research lead to- ✧ 9 direct interviews with experts and a timeline of our endeavors as a start-up.
- ✧ Legal, organizational and structural for creating a MedTech start-up.
- ✧ An analysis of the competitor landscape and the current data gap in the industry.
- ✧ Discovery of potential customer segments through survey.
- ✧ A clear layout of the next steps to accomplish product launch.
Timeline
Start-up Bootcamp: Essentials
SUND Hub is an innovation environment for students, part of the Faculty of Health and Medical Sciences (SUND in Danish). This Hub helps students pursue their ideas or help to initiate startups while building skills in entrepreneurship and innovation. The SUNDHub Start-up Incubator is a program aiming to kickstart established ideas in the Start-up world.|| June 18th || SUNDHub Start-up Incubator: Workshop 1, Peter Birk & Anders Graabæk
The Bootcamp Session was primarily lead by Peter Birk from Accelerace and Anders Graabæk from Validate, two Start-up acceleration Organisations. In this workshop, we were introduced to the Entrepreneurship path, with elements such as the “Five anchors of a good opportunity”. This concept invited us to think if our solution was creating significant value for a compelling medical need or problem; if it was a good fit and timing and with a differentiation and sustainable advantage over other solutions; and lastly, whether it would have a profit and return potential.
We were also advised to “Love the problem, and not the solution”, to allow for innovative ideas upgrading our solution, avoiding staying static in one solution that does not fit the needs of the patient.
Moreover, we did several exercises to learn how to frame our goal in order to articulate it better when presenting it to people outside of the project, through the NABC model (Need, Approach, Benefits, and Competition). We felt inspired by this articulation of our purpose and decided to also create a Golden circle where we showed first the WHY, then the HOW and in the end the WHAT or our solution.
Meeting with Start-up experts from SUNDHub
|| July 9th || Nadia Storm & Peter Løvschall
As a part of the SUND Hub Start-up incubator program, we had to present our projects to Nadia Storm and Peter Løvschall, in order to get the perfect guidance on how to start diving into the entrepreneurial part of the project. In this meeting, we realized how important is to know the audience background before you pitch your idea, and the need of always summarising the entire project in the first lines, and then explain each part more thoroughly. We also received feedback on what other information we needed to be more credible when pitching, such as experts backing up assumptions we drawn from papers, or patient stories that would make the problem more tangible.
Strategies for medical devices
|| June 9th & July 21st || Caroline Lærke Oldin, Student Assistant at Ambu, specialised in medical devices
We had thought a bit about how CIDosis would fit into a competitive consumer market. However, none of us had any expertise in business management, let alone how one would go about getting a GMO medical product approved for the market. Luckily, we were able to have two meetings with Caroline, a Business Master student working in medical devices. She gave us some inspiration for different kind of analysis we could make for our product, but most importantly, she was the first person that recommended us to launch our product to just one or two target diseases. She explained that even though we wanted to create our product for several diseases, we would get an easier approval if we started with the most important or the one we could create the most impact on, and then continue with the rest.
Biobusiness Summer School by Synapse x BCG
|| August 10th-14th ||
The BioBusiness Summer School was a full-time week event organised by Synapse (Student Organisation aiming to bridge the gap between academia and industry) and BCG (Boston Consulting Group). In this event, different field experts and start-up owners where teaching the participants the key concepts and considerations to create a BioStart-up, motivating us towards the entrepreneurial journey. Moreover, we had two training sessions with BCG, for structuring and analysing problems, and for properly pitch an idea in a structured way.
How to be a successful Bioentrepreneur
Christian Groendahl, CEO, SNIPR Biome
Christian Groendahl, founder of SNIPR Biome, told us about the importance of developing a “T” and not an “I” personal profile, where we have spread arms towards more knowledge, and not deep expertise, and not just the deep expertise. He introduced us to the IPO concept (Initial Public Offering), that we would have to consider if some day we decided to take a start-up to the public stock markets. He incited us to first do due diligence of our idea, and if after that, the idea works and it is still a great idea, we shouldn’t let anyone make us doubt about it or renounce.
BioBusiness Vocabulary
William Bullock, Consultant, NNIT
William Bullock, Consultant from NNIT, introduced us to an alphabet of business terminology. Our key take-aways from this talk were the difference between Material Transfer Agreement (MTA) and Licensing Agreement (LA), where the latter is just the idea and the former is also the material goods involved in it.
Why businesses need IPR
Pernille Gojkovic, Patent Attorney, Høiberg
Pernille explained us how essential is to have Freedom to Operate (FTO) as well as Intellectual Property Rights (IPR) over an idea. She summarized the entire process in 4 steps:- •Check patent requirements (it should be statutory, novel, useful and non-obvious). In this step, Pernille made a really good job making us conscious of the importance of the “novel” part. The idea should have never been disclosed before, which is why she remarked several times during the presentation that scientists trying to guess the future applications of their discoveries in the discussion parts of the papers, are their own enemies in case they want to get a patent on their discovery.
- •Secure the investment: once we have gotten an IPR license, as this is usually what investors require for large investments.
- •Obtain the FTO: as sometimes you might fall inside a bigger patent that prevents you from exploiting yours. Therefore, you then need to obtain a license from them, with a monetary cost.
- •Commercialising your product.
Legal challenges when starting a business
Horten Attorneys
Two attorneys from Horten explained us 4 of the most important legal aspects to take into account when creating a business:- • Company form: they introduced the audience to the different types of legal company forms, their protection for the owner, and their economical liability, which made us consider the option of creating a Private limited company (ApS in Denmark), where we would need a minimum of 40.000DKK, but it would grant us economic protection.
- • Shareholder agreement: this agreement is the one that states how the company is managed. It is the contract between the owner/s and the company, where the responsibilities of each are explained. they introduced us to the Tag alone or Drag alone clauses, which can be stated in the Shareholder agreement. These are different clauses that can be used strategically to bound the second party to buy or sell more shares. Another clause that can be included is for example the Deadlock situation, which appoints a 3rd professional party to make a decision if there is a 50/50 situation.
- • Funding: There are 3 options often used:
- > Convertible loans: where after a certain period of time, the money owed can be converted to shares.
> Crowdfunding: in the form of donation/reward (where you don’t need to pay back the money), peer to peer lending (which is similar to a loan) or investment (with which you need an investment agreement).
> Grants: which are donations to the project usually by big funds. - • Workforce: There are differences in the protection rights of each type of title, and therefore, the funders do not have any protection right status, the employees do have protection rights (contracts, insurance, holidays,...) and consultants don’t have protection rights, and are usually autonomous.
How to make an Environmental Impact Assessment (EIA)
|| August 27th || Hanne Dalsgaard, MSc Environmental Engineering, DTU
Making sure that our environmental impact is as low as possible is not only important for ethical reasons, but also important for getting a CE approval. In order to know more about the subject of making an environmental impact analysis, we had along meeting with Hanne Dalsgaard Nicolaisen. She shared her knowledge on how to do a EIA and the key points to consider. You can read more about it on proposed implementation
Planning for lab space after iGEM
|| August 28th || Symbion opening ceremony of CPH-labs
The team was invited to the Symbion Lab Opening Ceremony. Symbion is a coworking start-up space, that recently constructed a laboratory to be used by some of the start-ups. We got offered free lab space during idem and also one bench space to continue our research after finishing iGEM.
Deep customer discovery
|| September 15th || SUNDHub Start-up Incubator: Workshop 2, Customer discovery
We followed a presentation on exploring our customers - how they are, how they think and feel, how they behave. Special attention was paid to qualitative methods – in-depth interviews, behavior observation, play. Such an approach was especially recommended to early startups. After the presentation, we engaged in a series of exercises – empathy map, five whys, stakeholder analysis, the qualitative interview, open-ended business-model questionnaire.
While discussing our customer insight with Anna, one of the SUND Hub leaders, she reminded us of the importance of healthcare decision-makers and pharmacies for our business model. She suggested that we focus a little bit more on these, as we had already gathered a significant amount of knowledge about users (patients and doctors) who might not be customers, however. Together, we identified a couple of domain experts to reach out to in order to strengthen our business model.
While discussing our customer insight with Anna, one of the SUND Hub leaders, she reminded us of the importance of healthcare decision-makers and pharmacies for our business model. She suggested that we focus a little bit more on these, as we had already gathered a significant amount of knowledge about users (patients and doctors) who might not be customers, however. Together, we identified a couple of domain experts to reach out to in order to strengthen our business model.
Practising our elevator pitch
|| September 29th - October 2nd|| Global Synthetic Biology Conference
We attended the Global Synthetic Biology Conference, where we talked to a variety of people representing various companies and occupations, ranging from academics to investors. Based on our discussions, we understood that early stage investors emphasized interpersonal skills, the importance of functioning team, passion, ability to take suggestions from others.
We were encouraged by generally positive feedback for our project, and we also discovered there were more potentially useful applications of our solution. For instance, John from ZBiotics proposed us a potential future partnership if we managed developing our product.
We were encouraged by generally positive feedback for our project, and we also discovered there were more potentially useful applications of our solution. For instance, John from ZBiotics proposed us a potential future partnership if we managed developing our product.
Ensuring future mentorship
|| October 13th|| Accelerace mentorship
During the last sprint of our project, we were contacted by Accelerace, that offered mentorship to continue our project after the competition and help us realize how to make the science start-up together with NovoNordisk Fonden.
Overview of the entrepreneurial process
|| October 21st|| SUNDHub Start-up Incubator: Workshop 3, From idea to Business
During this workshop, we engaged with different experts that SUNDHub had brought for the Start-ups to ask the different considerations. As we thought we needed some extensive help in areas such as patents and regulations, we decided to plan bigger meetings with two f them: AWA Patent Attorneys and Rømer Consulting, for IP and regulatory advise, respectively.
Future IP steps
|| October 22nd|| Rasmus Kvist & Helene Robertsen, Patent attorneys, AWA
Rasmus and Helene introduced us to the normal timeline for obtaining an IP. They explained to us that we have to start at least 3 months in advance doing a novelty search and drafting the application, and then the clock starts at the DoF (Date of Filing). Six months later, a Search Report (SR) and Written Opinion (WO) is received from the authorities. These documents usually give an idea of whether you can file a patent or not, depending on the information available. After that, it comes the Date of Priority (DoP). Before this day, you can file other applications claiming priority to the initial one, and it is 1 year after the DoF. Therefore, you usually can change the patent claims during the 1st year, while at the same time provide all the necessary data to prove that your claim works.
Patents are published 18 months after the DoF, which means that you can still file a patent for 1,5 years and still get no indications of an existing patent in the SR. Two years after the DoF, every patent becomes publicly available.
They explained that usually it is first applied in PVS (Denmark), as it is less costly, and then to EPO (Europe) or PCT (international). Thirty months after the application to the PCT (international patent), the IP dies and you have to apply to the specific authorities, usually quite costly. Therefore, they explained to us that, by then, we should have already started selling our product for having bigger funding.
Patents are published 18 months after the DoF, which means that you can still file a patent for 1,5 years and still get no indications of an existing patent in the SR. Two years after the DoF, every patent becomes publicly available.
They explained that usually it is first applied in PVS (Denmark), as it is less costly, and then to EPO (Europe) or PCT (international). Thirty months after the application to the PCT (international patent), the IP dies and you have to apply to the specific authorities, usually quite costly. Therefore, they explained to us that, by then, we should have already started selling our product for having bigger funding.
Diving into the regulatory landscape
|| October 23rd|| Claus Rømer, CEO, Rømer Consulting
We contacted Claus with the concern of our product having GMO as a key component, being a problem regarding regulatory approval. We had explored before on the regulations and saw that it should be a class I medical device but were unsure about our judgment. Together with Claus, we went through the MDR (European Medical Device Regulations) and confirmed that the patch would be classified as a class I (as we will explain later in this page, under regulatory measures). It would be classified as a Diagnostic medical device. However, he explained to us that the idea of the app for monitoring progression and sending the relevant data to the doctors would be classified as a class IIa, and therefore would need more time to be approved and it would need a bigger amount of capital.
We also explained our feasibility concerns on getting approval between US or EU due to differences in GMO regulation, but he expressed there were no big differences between the two, and therefore it was probably more convenient to enter Europe first. And lastly, he cleared some of our doubts on when was it needed to apply for a CE marking approval, that should be the last step before market approval, when we already got all the clinical data and regulatory approval .
We also explained our feasibility concerns on getting approval between US or EU due to differences in GMO regulation, but he expressed there were no big differences between the two, and therefore it was probably more convenient to enter Europe first. And lastly, he cleared some of our doubts on when was it needed to apply for a CE marking approval, that should be the last step before market approval, when we already got all the clinical data and regulatory approval .
Business landscape
Introduction
Being a small start-up in the med-tech industry is complicated due to the many regulations and requirements such as clinical trials before your product can enter the market. Thus we have not focused our work on a business plan and return of investment predictions, rather we have attempted to navigate the regulatory landscape. We wish to showcase the requirements of a med-tech start-up in a transparent way. After a short introduction to the company idea, we start by presenting a possible market access strategy for our product. Then we highlight the unmet needs in the industry and present our potential customers. We end by discussing the product development plan, leading to the next steps.
Company description
CIDosis provides a monitoring device for patients with chronic inflammatory diseases, allowing them to track their inflammation and assess the efficacy of their treatment. We are developing the CIDosis patch; A sweat-patch with a yeast-based biosensor to detect inflammatory biomarkers in sweat. When placed on the skin, the patch produces a color output matching the level on inflammation. This color can be recorded and the disease tracked with the dedicated CIDosis App to allow for easy and stressfree monitoring. Our monitoring device is like nothing on the market and will be provide valuable data for patients with a broad variety of CID's. The CIDosis patch will supplement patient monitoring, providing a practical solution for requiring the data needed for continuous treatment adjustment, improving patients' quality of life.
With the help from the SUND Hub Start-Up incubator we created our first business plan overviews, including
You can see these below:
With the help from the SUND Hub Start-Up incubator we created our first business plan overviews, including
- • NABC model - which helped us framing the situation in a more specific manner .
- • Golden Circle - which defines our purpose in a more specific and organized way .
- • Lean Canvas - This is a version of a typical Business Model Canvas, that has been optimized for Start-ups, in order to faster discover if the proposed Business model is viable. It allows for a faster and more agile transformation and iteration in order to find a working model .
You can see these below:
Market access strategy
Making a device that is intended for the med-tech market is easier said than done. The med-tech market is heavily regulated in order to ensure that patient safety is maintained. Understanding these regulations and how they relate to your product is difficult. In order to make the process of getting regulatory approval transparent, we relied on the guidance of different experts. Our work, based on expert input and our own research, is featured here to provide a clear overview of the regulations for our product and also so that future iGEM teams developing a med-tech device can gain insight into the regulatory world.
The classification rules in ANEX VIII classify our patch as an inactive non-invasive device. However, the idea of a future app with an algorithm (which will be presented below) would classify as an active device, as stated in Rule 11 (Software providing information which is used to take decisions with therapeutic purposes). And it is due to this Rule 11 Anex VIII that the app would be considered as a Class IIa Medtech device.
Moreover, our patch would classify as Class I as it doesn’t apply to any of the Classification Rules 2, 3, or 4 in Chapter III, nor any of the special rules. These 3 rules and the relevant special rules are summarized here:
Another consideration was the nanofilm we would use to separate the yeast from the skin. This nanofilm has a pore diameter that allows the cytokines to pass through but doesn’t allow the yeast to get out. We researched if the use of this part of the patch would fall inside the nanomaterial category, and therefore convert our patch in a class IIa, IIb or III. However, definitions in Points 18-21 of Article 2, prove that this nanofilm would not be considered a nanomaterial.
Regarding the Clinical Trials, Caroline Laerke Oldin (find interview in timeline) recommended us to choose 1 or 2 target groups in order to get meaningful results faster, and therefore an easier and faster approval, and then we will keep widening our scope once we have the use towards some target groups approved. An example could be Crohn’s and Colitis, as this is a patient group that we found out to be in need of our technology through our integrated human practices work.
After obtaining data from clinical trials proving safety, and efficacy, we could apply for a CE mark, which would be the last step before receiving a regulatory approval for market access. In this case, we will have to prove quality and risk management systems that ensure the necessary quality. Some of these steps are the ones we should take after developing the scientific part of the project. We have included a more detailed step by step process in "Next steps" at the bottom of this page.
Because the app requires mor resources we could develop the patch as a single product and start creating revenue. Along with this patch a non medical app could be develop that does not act upon the data but simple allows the patient to store it in a calendar format. Below you can se a mock-up fo this app, which is our first step towards developing a dedicated app to increase the usability of our CIDosis patch.
After commercializing our patch, creating revenue, and proving market demand we will develop a class IIa medical analysis app to work with our patch, providing the patients (and doctors) with the best possible service .
Regulatory measures
Before getting our product to the market, we need to get it approved by the different authorities. First, we need to get MedTech Device regulatory approval. Our patch would be classified as a class I MedTech Device by the new European Medical Device Regulation (MDR) that are entering into force on May 26th 2021 .The classification rules in ANEX VIII classify our patch as an inactive non-invasive device. However, the idea of a future app with an algorithm (which will be presented below) would classify as an active device, as stated in Rule 11 (Software providing information which is used to take decisions with therapeutic purposes). And it is due to this Rule 11 Anex VIII that the app would be considered as a Class IIa Medtech device.
Moreover, our patch would classify as Class I as it doesn’t apply to any of the Classification Rules 2, 3, or 4 in Chapter III, nor any of the special rules. These 3 rules and the relevant special rules are summarized here:
- • Intended for channeling or storing or liquids for the purpose of eventual administrating in the body
- • Modifying biological or chemical composition of the human tissues, or substances taken from the human body to be used in vitro before implantation in the body.
- • Devices in contact with injured skin or mucous membrane.
- • Device manufactured utilizing tissues or cells of human or animal origin.
Another consideration was the nanofilm we would use to separate the yeast from the skin. This nanofilm has a pore diameter that allows the cytokines to pass through but doesn’t allow the yeast to get out. We researched if the use of this part of the patch would fall inside the nanomaterial category, and therefore convert our patch in a class IIa, IIb or III. However, definitions in Points 18-21 of Article 2, prove that this nanofilm would not be considered a nanomaterial.
Regarding the Clinical Trials, Caroline Laerke Oldin (find interview in timeline) recommended us to choose 1 or 2 target groups in order to get meaningful results faster, and therefore an easier and faster approval, and then we will keep widening our scope once we have the use towards some target groups approved. An example could be Crohn’s and Colitis, as this is a patient group that we found out to be in need of our technology through our integrated human practices work.
After obtaining data from clinical trials proving safety, and efficacy, we could apply for a CE mark, which would be the last step before receiving a regulatory approval for market access. In this case, we will have to prove quality and risk management systems that ensure the necessary quality. Some of these steps are the ones we should take after developing the scientific part of the project. We have included a more detailed step by step process in "Next steps" at the bottom of this page.
Strategies for medical app
We wish to have an app that allows for tracking and analysis of the patients' inflammation level, ideally selecting when to share this information directly with the doctors. This would be achieved by developing an algorithm to process the patch information and alert the doctors regarding important changes. This intelligent algorithm would decrease the workload that otherwise would come with an increased amount of patient data to be analyzed by the doctors. The need for the algorithm was brought to our attention by medial expert Jakob Seidelin, therefore getting input from more stakeholders in this field is crucial for the correct development of this app. Having a medical app, however, creates complications regarding regulatory approval and safety . A medical app is considered a med tech device of class IIa, which requires more in-depth analysis and results (more capital and time) than our class I CIDosis patch. This means more resources is needed to get this app approved for market entry, and we thus were advised by Claus Romer to consider alternative market strategies for our patch and app- 1. Both patch and medical app
- 2. Only patch
- 3. Patch and non-medical app
Because the app requires mor resources we could develop the patch as a single product and start creating revenue. Along with this patch a non medical app could be develop that does not act upon the data but simple allows the patient to store it in a calendar format. Below you can se a mock-up fo this app, which is our first step towards developing a dedicated app to increase the usability of our CIDosis patch.
unmet needs and competition
Currently, there are many products on the market for treating chronic inflammatory diseases. Patients often try many types of medications and undergo frequent period testing to keep track of their disease progression. In general self-diagnostics and medical apps are becoming increasingly popular and useful. Self-testing methods via stool samples for CIDs such as Crohn's are being developed. However, there is a lack of comfortable, non-invasive inflammation monitoring devices for self-testing in the market. Here we investigate the competitors in the market and present the need for new methods based on patient input.
Competitors analysis
We explored the different options available for detecting inflammation levels in the body. We found three other options, being blood test the most common, followed by stool test and saliva as the least used. In order to easily compare each of them, we decided to explore 6 different areas. In the following figure we show in a visual manner the differences between them. We defined "direct result" as the non requirement of lab processing the sample to obtain the results, and Comfortability referred as both mentally and physically.
These results reflect the need for improvements. Patients undergo periodic testing and still many are not entirely satisfied with their treatment. The tendency to switch medication often demonstrates the broader need for better monitoring solutions to provide optimal data so that medication adjustments can be made faster.
Patient needs
Even with the methods already on the market for testing inflammation, there is room for improvement. Below you see a snippet of results from our survey. We received 68 responses from patients with CIDs in this survey:Customer discovery and applicability
In order to reach patients with CIDs we have reached out to danish associations for CID patient groups. This allowed us to get a sense of the patient needs and willingness to supplement their disease monitoring with our patch. This patient group serves as a validation for our products applicability and demand. Again, we received 68 responses to the following questions in our survey:
These responses demonstrate the versatility of our patch and applicability to a wide patient group, spanning from age 18 to >60. This shows that we can expect to find potential customers in all age groups for our patch and that target groups could be multiple diseases. However, due to regulations, it can be hard to be approved for multiple patient groups at once, thus we plan to conduct more patient research to find disease target groups, for which we can launch our product initially. After proof of concept, it can be expanded to multiple other CID patient groups. The willingness to wear our patch often (a majority every week) expressed by the patients, strengthens the marketability of our products.
Next steps
We decided to build a Quarterly Roadmap that would express the goals already set for a future product development
Q1/2021:
- Transition from an iGEM project into a start-up
• Registration as a Private Limited Company (ApS).
• Sign Shareholder Agreement.
• Expansion of skillsets on the team- App development and scientific confirmation.
• Identify challenges and deadlines with experts regarding applications and approvals.
Q1/2021:
- Securing Idea
- Securing Idea
• Establishing strategic partnership- experienced in GMO or MedTech
• Finding a sponsor/investor/funding
• Application for Intellectual Property (IPR and FTO)
• Finding a sponsor/investor/funding
• Application for Intellectual Property (IPR and FTO)
Q3-Q4/2021
- Strengthening scientific context
- Strengthening scientific context
• Prospective study on cytokines in human sweat: through CRO (Contract Research Organisation)
• Optimize patch design and yeast implementation
• Optimize patch design and yeast implementation
Q1-Q2/2022
- Preparation for clinical trials
- Preparation for clinical trials
• Consult experts about authorisation and human resources needed for Clinical Trials
• Applying for clinical trials: Developing the Clinical Research Manuscript
• Finding a production partner
• Getting more investors
• Applying for clinical trials: Developing the Clinical Research Manuscript
• Finding a production partner
• Getting more investors
Q3/2022 - Q1/2024
- Develop clinical trials
- Develop clinical trials
• Clinical trial operations management
• Prepare preliminary market approval
• Figuring out details about productions
• Finding strategic partners and investors
• Prepare preliminary market approval
• Figuring out details about productions
• Finding strategic partners and investors
Q2-Q3/2024
- Preparation for Market Entry
- Preparation for Market Entry
• Application for Market approval
• Finding a marketing partner
• Start planning Sales force and Marketing strategy
• Scale-up of manufacturing production
• Finding a marketing partner
• Start planning Sales force and Marketing strategy
• Scale-up of manufacturing production
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