Revision as of 13:46, 16 September 2015

Policy and Practice

External environment influences the design of new technologies. Human practices, public engagement and education.

Overview

Subtitle or summary goes here. Should be short - two or three sentences.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Praesent ultrices tincidunt ipsum, vitae tempor nibh porta ac. Fusce consectetur neque et dolor vestibulum iaculis. Nunc pretium turpis at arcu tempus vehicula. Nam nec accumsan metus, ac tempus tortor. Aenean euismod elit vitae ex ultrices pulvinar. Etiam rhoncus non urna vel volutpat. Donec ut erat ornare, faucibus quam a, posuere urna. Phasellus at nisl sed erat ultricies commodo vel ut mauris. Morbi ac mauris dui. Cras sit amet ornare nisl. Suspendisse lectus mi, ullamcorper et dolor a, vulputate condimentum velit. Morbi dolor eros, cursus euismod magna sit amet, tempus volutpat quam. Morbi at est sed erat efficitur lobortis nec non elit. Integer urna nisi, dapibus nec magna non, pharetra sodales felis. Fusce dignissim elit sit amet purus aliquet, quis luctus tortor commodo. Donec viverra enim vel ultrices iaculis.

Regulations

Remember to include safety also. Subtitle or summary goes here. Should be short - two or three sentences.

This section first discusses synthetic biology regulations, and then details possible regulations of our project. Synthetic biology is a multi-disciplinary science that has seen much advance in past years. However, there still is some confusion about what regulations apply to the field, because Synthetic biology is a broad term. When one or more synthetic biology aspects are specified, discussions about regulation and safety are clearer.

Different regulations apply for different regions. In the European Union, the European Commission considers to apply the existing regulatory framework of GMOs (European Commission, 2010). In the USA, the regulatory framework of Biotechnology applies and adaptations are made to address SynBio novelty (Carter, 2014).

Worldwide, the United Nations Convention on Biological Diversity (CBD, 2011) targets three objectives that focus on:

Conserving biodiversity.

Sustainable use of biodiversity

Fair and equitable sharing of benefits arising from the utilization of genetic resources.

The objectives concentrate on implications of releasing synthetic organisms, cells or genomes into the environment. However, despite the best intentions of this convention, their findings seem orientative, not leading to major changes in policy worldwide - countries and regions maintain their own way of regulating synthetic biology. For example, the USA is not bound by the CBD decisions, and other wealthy countries with strong biotech industries oppose them (UK, Australia, Brazil, etc.)

With respect to biofilms, specific regulations are almost non-existent. One of the causes for this regulatory gap is political and industrial lack of understanding of biofilms.

Regulations (of biofilms) are non-existent in North America, and still in their infancy in most of Europe.

Jonathan Tyler, CEO Tyler Advanced Corrosion Technologies, Questionnaire on Biofilms and 3D biofilm printing.

The biofilm industry is generally regulated with respect to bacteria present in the biofilm. Thus, diverse regulations may apply. A special case appears when conducting clinical studies; regulations are very strict. Clinical studies are investigations on humans intended to discover or test the effects of medicinal products (European Commission, 2001). We found out from both interviews and regulatory documents that this type of studies are cumbersome because of regulations, research being possible on in strictly controlled and licensed environments.

Almost all microbiological research is currently based on in vitro models, which have nothing or very little to do with what is observed in clinical samples.

Steffen Eickhardt, Head of Biofilm Test Facility, The University of Copenhagen.

This is a gap that Biolink could fill - if bioprinted biofilm testing reliability could get closer to that of clinical testing, we would have an easier and safer way to test products. Instead of having to pass through strict regulations of clinical testing in order to ensure the highest quality of a test, artificial test conditions could created with 3D-printed biofilms. In this sense, it is easier and cheaper for industry to work with biofilms. Another dimension is safety. Clinical testing is strongly regulated because it poses significant health and environmental risks. When testing a printed biofilm, there is no live test subject, and therefore minimal safety risks.

Another regulatory field we consider is bioprinting. Bioprinting is a highly debated topic, because it is new and unexplored, with various moral, financial and political interests at stake (Mearian, 2014). Conflicts mostly exist in the area of tissue printing with human cells (or other living cells). Bacterial bioprinting is not yet regulated - we propse that bacterial bioprinting adopt regulations of different fields. By merging regulations of bioprinting and biofilms, we assume that environmental and human safety, biodiversity, and legal ownership issues are taken in account. One field offers control over printed items while the other control over bacteria used to print items. Moreover, the open-source character of our project allows for transparency - science, regulatory and societal stakeholders can contribute to shaping 3D biofilm printing in a responsible and safe way for the future.

In conclusion, our 3D biofilm printing may be a future alternative to clinical testing, a safer and less controversial option for testing biofilms and anti-biofilm products. The Biolink project is driven by regulations that help control harmful bacteria and ensure that no ownership issues arise with printed items. Depending on what types of bacteria are used to print the biofilms, if the Generally Recognized as Safe (GRAS) status is granted, 3D biofilm printing is allowed.

Synthetic Biology & Biolink: Risks and ethical aspects

It is important to address relevant social and ethical issues right from the start of any project. We will describe the ethical issues related to iGEM in general and to the open-source technologies we have developed: the DIY printer in combination with the bacterial bioink.

Let us begin with an example that illustrates why it is essential to consider ethical issues. In 2014, the Belgian firm Ecover announced that they wanted to shift from palm kernel oil to a more sustainable basic ingredient for their soap products; an oil produced by algae (The Ecover Team, 2014). These algae were a product of synthetic biology. Palm kernel oil is considered to be an important cause of deforestation of tropical rain forests (Strom 2014) and therefore Ecover was looking for more sustainable alternatives.

However, Ecover received a lot of criticism from the Environmental Testing & Consulting (ETC) Group and Friend of the Earth (Rerimassie & Stemerding, 2014). The basis of the criticism was the fact that “synthetic biology” was perceived as “not natural”. As a result, on the 27th of June 2014, Ecover announced that they want to have a science-based discussion, to establish how to responsibly use biotechnology.

As the above example describes, discoveries within the field of synthetic biology can raise complex issue points when discussed with societal stakeholders. Considering their ethical concerns early on can smoothen the road of research and development.

The Ecover example showed that people might perceive synthetic biology tools as unnatural. It is true that one of the goals of synthetic biology is to engineer new organisms with functions that are not found in nature. This is a difficult issue to tackle, but we think that the choice of words and way of phrasing used to describe a certain process is decisive for public acceptance and in the end failure or success (described as well by iGEM Gent team 2013). For example, when Ecover described their solution as “sustainable”, they were criticised by opponents that did not associate this term with synthetic biology.

In the case of iGEM, for every team’s project introducing a new problem-solving technology, there may exist several yet unknown, potentially harmful consequences. Although synthetic biology is based on rational approaches, the new developed strains might have negative effects on the environment or human beings (Rerismassie, Stemerding, 2014). This however is a characteristic of progress, independent of the field of research and discovery, for example nuclear energy. For this reason, risk assessment is an important part of innovation, also in synthetic biology. In biotechnology, these types of concerns are related to the biosafety issue. A specifically sensitive issue relates to releasing engineered microorganisms in the natural environment. As an example, we can take the “oil eating” bacteria proposed by team TU Delft 2010. To mitigate the issue, synthetic biology comes up with the idea of a kill-switch, to reduce the risk of unwanted side effects on the environment. The iGEM team of Wageningen 2014 incorporated a kill-switch in their BananaGuard. The team designed a Pseudomonas putida that could detect and destroy a pathogen that threaten banana plants (Fusarium oxysporum). The genetic system of the BananaGuard becomes active when it senses fusaric acid, the compound secreted by the pathogen. After the pathogen is removed from the banana plant, the BananaGuard will kill and remove itself by producing toxins (iGEM Wageningen, 2014).

Biosecurity and Intellectual Property Rights

Another issue in SynBio is biosecurity and proprietorship. The BioBricks^TM we are developing during our iGEM project are meant to simplify the engineering of organisms with new properties and make a standardized process possible (Vriend, 2006). All the BioBricks^TM designed will become part of the so-called Registry of Standard Biological Parts, an open source database of genetic building blocks. However, we must consider possible vulnerabilities of this system. Simplification of the building process and the open source system makes biotechnology more accessible to non-experts. Therefore, there is a threat that people will use biological elements in harmful ways, escalating even to bioterrorism; This is what the issue of biosecurity discusses.

From the biosecurity discussion arises a novel term: biohacking. Biohacking involves designing and manufacturing biological systems freely, but with hardly any regulatory oversight or enforcement in place (Schmidt, 2008). For example, on YouTube you can find tutorials on how to make your own biofuel. Moreover, there is a ‘DO-IT-YOURSELF’ society (DIY Biologists) who support the following statement: “Central to our mission is the belief that biotechnology and the greater public understanding about it, has the potential to benefit everyone” (DIY Bio, 2008). This mentality can cut both ways. On the one hand, the DIY biologist society may have experts that can teach people how to work safely in a lab, spreading the benefits of Biotechnology. On the other hand, practically anybody is free (and has the means) to create novel organisms in their basement, unchecked by regulation and without adherence to any professional and moral code.

Apart from biosecurity, open source can raise the issue of intellectual property rights. As in the case of DIY Biologists, there are two conflicting views that both have pros and cons. Supporters of an open source system for Synthetic Biology claim that innovation can be sped up, thus making the benefits of the field available more quickly. Proponents of patenting believe that commercializing synthetic biology products is impossible in an open source environment (Rerimassie & Stemerding, 2014).

Biolink: risks and ethical issues

As we described above, risks can arise when utilizing our Biolinker and printing a biofilm. To reduce the risks, Biolink users should be aware of some safety aspects. First of all, the preparation of the bioink must follow a protocol, just as any other step in the lab. A protocol ensures personal and environmental safety. If preparations are done in a ML1 environment, we think there should not be significant risks. Any actions done without respecting ML1, are not control. In our project the bioink is printed with a DIY printer made out of K’NEX. Since the material is in contact with microbial material it is important to only use the printer in a laboratory environment and not as toys for your kids anymore. After printing the biofilm, there is the risk of spreading microorganisms. In our project, we are working with a safe strain of E.coli. As an additional safety feature the nanowire formation only starts after induction with Rhamnose. The absence of Rhamnose prevents undesirable biofilm formation.

Another aspect, more related to biosecurity, is the fact that we publish a manual on how to engineer our organism and how to build our printer in an open source system. Although this is related to the DIY mentality, we only provide information on how to print with our safe bacteria. During the RIVM/Rathenau Institute debate we found out that policy makers would not have problems with allowing this technology in an open source system.

Besides risks, ethical issues such as ‘unnaturalness’ (like the Ecover case) or ‘playing for god’ are hard to tackle. To understand the actual feeling and opinion of the public, we developed a Biolink policy and practice tool to make the issues related to an iGEM project more concrete. Based on the outcomes of the tool, communication about the project can become more concise and helpful.

Experts' Opinions

This section summarizes some of the most interesting responses we received from key people working in various biofilm-related fields.

Data collection

A project is shaped by its ecosystem - the complex network of interconnected entities such as stakeholders, resources, technologies, trends, regulations and so on. But the relationship is not unidirectional; the project itself can impact elements of the environment, changing it as a whole. Starting with this line of reasoning, we try to predict how Biolink can impact society and industry. We thought that the best way to do this is by asking researchers, scientists and managers that have experience in biofilm or 3D printer related fields.

Remember kids, the only difference between Science and screwing around is writing it down

Adam Savage, Mythbusters.

To collect data in a structured way, we formulated a questionnaire that we’ve sent out, after introducing our project to experts. In this way, we could study different responses on the same questions, gaining a broader view on our project. With the questionnaire, we tried to funnel questions from broad (common biofilm technologies and practices used) to specific (how does 3D biofilm printing fit in). We also formulated questions that seek answers related to biofilm-related ecosystem entities (industry, ethics, regulations, social responsibility, business, research, etc.). The template questionnaire can be viewed here:

Interesting Findings

These responses are fundamental for guiding our project, but they will not be individually discussed here, but rather their influence can be seen all across the project. The most helpful and interesting answers are gathered and categorized.

As a starting category of answers, we wanted to find out the current state of biofilm technologies, in what areas they are most used, and what their strengths and weaknesses are. We received responses from several people that work in both industrial and research settings.

Santiago Salas, Scientist at Colgate-Palmolive

A lot of money and resources go into finding out how to prevent and remove biofilm formation in oral care and pipelines/equipment

Santiago Salas, Scientist at Colgate-Palmolive

“From the point of view of consumer products, it is required to determine the mechanisms by which biofilm can attach to a surface and ultimately whether these can be disrupted or inhibited. The weakest point is that like many other methodologies, it cannot be a substitute for highly expensive clinical testing.”

Dr. Jonathan Tyler, CEO, Tyler Advanced Corrosion Technologies (TACT)

Biofilms are studied due to “Health concerns, industrial damage, and the ecological impact of biofilm-influenced corrosion.”

“There are few strong points to current biofilm technologies, with little or no industry standards, and a profound lack of awareness by industrial leaders and society in general. Biofilms are so little understood by industry (and society) that the problems they cause are essentially hidden. Without education, the problems will only continue to grow. “

Steffen Eickhardt, Head of Biofilm Test Facility, University of Copenhagen

“Almost all microbiological research is currently based on in vitro models, which have nothing or very little to do with what is observed in clinical samples.”

Steve Diggle, Steve Diggle Research Group, University of Nottingham

“Biofilm research is not really getting anywhere or providing solutions - innovations are more than welcome. Biofilms currently are not representative of reality and the field would benefit from a device mimicking a more realistic environment.”

Another category of answers refers to the importance of reproducibility and closeness to natural conditions for biofilms, characteristics that we identified as lacking in current biofilm formation technologies.

Reproducibility is a laudable goal and the prospects for process and product innovation are good, but only if the biofilm being produced synthetically actually mimics naturally occurring biofilms.

Dr. Jonathan Tyler, CEO, Tyler Advanced Corrosion Technologies (TACT)

Steffen Eickhardt, Head of Biofilm Test Facility, University of Copenhagen

“Our methods of testing are based on the current understanding of in vivo biofilm formation and chronic diseases. We strive to develop methods as close to in vivo as possible, whereas similar companies use methods developed in previous decades, which are primarily based on in vitro settings which are rarely applicable for chronic diseases.”

The last category shows thoughts on how Biolink - 3D printing of biofilms - can help industry and research.

Marko de Jager, Principal Scientist & Thought Leader, Philips Research

“With a 3D printer, there would be the ability to create multiple geometries independent from bioreactor constraints. Currently used biofilm models allow for flat or simple curved surface areas. With a Biolinker, there arises the opportunity of creating even the more complex geometries.”

“Adhesion to surface/substrate and co-adhesion within the biofilm are essential properties. The possibility to fine tune these parameters in a consistent and predictable way, allows us to find the optimum between safety and efficacy for mechanical removal with either a toothbrush or water jet, depending on case.”

Santiago Salas, Scientist at Colgate-Palmolive

For product testing in production industries: “Most likely in terms of lab testing downtime and reproducibility, the industry could benefit from 3D printing biofilms.”

Steffen Eickhardt, Head of Biofilm Test Facility, University of Copenhagen

“For research based applications, 3D biofilm printing could be used in combination with human cells (tissue engineering) to test host-pathogen interactions. Enabling studies such as these could in time influence how we treat patients and also change the way research is done on chronic bacterial infections.”

Henk Noorman, Corporate Scientist, DSM

“Bacteria are much more sensitive than any electronic device. A layer of bacteria could be microprinted as sensor on a microchip and inserted it into the body. It could detect all kinds of signals - glucose level in blood, food patterns in the intestine, and transmit them for analysis.”

Sander van Pelt, Scientist at Cross-Linked Enzyme Aggregates (CLEA Technologies)

“Pharmaceutical industries will favour batch processes in the foreseeable future due to better process control and controlled risks. In the field of bulk chemicals and some fine chemicals, application of continuous processes might be interesting.”

The iGEM Community

For a complete policy and practice assessment, we thought it would be nice to not only include companies and research groups, but also the iGEM community.

For a complete policy and practice assessment, we thought it would be nice to not only include companies and research groups, but also the iGEM community. Since many iGEM teams are dealing or working with biofilms or co-cultures, our technology could be fruitful for a lot of these projects. In this section we will show you how our project could be used in combination with other iGEM projects. With these examples we show that our DIY printer and the biolink system form a useful addition to the iGEM community. The application scenarios described below are discussed and written together with the iGEM Berlin and iGEM KU Leuven team. Our collaboration with these teams was a great opportunity to share our technology and use it for other applications.

iGEM Berlin

The iGEM team of Berlin uses synthetic biology to develop a molecular filtering machine. This project has great opportunities in solving the problems with microplastics finding their ways into the wastewater treatment plant. During the wastewater treatment, the microplastics are not removed sufficiently. The ‘escaped’ microplastics are taken up by organisms living in rivers, lakes and the oceans, but also by human beings through the food chain. To date, no scalable approaches have been found to solve this problem.

Luckily, the iGEM team of Berlin is proposing a solution to this problem; a molecular filtering machine. Their proposed filters consist of a surface made of cellulose to which bacterial flagella will be immobilized. The attachment required for this will be achieved via a cellulose binding domain. The single flagella-subunits, also known as flagellin, will be interlinked with plastic-degrading enzymes. Thus, this system enables an increased specific surface with high catalytic activity.

We believe that combining our projects would open up even more opportunities. With our nanowires, we provide a stable structure to the bacteria used for the filtering machine. With our 3D printer, layers of bacteria can be formed in a predesigned way. Another advantage of this technique is that the enzymes produced by the bacteria can covalently bind to the nanowires (Botyanszki, Tay et al. 2015). In this case, the scaffold of cellulose is not required anymore. Moreover, the printer and nanowires generate a highly flexible machine, since any cell type and any enzyme could potentially be used. One of the requirements posed by Berlin’s team is that the filter is highly flexible in use, so that it can

KU Leuven

KU Leuven team developed a ‘proof-of-principle’ which can form the basis for unravelling the secrets behind bacterial pattern formation. Patterns are formed by engineering bacteria themselves in a controllable way, by using different types of chemicals.

The similarity of our projects is the formation of certain structures with bacteria. Our printer could facilitate the process of making patterns in a more reproducible and automated way. This could be useful for the formation of artificial bones, by using bacteria that can produce porous structures similar to bones. With our printer we can design a unique bone structure exclusively made for the patient.

Another application for a collaboration would be to use the nanowires in combination with the cell-cell communication approach of KU Leuven. Their engineered bacteria could form an addition to the formation of specific biofilms with our nanowires. The moment bacteria find a suitable location, with the method of KU Leuven, the production of nanowires will be induced. Then, the bacteria will be fixed to this location.

By using these two example we have proven that combining our projects would proceed in future applications. To achieve this further fundamental research is required in combination with practical engineering.

Biolink Policy and Practice Tool

Risks of iGEM Projects

The bioethics of synthetic biology are discussed and described intensively in research. However, it is certainly not always clear how to apply these ethical concerns to your specific iGEM project. We were asking ourselves the question; ‘how could we improve the communication and discussion about your particular iGEM project?’ Here we propose a solution with our Biolink Policy and Practice tool.

This tool can be used for testing both the team management and the direct application of your project. The team management section is about the internal relations and collaboration within the team. The application section describes how the general public relates to your project. By asking them to participate into a questionnaire you will have the opportunity to engage the general public more in your project and improve your design. In both cases, the participant gets a list with statements. Each statement will be evaluated with a number between 1 and 10 (1 means total disagreement, 10 total agreement). Based on these statements, scores in different categories will indicate the expected risk or action you should take. Based on the scores in each category, the discussion can focus more specific on the points of high risk or disagreement.

To achieve the best practice with our Biolink Policy and Practice Tool, you can better use the tool at more time points during your project. Based on the outcomes of the tool, you can change the direction of the project at the right time and maybe even improve it. Before the wiki freeze you can show the differences between the starting and end point to evaluate how your project developed using the feedback from this tool.

Design of the Biolink Policy and Practice Tool

We have created an overview of the risks and discussion points which we consider to be important related to your iGEM project.

Click the Policy and Practice Tool button below to download an excel file containing the statements and calculation form.

Policy and Practice Tool

Application

Synthetic biology is a technology not readily accepted by the public. Due to unknown implications, people have to have the feeling the benefits are worth the risks in order to accept the technology. Therefore, the Biolink Policy and Practice tool provides you a list of statements that any person of your choice can evaluate. Based on the results you can conclude what kind of aspects of your project people are willing to accept (that they evaluate as having a low risk) and what they refuse. For this part we considered the socio-technical, socio-economical and the market performance to be important.

Socio-technical

This cluster is about how technical details and performance of your project integrate to socially important aspects.

Ethics: here statements related to “unnaturalness” and “playing for god” are considered. Another important aspect in the bioethics is about patenting/open source and whether the technology is beneficial to everyone.

Biosafety: did your team added enough information on how to work safe with your constructs and how you prevent a microorganism spreading through the environment in the project? And did you provide sufficient solutions to that?

Biosecurity: are people afraid that the project could be used for bioterrorism for example?

Socio-economical

This is more about whether people will accept your developed technology/end product and see the importance in the project.

Achievement goals: does an outsider think your end product/technology solves an important problem? Also: is your team capable of communicating about these goals?

Acceptance: are there extra regulations required for your technology/end product and do they actually accept the way you are achieving your product goals.

Market performance

Functionality here you can actually test whether the outsider thinks your promises can become true.

Project Management

We discovered that teamwork is not always easy and therefore we decided that the tool would also be useful in guiding the teamwork. To have successful project management, we considered both the technical and personal aspects related to the project.

Technical aspects

Nationalities/expertise: we did not define this as a direct risk, since a mixture of people and cultures could be beneficial for the project. However, every team member has to be aware that differences in background or culture could cause communication problems.

Supervisor: every successful iGEM team has a supervisor. Not to tell the team exactly what to do, but to educate them, provide technical details and also to keep the team on track. Therefore, a low score in this part could be signal that some things should change.

Trust: in teamwork it is very important that team members trust each other. If there is a low score in trust, we advise you to have a constructive talk with each other.

Personal

Skills: first of all, it is the question whether every person has the skills to perform his/her tasks. Moreover, it is about the totality of skills present in the team necessary to achieve the project goals. Also experiments are part of almost every project and therefore it is important that the team trusts the persons in the lab know what they are doing.

Tasks: it is important that people know what they have to do, so tasks that are clear and structured will make the work easier. Also communicating about what has been done is an important skill, so all team members can understand the result.

Project achievement goals: what we discovered during the project is that everyone has personal goals within the project besides the main project goals. In case you are working with a group of persons with a different background, it might also be the case that everyone understands the project achievement goals differently. It will ease the teamwork if you know what goals the team wants to achieve and what personal goals each team member wants to achieve.

All the different elements will be counted according to relative weighting factors. In the Figure, the biggest arrow means a relative weighting factor of 3, the somewhat smaller one represents a factor of 2 and the smallest one a factor of 1. These weighting factors are a first estimation of relative importance. In the future, one of the team members is going to improve this tool.

Results

Project Management

Three of our team members did test the tool when it was finished. The results are showed below.

Outreach

Reaching out to the public in order to show the opportunities synthetic biology has.

Synthetic biology has a lot of opportunities, for example in the improvement of healthcare and the production of sustainable energy. However, the idea that we could create "new" life with synthetic biology, is for a lot of people kind of frightening. Within our outreach part, we taught the public the basic concepts of synthetic biology. Moreover, we showed that the improvement of living creatures, by human kind, has been performed for ages. Finally, we discussed our project and its possible applications. Due to the multidisciplinary team, we already practiced the science communication by discussing everything in such a way that the whole team could understand it.

A Day of Wonder

During the first week of June, the international Festival of Technology (iFOT) was organized for and by students of the Technical University of Delft. During the week, a rowing event was organized, a Heineken bridge was built by civil engineer students and many more activities took place. In order to officially close the festival, A Day of Wonder was organized on the fifth of June.

Description of the event

A day of Wonder was the spectacular final of an entire week of celebrating technology. The event gave intellectuals and curious minds a chance to see innovations on the edge, with a mix of technology, music, art and great food. The Health Area was located in the Aula where all projects related to health topics were presented, ranging from end projects of master students, such as the Exoskeleton and the Buddy, to the fall course in which cameras were used to register the exact movement during the process of falling. We had the opportunity to be part of the health area and present our own project to the visitors of the festival. Our aim was to teach the public more about synthetic biology and to make them excited about our project.

Our stand

Since the festival was for everyone interested, ranging from young to old and higher to lower levels of education, we organized our stand in such a way that we could explain the basic concepts of synthetic biology and the iGEM competition. In order to teach, in a visual way, what synthetic biology is, we designed two puzzles, representing two types of bacteria. With these puzzles, we could explain how genes can be transferred from one bacteria to the other. Moreover, we brought some microscopes and lenses (built with Lego) to show the people how to enlarge pictures.

Activities

To have an interactive activity, we gave the public the task to write down their first thought when they hear about bacteria. The replies ranged from ‘dirty’, ‘zombie apocalypse’ to E. coli. In our opinion it was really funny but useful to see what the general knowledge (and opinion) is about bacteria. Our main attraction was the functional 3D printer that we had lent from Frank & Frens. With the printer we were able to show the public how the process of 3D printing works, what we want to do with the bacteria and why 3D printing could lead to more precision and accuracy.

With our project we aim to print a well-defined biofilm in 3 dimensions. Since the biofilm can be created at a certain rate and pattern, it is possible to create a well-defined structure. In order to show the existing problems, we have used pictures of dental plaque and biofilm formation within pipes to show them.

Winner of the contest

Bio³Dimensions Business Case

Educating people is not only about giving lectures, it is also about offering the opportunity to feel and think the subject. We wanted to give this opportunity to students of the TU Delft in the form of a business case.

Bio³Dimensions – Business Case

Educating people is not only about giving lectures, it is also about offering the opportunity to feel and think the subject. We wanted to give this opportunity to students of the TU Delft in the form of a business case. The assignment made students think about how they would use a 3D biofilm printer for a practical, marketable use, and present their idea. Since the participants had different expertise, we started with a general introduction to iGEM, synthetic biology and our project. After that, groups of three persons were formed,each group having one of the iGEM team members as a tutor.

Based on the information about our project, the different groups could use one of our applications or come up with one on their own. They also had to choose their market of interest, think about the drawbacks of their technology and sketch a market plan. In the end, every group presented their idea with a poster pitch. We closed the meeting with a free barbeque to thank the participants, and continued discussions in a more informal setting.

Group Ideas

Smell Eaters

The first group presented a shoe sole on which a biofilm with the smell eaters (good bacteria) was printed and attached. The group knew about some “good bacteria” as being used for treating bodily odour. The “good” bacteria would produce substances that inhibit the odour compounds made by “bad bacteria”. Based on this, the group wanted to apply the idea to the shoe industry. Since the feet shape and size differ from person to person, the printer is useful because it can be adapted to every type of feet. The project’s poster is shown in Figure 1.

According to this group, the technology could be useful for everyone with smelly feet. Since you want to make it suitable for every type of feet and shoes, they propose coupling to stores specialized in making individual shoe soles. In the future, they want to implement a system that could protect the user for ‘escaping’ organisms.

Purity straw

The second group provided a solution for the contamination of drinking water, the Purity Straw. The straw has a membrane inside, which can clean contaminated water. The straw is suitable to use it in most situations where access to clean water is limited.

The printer gives the opportunity to print different kind of membranes, which makes it useful for every type of contamination.

Figure 2.

The team surprised us with a short but to the point market strategy on their poster (Figure 2). According to them, the product could be useful for humanitarian organisations in helping developing countries to get clean water. Moreover, the army can get access to clean water everywhere. With this technology they target especially remote areas, over populated regions and areas struck by disaster. Finally, why did they think the technology was useful and beneficial? Well, it is easy to use, the material is light and therefore easy to take with you. Finally, it could be small.

The discussion after the presentation contained some nice questions:

“What about the fact that people could swallow the bacteria during drinking? The team answered with: “People should just adapt to this situation, since the bacteria in the straw are less harmful than the bacteria present in water”. Actually, by using this device, the bacteria should have a GRAS status;

According to a student of industrial design, such a technology already exist. So, this team did a really nice job here!

Lumy

Another team came up with a totally different application of our construct; ‘The Lumy”. Lumy provides a sustainable version of lights for bicycles. The Lumy can be ordered at a special website in every shape you like. The product you will receive at home consists of a sticky layer, a layer of nutrients (medium), the biofilm which has the property to emit light. So, the only thing you need at home is medium for the bacteria! Since batteries are not necessary anymore, the product could be highly sustainable.

The Lumy is especially useful in a country like the Netherlands (students for sure), since everyone uses a bikes often. Moreover, since the equipment is closed, the bacteria cannot escape.

Figure 3.

Bactoplast

The final concept presented was similar with the idea Groningen’s iGEM team had two years ago. The printer will be used to print the biofilm required at that moment for healing processes. The so-called bactoplast is placed on the wound and will increase the healing process. Afterwards the signal molecules of the wound will disappear. This signal activates bacteria’s kill switch. Therefore, there is no danger of bacteria that will escape.

Since it is difficult to keep the Bactoplast fresh, this group aimed for hospitals and doctors. However, it would be even nicer if people could use the device at home. In that case, the bactoplast can be used in every kind of wound.

Wrap-up

After the hard work of the teams, it was time to relax. We organized a free barbecue with drinks in the company of the Netherlands’ very occasional, sun. We all enjoyed the evening and received constructive feedback from the participants. Students who at first knew little about the field, found out many interesting things. They left with a good impression about synthetic biology and its future.

Synthetic biology in action

RIVM (Governmental agency for public health and environment) and Rathenau Instituut organized a discussion about the advances in technology that may have a large impact on society and industry.

For the second time, the RIVM (Governmental agency for public health and environment) and Rathenau organized a discussion about “Synthetic biology in action”. The need for this discussion is because nowadays the advances in technology are taking big leaps, which the public is not aware about. Therefore the Dutch ministries want to stay up to date with current developments, in order to regulate them correctly. The role of the Dutch iGEM teams was to show what students were actively working with in synthetic biology.

All the Dutch iGEM teams were actively involved in organizing the event. We had two preparation meetings. The first meeting was about what we wanted to achieve and what the iGEM teams could mean for the discussion. In the second meeting, all the Dutch teams practiced their pitch that they wanted to present at the discussion. It was really inspiring and lovely to see what the other teams had accomplished during the previous months.

7th of September 2015

On the 7th of September it was time for the real event. The invited public consisted of people who had expertise in government affairs, synthetic biology, and industries, and therefore look at synthetic biology from different perspectives. The aim of the day was to create a discussion about the advances in technology that may have a large impact on society and industry.

Introduction to synthetic biology from different viewpoints

The day started with an introduction into synthetic biology, taught by Jack Pronk, a professor at the TU Delft. He gave a lot of insights in what kind of opportunities synthetic biology could give in terms of research and development. The next talk was given by Dr. Bart Wesselink, RIVM. He discussed the meaning of sustainability in the biobased economy and industry. He succeeded in relating the subject of synthetic biology to the social and economical impacts of a biobased way of thinking. The last presenter was Dr. Dirk Stemerding, senior researcher “technology assessment” at the Rathenau institute, who expressed feelings surrounding the implications of synthetic biology and that social debate is necessary. He related this thought to the Ecover case, a producer of cleaning products. Ecover did not want to use any palm oil for their products and therefore decided to use genetically modified algae for the production of oil. However, this raised a lot of resistance from people who thought oil produced by genetically modified algae was not ‘natural’, while palm oil was. According to Stemerding, this case illustrated an early warning. This talk was the most related to what we understand as the main goal of the “Policy and Practice analysis” of iGEM. We, as an iGEM team, should encourage debate, education and maybe even acceptance.

iGEM teams and related discussions

After a short break the stage was ready for the Dutch iGEM teams to pitch their projects, and what their views were of iGEM in the synthetic biology world. First to start was our project, represented by Max van ‘t Hof and Michelle Post and our DIY printer. iGEM aims to be a platform that informs the world about synthetic biology, via students who are open-minded about ethical issues. In this way, it can reach a large public. This is combined with full transparency on all achievement reached by its participants, in both our wiki and the iGEM database. We described our concerns about being transparent and therefore being an open source for people who haven’t been in contact with iGEM. We explained the issue about anybody being able to access information about synthetic biology and in that way being able to recreate entire experiments. All iGEM teams must comply to this transparency to be able to fulfill medal requirements. We mentioned that our 3D printer could be recreated by anybody, because a manual will be placed on their website stating all the steps to create this machine out of children’s toys. Our final statement was as followed:

“The open source mentality of iGEM is not so threatening as that this system should be forbidden”.

We chose this statement because for requirements of our assigned track, Hardware, we are required to have all information present on our wiki. This also includes the manual for creating the 3D-printer with K’NEX.

The public had been handed out green/red cards, to indicate if they agreed or disagreed with this statement. The public was almost entirely unanimous in agreeing with the Delft’s students. Besides the agreement, there was a technical philosopher who said that although we should aim to an open source system to stimulate innovation, we should also be aware of the risks related to such a system. Such as the misuse by malicious people to create “evil”bacteria. The pro of the iGEM mentality being an open source was that for agencies it is easier to control what the newest advances are, and other researchers are able to easily find new experiments or techniques. We believed that open source would be met with more resistance, but the public was quite positive for the reasons above. Although we agreed on this point, we were also very glad to see that almost everyone saw the benefits in an open source system as used by the iGEM community.

The next team was Groningen who talked about their biofilm used for the production of blue energy; the production of energy based on the difference in salt concentration between salt and fresh water. They stated that it should be possible to allow GMOs outside closed circuits. The public was a bit more hesitant in agreeing with this, mentioning that it can be unpredictable what the effect of these GMOs will be on the environment. Prof. Pronk added that naturally occurring microorganisms will, in most cases, outcompete the GMOs.

The third team was Amsterdam, who explained their project incorporating symbiosis between E. coli and cyanobacteria to produce biofuels. The costs of biofuels are not favorable compared to current fossil fuels due to the production costs. Therefore, the students from the capital stated that they believe that the Netherlands should invest in such innovations, even if it would lead to a less favorable economical situation in the near future.

The last Dutch team was Eindhoven, who introduced their modular device to biosense diseases. Their statement was that the patent regulations should not apply for applied research. This was met with the most ambiguity throughout the audience. There were comments stating that patents were only used if the “new” products made with the help of patented items, had to be payed for, and not if used only for research.

Drinks and acknowledgements

The day was finalized with drinks and an opportunity for the audience to mingle and discuss further with other professionals. It gave us an unique chance to talk with people who deal with these kind of issues on a daily basis. We also had the insight that the discussion after the presentations could even be more fruitful by raising specific situations instead of open-ended statements. Moreover, a lot of people agreed that the open source system has a lot of promises, but that we should look at the consequences and at each case specifically. This also relates to the aim of our policy and practice tool.

We would like to thank the RIVM and Rathenau institute for making this day possible. A special thanks to Virgil Rerimassie, Korienke Smit and Jaco Westra! And also to Loesje Praktijken for making the nice pictures!

Science Center

In the spirit of the Science Centre, we want to inspire children by letting them design their own imaginary bacterium through their own creativity. In order to achieve this, we set up a workshop about synthetic biology. We designed the workshop in such a way that every future iGEM team could use our format if they want to.

When asked what they want to be when they grow up, children often reply with pilot, firefighter, police officer, veterinarian or any other “superman”. Kids usually don’t scream out “MICROBIOLOGIST”. By inspiring children in the field of science, they will be more prone to develop interest in research and technology. This is a challenging goal we have taken on. We would like to both reach out to the public and educate them about the wonderful world of synthetic biology. For this, we believe that the Science Centre of Delft is the perfect place. The museum turns the Delft University of Technology inside out and allows you to see the role technology and science plays in society. The Science Center invites the public to participate and contribute to its development.

This year the newest addition to the exhibition of the Science Centre will be the 3D-printer completely made out of K’NEX. This printer is quite special, because it has been used to print with bacteria. The other objects of the exhibition are the result of years of research, teaching, graduation assignments and competitions entered by TU Delft students and scientists.

In the spirit of the Science Centre, we want to inspire children by letting them design their own imaginary bacterium through their own creativity. In order to achieve this, we set up a workshop about synthetic biology. We designed the workshop in such a way that every future iGEM team could use our format if they want to.

Click on the button “workshop design” to see the first draft of the workshop. After the jamboree we will discuss and design the workshop in more detail.

Workshop Design

Business Plan

Helping the iGEM community - How to write a Business Plan

With this section we aim help other iGEM teams by providing a guideline for writing a successful business plan. Further more we present Biolink, a revolutionary way of 3D printing biofilms into a desired form, adding control, replicability and automation over classical biofilm formation methods.

How to Write a Business Plan

A business plan is useful for more than just attracting investors. It helps both the project team and the audience gain a business perspective, which complements scientific and social views. We want to help future iGEM teams to write a business plan specific to their project, so that the business perspective is more thoroughly addressed in future iGEM projects. Therefore, we propose a few guidelines, and direct iGEM teams to literature for further details of business plan writing.

Start with target audience

Before starting to write a business plan, you should identify the target audience of your project. In general, a business plan is a basic document required by any financial investment source. It is an opportunity of an entrepreneur (who wishes to create a new venture) to impress investors and attract funding. (Mason, 2004).

However, even if you are not planning to start a business from your iGEM project, writing a business plan can be useful to communicate the key business elements to a different target audience: the iGEM community and the general public.

Structure the Business Plan

A classical model of a Business Plan can be found in literature as described in (Abrams, 2010). There are many books and websites with various advice about writing such a document. The structure can be variable, depending on what information you want to give and to whom. Regardless of what the theme of the project is, its business plan should include at least the following core chapters:

Executive Summary. The definitory part of any business plan, the executive summary provides a concise and attractive overview of the entire project. It is meant to both inform and catch the audience’s attention. Keep in mind that it has to be attractive for an audience with various backgrounds - both scientific and nonscientific.

Company / Project overview. High level description of the elements of the business/project and how they integrate with each other. Motivation and core arguments supporting why the project will be a success are included here.

Market / Industry Analysis. The project is enveloped within the context of an industry/market. Market research is done on current and future market trends, competition, complementary products, suppliers, clients, etc. Based on this information, a competitive analysis is made to establish how the project (future company) could succeed in the respective environment (for example, by a SWOT analysis - will be explained later).

Product / Service. Describes the final product / service meant to be sold. Advantages or disadvantages of the product should be compared to existing similar solutions. Included is a description of R&D activities, evolution of product (life cycle), and legal issues or patenting if the case.

Marketing & Sales strategy. What customers can you sell to, how to communicate with them, how to sell the product/service. Moreover, this section must describe a long-term strategy on how to maintain and increase client base, while fending off competition.

Management and Organizational Structure. Essential to any project or company are its people and their interactions. This section should detail what kind of people the company will employ (both personal and professional typologies) and how they will be managed within a chosen organizational structure.

Social / Environmental impact. Although this section is not a must-have for regular business plans, it is highly recommended for iGEM. A core iGEM goal is to make Synthetic Biology known and understandable to the world. Therefore, it is important to predict how the project will be perceived by society, and how society can influence the evolution of business. NOTE: One should be aware not to repeat information that is already treated in Policy and Practice modules. Rather, impacts found in the Policy and Practice section should be analysed here from a business perspective.

(Optional) Investment and Financial forecast. This section is traditionally necessary for a business plan, but an exception can be made in the context of iGEM. As the target audience are not necessary investors, but the iGEM community and public, this section may be skipped. Moreover, financial forecasts and investment plans require considerable effort and expertise in order to be convincing. It is better to skip this part than write an unrealistic plan.

Use business theory and concepts

When writing a business plan, content information needs to be supported by existing business theory. Here are some points to consider:

Critical factors for new businesses. One can start developing a business plan by considering four essential factors that make or break a new business as proposed by (Sahlman, 2008). Here is an example of analysis that focuses on four interrelated factors critical to new businesses:

1. People: Initiators of business and external parties with key services and resources (suppliers, experts, lawyers, accountants, etc.). Execution skills and quality of people count more to realizing a business than the business idea.

Key points:

a. How familiar are team members with industry players and dynamics.

b. How well known is the team and it’s people within the network, what reputation does it have?

c. Quality, knowledge and experience of team members.

2. Opportunity: Product/Service sold, customers, growth/diffusion curves, barriers towards success.

Key points:

a. Is the market that the project targets large and fast growing enough?

b. Can market share be easily obtained (new, emerging market) or is a fight needed with entrenched competitors (mature/stagnant market)?

c. How is the product sold (pricing scheme), to whom, why is it compelling for the customer to buy it? How expensive is it to acquire and retain a customer - access to customers is easy?

d. How much capital equipment and assets are needed to support setting up business and sales.

e. What’s the competition in the market? What are their strengths, weaknesses, resources? How would they respond to our technology? Can alliances be formed?

3. Context: regulatory environment, demographic trends, other uncontrollable and variable factors.

Key points:

a. Is there a favorable regulatory and macroeconomic landscape?

b. Are there growing trends that encourage products and services in the industry?

4. Risk and Reward: Assessing what can go right and wrong and how the entrepreneurial team respond.

Key points:

a. What risks are there and what measures can be proposed to diminish them?

b. Can a deal with investors be simple, fair and emphasize trust rather than legal ties?

c. Can the business be seen as an adaptable series of experiments that are open to change? Can experiments be made to test feasibility?

Enabling or hindering elements of a business. To consider both internal and external factors that can block or help an emerging business, a SWOT (Humphrey, 2005) analysis can be made. A Strength-Weakness-Opportunity-Threat (SWOT) is only one method of many, to evaluate these factors.

Marketing/Sales Business models. To gain clarity and structure how a product is marketed and sold, sales models can be used. In addition, comparison with sales models of successful companies can be helpful. After deciding on the model, a graphical scheme can be used to illustrate the entire supply chain. This shows where the new business comes into play in the chain.

Industrial trends and market niches. Choosing where to sell is a prerequisite for production, as each industry has different trends and market segments to sell into. Trends can help forecast what to sell, and identifying untapped market niches suggest where to sell.

Inter and intra-organizational structure. Depending on the company goals, products, industry and market, there are several organizational structures that can be chosen to better support the business model. Structures range from mechanistic to organic with various combinations between them (Burns & Stalker, 1961).

Science communication. Often there is a communication gap between scientists and managers or public. Science communication involves relaying specialized knowledge to non-specialists and is key to mutual understanding between different background people.

Innovation management. As iGEM promotes creativity and innovation, considering how they can be included in the business plan is essential. Innovation patterns and concepts applied on a project help understand how innovation pushes an idea to a marketable application. For example, Henderson and Clark identify four types of innovation depending on its impact on existing competencies and their linkages - Incremental, Radical, Modular or Architectural Innovation (Henderson & Clark, 1990).

Identify and fulfill audience expectations

The business plan should align with, and support the entire project. Readers will be confused if too much new information is added, or if the information is not consistent with other sections of the project. We propose taking in account the following key points:

Direction The business plan helps delineate a strategic direction, clarifying project goals and progress to both iGEM team members and audience. On the long run, a strategic direction aids in keeping the project on track and observing if adjustments are needed.

Integration When doing research for the business plan, new knowledge and arguments come into play. Sometimes it is easy to deviate and include concepts irrelevant for your project. Make sure that new insights stay on subject by always relating them to your project. If they don’t relate, focus on only a few concepts that can be strongly tied to the project.

Validity Prove that assumptions and analysis are valid. Validity can be enhanced by supporting assumptions with interviews, questionnaires (or other data collection methods) and literature reviews.

Combine theory and practice within structure

After deciding on what theoretical concepts can explain project aspects, they can be included within a chosen structure. The executive summary should be left for last, as it is an overview of all the essential aspects identified through analysis. A business plan does not have to be rigid. It should be perfected as the iGEM project progresses.

Final thoughts

Finally, we stress the point that a business plan should be useful. It should help guide the project with respect to what is feasible or not from a business perspective. Moreover, it should be interesting to read for your audience, reflecting ideas of how the project could develop into a business.

Back to Top

Biolink - Business Plan

Biolink was born from TU Delft’s team participating in iGEM 2015. Our aim is to develop a creative, yet simple solution solving a complex problem in the biofilm-related industries.

Executive Summary

Introduction. For testing biofilm removal products, it is essential to produce an artificial biofilm yielding reliable results. Biolink proposes a revolutionary way of 3D printing biofilms into a desired form, adding control, replicability and automation over classical biofilm formation methods. The many fields of application (biofilm research, industrial and healthcare product testing), growing trends of 3D printing industry and Synthetic Biology, and positive feedback received so far offer promise towards our success.

Biolink was born from TU Delft’s team participating in iGEM 2015. Our aim is to develop a creative, yet simple solution solving a complex problem in the biofilm-related industries. Certain biofilms, forming in or on our body, pose serious threats to our health. Products, such as toothpaste or antibiotics, aim to remove these detrimental biofilms. To measure removal efficiency, products are tested on biofilms formed in laboratories. Because biofilm growth is difficult to control, these artificial biofilms are unlike naturally occurring ones. This translates into unreliable product testing - a disadvantage to both companies and their clients.

Our solution can mitigate the disadvantage. On the one hand, safety and efficiency of biofilm removal products can be increased, if biofilms formed are closer to real conditions. On the other hand, increased automation and control over biofilm formation yields a cost advantage for production processes. Biolink brings together more than just biofilms; it combines the novel fields of synthetic biology and 3D printing into forming a new competency. By partnering with 3D printing manufacturers, we want to offer a highly-customized and specialized 3D biofilm printing service.

To gain a competitive edge, Biolink will form and preserve close relationships with clients, concentrating on high quality and specialization, rather than mass production. Clients targeted are from both healthcare production and industrial manufacturing industries (companies selling biofilm removal products). Co-development of our service with our clients is crucial for achieving an optimal solution, tailored to their needs. We can find clients and 3D printer manufacturers leveraging our professional network gained through iGEM. Discussions already held with various actors from the industrial and academic setting seem encouraging. Moreover, reports of growth in both 3D printing and Synthetic biology industries reflect a favorable business environment.

The future business will build upon the iGEM team structure. The Biolink team structure will be versatile, so that it can easily adapt to special requirements of clients and speculate emerging technology. We are proud of being a strong team, with cohesion compensating for lack of experience. By adding team members that fill our expertise gaps, we will be able to competently run a company providing the service we are proposing.

With Biolink, we want to form an image that encourages creativity and sheds light over synthetic biology. Our current 3D printer is made out of a DIY kit that is easy to build. Moreover, we organized social events with students to see what they think about Synthetic Biology in general and our project in particular.

Company and Project Description

Our mission is to contribute to better and cheaper pharmaceutical and health products. By ambitioning to provide an innovative method of biofilm formation, we want to help increase the efficiency of manufacturing and testing processes. We deliver a partly automated, replicable and efficient solution by 3D printing biofilms. The method will partially replace some manual steps of current biofilm formation processes.

Back to Top

Healthcare systems are developing all over the world, increasing the demand for pharmaceutical and healthcare products yearly. In order to increase supply, while maintaining or even lowering prices, the production process needs to be more efficient. Our vision is to partly automate biofilm processes for producing medicine and health care products, and removing detrimental biofilms that affect industrial equipment.

Back to Top

In realising our mission, we are guided by our core values:

Integrity:

to be self-critical, to respect regulations and never knowingly act in the detriment of any group or individual.

Ingenuity:

to continuously seek for improvements of our project.

Openness:

to provide full access to our project results and methods, openly aiding anyone who requests help and accepting external ideas for improvement.

Harmony:

to synchronize with the needs of industry, the demands of our supporters and the expectations of society.

Collaboration:

to achieve more purposeful results by collaborating with other iGEM teams, researchers and industry.

Growth:

to gain expertise, communication skills and build a professional network, while enjoying the work we do.

Back to Top

Project description - Why biofilm printing?

Beneficial and detrimental biofilms form naturally in nature. Research on biofilms is twofold: One - preventing and removing detrimental biofilms, and two - exploiting beneficial biofilms.

- Beneficial biofilms are grown for water and wastewater treatment, bioremediation of contaminated soil (from gasoline, chemicals, oil, etc.), microbial extraction of natural resources, and for producing useful compounds or substances.

- Detrimental biofilm research aims to efficiently prevent and remove biofilms appearing in a multitude of contexts. They can affect installations and equipment in the industrial landscape, form in/on the human body (plaque, skin affections, bacterial layer on skin, lung bacterial biofilms, medical implants), form on medical devices and cause infections (catheters, medical equipment, wound dressings).

Biofilms cause well over a billion dollars' worth of damage every year in industrial settings, affecting human health and companies' abilities to manufacture their products efficiently

CBE, Montana State University

How does printing biofilms help the industry and end-user clients?

With respect to the detrimental biofilms, Biolink binds together biofilms, forming 3D shapes on which removal products are tested. Printed biofilms are very reproducible, thus more similar to each other than grown biofilms, making biofilm removal results more reliable. Moreover, automation makes the biofilm formation process more controllable, thereby increasing efficiency of testing. In short, production costs decrease and product effectiveness increases.

On the client side, thorough testing of biofilm removal products increases their safety and reliability. People are interested in efficiently removing detrimental biofilms, but are equally (if not more) concerned of negative side effects that may appear. Moreover, cost advantage for production companies can translate in either lower prices for customers, or higher quality of products through re-investment and innovation.

Concerning beneficial biofilms, we plan to expand in this field in the future. With cell-immobilization, the bioprinter could form several layers of different cells that through interaction, produce useful compounds. Biofilms can also be formed out of beneficial bacteria on 3D structures or on surfaces (filters, pipes, etc) for creating protective layers.

Industry Analysis (Abrams, 2003)

This section sets the industrial network in which our project operates as a business. An overview of potential customers, supply chain, competition, and industrial trends is shown.

Industry network description

Our Business Sector: Service & Manufacturing of Biofilms

Our Market Segment (by Technology): Biological Components and Integrated Systems (Transparency, 2015).

1. Potential Customers:

a. Health & Personal care companies (Colgate-Palmolive) - dental surface biofilm removal

b. Pharmaceutical companies

c. Biofilm removal and treatment companies (TACT Engineering)

- Removal of biofilm from air ventilation systems

- Removal from water/wastewater systems

- Removal from industrial pipes, containers, reactors, etc.

d. Biofilm research facilities (University of Copenhagen Biofilm Test Facility)

e. Antibacterial product testing companies (Innovotech)

2. Suppliers, Distributors, Sales

- 3D printer companies (UltiMaker)

- TU Delft research network (Industrial Design for 3D printing expertise and Life Sciences for Synthetic Biology purposes).

- Biofilm material providers (Bacteria providers)

- Biofilm research groups (Copenhagen University Biofilm Test Facility)

3. Competitors

There are some scientific publications where bacteria are 3D printed, with the purpose of studying bacterial colony behaviour and antibiotic resistance. (Connell, 2013). However, to our knowledge, this idea has not been commercialised. In addition, our ideas on applications are novel.

Nevertheless, there are multiple potential threatening companies or groups that could compete with us:

- Biofilm research institutes.

- Biofilm testing facilities.

- Industrial Biofilm removal companies.

- Healthcare/Pharmaceutical producers preventing or treating biofilms (such as plaque).

- 3D Bioprinter companies (printing human tissue or organs).

4. Similar products.

- 3D organ and tissue bioprinters.

5. Potential investors

- TU Delft Incubator: YES! Delft is a TU Delft supported organization that offers advice and space for starting a company. They also help with a starting loan and establish contact between startups and possible investor network.

- TU Delft research grants are also a viable option, as the project is currently held and supported by the TU Delft Bionanoscience Research Department.

- A corporation or established company interested in our project can invest in co-development. Such a partner/investor that can more easily support costs for perceived future gains.

Trends in industry & Strategic opportunities

Past and future growth of business sector:

- Biotechnology industries are slowly growing again after the downfall of the financial recession.

- Increased number and decreased strictness of FDA approvals in previous years. (Song, 2014)

- Synthetic biology markets are estimated to grow by an average of 33.8% yearly until 2018. (DALLAS, 2014)

Industries of operation: Synthetic biology, Pharmaceutics, Industrial biofilm removal, 3D printing. Each of these industries are either growing or stable, with no apparent threat of disappearing or drastically decreasing in size.

Barriers and Disadvantages of the industrial ecosystem.

Investors have high bargaining power; Because our project combines two relatively new technologies, it can be labeled as a high risk investment. This means that investors will be more reluctant to fund us, or demand high returns to compensate for the high risks.

Client high bargaining power; The nature of our customer intimate strategy implies that we have only a few customers for whom we provide a tailored service. Losing one client poses a high threat to the us, therefore placing our clients in an advantageous negotiating position. However, if we can become indispensable to our clients and difficult to imitate by other companies, the advantage can turn to our side.

Strong potential competition; A significant number of established companies with financial and technological strength can threaten our small business if they replicate our services.

Biotechnology industries historically have long development periods with low returns and tricky product approval cycles. Moreover, research requires high capital investment needs.

Technological Innovation and Adoption Strategy

In this section, we describe how Biolink can grow from idea to service. We describe the innovation process and utilize a strategic analysis tool: Strengths-Weaknesses-Opportunities-Threats (SWOT) Analysis to underline key elements that can help or hinder our technology and its emergence.

Type of Innovation. Biolink aims to improve a technological process by partly changing technology used, thus realizing a Technological Process Innovation. As the improvement builds upon the existing biofilm formation process, without any radical changes, we label it as incremental. The innovation aims to increase productivity and reduce costs of the entire production/research process. We argue that effects are not directly noticeable by biofilm removal products’ end-users.

Innovation Process. Because it involves advanced technologies, innovation will continue in an industrial and/or academic setting. We perceive three main actor groups enabling innovation:

Academia: the foundation of our project. The academic network can provide knowledge and finance to help kick-start and incubate innovation in the beginning. Within a business incubator, our project can reach a mature enough phase to begin industrial development.

Industry: By industry we refer to any industrial sector that utilizes (or is affected by) biofilms in some way relevant to our project. Collaboration with industry provides an application-oriented direction and financial support. Moreover, co-development with a company offers Biolink access to a larger pool of shared resources, and helps distribute risk.

3D printer producers provide us with a necessary enabling technology. We collaborate with them regarding 3D printer technology, integration with biofilm formation and analysing if market requirements can be fulfilled. An alternative to contracting 3D printer producers directly would be including students from Industrial Engineering in our project. Through this faculty within TU Delft, Biolink can gain future employees that could form a 3D printing department within our business, removing the need for external collaboration.

Adoption at organizational level. Following the innovation phase, we plan to market our product to companies with whom co-development was done. Pioneer companies who invested in co-development are best prepared to adopt our solution and continue to support it until it becomes profitable. Successful adoption of the new technology will encourage other companies to consider our services. This offers an incentive for business growth, expanding service breadth (different companies will want customized solutions) and specialization.

The SWOT Analysis highlights what internal and external factors can influence the evolution of Biolink. These factors mostly affect Biolink at strategic level (how the company performs on long term). Strengths and Weaknesses refer to internal characteristics of Biolink as a company and our capabilities of performing operations. Opportunities and Threats are external factors that might influence our progress.

Sales and Marketing Strategy

Sales business model.Biolink provides a full service: 3D-printing tools, set-up of equipment on-premises, training, maintenance and customization based on needs.

Customer intimate competitive strategy. To gain a competitive edge, we cultivate unique relationships with our clients. By providing an end-to-end service to just a few clients (instead of limited services for a large number) we achieve a double effect. First, we retain our clients on long term by gaining their trust and ensuring satisfaction. Second, the customer intimate strategy and high customizability offered will be difficult to imitate by competitors. (Treacy, 1997)

To achieve positive market results with this strategy we plan the following:

- openly communicate with clients to increase service efficiency and quality.

- offer consultancy on how clients can best fit our solution to their processes.

- invest in R&D improvements of our core services and for potentially radical changes.

- invest in providing high customizability of services based on customer requirements.

- provide on-premises installation, testing, maintenance and upgrades.

This strategy requires a strong understanding of clients and their processes. It also demands a decentralized company structure that can quickly react to changes in clients’ needs. (Treacy, 1997).

Management and Organizational Structure

We propose an organizational structure based on the iGEM team structure.To provide high quality, specialized and customised services for a small number of clients, we organize as a Holacracy (Robertson, 2007). Similar to the iGEM team structure, a holacratic organization removes hierarchy by distributing responsibility and power across distinct roles.

Just like in iGEM, people are responsible for certain roles (such as R&D, Sales, Customer support, etc.) while also being free to help out in other areas. In this way, employees are involved and responsible, feeling that they drive the company forward by doing what they are best at. People can have several distinct roles and work on several different tasks/projects.

For example, in a 3D printer project specifically designed for a toothpaste manufacturing company, a team of several members with various roles can be assembled to fulfil requirements. Some members are fully dedicated to this project, while others work on it in parallel with different projects. This structure supports high flexibility, reaction and development time, while encouraging innovation and creativity. While teams self-organize, an overview and general direction of projects is given by a broader circle containing the team - instead of exerting authority, it guides teams on the right track.

The holacratic organizational structure is graphically presented below (Robertson, 2007):

Because the holacratic structure involves high employee autonomy, it requires several traits from people working in this system (TheWorkologist, 2015). These traits are similar to the ones identified in freelancers and entrepreneurs:

Self-leadership and motivation

Personal productivity; drive towards efficiency without supervision.

Ambiguity tolerance; Ambiguity is beneficial for fast adaptation to change and creativity but may create confusion and lack of direction.

Psychological capital; the extent to which employees are efficient, optimist, hopeful and enthusiastic about their work.

Regarding our inter-organizational network, we believe that loose connections with industry and academia are appropriate for our type of business. In a loosely coupled network, actors have higher self-determination and are more observant of the environment. Therefore, we can be more adaptable. Because we will be a small, specialized company, we need to keep track of emerging technologies to quickly adopt them. Both size and organizational structure enables us to speculate opportunities and avoid threats faster than large companies. When an opportunity or threat arises, we can seek for help in our network and change certain relationships from loose to strong, until solving the issue.

For example, collaboration with a 3D printer manufacturer would need to be strong in the beginning, until a viable solution is finalized. Afterwards, loose connections with the 3D printing industry would be more beneficial, so we can scan for incremental advancements improving our existing solution.

People are the foundation for growing an idea for any business or project. Our team members’ backgrounds are diverse and can fulfil most of the functions needed to start a business. Strong cohesion of the group is also paramount for success.

Science and technology are most well represented by knowledge of Life Sciences, Chemistry, Biotechnology, Nanobiology, Physics, Biomedical lab-work, Computer Science and Systems Engineering. Each part would contribute to designing and constructing a 3D biofilm printer, programming and testing it, and growing the bio-gel needed for printing various biofilm structures.

Management of Technology expertise broadly covers the areas of entrepreneurship, leadership, management, marketing and business strategy, by working in collaboration with science-oriented team members. Basic Economy and Finance operations can be also covered temporarily until an accountant is hired.

Positive team dynamics is key to a successful project. After more than half a year of working and spending time together, we made an idea of how to combine our strengths and minimize our weaknesses. Because we have team members with both strong and no biotechnology backgrounds, we exercised science communication - an essential part in developing our project such that its usefulness is understood to non-scientific stakeholders. After practicing this type of communication in the team, we are better prepared to achieve impacting outreach efforts.

Building consensus. Successful science communication helps in building consensus between members with different backgrounds. In our case, while some team members support the usefulness and marketability of the solution, others ensure scientific soundness and validity. Productive conflicts that occur shape our project into something meaningful from several different perspectives.

Project limitations and acknowledgements

We acknowledge the limitations of our current team and project structure. First of all, for both cases of future failure or success, the structure and strategy of the company would need to be revised and adapted. Because prediction is nearly impossible, we acknowledge that the proposals in the business plan fit the present, but are fully subject to change depending on the evolution of events.

We identify some of the limitations that may hinder future business development.

For constructing the printer, we lack electronic, mechanical and industrial designers. This problem can be mitigated by co-developing the 3D printer with an external company or collaborating with Industrial Design within TU Delft.

We have limited work experience in business and industrial setting.

As students, our knowledge and professional network is still in development. Despite our large academic network (TU Delft, other iGEM teams, supporting organizations, etc.), our ties with industry are still thin. However, with networking efforts, this downside can be reduced during, and after starting the business.

Back to Top

@@ Line 358: / Line 358: @@
          <p class="lead">Synthetic biology is a technology not readily accepted by the public. Due to unknown implications, people have to have the feeling the benefits are worth the risks in order to accept the technology. Therefore, the Biolink Policy and Practice tool
            provides you a list of statements that any person of your choice can evaluate. Based on the results you can conclude what kind of aspects of your project people are willing to accept (that they evaluate as having a low risk) and what they refuse.
-           For this part we considered the <b>socio-technical<b>, <b>socio-economical</b> and the <b>market performance</b> to be important.</p>
+           For this part we considered the <b>socio-technical</b>, <b>socio-economical</b> and the <b>market performance</b> to be important.</p>
          <p class="lead"><i>Socio-technical</i></p>
          <p class="lead">This cluster is about how technical details and performance of your project integrate to socially important aspects.</p>
@@ Line 442: / Line 442: @@
      <div id="tool_collapse4" class="panel-collapse collapse" role="tabpanel" aria-labelledby="tool_heading4">
        <div class="panel-body">
-        <h2>Results</h2>
          <p class="lead"><i>Project Management</i></p>
          <p class="lead">Three of our team members did test the tool when it was finished. The results are showed below.</p>

Difference between revisions of "Team:TU Delft/Practices"

Revision as of 13:46, 16 September 2015

Policy and Practice

Overview

Regulations

Synthetic Biology & Biolink: Risks and ethical aspects

Biosecurity and Intellectual Property Rights

Biolink: risks and ethical issues

Experts' Opinions

Data collection

Interesting Findings

The iGEM Community

iGEM Berlin

KU Leuven

Biolink Policy and Practice Tool

Design of the Biolink Policy and Practice Tool

Design of the Biolink Policy and Practice Tool

Application

Application

Project Management

Project Management

Results

Outreach

A Day of Wonder

Description of the event

Our stand

Activities

Winner of the contest

Bio3Dimensions Business Case

Bio3Dimensions – Business Case

Group Ideas

Wrap-up

Synthetic biology in action

iGEM teams and related discussions

Drinks and acknowledgements

Science Center

Business Plan

How to Write a Business Plan

Start with target audience

Structure the Business Plan

Use business theory and concepts

Identify and fulfill audience expectations

Combine theory and practice within structure

Final thoughts

Biolink - Business Plan

Executive Summary

Company and Project Description

Project description - Why biofilm printing?

Industry Analysis (Abrams, 2003)

Technological Innovation and Adoption Strategy

Sales and Marketing Strategy

Management and Organizational Structure

References

Bio³Dimensions Business Case

Bio³Dimensions – Business Case