Theresa
Rambaran
*a and
Romana
Schirhagl
b
aDepartment of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, 90187 Umeå, Sweden. E-mail: theresa.rambaran@gmail.com
bDepartment of Biomedical Engineering, University Medical Center Groningen, Groningen University, Antonius Deusinglaan 1, 9713AW Groningen, The Netherlands
First published on 1st August 2022
Nanotechnology holds great promise and is hyped by many as the next industrial evolution. Medicine, food and cosmetics, agriculture and environmental health, and technology industries already profit from nanotechnology innovations and their influence is expected to increase drastically in the near future. However, there are also many challenges that need to be overcome to bring a nanotechnological product or business to the market. In this article we discuss current examples of nanotechnology that have been successfully introduced in the market and their relevance and geographical spread. We then discuss different partners for scientists and their role in the commercialization process. Finally, we review the different steps it takes to bring a nanotechnology to the market, highlight the many difficulties related to these steps, and provide a roadmap for the journey from lab to industry which can be beneficial to researchers.
All inhabited continents are represented among the top countries involved in scientific publishing; however, only Europe (14 countries), Asia (8 countries), North America (2 countries), and Oceania (1 country) are included among the top 25 countries involved in the patenting of nanotechnology developments. Seventeen countries were common factors among both publishing and patenting discoveries. It is also noteworthy that the two countries that had the highest investments in scientific research (China and The USA) produced highest numbers of publications and patents, respectively. Patents can be used as technological indicators as they provide an insight into the research and development activities that are intended for commercial gain.12 The transfer of these nanotechnology advancements to commercialized end products is however a major challenge that the scientific community faces. However, it has to be noted here that there are also quite some differences in culture when it comes to patenting. There are differences between countries in how buerocratic the patent process is. Additionally, there are differences in how much is patented at all. In some cultures, it might be more common to keep innovation a secret than to patent. There are also differences in how patents are made. In some places there is a high number of smaller patents while in others there are a few more elaborate ones.
Company | Operationa | Country |
---|---|---|
a Operations listed might not be exhaustive. | ||
3M | Manufactures numerous nanomaterials | USA |
Advanced Material Development | Develops 2D nanotechnologies and metamaterial systems | UK |
Applied Graphene Materials | Develops and applies graphene nanoplatelet dispersions | UK |
BNNano, Inc. | Manufactures boron nitride nanotubes (NanoBarbs™) | USA |
CelluForce | Produces a form of cellulose nanocrystals (CelluForce NCC™) | Canada |
Cerion | Manufactures metal, metal oxide, and ceramic nanomaterials | USA |
INNOVNANO | Manufactures ultra-fine nanostructured ceramic powders | Portugal |
Nanogap | Manufactures novel nanomaterials from atomic quantum clusters | Spain |
Nanomakers | Develops and commercializes nanoparticles of silicon carbide | France |
OCSiAl Luxembourg | Produces graphene nanotubes | Luxembourg |
RAS AG | Produces and distributes of nanomaterials | Germany |
Rezenerate NanoFacial | Develops nanofacials using innovative devices for cosmetics delivery | USA |
Superbranche | Develops functionalized metallic oxide nanoparticles | France |
Zeon Corporation | Manufactures single-walled carbon nanotube | Japan |
INNOVNANO | Manufactures ultra-fine nanostructured ceramic powders | Portugal |
Nanogap | Manufactures novel nanomaterials from atomic quantum clusters | Spain |
Nanomakers | Develops and commercializes nanoparticles of silicon carbide | France |
OCSiAl Luxembourg | Produces graphene nanotubes | Luxembourg |
RAS AG | Produces and distributes of nanomaterials | Germany |
Rezenerate NanoFacial | Develops nanofacials using innovative devices for cosmetics delivery | USA |
Superbranche | Develops functionalized metallic oxide nanoparticles | France |
Zeon Corporation | Manufactures single-walled carbon nanotube | Japan |
These two approaches show how innovation relies on technology seeds and market needs. One might ponder which of the two approaches is better. There are both merits and challenges associated with each approach. While each can lead to innovation, a pairing of the two is recommended. When closely integrated, the potential impact of the innovation increases. This synchronization of the ‘seed’ and ‘need’ approaches is called accelerated innovation. It enables the restructuring of research and development, and innovation processes to make new product development dramatically faster and less costly.15 Furthermore, it also facilitates functional thinking and exaptation where the latter refers to the discovery of unintended functions for technologies. Altogether creating the ideal conditions for researchers to make radical innovations and bridge the gap between academia and industry.
Breakthrough technologies, especially those incorporating the use of nanotechnology, are intended to create value. Value is created via this technology when there is meaningful performance improvement or when the cost of solving problems is significantly reduced. There is however a major challenge for nanotechnology innovations in terms of a business model, and that is, the challenge of taking the product to customers. Several factors can influence this (for example, having limited resources) and for this reason, a go-to-market strategy is critical.
A joint-development partnership is an agreement between two organizations to develop a new product or service. It is a strategic alliance that serves to leverage the assets of each company to create a new offering for commercialization that would be difficult to achieve individually. This type of partnership is commonly used for product development or beta testing. Typically, these agreements are not binding and one party can quit at any time. Profits, access, expenses, and losses are usually shared between the companies. With this type of business partnership, it is important to have a close business relationship with the company before engaging in this agreement. As is the case with licensing arrangements, the most ideal joint-development partnership can be determined with the assistance of an attorney. Matters relating to the ownership and access to intellectual property, responsibilities, disengagement, and termination are some of the issues to be discussed with a suitable attorney before engaging a potential partner.
In partnerships, securing intellectual property early remains crucial. In an innovative nanotechnology business, the science underpinning the technology is critical and must be protected. This can be achieved by engaging an intellectual property counsel. The services of a corporate counsel should also be acquired early to ensure the start-up is properly incorporated. These parties should be appointed at the early stages as they help with structuring the company. The technology transfer process which is discussed in Section 3.3 helps to get these counsels on board.
There are some key players that are needed to guarantee a good business model and these are outlined in Fig. 4. To assure a diversity of skills that are necessary for success, an often overlooked group of individuals is needed. This is a company board. This can include a board of advisors and a board of directors. The functions of these two bodies bear some similarities and differences. The board of advisors is composed of business professionals who fill skill and expertise gaps and can offer guidance to the management team. This can include matters concerning business performance, market trends, long-term goals of the company, and financing to name a few. While the additional skill set required in a science-based industry might be in business management, it is not unusual for additional technical expertise to be warranted. This can include the skills of fellow scientists who have had prior success in transitioning science to the marketplace. These scientists, when recruited, could form a scientific or technical advisory board. Regardless of the composition of the advisory board, their core function is to provide non-binding strategic advice. Their role is not fiduciary. This means that the team of experts and community leaders has no legal responsibility to the company. Their role however remains critical as they can compensate for some of the weaknesses within the management team and bring different opinions, perspectives, and experiences to the table. The board of advisors is particularly helpful for start-ups. A board of directors, on the other hand, is essentially a panel of people elected or appointed to represent shareholders. They oversee the activities of the company and have a fiduciary responsibility to represent and protect the members' or investors' interests in the company. The management team however reports to the board of directors. Larger companies that will require significant funding need a board of directors. Both the boards of advisors and directors can assist with strategic planning, the development of new ideas, improvement of management structure, improving company image and reputation, reassuring stakeholders and investors, and overall, help to ensure the success of the company.
The management team and the company board can together decide on the most suitable business model for the company. In making this decision, special focus should be placed on the model that will create and deliver great value to customers while simultaneously delivering great margins. The model should also hedge against customer dissatisfaction or dissonance and issues securing adequate funding. While the team is now multifaceted, additional support to make the right decisions that will position the company for success can be sought. This can be achieved using accelerators and incubators (which might be available within the university or municipality), government agencies such as the local chamber of commerce, and small business and technology development centers. Start-ups are generally encouraged to not employ at the early stages and to instead contract personnel for specific functions if necessary.
The efficiency of the transfer of nanotechnology innovations from the lab to the industry is dependent on the efficacy of the technology transfer process. Countries that invest in improving nanotechnology transfer policies and practices have greater nanotechnology outputs. This is evident in the United States where the National Nanotechnology Initiative (NNI) was developed. It is a collaboration of federal departments and agencies with interests in nanotechnology research, development, and commercialization.17 Within the NNI are agencies such as the Nano manufacturing and Small Business Innovation Research (SBIR) programs, and the NNI's National Nanotechnology Coordination Office (NNCO) that are concerned with the transfer of newly developed nanotechnologies into products for commercial use. In Asia, there has been an increase in expenditure towards nanotechnology research and deliberate efforts to transfer research findings to industries. While the production of nanotechnology publications in China is higher than in other countries (Fig. 2a), the transfer of these technologies to industries is not equivalent.18 The National Steering Committee for Nanoscience and Nanotechnology (NSCNN) was established to oversee and coordinate nanotechnology policies and programs in China. Some key members of this group include the Chinese Academy of Sciences (CAS), the National Natural Science Foundation of China (NSFC), the National Development and Reform Commission (NDRC), and the Chinese Academy of Engineering. These agencies are expected to impact the technology transfer process within the country.
The success of the transfer of technology in The United States reveals that more favorable environments for nanotechnology transfer need to be created globally. This will create a stronger ecosystem for nanotechnology research and innovation, and in turn, result in greater success in the use of intellectual property to facilitate the creation of start-ups formed from the ground up or through partnerships. Some nanotechnology and nano-engineering associations across the world that can be modelled in other countries to positively impact the transfer of technology are outlined in Table 2. These associations were selected from the Nanotechnology 2020 Market Analysis.9
Association | Country |
---|---|
Alliance for Nanotechnology in Cancer | USA |
American National Standards Institute Nanotechnology Panel | USA |
Centre for Nano and Soft Matter Sciences | India |
Collaborative Centre for Applied Nanotechnology | Ireland |
Indian Association for the Cultivation of Science | India |
Iranian Nanotechnology Laboratory Network | Iran |
Nano Medicine Roadmap Initiative | USA |
National Cancer Institute | USA |
National Institutes of Health | USA |
National Research Council Nanotechnology Research Centre | Canada |
Russian Nanotechnology Corporation | Russia |
S.N. Bose national Centre for Basic Sciences | India |
Waterloo Institute for Nanotechnology | Canada |
Technology readiness evaluates the technology itself and seeks to determine if the technology will maintain itself in the market. This is usually determined by performing a technology readiness assessment (TRA). It is recommended that this TRA is done at several points during the ‘life cycle’ of the new technology or system. Possible components of this assessment include an evaluation of the conceptual design, a clear protocol to facilitate a decision from among several competing design options, and similarly, a defined approach to decide when to begin full-scale development. These decisions might be made by the research team or they can be more complex and warrant an external, independent peer-review process.20 Market readiness assesses how marketable the technology is; that is, how well the technology will be accepted by the target market. This is generally done by examining whether the technology offers meaningful identifiable and quantifiable benefits, has distinct advantages over competing products, has access to a market of a suitable size that is defined and is growing (demand-based), has immediate market uses, and has feasible manufacturing requirements.21
The commercialization readiness assessment also evaluates the readiness of the technology's business model. This is done to verify the stability and readiness of the foundation upon which the technology will be delivered. Within this component, parameters for assessment include determining whether prospective licensees are identified, if industry contacts are available, and if further development or patenting is possible based on the availability of financial support for the licensee. Additionally, anticipated future royalty revenue of the license, access to venture capital, a profitable investment, and availability of government support for additional development for innovations resulting from universities are also crucial.22 The last key area is management readiness which assesses the readiness of the management team that is responsible for the technology. It addresses matters such as the ability of the inventor to champion the innovation as a team player, whether the inventor's expectations for success are realistic, if the inventor is recognized and reputable in the field, if commercialization skills such as sales and marketing skills are available, whether management capabilities are available, and also whether the inventor is the patent holder for innovations resulting from government labs.23
A method of quantifying the judgments made for each criterion of the four areas of the Cloverleaf framework to determine the degree to which each condition is met was suggested.19 If all components of the criteria list for the four ‘leaves’ assessing readiness are satisfied, then the technology is ready for commercialization. If a partnership agreement is being utilized, some components should be completed before engaging a partner and others should be finalized with the partner. Regardless of the business model, if any area is found lacking, additional preparation is warranted to ensure the success of the venture when it enters the market.
Alternative to the Cloverleaf framework is the Technology Readiness Levels (TRL) model. This was developed by NASA and is a type of measurement system that is used to permit more effective assessment and communication regarding the maturity of new technologies.20 The different levels of the framework are outlined in Fig. 6. There are nine technology readiness levels. A project is evaluated against the parameters for each technology level and is then assigned a TRL rating based on its progress. TRL 1 is the lowest level and indicates that a technology requires further research and development, and testing. TRL 9 is the highest level and signifies a mature technology that is proven to work and may be put into use and commercialized.
Fig. 7 Phases of a company's growth (a), (b) and the different funding instruments that are available at the different stages (c).24 |
Another type of capital provider is venture capitalists. These private investors provide funds to early-stage companies that are pursuing big opportunities with high growth potential. Venture capital firms exchange capital for equity ownership and can also provide strategic assistance, and an invaluable network. To capture the interest of a venture capitalist, a start-up should have a good “elevator pitch” and a strong investor pitch deck for their innovative product. This should therefore include the strength of the management team and clearly outline the large potential market for the nanotechnology innovation, and a unique product or service with a strong competitive advantage. Another entity that can provide financing and has a similar structure to a venture capital firm is a family office. This is a special investment firm that manages the wealth owned by individuals and families with a high net worth.26 Family offices make optimal investors and are increasingly entering venture investment as a relatively new capital provider. They are comprised of qualified professionals with extensive experience and tend to offer more patient capital and expect lower returns than traditional investors.
Fig. 8 Summary of start-up lifetime and the most common reasons for failure. Adapted from Cantamessa et al. with permissions from MDPI.25 |
Biological or environmental challenges are other factors that can impede the transfer of nanotechnology from the lab to the industry. Biological challenges include insufficient knowledge involving the interaction of nanomaterials in vitro and in vivo, inadequate information on their bioaccumulation in target organs, tissues, and cells, and also limited information on their biocompatibility.30,31 Physical properties such as particle size, composition, surface area, surface charge, surface chemistry, and agglomeration state all influence the biocompatibility of nanomaterials and so more information is needed on their safety in vivo.31 Environmental challenges include nanomaterials entering the environment either directly or indirectly (for example, via landfills). Nanomaterials can have potentially adverse effects on natural systems and can enter the environment at different stages of their life cycle. Three emission scenarios that are generally of relevance are (i) release during the production of various nanotechnology products or nano-enabled products; (ii) release during use; and (iii) release after disposal.32 While present in the environment, nanomaterials can then undergo many transformations. These include chemical transformations (for example, photo-degradation), physical transformations (such as aggregation), biologically-mediated transformations (for instance, redox reactions in biological systems), and interactions with macromolecules (for example, flocculation).30 The interplay between these transformations and the transport of the nanomaterial within the ecosystem ultimately determine their fate and ecotoxicity.
Possible biological and environmental impacts of nanotechnology innovations should be determined with in vitro and in vivo models, as well as within aquatic and terrestrial ecosystems. The production process from which the nanomaterial results should also be considered so that any such material emitted during this time or released from nano-enabled devices during their fabrication, use, recycling or disposal can be studied and minimized. Biological and environmental challenges can also be mitigated by providing employers and the extended workforce with information on the potential toxicity of nanomaterials at different stages of their life cycle. With the help of modelling, recent developments have been geared towards predicting the fate, behavior, and concentration of nanomaterials in the environment.33 While these simulations can be helpful, more efficient and reliable analytical instruments and methods must be developed so that nanomaterials can be satisfactorily characterized and quantified, and the necessary tools developed to detect, monitor and track them in biological media and complex environmental matrixes.
The nanotechnology industry plays a major role in economic development; however, several economic challenges can hinder the transfer of innovations from the lab to the industry. Generally, these include limited investment in relevant research and development activities and a lack of appropriate mechanisms to secure these investments, lack of laboratory equipment and appropriate infrastructure to facilitate research and its commercialization, and insufficient funding opportunities to engage in research that has the potential for commercialization. Constraints imposed on the activities needed to commercialize nanotechnology outputs are also impacted by the socio-economic dynamics of innovation. While many believe the rapid growth in nanotechnology will have significant economic benefits, some advocate to reduce or halt its development. The backlash against nanotechnology by this group is based on the belief that it will exacerbate problems concerning existing socio-economic inequity and power imbalance caused by inequality. This, they suggest, will cause a nano-divide which refers to differing access to nanotechnology between low-, middle-, and high-income countries.34,35 The ethical criticism is mainly concerned with inequity based on where knowledge is developed and retained and a country's capacity to engage in these processes.35 An attempt to combat these challenges is outlined in the European Union's Framework Programs through the Responsible Research and Innovation (RRI) approach. This approach ‘anticipates and assesses potential implications and societal expectations concerning research and innovation, intending to foster the design of inclusive and sustainable research and innovation’ (https://ec.europa.eu). These measures which are intended to facilitate broader access to nano-technology and its innovations globally are critical in addressing a nano-divide.
The final category of challenges that can significantly impact the transfer of nanotechnology from the lab to the industry is regulatory challenges. These are concerned with a lack of clear regulatory guidelines for nanotechnology and nanotechnology-enabled products. Some regulatory challenges include inadequate policies to foster the development and operation of nanotechnology businesses or insufficient strategies implemented by governments to attract nanotechnology business initiatives. Additionally, a lack of technology transfer protocols, or requisites for regulatory approvals to facilitate the movement of innovation from the lab to commercial products are problematic.36 The multidisciplinary nature of nanotechnology also presents regulatory challenges. With its cross-industry applications, policing and enforcement nanotechnology patents have proven to be prohibitively expensive (WIPO, 2011). New intellectual property practices and protocols are therefore required to simplify the pathway from lab to industry thereby reducing time and expense.
The technical, biological, environmental, economic, and regulatory challenges of nanotechnology need to be addressed urgently. Policies governing all aspects of nanotechnology research and subsequent commercialization must balance its potential benefits with its current challenges. Combatting these challenges will require considerable efforts to prevent any possible harmful effects of nanotechnology while also facilitating the awareness of its benefits to society.37 The involvement of scientific, governmental, industry, and labor force representatives is therefore critical in decision making so the challenges associated with the commercialization of nanotechnology can be controlled, minimized or mitigated.
The necessary risk assessment to understand the potentially harmful effects of products resulting from nanotechnology have however not kept pace with their proliferation; and researchers are racing to address this knowledge gap.38 Companies resulting from the transfer of nanotechnology innovations from the lab to the marketplace must therefore have rigorous risk management protocols where risks are identified, control measures are planned and implemented, and risks communication.37 Identified regulatory impediments should also be addressed and technology transfer policies and practices implemented. Entrepreneurial education and training, and the establishment of business incubators should also be supported within the necessary departments or research institutes. Improvement in the understanding of nanotechnology within society would also help commercialization efforts. Overall, societal actors such as researchers, policymakers, investors, citizens etc. must work together during the research and commercialization stages so that the many benefits of nanotechnology outputs can be aligned with the needs and expectations of society.
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