Author : Charlotte Reypens
Publisher :
Page : pages
File Size : 17,74 MB
Release : 2012
Category :
ISBN :
There are many advantages associated with intradermal injections such as increased safety and reduced pain perception. To fully leverage these benefits there is a need to optimize old and new techniques to administer vaccines intradermally. The VAX-ID device will be able to administer several preventive and therapeutic vaccines to children, adults and the elderly at different anatomic sites, e.g. the forearm. The European Union and the United States were chosen as the main target markets. As an introduction, the development process of innovative medical devices is shown to get a general overview of all elements at stake. The scope of the VAX-ID project is limited to the first three steps hereof: from research to pre-market clinical evaluation. The market analysis is the starting point of this thesis. In a next step, the value chain of the device was constructed and adoption factors critical to each player in this chain were identified. Finally, all this information was incorporated in the design of the business model. The market analysis includes an assessment of the competition within the industry by means of Porter's five forces framework and an overview of the external forces that have an impact on the industry by means of a PESTEL analysis. First of all, it became clear that the industry is hard to enter because high invested is required and products are protected by patents. Furthermore, there are several substitutes available in the market, out of which microneedle patches will pose the biggest threat in the future. With respect to the customers, a distinction was made between the direct customers, i.e. the vaccine manufacturers , and the end users, i.e. the healthcare providers and the patients. Both categories have significant power in deciding which devices they use. Therefore, this can also be considered as a threat. As far as the suppliers are concerned, there are high switching costs because they need to live up to high standards, e.g. with respect to sterility. Finally, the industry is characterized by intense rivalry and many companies are active in the intradermal injection market. Regarding the external forces, the political aspect was first of all investigated by looking into the healthcare systems in the European Union and the United States. In both continents, reforms are in order to keep the current policies sustainable, which leads to uncertainty for medical device developers. On an economic level, an unfavorable combination of economic slowdown and rising costs raises the question of who will pay for these expenses. This forces medical device developers to cut costs. With respect to the social aspect, several positive trends were discussed. Firstly, the population is growing bigger and older in the European Union and the United States, leading to more people requiring daily care. Furthermore, due to globalization clinical trials can be outsourced to cheaper destinations. Finally, the immunization policy in the European Union and the United States was examined. From a technological perspective, a culture of innovation is a critical success factor. Open innovation is a crucial element in the medical device industry allowing several parties to openly work together on the development of a new product. Next to this, it can be noted that due to the expansion of the internet and social media, patients are more informed and can be reached through new communication channels. As a medical device developer, it is important to embrace this trend. Lastly, 3D printing is a cost efficient and environmental friendly production technique that holds tremendous opportunities for the medical device industry. As for the ecological aspect, a growing emphasis is put on waste management. Finally, the legal environment can be considered risky since it is highly regulated. Overall, the medical device industry is hard to enter and prosper in. However, the opportunities on the social, technological and ecological level increase the chance of success as long as the threats are properly managed. In a second step, the value chain of the device was constructed in order to get an overview of the adoption factors that are important for all the stakeholders in the chain. The device will reach the healthcare providers through intermediaries (group purchasing organizations, wholesalers...), after which it is used to treat the patients. Apart from this, there are two other important actors in the value chain: the health technology assessment agencies ,that influence legislation and evaluate new technologies, and the insurance agencies that partially or fully reimburse the treatment. For each of these stakeholders, several adoption factors that influence the uptake of the device were identified. First of all, for device developers the legal framework is a determining factor. In this respect, the requirements to obtain market approval were looked into both for the European Union and the United States. The most important implication hereof was that in the European Union devices are often launched first due to less stringent regulations. Moreover, the risk and uncertainty levels of the project influence its chance of success. As a result, it is crucial to perform a thorough risk assessment focused on human blunders. Lastly, from the perspective of medical device developers, including cross-functional expertise and making room for social interactions positively impacts the outcome of the project. For health technology assessment and insurance agencies, the quality of the product plays a crucial role in their decision to adopt the device. To demonstrate the quality of the VAX-ID device, it was benchmarked against several intradermal injection techniques with respect to six criteria. This led to the conclusion that the features "compatibility with the vaccine" and "patient acceptability" should be leveraged as competitive advantages. Apart from the quality of the product, clinical evidence will support the adoption process of the device. As for the healthcare providers, the added value of the product is a significant factor as well as information and follow-up. It appears that when the benefits of an innovation are explicitly communicated to its users during the development process, the probability of adoption increases. Finally, to increase commercialization success it is of vital importance that the technology lives up to the patient's expectations. Human-centered design implies that the design of the device is adapted according to who uses the device and in what context it is used. For the VAX-ID project, many of these aspects were directly incorporated in the development of the device. Finally, the business model canvas tool was used to create the business model for the VAX-ID device. The canvas consists of nine building blocks and shows how value is created with a certain technology. The first part entails the identification of the customer segments. For the VAX-ID device, these are the vaccine manufacturers, healthcare providers and the patients. For each of these segments, a value proposition was formulated. Performance, cost reduction, risk reduction and usability are the main drivers of value with respect to the VAX-ID device. In a next step, the channels through which the customers will be reached were looked at and the relationships that need to be established were determined. If all these aspects match, this will lead to revenue streams. Key resources indicate which issues are necessary to be able to deliver the value proposition. In terms of the VAX-ID project, knowhow, partnerships and intellectual property are essential to reach our goals. After that, the key activities need to be spelled out. Evidentially these cannot be carried out alone, but partnerships are required. The VAX-ID project first and foremost relies on the parties primarily involved in the project. Other than BiR&D and Janssen Pharmaceuticals, we rely on the support of external parties such as patent lawyers and the government. When all these elements are described, the cost structure becomes clear. This way, a comprehensive overview is given on all the essential elements of the project. In the conclusion, all these insights were translated into practical managerial insights and suggestions for future research.