12 Steps to Market Entry
To be able to transform our Gutlux capsule into a marketable product, we have set out a roadmap for market entry with the help of expert Rosa Tengvall, a lead quality engineer at Kasve. The roadmap in Figure 1 illustrates 12 steps to market entry, which are necessary for medical device manufacturers (MDCG, 2019). In addition, we have conducted thorough market analysis to understand the business potential and competition in the field of ingestible devices. We have also researched the existing regulations and legislation to understand the requirements for our product development in the field of medical devices. Detailed information on Medical Device Regulation can be found on Implementation.
Business Strategy Development
To analyze and identify the internal and external factors that affect our project, we conducted a SWOT analysis. SWOT analysis is a method for analysing and identifying the Strengths, Weaknesses, Opportunities and Threats of a plan, project or a business. Through this analysis, we realized that our main weaknesses are our restricted and highly-regulated market segment, capsule safety and recycling as well as financial concerns. As to our strengths, our tool has great potential to expand its application area, and it responds to the lack of competition in the market for ingestible capsules. The high-end nature of our product could also prove to be a strength, as it is developed according to high standards. The results of our analysis are presented in Figure 2 below.
Market and Competitive Analysis
We want to target our GutLux capsule primarily to the Finnish market. To identify the external factors that have an impact on our market entry and position in this market area, we conducted a PESTLE analysis. PESTLE analysis helps us understand our market environment by looking at potential Political, Economic, Social, Technological, Legal and Environmental factors related to our product. The results of our analysis can be found in Figure 3 below. In addition to the external factors in our market area, we need to identify our competitive position within the market segment as well. To achieve this, we have analyzed our competitive environment with Porter’s Five Forces model. The analysis was conducted for the market of ingestible capsule devices, as we do not currently have direct competitors for our product. The competitive analysis results are presented in Figure 4.
Porter's Five Forces Model
Customer and Investor Network
Through our Integrated Human Practices, we have acquired contacts to local research groups and companies in the field. We are also a part of the Finnish network for synthetic biology through our collaboration with SynBio Powerhouse, which brings together researchers, investors and entrepreneurs collectively within Finland. Through these networks, we are connected to our primary market area and have been able to develop our project based on the opinions from potential end users themselves.
In the future and the implementation phase of our project, we would have great possibilities to benefit from this network, as it connects us directly to experts, investors and end-users. This will greatly help our product development, R&D funding and market entry.
1. MDCG 2019-15 rev1: Placing Class I medical devices on the market: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance-manufacturers_en.pdf