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The immense amount of literature that
imparts knowledge about international market entry mode research (Brouthers and
Hennart, 2007; Weisfelder, 2001; Werner, 2002) shows the broad significance of
choosing the correct market entry mode because it determines the success and
stability of a company’s international operation. it means, one wrong action and
it cannot be  rectify without severe
implications to the firm’s future (Pedersen et al., 2002).The innovations for
specific region and waiting for clients to approach them are a decade back history.
Organizations must realize that their services and products, regardless of how
good they are, simply do not sell themselves (Kotler, 2011).


The interest of study is on high regulated market with
innovative offering by a new entrant and the barriers associated with the entry
in market. As per the research and statistical analysis only a fraction of new
entrants survive after a couple of years of operations, failure rate of new
ventures in first year its self is around 40 percent. up to four year survival
companies are around 50 percent, and mostly less than half cross more than five years (Timmons 1990). Market selection techniques and financial
constraints are the most important factors of failure of new entrants is argued
in a journal by (cabral and mata, 2003). This argument is also supported by
several well-known authors whom mentioned these barriers and several other
barriers are a block for market entry for small scale ventures (Hariharan &
Brush 1999). These researches found also low rate of innovation and high
barriers to entry have a common link, especially in high regulated industries
which results in lower number of entries of ventures (Friedman & Taylor
2011). previous studies also figuring out that high entry barriers have a
strong influence on the industry performance, reducing productivity, employment
and increasing labor costs, decreasing R&D efficiency, hampering innovation
and leading to suboptimal allocation of resources(Cullman & al. 2012).

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From years to years each
researchers depending on industry and regions did researches on different
barriers of market entry and it always varied to each other. Especially for new
innovative startups/ entrants always need to face the heights of barriers
especially in regulated industry. Lately, barriers to entry
have been defined as factors that limit competition by preventing market entry
of new firms and in the process often leading to an increase in the profits of
the established incumbents in the marketplace (Karakaya
2002). There is always also a lack of research on different variables of
barrier of different industries and it affects the new companies who would like
to make their entry. While we talking about high regulated industries these
kind of practical studies of industry are missing and it always stand as high
barrier industry and results in less entrants (Lutz & al. 2010)


study on barriers for each industry are diverse with different factors and more
of its characteristics in the market. While doing the empirical studies the
barriers are totally different in high regulated industries and we need to
consider the characteristics of new startup company, its industry life cycle,
the markets which they intended to entry and also the product specifications.
The new entry companies with new markets in mind need to face no further
experiences of market and financial capital issues. So in this thesis we are
discussing about the new entry company which is specialized in patient care
devices and would like to enter new markets with no further experiences. We are
also discussing about the barriers associated with new markets and how to find
a solution out of it and also proposing a market entry strategy. While talking
about the medical device industry, most of segments are handled by most strong
established, existing and experienced companies in the markets, and the profit
margin associated with these segments are totally diverse from other industries
due to their monopoly, sustainability and wide customer segments. The main
barrier we see in this industry which makes the giant companies stronger and
keep away from new entrants is the high regulated government policies from
different authorities.


In this thesis we analyzing Germany as target
market to entry and thereby in empirical studies we need to analyze the
economic conditions, government policies and medical regulations. The company
is United Kingdom Based new entrant named Diabetic boot co. and they coming
with a unique product with multiple technology which can treat the diabetic
ulcer related issues affected on feet’s and they are trading the product in a
brand name of Pulse Flow DF. The
Diabetic Boot Company has transitioned from a Start up to a trading SME in
2016. The product is belonged to class 2 medical device and its characteristics
and specifications can help to achieve good results in diabetic affected
society. As its coming in high regulated industry, the barriers associated are
unique for patient care device segments. 
We will be interviewing also the industry experts in each countries to
get best analysis and real time scenarios associated with barriers. In this
literature we will be examining the associated barriers for Diabetic Boot
Company to enter the market. And it’s a known fact that strong economic regions
like Germany and Switzerland got very hard regulations for a new company to
start their operations and trade. This literature also providing a potential
solutions to influence the barriers to entry from the point of view of the
entrant and also the government in aiding innovation diffusion in health care
leading to improved social welfare consequences

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