Samenvatting

This research paper was written for [Company] which is a start-up company from Delft, The Netherlands. [Company] has developed an innovative new product in the MedTech industry which uses robotics and AI to deliver an autonomous Transthoracic Echocardiogram (an ultrasound scan of the heart).

[Company] is looking to enter the USA healthcare market and understand the healthcare environment to build an effective marketing strategy. The Central Research Question for this report is:
“What is an effective marketing strategy for [Company] to enter the USA healthcare market to provide autonomous cardiac ultrasounds in Q4-2026?”

There are six sub-questions that it will help to answer the central research question. The report is structured into the main themes of understanding the healthcare environment, looking at the market, segmenting and targeting customers, and finally understanding the buying process to deliver strong value propositions. These themes are all explored through desk research and qualitative interviews for primary data.

The desk research showed that to enter the US healthcare market there are regulatory barriers in place which [Company] must go through before being able to market their device. [Company] will need to apply through the 510(k) program as a Type II medical device: Echocardiograph (870.2330). This can be an expensive program, but [Company] can apply for a small business fee reduction to $5,000. The other policy that [Company] needs to have in place to market their product is a reimbursement strategy. This can be a time-consuming process and one that should be started early if new codes are necessary. Despite these barriers, programs such as the Breakthrough Devices Program could help them in entering the US market.

The desk research also showed that particular states are more attractive than others. This paper explored three states, California, Massachusetts, and Michigan. California looks to be the most promising state with a wealth of hospitals and imaging centres to target. Other promising criteria are an aging population, heart disease as the leading cause of death and wealth of VC companies that invest in innovative technology.

Internal interviews were carried out with senior management from [Company]. The findings showed that [Company] is at an important stage in their growth. Some
important findings were:
• The company has a well laid out strategy and has confidence in its progression.
• They are confident they are solving a clear business and societal problem with a clear solution.
• The participants view the team and employees at [Company] as one of the major strengths of the company.
• On the other hand, they also see the near future as a potentially difficult period to recruit and retain the necessary employees.
• As a start-up, investment and cash resources are needed to continue growth, although until now this has not been a significant barrier.
• Sales will become a crucial part of their business in the coming years to start bringing in revenues.

External interviews highlighted how it is important to be a part of the ecosystem of a hospital. Many hospitals are part of a network and targeting these networks could be the best way to get a foothold in the market. Having a champion to promote the product is also an important part of connecting with the US hospital system. Champions can operate and network with the Value Asset Committee and showcase how [Company] product can bring value in the form of operational improvements, money saving and improved patient care.

The conclusions outline an implementation plan for [Company] to apply for Breakthrough Devices Program and FDA 510(k) program. Following the regulatory programs, [Company] need further research to follow this report. Finally, having a champion and salesperson in place within the chosen state of California to start the process of networking with medical facilities. Having this done 6 months before selling at the start of 2027. Selling by Q4 of 2026 may prove to be a little too early for [Company], especially if any delays are encountered during the regulatory process.