Entering the U.S. Healthcare Market

Meeting the Unmet Need

The key to success in U.S. market entry is picking the right commercial partners, says Ernesto Chanona, Director of Business Development at CSSi LifeSciences.

The first half of 2021 saw more investment into the biotechnology sector than all of 2019, Silicon Valley Bank reported.

It remains an excellent time for the life sciences sector. Many seek the necessary steps to enter the U.S. market by obtaining regulatory approval for medical devices, diagnostics, biologics, vaccines or drugs.

Currently, 35% of approved medical devices in the United States, 40% of finished pharmaceutical drugs for the United States, and 80% of APIs (active pharmaceutical ingredients) are manufactured or compounded from foreign entities. 

Success and commercialization are attainable goals for those equipped with a deep understanding of the tedious and costly aspects of entering the U.S. market.

Ill-prepared companies face difficulty crossing the all too well-known valley of death. But as we’ve seen, success is possible. The critical question is where to take the first step to begin your U.S. market entrance journey.

First, companies need to ensure that they are prepared before they take their first step. When entering the U.S. market, foreign companies should spend time on market and revenue research, creating a comprehensive project timeline, and estimating costs. As this process unfolds, there are a few questions to consider:


  • What unmet public need are we solving with this product?
  • Are we planning to launch our product in multiple markets?
  • How much should our product cost in each market?
  • Are we seeking dilutive capital from U.S. investors to support regulatory approval and commercialization?
  • Do I meet all regulations and requirements required by the FDA?
  • How do I establish a business in the U.S.?
  • Who are the stakeholders (economic development, academic, government, services) in our U.S. biotech hub that could support my company and my technology?
Life Science Entrepreneurship

These questions are best answered by a consulting team that has already and repeatedly made this journey and possesses in-depth knowledge of the path ahead.

Picking the right partners is the key to commercial success. That includes whether to out-license or sell a technology, or to find the right distribution partners for entering the hospital supply chains in the U.S. oreign companies looking to enter the U.S. market must designate a United States agent as required by the FDA. They must reside at a U.S. address and act as a liaison between the FDA and the life sciences company. Selecting the right U.S. Agent liaison can best position a company for a swift and cost-effective regulatory approval, The right liaison also provides connectivity to supportive partners and investors and guides the accomplishment of commercialization goals within the allotted timeframe and budget.

In the case of medical device companies, regulatory requirements that need to be met include a Quality Management System that meets U.S. standards, approval through the appropriate filing process with the FDA, and annual reporting and registration. There are four common types of premarket submissions: 510(k) (Premarket Notification), PMA (Premarket Approval), De Novo Classification Request, and HDE (Humanitarian Device Exemption). 

The device regulatory path depends on the case that is made to the FDA. Your regulatory consultant writes and delivers the case to the FDA, and obtains the agency’s buy-in to secure the swiftest, most affordable path forward. Some of the questions they will answer include: 

  • What submission is best for my device?
  • What is the most suitable indication?
  • Is a clinical trial required? How extensive?
  • Are we eligible for any special designations from the FDA?

Investor relations is another critical aspect to successfully commercializing technology in the United States. Finding the group with an investment thesis that aligns with your technology and goals can be challenging. Moreover, understanding the needs of the American investor community is not always straightforward. Investors want to see clearly defined milestones and associated costs. The team should be able to elaborate on the rationale behind the costs assigned to aspects such as manufacturing, FDA submissions, and testing. The timeline for the return on investment also needs clear definition . By understanding your technology and the FDA requirements, your regulatory team can generate this information, further de-risking your technology to investor groups.

With multiple moving pieces to the U.S. market entry process, having a strong team that supports each piece is the key to commercialization success. While the entirety of this process can be overwhelming for companies lacking this specialization , collaboration and partnerships with experienced consultants and organizations can give foreign life sciences companies the counsel and expertise needed to make the journey navigable. Proper guidance makes any FDA entry journey achievable, no matter how challenging.

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