Considerations When Bringing Your Medical Device, Biotech, or Healthcare Startup to the US

By |Published On: January 10, 2024|

When you have an incredible innovation and a booming business abroad, it’s time to start thinking about taking the next big leap. For many startups that means bringing your medical device, biotech, or healthcare company to the US market. The prospect of limitless opportunity in the hub of innovation sounds promising, but achieving that dream is no easy feat. However, taking your startup to the next level and bringing your life-changing technology into hands that need it is well worth the many considerations and challenges that come along with it. Between medical device risk management, healthcare regulatory compliance, strategically selecting a location, providing world-class service, and many other factors, you’ll need all the information you can get your hands on to make sure your expansion runs smoothly.

As Founder and CEO of Preferred Depot, the premier white label operations management and consulting partner for medical device, biotech, and healthcare companies launching and growing in the US, understanding all of these considerations is central to my role. So, to help international startups successfully bring their companies to the land of seemingly boundless growth, I am providing several of the most key factors that companies in the medical technology and healthcare industries should be aware of before starting their startup’s hop across the pond or over the sea.

Risks and Compliance

When you work in the health and medical industries, there are a lot of people counting on the quality and efficacy of your products. That is why the US takes healthcare, biotech, and medical device risk management so seriously. Understanding industry rules, regulations, and labor laws is absolutely crucial to keeping your business afloat in the US. While it is ideal to assess all of these aspects before you make the move, risk management and healthcare regulatory compliance can be especially challenging to navigate for foreign companies. Even more, slipping up with these key elements is often detrimental to a business in this industry. Because of this, I always recommend working with an operations management team or startup consulting expert that specializes in operations. Teams like the skilled staff we have at Preferred Depot exist to make sure your operations are above board for your success, safety, and peace of mind.

Service Strategy

When bringing your startup to a new country, especially the US, you have to understand the culture of the new location and its people in order to be successful. That means prioritizing excellent customer service and hiring top talent to build trust and loyalty among your customers. Your employees and customer support team need to really understand the product, the local market, and how to speak to Americans. Of course, this is because different countries have wildly different cultures when it comes to customer service. The US is known for its customer-first attitude. Hiring the right staff or working with a company that understands this can be essential to forming and retaining a loyal customer base. So, as you move forward with hiring or forming partnerships, look for people that can help your business integrate successfully.

Tech Support

When running a medical device, biotech, or healthcare startup, excellent tech support is absolutely paramount to a successful business. People need to know how to use your products safely and keep them running smoothly. This means you need an incredible tech support team to help with how to use the product, assistance with refurbishing, explanations on proper sterilization, and information on how to deal with hazardous materials. Your tech team needs to understand the product in and out including repair, tools, certificates, traveling with it across the US, importation of spare parts, and even exportation of defective parts to their origin country. Of course all of these factors show that tech support in this industry is far more complex than a few representatives answering phones. So, be sure to find the right people, not necessarily the least expensive people, to run these operations in order to protect your business and the people using your products.


While you might not be making the move to the US for the great weather, it is one of the many plus sides to taking your startup to the west coast. California in particular gives you access to a temperate climate with the best shipping opportunities, access to top investors, proximity to excellent ports with a convenient route to Asia, and a strategic time zone. When deciding on your US location, it is important to consider not just the preferences of your headquarter location abroad, but also who you work with all around the world. Choosing strategically can help you best serve as many aspects of your business as possible especially when it comes to customer service operations. Another consideration that is not to be overlooked is tax advantages. Taxes are based on where your products ship from rather than your office location, so be sure to select both places with intent.


One of the most important and often unforeseen considerations when bringing your startup to the US is whether or not you need to establish a new entity. While it might seem more convenient to avoid it at first look, a company that does not have an entity in the US cannot collect payments from customers. In addition, an entity is covered by insurance. Finally, having an address and phone number in the US can often be crucial to doing business successfully. Handing out business cards or otherwise using a foreign address and phone number can make some potential partners or customers reluctant to work with you out of risk or convenience concerns. Working with a skilled operations management team such as Preferred Depot means that you have a team that can act as a local agent, making this otherwise difficult process harmonious.

At Preferred Depot, our mission is to support medical device, biotech, and healthcare companies looking to launch or grow in the US. We have seen time and time again how important understanding all of the key considerations and preparing for unforeseen challenges can be in helping startups thrive and bring their life-saving tech to the people that need it. That is why Preferred Depot provides startups with an experienced operations management partner that seamlessly and transparently integrates within companies to ensure they approach their operations and business development in the US in the most effective way possible. To learn more about how we can help your startup launch and thrive in the US market, visit us at


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2492 Walnut Avenue,
Suite 120, Tustin, CA 92780

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14331 Chambers Rd.
Tustin, CA 92780