Why Access to the US Market is Key for Medical Device Manufacturers

Access to the American market can open up new opportunities for overseas medical device manufacturers.

According to a report by Grand View Research, the U.S. medical device market is estimated to be worth $177 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 5.4% from 2022 to 2029.

The combination of market size and growth makes the U.S. a desirable country for device manufacturers worldwide to target. However, there are several factors to consider before getting started.

US Market Access

Regulations for device manufacturers

The U.S. is a highly regulated market for medical devices. Various laws determine which devices can be used in the country and how. Medical device manufacturers must comply with these rules to ensure their products are effective and safe for patients.

Competitive landscape

With a vibrant and competitive medical device industry, the U.S. has plenty of prominent players competing for market share. The biggest companies are all vying for leadership positions, with acquisitions regularly being made to bolster market share.

New products are regularly launched, with heavy R&D activity fueling innovations and technological advances.

Current trends in the medical device industry

Many forces impact the medical device industry in the United States, including:
  • Demand for innovative new products and services
  • Increasing lifestyle-related diseases
  • The need to adapt to regulatory changes
  • Mounting pressure to enhance efficiency and reduce costs
These high-level trends are a few factors underpinning the rising demand for medical devices in U.S. medical institutions.

Benefits of selling medical devices in the US (for manufacturers)

Gaining distribution and a sales force in the U.S. should be a top priority for overseas medical device manufacturers. Here are a few reasons why this is the case.

Large market size

According to the U.S. Department of Commerce, the U.S. is the largest medical device market in the world, with a value of over $180 billion in 2020.

Stable regulatory environment

Regulations governing medical devices in the U.S. are transparent and established. For overseas manufacturers, this makes it worth going through the challenge of getting acceptance for a given device.

Culture of innovation and investment

Many resources are available for global medical device manufacturers in the US. Manufacturers can find everything from R&D facilities, universities, venture capital firms, and talent in America. These all play a crucial role in bringing innovations to market.

Patient-driven, high-quality healthcare system

The medical system in the U.S. is world-class. With a strong focus on patient outcomes, medical institutions are open to hearing about technologies that can improve efficiency, enhance ergonomics, and create a better patient experience.

The opportunity for overseas medical device manufacturers

Many medical institutions, including hospitals and clinics, must innovate to reduce inefficiency. Upgrading to the latest technology is one way to achieve this goal.

Manufacturers from around the world who can present technology that solves the biggest challenges facing American medical institutions have a compelling opportunity in front of them.

There are, however, a few challenges with expanding into the U.S. market for overseas medical device manufacturers.

Obstacles facing device manufacturers outside of America

Aside from overcoming regulatory hurdles, building sales channels must often be done from scratch. Without an office, physical presence, or “boots on the ground,” it can take months—if not years—to gain the trust of key decision-makers.

IML: your solution for accessing the US market

We source and import the world’s most innovative medical devices from leading manufacturers across the globe. Our network of dealer partners then sells your devices to U.S. hospitals, clinics, and other medical institutions on your behalf.

By partnering with IML, medical device manufacturers can save time, increase go-to-market speed, and streamline their sales process.

Becoming an IML manufacturer partner

Are you a medical device manufacturer that wants to expand into the U.S. market? If this sounds like you, get in touch, and a leader on our team will gladly answer your questions and address any concerns you may have.