The medical device industry in the United States is expected to reach $208 billion by the year 2023. Americans represent approximately 43% of the worldwide market for this industry. Further, the average American spends about $400 on each medical device they use. As the consumer medical device industry evolves, so does the buying and selling these products.
In addition, the consumer medical device industry is one of the world's most exciting and rapidly growing industries. It's also getting more complicated, with more products on the market than ever and changing regulations requiring manufacturers to adopt new technologies. That makes e-commerce a crucial part of the business model for medical device sellers in 2023.
Ease of access to information, customer service, and product selection are just some things that make e-commerce a vital part of any consumer medical device company's strategy.
What are some examples of medical devices?
Consumer medical devices include things like fitness trackers, smartwatches, blood pressure monitors, and glucose monitors. They are often handheld and portable, making them easy to use on the go.
Medical devices can be simple or complex, but they all have one thing in common: They are used to diagnose, treat, or prevent disease. Medical devices also fall into three categories:
Diagnostic devices (this includes ultrasound machines).
Therapeutic devices (drug delivery syringes and catheters).
Surgical instruments (scalpels and bandages).
How to sell medical devices in the U.S.
Here are the steps you need to take to sell medical devices in the U.S.:
Register with the FDA as an importer or manufacturer (depending on your business model).
Obtain a physical address in the United States that can receive shipments from China and other countries (or have someone at home willing to accept your packages on their doorstep). Remember that if you're selling through Amazon, they will require a valid street address; this means that if you choose to mail from China, it will be difficult for them to accept your products into their warehouse—and as a result, they may not list them for sale on their site either.
Obtain a business license and tax ID number to pay sales tax when needed (or avoid paying taxes altogether).
Open up a business bank account for tax purposes.
How to select a medical device wholesale distributor
Online consumer medical device sales continues to skyrocket as consumers become more comfortable with online purchasing and self-diagnosis.
Medical device distributors are companies that buy and sell medical devices, often through a network of manufacturers, sales representatives, and other wholesalers. If you're interested in becoming a distributor for the company you're working with, there are several things to consider:
What kind of products do they distribute? Is it something you can handle?
Do they have a license to distribute these products? Will they be able to provide documentation if necessary?
Are there any restrictions on who can sell their products (only U.S.-based companies)?
Once you've gone through this process and determined that your new partner is willing to work with you as a medical device distributor—and they've also cleared all legal hurdles—you'll need to take care of some administrative tasks before launching your online store.
What do I need to start a medical device e-commerce store?
To start a medical device e-commerce store, you need the following:
A website that can be accessed from mobile phones and tablets.
Payment processing services for credit cards, PayPal, Apple Pay, and more.
Suppliers of the products you want to sell online.
An e-commerce platform (like Shopify or Magento) from which to run your store. You'll also need an SSL certificate to sell medical devices online.
Do you need a license to sell medical devices?
Products that reduce medical costs and improve patient care are a big business for e-commerce sites.
While no federal regulations mandate a license to sell medical devices, at the state level, you may be required to obtain a medical device license depending on the type of product you want to sell.
For example, to sell diagnostic or radiation-emitting products in California, you must apply for and receive a certificate from the California Department of Public Health (CDPH).
Keep reading with a 7-day free trial
Subscribe to BowTiedParrotFish’s Newsletter to keep reading this post and get 7 days of free access to the full post archives.