Me-Too Medical Products: How to Avoid the Top Five Mistakes

Let’s say one of your competitors introduces a successful new medical device to the market that would make sense as part of your suite of products. If you’re like most medical device companies, you’re probably tempted to bring your own version of the product to market as quickly as possible in response. The desire to develop so-called “me-too products” makes sense. Gaps in your product lineup don’t just leave money on the table. They can also hurt existing sales by undermining your relationship with customers (such as hospitals) seeking to streamline their procurement efforts.

When medical device companies consider me-too products, they sometimes expect a faster and cheaper development process. After all, there’s already a product with proven success in the marketplace and an existing set of features and functionalities to guide your own product’s development. But me-too products are a lot more complex when they’re medical devices, and assuming a consumer-product mindset is risky when applied to the development of an FDA-regulated product. This misconception can lead to canceled projects, wasted resources, and less-than-stellar products.

These are the most common mistakes that medical device companies make around me-too product development — and how to avoid them.

1. Attempting to reverse-engineer your me-too medical product. 

It can be tempting to try and simply reverse-engineer me-too products by allowing your competitor’s product to lay the groundwork for your own product’s features and specs. But doing so ignores both user needs and the context in which the original product was developed. Mimicking features without validating them can lead you down a development path that doesn’t truly meet your users’ needs or represent the best-fit solution for your specific product.

Even worse, it may lead to a final product that feels inauthentic. When that happens, your product can seem more like a knock-off of your competitor’s device than an original offering intended to solve the same problem in a unique way. Keep in mind that some of your market will already be used to seeing and using your competitor’s product. You want your customers’ first impression of your product to be, “this will be so helpful” — not, “it’s just like the other one.”

Rather than starting with a list of your inspiration product’s features, you should begin the development process as you usually do. That means defining the problem your device is trying to solve for your market and getting to know your users (who they are, why they need your intended device, and how they will use it). Only then can you be sure that your development process is moving in the right direction. Your device may end up having many of the same features as that of your competitor, but you’ll arrive at that place knowing that its properly optimized to meet the needs of your specific market.

Remember: Your main goal in developing any medical device product — even a me-too product — is not simply to grab or defend market share. It’s to create value for your customers and help them improve or maintain their health.

2. Underestimating development and manufacturing costs. 

Medical device companies often attempt to estimate the cost of developing a me-too product based on a thorough examination of the existing product. But this approach inevitably leads to underestimated costs because it fails to account for:

• The complexity of the medical device development process. The more complex the device you are developing, the more expensive and time-consuming your development process will be.

• Product-specific patents that your competitor may hold. When it comes to me-too products, intellectual property (IP) can be a minefield. Without doing thorough research, you can’t know which pieces of your inspiration product are covered by patents and how difficult they might make your own development process. For example, you may find that you need to design new mechanisms just to get around your competitor’s patents. Depending on the amount of IP buffer around your competitor’s product, this can inflate your development costs and timeline significantly.

• Your competitor’s manufacturing efficiency. You can’t know what your competitor is paying to manufacture their product. But it’s safe to assume that the longer their product has been in production and the more volume they are producing, the more efficient they are in their own production costs. You may not be able to effectively compete with their manufacturing costs, at least not at first.

3. Not creating enough original intellectual property to overcome competitive momentum. 

If your product development process is driven by a desire to recreate a competitor’s product, you aren’t operating at your team’s highest level of innovation.

For every product you develop, you ideally want to create enough patent cushion that it becomes challenging for your competitors to catch up and create their own me-too products. Unless you approach your me-too product with the same level of vigor as you would any other product, you’re unlikely to break much new ground with your own version. And that will leave you and your product vulnerable to the other competitors who may decide to follow suit.

4. Not doing due diligence around regulations. 

Especially if your me-too product represents a step into new territory, you’ll want to be sure to do due diligence around any regulations that apply to your product.

Unforeseen regulatory roadblocks can cost you both time and money. The more risk-adjacent your product, the more regulatory bodies you may be subject to (for example, your product may be subject to a hospital’s internal review board before being accepted for clinical trials). Of course, you can’t truly know what will be required of you until you go through the process for the first time. But the more thoroughly you do your homework, the less likely you are to be caught off guard by unpleasant surprises.

5.  Not considering more than just the product. 

You likely need to do more than just develop and manufacture your me-too product for it to truly compete with your competitor’s original offering. Your market offering is more than just the product itself — it’s the full experience that goes with purchasing and using your product. Don’t forget these important elements:

• Training and education. If your competitor’s product has been on the market for 10 years, you’ll need to think through how to teach your market to use your new, similar product. (They already know how to use your competitor’s product and may be disoriented by the differences in your product.)

• Ordering systems. How will your customers order your product? In some cases, in order to truly be competitive, you’ll need to carry the same overall line of products as your competitors in order to satisfy the needs of your customers’ procurement offices.

• Customer assistance and troubleshooting. Your staff must be trained and ready to help customers understand how to use your product and troubleshoot any issues they encounter. When they call your company, will they encounter someone with knowledge at the other end of the line who can help them?

It often makes perfectly good business sense to produce me-too medical devices. But these products should never be mere copies. You must approach their development with care – and the same robust process that you’d apply to any new product. Do that, and you’ll create something that truly stands on its own.