Most early-stage MedTech companies tend to focus their efforts on gaining market access. In other words, they want to get FDA approval to market their medical device in the US.
Oftentimes, this means taking the 510(k) regulatory pathway, which allows a manufacturer to enter the US market if they can prove substantial equivalence to a predicate device already on the market. The 510(k) is sometimes called the “me too” pathway because of this reliance on a predicate device.
A 510(k) does not typically require manufacturers to perform clinical trials with their device. Most of the time, proving substantial equivalence with a predicate device is enough to gain FDA approval.
However, just because you don’t need a clinical trial to get your device to market, that doesn’t mean you’ll never need to carry one out. Market access is just the first step. Then you have to get clinicians to actually use your device—and oftentimes that requires clinical evidence.
In this article, I’ll break down why your Class II device may need a clinical investigation and what endpoints you should be looking at as you build your study.
It’s easy for MedTech founders to get caught up in product development. They truly believe in the technology they’re building and they may think that if they can just get it to market, the benefits will be clear and adoption will take care of itself.
Unfortunately, that simply isn’t the case. Remember, if your device has taken the 510(k) pathway to market, that means there is already at least one alternative to the device on the market—the predicate device.
Now, let’s say your device is used during orthopedic surgery; in order to get market adoption, you need to get orthopedic surgeons to start choosing your device. But the predicate device has been on the market for a decade and has a high rate of adoption among surgeons. They know the device and how it functions. And even if the predicate device isn’t perfect in every way, the surgeons understand its limitations and are comfortable using it.
Which leads us to the big question: why would they stop using that existing device and start using yours?
You may know in your bones that your device is better, but without proof, it’s going to be a hard sell. Without clinical evidence to demonstrate the superiority of your device, market access won’t necessarily lead to market adoption.
Market adoption is the reason that a device in the 510(k) pathway may still need a clinical investigation—not to gain market clearance, but to encourage clinician use and secure insurer reimbursement.
I recently spoke with Shaherah Yancy, CEO of Research Lifecycle Solutions, on the Global Medical Device Podcast about clinical evidence and the key role it plays in market adoption. One of Shaherah’s pieces of advice was to start thinking about your regulatory and clinical strategy as early as possible. You don’t want to get market approval from FDA and then realize no one is ready to adopt your device. At that point, you’ll be scrambling to generate the clinical evidence you need—and clinical timelines are always longer than you think.
For MedTech startups, this kind of backtracking can be devastating. The statistics tell us that somewhere around 75% of small medical device companies will fail. If you haven’t planned for clinical investigations, and assumed adoption would happen naturally, then you may not be able to convince investors that another round of funding will pay off for them.
Instead, you need to be thinking about market adoption—and how you’ll drive it—as early as possible. Shaherah pointed out that while many founders get caught up in describing the technology and the benefits of their product, investors are more interested in how you’ll get from A to B. In other words, when you raise this money, what is the step-by-step plan for using it to create market adoption?
If you’re raising money for a clinical investigation, you should be able to talk an investor through the endpoints that you’ll be trying to prove and how a successful study will drive adoption.
So what are the endpoints that will help you gain market adoption for your device? Shaherah urges MedTech companies to think beyond safety and effectiveness. Proving your device is safe and effective is how you gain market access, but it won’t necessarily drive adoption—especially if there are other safe and effective devices on the market.
Instead, look for endpoints that demonstrate benefits to patients, hospitals, and clinicians. Try to measure the health economic benefits of your device. For example, if your device improves the operational workflow in the OR and saves surgeons time, that makes it more cost-effective.
Or perhaps your device reduces recovery times for patients. A faster recovery time has a number of carryover effects. It reduces costs for both patients and hospitals. It may also reduce rates of infection if patients are leaving the hospital earlier. And if patients are recovering faster and getting fewer infections, that looks great for both the surgeon and the hospital—and also makes insurers happy.
Shaherah also pointed out that it’s important to collect long-term data through patient reported outcomes (PRO) to continue gathering evidence of your device’s benefits to patients. You can always extend your study to continue following the device or the patients’ experience with it via PRO. How is their quality of life at different points in time?
I know these examples won’t be relevant to every device, but hopefully they get you thinking about the type of clinical evidence you can generate to demonstrate the superiority of your device for patients, clinicians, and insurers.
Running clinical trials and getting the clinical evidence you need for market adoption may seem daunting, but there are a number of steps you can take to make the process easier on you and your team.
One of the most important steps is choosing an electronic data capture (EDC) system that is built specifically for medical devices. With Greenlight Guru Clinical, you won’t have to worry about slogging through endless features meant for pharmaceutical trials. Instead, you’ll have a modern, intuitive interface and a simple, three-step study builder.
Our MedTech-specific EDC software comes pre-validated to both FDA and EU regulations, as well as ISO 14155:2020, so you can get to work building and carrying out your study without worrying about compliance.
If you’re ready to see how Greenlight Guru Clinical can help you get the clinical evidence your device needs, then get your free demo today →