As an industry, medical device manufacturers and regulators have an obligation to ensure that children are not left behind when it comes to the innovation and development of products to treat childhood conditions and diseases. The reality is that the innovation of pediatric devices lags far behind the resource investment into devices for adults.

Without intervention from regulators, manufacturers have little incentive to invest the necessary resources to develop these types of products. Fortunately, the Food and Drug Administration (FDA) recognizes these issues and is working hard to encourage the development of pediatric medical devices. 

Manufacturer Challenges with Pediatric Medical Devices

Historically, device manufacturers have not been incentivized to focus on the pediatric market. Paired with the inherent challenges of developing devices for this population, it’s not surprising that there are gaps.  

Limited Market Potential

Pediatric medical devices — defined in the United States as patients who are under the age of 22 — are not lucrative when compared to those indicated for adults. There is a smaller population with childhood conditions and diseases and, therefore, less market potential for manufacturers. Pediatric patients may also eventually age or grow out of the devices designed for them. This further limits the market potential and is often a factor in why pediatric populations are not prioritized when creating product portfolio strategies.

Higher Risk

No one wants to make a sick kid sicker. When pediatric medical devices fail, the risk to a manufacturer’s reputation may be too great for the company to bear. Even if the percentage of devices that fail is small, and parents or caregivers might be willing to take that risk in hope of some benefit for their child, this risk can be a significant deterrent to entering the market.

Challenging Data Collection

Clinical testing for pediatric devices can also be more challenging, often because the patient pool is smaller. In some cases, there might not be enough people to support robust clinical trials. This limiting factor is out of the control of device manufacturers, even when they are motivated to develop products for the pediatric market.

Current Approach to Overcoming Challenges

When a pediatric device doesn’t exist for a particular need, physicians often use adult devices off-label. While this can be beneficial to pediatric patients, especially when there are no other alternatives, it’s not ideal. Kids need devices that are designed with them in mind and are suited to their bodies. 

FDA Incentives for Innovation in Pediatric Medical Devices

The FDA is committed to helping patients and physicians get safer, effective devices for children and is demonstrating this commitment through several initiatives.

Investment in Consortia

The FDA is investing in consortia that act as fund managers and offer grant programs that provide funding to encourage manufacturers to develop pediatric devices. These consortia also offer services to supplement manufacturer resources, including intellectual property, business development, engineering, clinical trial design and regulatory affairs support. Another example is the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD), which is actively working to create solutions and overcome barriers to pediatric device development. 

Data Collection

The FDA is actively collecting data to determine the unmet needs that pediatric medical devices can help address. This will help the agency determine where to focus future efforts so the industry can meet the most pressing pediatric needs.

Building Expertise

After realizing that the agency had very few professionals with pediatric expertise in-house, it focused on hiring more pediatricians. Pediatric experts are also being added to advisory panels when the device may be used for children. Many of these professionals are still practicing, which is a strong benefit when determining the benefit/risk ratio of pediatric devices.

Waiving Fees

The FDA waives submission fees for pediatric devices to incentivize manufacturers to innovate in that area. Manufacturers are still responsible for the costs of development and clinical trials, but waiving submission fees creates one less financial barrier.

Flexibility with Clinical Data

For pediatric devices, the FDA may allow manufacturers to use data from clinical trials with children, extrapolate data from adult trials and incorporate real-world data. Allowing some flexibility with data sources makes it easier and less expensive for manufacturers to demonstrate that their devices are safe and effective for use with children.

Best Practices for Submitting Pediatric Medical Devices

When submitting pediatric medical devices for FDA clearance or approval, there are steps manufacturers can take to streamline the process.

Meet with the FDA in a Pre-Submission

Before submitting an application, have a meeting with the FDA review team to gain an understanding of what testing they will want to see. This can help ensure that you are investing your resources appropriately and improve alignment with the agency.

Involve a Pediatrician

If there is potential to adapt an adult device, involve a pediatrician early in the development process. The earlier they are involved in the design process, the better able they will be to contribute guidance and improve efficiency when the pediatric device is developed. 

Justify the Benefit/Risk Ratio

Justifying the benefit/risk ratio can be challenging for any type of device, but it’s an essential part of the review and approval process. Make sure to also consider the risks if the device does not get on the market as part of your rationale. 

Be Creative and Collaborative with Your Regulatory Approach

Consider submitting through the Safer Technologies Program, Breakthrough Devices Program, Humanitarian Use Device Designation Program or the Humanitarian Device Exemption pathway. Children may be considered a new or small enough population from the FDA’s perspective, which could create the opportunity to use these programs for market entry to get a faster review cycle for pre-submission.

Get Support from RQM+

Through our tailored FDA strategy and submission services, RQM+ helps medical device and IVD manufacturers of all types overcome regulatory hurdles. From building strong relationships with the FDA to crafting clinical strategy, our team is here to help you bring your devices to market. 


To learn more about how RQM+ provides regulatory support for another device type that comes with common challenges, watch our on-demand webinar, “Common FDA and Notified Body Software Deficiencies and How to Avoid Them.”

Watch the on-demand recording of the RQM+ webinar "Common FDA and Notified Body Software Deficiencies and how to Avoid Them"

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