To advance pediatric medical device development from conceptualization to an actual working model requires some level of prototyping and manufacturing. Oftentimes, this is beyond the resources and expertise of the initial innovator, and additional assistance is required to develop a tangible device. To that end, it may be necessary to enlist the services of a contract manufacturer.

The following criteria should be considered when choosing a contract manufacturer:

What are their accreditations?
Certifications such as ISO 13845 and FDA Compliance should all be considered when choosing a device manufacturer.

Ensure that the manufacturer follows Good Laboratory Practices (GLP) and Good Manufacturing Processes (GMP)

Do they have clean room capabilities?
ISO 14644 and ISO 14698 both establish the standards for cleanrooms.

Can they deliver the product in a timely manner?

The PMD Launchpad is here to help find companies and academic affiliated enterprises that can assist in the manufacturing, instrumentation, prototyping, and scale-up that is required to advance a pediatric medical device from the concept to the bedside.

The following online resources can help assist you in your search for a contract manufacturer:

AdvaMed  The Advanced Medical Technology Association, is a national organization that maintains a pediatric medical device working group, that is a strong advocate for unmet needs. Their membership directory is available on their website (and can be accessed without becoming a member) and includes numerous organizations with resources for pediatric medical devices.

Qmed  The world’s only directory of pre-qualified suppliers of the medical device and in vitro diagnostics industry.

The Division of Industry and Consumer Education (DICE) within CDRH’s Office of Communication and Education (OCE) provides technical and regulatory assistance to industry, particularly small manufacturers, to help them comply with regulatory requirements for medical devices. The Division also assists academic and research organizations, consultants, attorneys, customs brokers, government agencies, and user facilities, as well as consumers, patients, and health care professionals.

If your organization is interested in being added to this list, please contact us.

The Pediatric Device Consortium (PDC)  Members can leverage their expertise to help you connect with the appropriate contract manufacturing laboratories. Please feel free to contact any of the five PDCs listed here: