Scenario 5

An innovator wants to develop a previously approved adult device for pediatric patients

Part of our unique strategy to device innovation utilizes our coach coordinators to provide an evaluation for all innovators wishing to work with the NCC-PDI. Below is an example of what a coach coordinator might suggest for this scenario:

Domain Expertise Questions / Topics
Business Plan Business Plan – The innovator must have
  1. a developed plan to take his/ her device to commercialization,
  2. identified the commercial value to the pediatric population,
  3. identified milestones and funding goals with an investment return timeline.
Regulatory Regulatory Strategy – Determine what pathway the adult device took to receive FDA approval
Clinical Clinical needs assessment for new population- The innovator must have data supporting why this is the correct treatment for pediatrics and how this addresses the clinical need specific to pediatrics.
Search of alternatives – There should be a background search to determine alternatives, or existing devices.
Data supporting safe and effective use in children – There should be reasoning behind the appropriate use in children.
Engineering Evaluation for significant design changes – The innovator should have a list of any design changes, size changes, material changes, etc. he/she envision would be needed to apply this device to pediatrics
Impact of design changes – The innovator should know the impact of these changes on the performance of the device.
IP Freedom to operate-Since someone else owns the product, you must have permission from the owner.
IP ownership –
  1. Who owns the IP?
  2. What are the innovator’s expectations regarding IP?

Many physicians are using adult medical devices off-label in pediatrics due to the lack of available solutions. As a consortium, we need to consider the everyday needs of pediatrics and how we can work to make devices that provide safer and more effective care to this underserved population. Even though FDA and other organizational incentives have been offered to encourage pediatric device development, the industry lacks behind clinical needs. Pediatric devices often require additional considerations to accommodate the physical and biological changes that occur from birth to adulthood. Such factors include accounting for changes in height/weight, rapid growth/development, disproportionate anatomical structures, hormonal influences, activity level, maturity level, immune status, physiological differences from adults and pediatric specific diseases/conditions. Furthermore if clinical data is needed one needs to make every effort to collect data from various subgroups or ages in which the device will be used to determine acute and long term effects of such device. For these reasons among other, changes related to labeling inclusive of pediatric populations are not as straight forward as other labeling changes. Therefore it is vital as a pediatric device consortium to assist those innovators seeking to make the intended use for adult devices more inclusive to include pediatric indications.

In this scenario there is not as much product development but rather navigating legal/regulatory rights and performing due diligence in expanding the indicated use. As part of our consortium, we strive to help all innovators whether they have a novel idea or want to make an incremental change. In this case we provide a “one stop shop” for the innovator to get the legal, regulatory, clinical, and engineering advice and assistance. As part of the effort to increase the quality and access of pediatric care, the FDA has implemented several policy changes over the past decade. These include developing the HUD/HDE exemption to the PMDSIA released in 2007 which permits extrapolation of adult data to support pediatric indications if the effect can be reasonably supported to be the same. Additionally the FDA has permitted limit profit on HUD/HDE devices for pediatric indications. The resources our consortium has gathered provide a more streamlined pathway for those device companies or innovators who look to expand device use into pediatrics.