A pediatric surgeon asks, “What do I need to consider as I move my pediatric device, which may be used about six thousand times a year in the United States, into clinical trials?”
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||Business Plan –
Project plan – There should be a project plan from the prior prototyping stage to show the history of the product development, as well as a detailed timeline to move this product through the clinical trial and regulatory process.
|Regulatory||Regulatory Strategy – The inventor should identify the class of the device and type of submission needed in order to scope our the clinical trial.|
|Clinical||Pre-clinical study – Before human trials can begin, the device must be proved safe in an appropriate pre-clinical study, (GLP, bench, etc).biocompatibility testing-The device must be documented to be safe for human use.|
|Engineering||Clinical grade device – While the device may not be in its commercial form, it should be safe and functional as intended.
Manufacturer in place- The innovator must have a manufacturing process in place to supply product during the trial.
|IP||IP protection field At minimum a provisional should be filed if not a utlity patent if applicable.
Prior art search- Due dilligence should be done to ensure there are no other alternative or existing devices on the market that serve the same purpose.
|Funding||Funding plan-Since the consortium has limited project funding, the innovator should have a plan to obtain funding for the clinical trial or existing funding.|
In this scenario the key factors of success include finding funding and early FDA talks regarding the structure of the clinical trial. With a small market size which is common in many pediatric devices, it is important the innovator to seek a strategic partnership with a larger company that can fund such trials and provide the distribution outlets. Alternatively, funding and support can come from patient advocacy groups if the innovator wants to maintain control initially. In both scenarios the consortium intake coordinator can provide such contacts to the innovator and facilitate meetings to find the best fit. As far as whether or not to move forward with the clinical trials there are 3 main factors to consider.
- Early identification of a strategic partner to conduct the trials, whether this is a corporation, advocacy group or hospital is essential for execution and success of projects like this. Clinical trials require strategic design, significant man power and regulatory approvals along with an inventory of said device. Without these resources, or the innovators willingness to procure these resources given the appropriate contacts moving forward with the clinical trial is not feasible.
- Communication is a big factor as well. If one does not clearly communicate with the FDA during pre-trial meetings then large sums of money and time can result in trial objectives which do not clearly state the safety and efficacy of the device. Our consortium has a number of experts who have led and designed a number of clinical trials in pediatric and neonatal space. In addition, we have the nation’s only pediatric CTSI whose core competency and service are to assist investigators to conduct pediatric clinical trials design and execution. We have engineering and industry partners who have extensive experience working with the FDA to agree upon the trial end points with whom we can provide as a resource for the innovator.
- Finally a solid business case is important. Having the innovator understand the value of the device and the financials required to execute a clinical trial and commercial launch can avoid simple yet costly mistakes.