| 2004N-0254 - Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments|
|FDA Comment Number :||EC1|
|Submitter :||Mr. Philip Kong||Date & Time:||07/19/2004 05:07:42|
|Organization :||Children's Hospital Boston|
| I am the Director of the Pediatric Product Development Initiative (the PPDI) at Children's Hospital Boston. Please see: http://www.childrenshospital.org/cfapps/Research_2004/data_admin/mainpageS49P17.html.
The goal of the PPDI is to foster the development and commercialization of pediatric medical devices. Pediatrics is generally an underserved population as the populations in various pediatric indications are not large enough to provide a financial incentive for medical device companies to invest in the infrastructure to produce medical devices for pediatric use. Transferring pediatric medical device technology to companies that will bring them to market required overcoming daunting challenges. The challenges affecting the availability of medical devices intended to treat or diagnose diseases and conditions that affect children include the limited size and fragmented nature of the pediatric market, and the fact that clinical development pathways require specialized expertise in design, development and testing before the medical device industry will evaluate product ideas. In the absence of initial development, the return on the investment required to develop these products usually falls below the target profit goals of most medical device companies. Reimbursement is also a very important issue. The CPT codes, for example, do not exist for many procedures involving children. This makes the billing and reimbursement process more complicated and is a factor taken into consideration when medical device companies contemplate whether to develop a product that treat pediatric conditions. The process of getting these codes in place is time consuming and expensive and without the attendant market size to go after, companies and their shareholders are unwilling. The prospect of profitable economics isn't there. But if we are able to take some of the risk out of the development process, then we help to 'jump start' this process.
As with most technolgies, 'gap funding' is an issue. With pediatric medical devices, it is an even more important issue if the economics of the market is not enticing enough to prompt capital investment. There is a gap between the ideas that we have to create needed pediatric medical devices and the ability to make prototypes, put those prototypes through well run clinical trials and get them to the children that need them. It is money that will bridge this gap. For example, if a program such as ours had access to product development funding, then with the organization that we have built, we could engage in the risky early stage development process where a company is unlikely to get involved and then gather the data that would show that a particular device idea has merit. Thereafter, we can engage with medical device companies in order to take the idea further and eventually into the clinic's, hospitals and pediatrician offices where they can positively impact children's health care. We carefully select the device ideas based on a number of criter here at the PPDI, and have chosen with our very limited resources to begin with the development of a couple devices that have a not-insignificant market size. The hope is that with hoped-for success in commercializing some of those devices, we can turn our attention to developing and commercializing those devices that would not have a chance of being developed at all. Devices that are needed in the area of fetal surgery come to mind. The area of pediatric medical devices generally is is an area that desperately needs attention and I hope that we can find a way to do the right thing for the sake of children in America. Thanks for your attention. I am available for follow-up at email@example.com or (617) 355-2835.
Sincerely, Philip Kong, JD, MBA, Director Pediatric Product Development Initiative, Children's Hospital Boston