Pediatric device development is one of the most challenging—and rewarding—in the medical device field. The challenges arise from the special requirements of these patients and the small size of the market that makes funding these complicated Research and Development programs difficult.
The problem is well recognized. The FDA Center for Devices and Radiological Health (CDRH) has developed programs to help accelerate innovation in these areas, but progress remains slow. In many cases, clinicians use outdated or devices designed for adult patients in an adapted way. This is often off-label use, where the device indications may not include young patients, or patients below a certain body mass size. This introduces its own set of new challenges as clinicians must rely on their own experience and the experience of others, and not product labeling and large well-controlled approval clinical trials.
There are, however, programs that are focused exclusively on pediatric applications—the unmet need is truly defined by the pediatric experience, requiring products where the design, clinical experience, and ultimate approvals will clearly encompass these young patients.
In this issue of Pulse, we have experience shared in both of these categories—the design considerations required to adapt traditional devices to pediatric use, novel approaches to speed development, and the work underway developing products for that market from the start.
This issue of Pulse also features a notable milestone—the sign-off column by Dr. Jay Goldberg, Ph.D., after 50 articles on the topic of capstone design. Over the years, Jay has profiled many of the aspects of successful senior design and experiences of projects and academic programs for this important topic. For most students, their capstone or senior design is the first true taste they have of applying their theory training to the realities of developing a project from start to finish. We look forward to continuing this feature with guest writers in issues to come.
Mike Hess,
Editor-in-Chief