As a Small Business, there exist unique challenges that you may currently face in developing your pediatric medical device, such as limited access to resources and expertise. Our goal is to bridge the gap between your pediatric medical device concept and the commercialization of your device. To learn more about some of the resources we can offer, select the topics that interest you below. If you're interested in speaking with us, feel free to visit the Contact Us page!

  • Unique to your commercialization pathway is the opportunity to apply for an SBIR Grant to support your device. We understand that the application process can be overwhelming for those with minimal experience in submitting an SBIR application. In our portfolio of innovators, we have multiple SBIR applicants with successful submissions to whom we can connect you. We are also able to sponsor your submission if you so choose. 

  • If you are looking for support to design your device, we can provide you with engineering resources. We have engineers available at the PPDC to support innovators, as well as connections with institutions able to provide expert engineering support to assist in your design. 

  • Speaking with the clinicians likely to use your device is a crucial step along the commercialization pathway. Given our roots in CHOP and connections to local medical schools, we are able to connect you with lead clinicians capable of providing you with valuable feedback regarding the use of your device. 

  • If you have a concept and sketch of your medical device, but aren't sure of the best method to develop a prototype, we can assist you in fabricating your prototype in a multitude of ways, with one of our largest resources being the 3D printing lab. We can also offer the resources of an FDA compliant (certified ISO 13485 and ISO 14971) medical device developer and manufacturer. 

  • Perhaps you have your prototype designed and built, but could use support with bench, animal, or human testing. We have a strong connection with industry partners who are able to not only advise the design of the testing, but also perform the testing under FDA standards and provide animal facilities. 

  • You might need help with the design of the clinical trial, or biostatistical support of your design, or even connections with Principal Investigators who are able and willing to conduct your trial - our goal is to assist you with these tasks. We have successfully worked in concert with innovators and clinicians at CHOP to develop a clinical protocol and support the trial once it is approved and enrolling.

  • If you are looking for advice for gaining approval of your device, we can support you in a variety of ways. We can assist you in submitting a short description of your device for a brief, non-binding review by an FDA reviewer, which can lead to a more successful Pre-Submission or ensure you are on the right path to approval. We can also connect you with experts in the field of Regulatory Affairs, such as NAMSA, to assist you in gaining approval for your device.

  • If you are looking to commercialize your device, but have minimal experience in determining the reimbursement potential of a medical device, we can assist in connecting you with an expert to help guide you through this crucial step towards commercialization.

  • If you have the technical expertise to develop your device, but need help determining the market, we can support you through our connections with The Wharton Small Business Development Center. The Wharton SBDC can assist in helping you identify the key questions that will influence commercial prospects, compile and analyze relevant market and technical data through secondary and primary research, provide concrete recommendations to support market development, assist in developing a marketing strategy, and produce investment-ready business plans and investor pitches.