Scenario 1

An innovator brings in a sketched idea for a new X-ray Imaging Device.

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 Establish a business case –
  1. identify the clinical/commercial value to the pediatric population,
  2. clearly define unmet clinical needs,
  3. explore competitive landscape and define competitive advantage of the proposed invention
Regulatory Regulatory Strategy –
  1. identify device classification and submission requirement,
  2. study radiation safety standard and compliance requirements
Clinical Clinical Impact-
  1. Is the identified clinical need real?
  2. Does the proposed design property address the clinical need?
Testing –
  1. How do you plan to test the device?
  2. What are the metrics that define “effective” and “safe” ?
Engineering Technical feasibility-
  1. Is the design realistic?
  2. What resources, both technical and financial, are anticipated?
IP Prior Art –
  1. What are the alternatives in existence?
  2. How is the proposed design different?
  3. is the difference “non-obvious”?
Funding Funding Source-
  1. How much funding is anticipated?
  2. What are the turn-around and timeline of the funding?
  3. Are they consistent with the development process?
In this scenario, the inventor is at the very beginning of the product development process, namely Discovery/Ideation.
  • Our engineering team will advise the inventor in flushing out his/her idea. Issues relating to complexity of developing potentially capital medical equipment and concerns for radiation exposure will be discussed
  • With a mature concept defined, we can help evaluate the IP landscape and file for patent protection.
  • Once, technical and clinical aspects are vetted, we will bring experts from our clinical, regulatory and IP partners to evaluate the development plan and strategy
  • Meanwhile a business development team will help identify opportunities for industry sponsored research, licensing agreement, or strategic alliances.
  • Exit strategy will be developed early and iterated often during all stages of development .