Applying the stage-gate model to medical innovation
The stage-gate model facilitates the development of drugs, devices, and regenerative medicine therapies by breaking the long, arduous journey from basic research to application into manageable stages.
The Japan Agency for Medical Research and Development (AMED) has adopted the stage-gate model for mapping and planning the progression of projects from basic research through to clinical applications. First developed in the mid-1990s, the stage-gate model has since been widely adopted in a wide range of industries. It has become very popular and is considered the industry standard in innovation. The stage-gate model involves taking the often turbulent process of taking a concept from discovery to application and breaking it down into smaller, more manageable stages (during which project activities are conducted) and decision points or stage gates (where business evaluations and go/no go decisions are made). It facilitates the continuous flow of innovation.
AMED has taken this model and adapted it for the two cases of drug discovery and device development.
For drug discovery and development, there are four stage gates:
- Completing the validation of drug target
- Completing preliminary work prior to commencing preclinical development
- Completing preliminary work prior to commencing a phase I clinical trial
- Completing a proof-of-concept trial
The device development model has three stage gates:
- Formulating the concept of the medical device to be developed
- Finalizing device specifications
- Starting clinical studies
In addition, the model for regenerative medicine is a modified version of that for drug development:
- Starting a non-clinical safety study
- Starting a phase 1 clinical trial
Each of the stage gates for the three project types have a checklist of several questions that researchers can use to determine whether their study has reached that stage gate.
For example, the questions for the first stage gate for drug discovery and development are as follows:
Questions relating to target or seed evaluation:
- Has appropriate target validation been conducted?
- Has examination of the target product profile begun?
- Have the screening systems or evaluation systems that will be necessary for the next stage been established or has possibility of establishing these systems been demonstrated? Alternatively, if there are currently no estimates for establishing screening systems or evaluation systems, are there reasons why the project will still attain the next stage?
Questions related to the research environment:
- Has development of intellectual property strategies been started, or has outsourcing with the help of intellectual property staff been initiated?
- Is a clear framework for cooperation in research and development (including the use of external organizations) for the next stage nearly in place?
For some questions, there are further questions that are more specific. These questions are helpful for reviewers of grant proposals to assess whether a project meets the requirements of a specific stage gate. It is important to note that even if a review of a research project finds that a project does not meet all the check items, the project may still proceed to the next stage provided that reasonable grounds can be provided to show it can be allowed to proceed.