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HealthTech Innovation Readiness Tracking

The journey from identifying and articulating an important unmet medical need to developing an innovative solution that becomes the standard of care is long and challenging. For investigators, the odds of success increase if they already have the experience and skills in this area. We understand that while many have experience with clinical research most are not trained on how to move their innovative ideas along the path to commercialization and need resources they can use to help bring their ideas to market and have a positive impact on patient care while they simultaneously develop these skills.

To help investigators, we have created the HealthTech Innovation Readiness Level Matrix. This tracking tool <LINK> outlines a series of milestones, each with a clear set of deliverables in the four key dimensions required for commercial success; clinical, market/business, regulatory, and technical. The figure below shows each milestone in the stages from “Invention”, to “Translation”, through “Commercialization”. Click on each milestone for an in depth descripton and related examples.

cycle-mapNeed Idea PoC PoF PoV ICT VoS A&L Use SoC

Need

Insights into unmet clinical needs and available solutions.

Examples:

Idea

Potential solution described to unmet need.

Examples:
 

Proof of Concept (PoC)

Key component concepts validated in models and value proposition articulated.

Examples:

Proof of Feasibility (PoF)

Feasibility of whole solution demonstrated in models and in feedback from stakeholders.

Examples:

Proof of Value (PoV)

The potential solution to work and create value for all stakeholders is demonstrated (initial commercial investment).

Examples:

Initial Clinical Trials (ICT)

Regulated production of prototypes and collection of clinical economic data.

Examples:

Validation of Solution (VoS)

The solution is shown to be effective and its value to all stakeholders is validated.

Examples:

Approval & Launch (A&L)

Institutional and regulatory approval recieved and sales launch.

Examples:

Clinical Use (Use)

The solution is used successfully in a day-to-day clinical practice.

Examples:

Standard of Care (SoC)

Recommended practice by medical specialty.

Examples: