clinical
List Title
It is essential to keep the clinical pillar in mind during each stage of medical technology innovation and commercialization in order to promote alignment between how innovators expect a technology to be used and how clinicians would actually benefit from the device.
Below, you can find clinical resources related to each stage of the innovation cycle as depicted in the GAITS wheel.
1. need
Insights into unmet medical needs and available solutions
Commercialization Checklist & Related Resources:​
-
Unmet need statement
-
Where to start with needs finding?​
-
-
Disease state characterization
2. idea
Potential solution to unmet need described, evaluated, and selected
​
Commercialization Checklist & Related Resources:​
-
Workflow scenario​
-
Updated need statement
-
Envisioned benefit statement
-
Feedback from 5+ clinical stakeholders
3. PoC
(Proof of Concept)
Key component concepts validated in models and value proposition tested
Commercialization Checklist & Related Resources:​
-
Feedback from clinical stakeholders in 5+ settings
-
Updated need statement and workflow scenario
-
Target outcomes
4. pof
(Proof of Feasibility)​
Feasibility of whole solution demonstrated in models and in feedback from stakeholders
Commercialization Checklist & Related Resources:​
-
Feedback from clinical stakeholders in 20+ settings
-
Updated need statement and Use Case scenario/workflow
-
Updated target outcomes
5. pov
(Proof of Value)
The potential of the solution to work and create value for stakeholders is demonstrated
Commercialization Checklist & Related Resources:​
-
Feedback from 100+ clinical stakeholders
-
Feedback from 5+ KOLs
-
Animal/first in/with man experiments
-
Medical advisory board
-
Clinical trial endpoints
6. trials
(Initial Clinical Trials)
Regulated production of prototypes and collection of clinical and economic data
​
Commercialization Checklist & Related Resources:​
-
Endpoints achieved in pilot clinical trials
-
Demo feedback from 20+ clinical stakeholders
-
Peer reviewed publication(s) submitted
7. vos
(Value of Solution)
The solution is shown to be effective and its value to all stakeholders is validated
Commercialization Checklist & Related Resources:​
-
Endpoints achieved in pivotal clinical trials
-
Peer reviewed publication(s) accepted
8. A&L
(Approval & Launch)​
Institutional and regulatory approval received and sales launch
Commercialization Checklist & Related Resources:​
-
Training materials & Support established
-
Specialty medical groups review in place
9. Use
(Clinical Use)
The solution is used successfully in day-to-day clinical practice
Commercialization Checklist & Related Resources:​
-
Included in local practice guidelines
-
Peer reviewed publications
10. soc
(Standard of Care)​
The solution is recognized as the standard of care
Commercialization Checklist & Related Resources:​
-
Recommended practice by medical specialty