Innovation Hub
From clinical problem to responsible adoption
An informational overview of the stages many surgical innovations pass through in the United Kingdom.
This overview is general information for surgeons and teams. It is not legal, regulatory, commercial or clinical advice, and it does not replace guidance from the relevant regulator, your employing organisation, or appropriately qualified professionals. Requirements change, and responsibility for any decision rests with the people and organisations taking it.
Stages
A typical pathway
- 01
Define the clinical problem
Describe the problem, who it affects and how current practice performs. A clearly stated problem is more useful than a proposed product.
- 02
Review what already exists
Search the literature, registries and existing services. Many problems have partial solutions already in use elsewhere.
- 03
Early development and prototyping
Work with engineering, data science or industry partners. Record contributions, funding and any intellectual property arrangements early.
- 04
Governance, ethics and data
Identify approvals needed, including research ethics, information governance and data protection assessments.
- 05
Regulation
Understand how the product may be classified in the United Kingdom and what evidence a regulatory route requires. Specialist advice is usually needed.
- 06
Evaluation
Plan a staged evaluation with predefined outcomes, including safety, learning curves and unintended effects.
- 07
Procurement and implementation
Consider cost, training, maintenance, consumables and capacity. Implementation is a service change, not only a purchase.
- 08
Monitoring after adoption
Agree how outcomes will be followed and how the decision to continue, modify or withdraw will be reviewed.
Working on something?
Members can share early-stage work with the innovation community, ask for critique, or look for collaborators. Sharing is voluntary, and ASTI does not take a stake in member projects.