A Novel Mixed-Methods Platform Study Protocol for Investigating New Surgical Devices, with Embedded Shared Learning:...

Area of Science:

• Surgical Innovation
• Medical Device Evaluation
• Breast Cancer Surgery

Background:

• New medical devices require thorough research for patient safety and informed consent.
• Introducing new surgical devices presents challenges due to learning curves and iterative practice refinement.
• This study pilots a national collaborative approach for medical device introduction in the UK, using breast localisation devices as an example.

Purpose of the Study:

• To develop an effective and transferable surgical device platform protocol.
• To embed shared learning into the medical device introduction process.
• To compare the safety and efficacy of novel localisation devices against standard wire-guided localisation.

Main Methods:

• A prospective, multi-centre platform study in the UK (iBRA-net localisation study).
• Compares Magseed® (pilot intervention) against wire-guided breast lesion localisation for wide local excision.
• Collects outcomes via an online database, with shared learning captured through questionnaires and focus groups.

Main Results:

• The study aims to collect data on 950 procedures per intervention over 18 months.
• Shared learning will be evaluated via thematic analysis to refine techniques and identify potential issues.
• Results will be disseminated through national/international conferences and peer-reviewed publications.

Conclusions:

• Outlines a novel methodology for a collaborative national platform study on medical device safety and efficacy.
• Addresses the need for improved registration and audit of new medical devices, aligning with the Cumberlege report.
• The platform is designed for future inclusion of additional localisation devices, enabling comparative analysis.