Monthly working sessions on evidence, ethics, and the difference between a biomarker and a business.
Places are few. Applications should include a device photograph, not a vision statement.
The circle exists because device translation fails for administrative reasons far more often than scientific ones, and because those reasons are entirely learnable. Sterilisation routes, quality system timing, usability evidence, sponsor responsibilities and the actual duration of a governance approval are all knowable in advance, and teams routinely learn them at the worst possible moment.
Sessions are working rather than instructional. A team brings a real problem — a protocol that has been rejected, a risk file that has become unmanageable, a usability finding that implies a redesign — and the group works on it. Clinicians, a regulatory consultant and teams a year further along all attend.
How it runs
The mechanics, stated plainly.
Monthly working sessions
Two hours in Bloomsbury. One team brings a live problem in detail; the rest contribute. Attendance in person is expected.
Clinician and regulatory input
A clinical academic and an independent regulatory consultant attend each session. Neither is there to endorse anything.
Protocol review on request
Participants may submit a draft protocol or risk file for structured review by the group ahead of a formal submission.
What you provide
- A working prototype, and a photograph of it rather than a rendering
- A named clinical collaborator who is genuinely engaged
- Willingness to discuss your difficulties in front of other companies
- Consistent attendance from someone senior enough to act on the discussion
What you get
- Structured review of a protocol or risk file before it is formally submitted
- Access to clinicians and to regulatory expertise without a consultancy engagement
- The experience of teams twelve months ahead of you, candidly given
- A realistic timeline, which is frequently the most valuable thing on offer
Terms
Agreed before anybody contributes anything, which is the only moment it works.
- All discussion is confidential to the circle, under a mutual agreement signed on joining
- No participant's device or data is discussed outside sessions
- Clinical and regulatory attendees provide input, not endorsement, and may not be cited
- Places are limited and reviewed annually; non-attendance forfeits a place