Medical Device Classification?

[Logan Wade]

Hello Everyone,

We are trying to obtain ethics to use OpenCap with NHS patients here in the UK for a research study to determine how feedback of their walking gait within a session improves their rehabilitation. To do this we have to apply for a pretty rigorous ethics through the UK NHS system. The university ethics department is concerned about whether we need to apply for ethics that classifies our study as a clinical investigation of a medical device, or, conducting a clinical trial of investigational medicinal products. As far as I am aware, OpenCap software does not have any license for medical use? We do not think that OpenCap would need this kind of medical mark (CE mark) to be used in a research study?

Has anyone else come across similar issues and have any advice for how to get around this?

Much appreciated,
Logan Wade

[Antoine Falisse]

Hi Logan,

I don't know the rules in the UK but OpenCap has been used in similar study designs here at Stanford and our IRB has not classified as a medical device or medicinal product (as far as I am aware). This document might be relevant: https://docs.google.com/document/d/1DBw ... kXtXI/edit

Best,
Antoine

[Logan Wade]

Hi Antoine,

Yes it seem to be very stringent here. Because we are planning to use the software for a research project within an NHS hospital setting, it comes down to whether the output of the device (software) is intended to affect the treatment of an individual. Because we want to record patient movements and then provide this information to their rehabilitation team during the session, to research if this could help inform the care team if the patient is improving their gait in the way the team would like, it is being argued that this will affect the treatment of the individual and therefore it needs to be classified as a medical device. We were planning on using the Opencap Core to process our videos locally, but despite this being a full research project and having no intention of marketting the software, this seems to be a big barrier.

We would argue that this justification means that any motion capture software used in an intervention would need to be classified as a medical device, as would recording high speed video on a phone, which the rehabilitation team would then watch back to provide feedback to the patient.

I was wondering if you have been in contact with any other research groups outside the US that have tried to use OpenCap in clinical practice? It would be great to contact them to get their input on how they navigated this issue.

Thanks so much,
Logan

[Antoine Falisse]

Hi Logan,

Thanks for the details. I am not an expert on all these regulations. OpenCap only provides raw kinematic data and no recommendations per se. Is there an argument to be made there?

I am not aware of research groups having implemented OpenCap in clinical practice, but will let you know if I hear anything.

Best,
Antoine

[Logan Wade]

That is the argument we are trying to make.

I will let you know if we are successful or not.

That would be great. Thanks.

Cheers,

Logan