Do subjects pay for a medical implant in PMCF study?

[Sarvesh95]

Hi,

I'm quite new to medical device industry, Our Organization is going to start a PMCF/PMS study in India and Europe as well. Since medical implants are very costly, do subjects need to pay for an implant? I have worked in a Pharmaceutical company where drugs are given to subjects free of cost and their travelling expenses are reimbursed.

Also, what should be the sample size in a PMCF study.

(I apologize if my questions are too dumb, I am a fresher. )

 

[paulag]

Hi,

for the EU, you could begin with studying the MEDDEV guidance for PMCF studies (MEDDEV 2.12.2) and maybe ISO 14155 for overall clinical study requirements.

 

[pkost]

For a Post market clinical follow up I would say that it depends very much on how novel your product is, whether it is normal treatment and whether you gain anything more than just a regulatory tick. Finally it comes down to what you are able to negotiate! try to approach it from a commercial point of view as well

If your follow up is not out of the norm of usual operations within the clinical setting and you already have good data supporting product efficacy then you can probably charge for the device and pay the HCP to write up for you

If your device is novel, the study is complex, requiring specific patient groups, blinded, multicentre and outside the norm of standard care (essentially requiring significant additional burden for both patient and HCPs) and you could benefit from a study that could then be used by your marketing team then I expect you would have to pay for everything

 

[Sarvesh95]

That was really helpful, thank you!