Seeking Insights on Outsourcing Clinical Evaluations for Medical Devices

parsa

Registered
Hello everyone,

I'm currently exploring the process of conducting clinical evaluations for medical devices and would love to hear about your experiences. Have any of you outsourced this process? If so, could you share insights on how it went, what to consider, and any ballpark figures on the costs involved? Any tips or recommendations would be greatly appreciated!

Thanks in advance!
 

yodon

Leader
Super Moderator
I had a client that engaged with a CRO before I came on board and there wasn't much in place other than the contract regarding cost. We came to find out that the CRO held all the data and would only publish a summary report. Since then, for any CRO engagement, I've always put a Quality Agreement in place and explicitly stated that the client owns all rights to the data and may request it, in full, at any time.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I dont know about EU but I've had FDA request the actual data from evaluations. "We appreciate your analysis and summary report. FDA is requesting the actual raw data for review"
 

Raisin picker

Quite Involved in Discussions
If you talk about clinical evaluations that finally result in a clinical evaluation report (CER) as requested in article 61 and Annex XIV, that's very common. I'd guess that more than 60% of companies outsource that task.
The results are somewhat divers, even within one service provider. You must completely read the final report before release. If possible, try to have someone from your company be involved as much as possible. I always cringe when I read something like "... according to the IFU provided ..." in a document that should be the base for the IFU.
Regarding costs, no idea. But I'd expect a high 4-digit or low 5-digit number in €.
 

Ronen E

Problem Solver
Moderator
I got the impression that @yodon and @Ed Panek were relating to Clinical Investigations (clinical trials), whilst @Raisin picker related to the literature-based Clinical Evaluation...?

I assume that the OP was referring to the latter.

I agree with @Raisin picker that most companies (especially small ones) outsource it to specialists. It is indeed a specialty, and sadly the level of competence varies a lot among those who offer this service. I highly recommend cross referencing anyone you are about to hire, and get confirmation from multiple past clients to ensure consistent good performance.

I can't comment on cost, but I can say for sure that lead time is a real issue. In my experience, the job is seldom done in the allocated timeframe, so whatever you go ahead with, I recommend accounting for at least double in your project plan. I also recommend allowing for multiple rounds of review (by yourself) and revision by the author. Obviously, the less straightforward the device is, it all has the potential to explode exponentially. It's one of the trickiest, and most important, tasks in medical devices development and regulatory clearance.

Also important to get an excellent understanding (in house) of your specific NB expectations around it, before engaging with anyone, and then making sure the CER author is on the same page (preferably, put it in the contract). At the end of the day, it's the NB clinical reviewer who will give the final blessing on the CER (or not). Which reminds me... include wording in the contract to ensure the CER author is available and committed for fixing any issues after NB review.

Please also note that you will need a clinical specialist in the relevant niche to endorse the evaluation (unless the author is also such a specialist, which is uncommon, they can't do it). CER authors don't necessarily provide that service, and expect you to bring on board your own clinical specialist (typically a Dr, but not always).
 
Last edited:

Raisin picker

Quite Involved in Discussions
Also important to get an excellent understanding (in house) of your specific NB expectations around it, before engaging with anyone, and then making sure the CER author is on the same page (preferably, put it in the contract). At the end of the day, it's the NB clinical reviewer who will give the final blessing on the CER (or not). Which reminds me... include wording in the contract to ensure the CER author is available and committed for fixing any issues after NB review.

To this I can add a helpful document from my NB. I'd expect that at least some of the other 40+ NBs (my current count is 49) have similar documents.
 
Top Bottom