In-house vs Outsourced PMCF: What actually works?

Have you successfully launched a medical device on the market? Then the next step to comply with the European regulations (EU MDR) is to perform Post-Market Surveillance and, by extension, Post-Market Clinical Follow-up (PMCF). In a nutshell, this means you must continuously collect clinical data on your device while it is on the market, and you need to be proactive about it.  

Unfortunately, collecting clinical data places a burden on the resources of your clinical and/or regulatory team. Resources that could also be spent on bringing new devices to the market or improving your existing ones. A logical solution would be to look into the possibility of outsourcing such activities, allowing your team to keep using their resources best. To help you make an informed choice and to see what actually works, we will explore the pros and cons of outsourcing PMCF activities to a specialized partner, like Qserve.  

Should I do my PMCF in-house or should I outsource? 

In short, a smooth PMCF process hinges on three key aspects: resources, knowledge and access to relevant clinical data sources. So, when you are doubting whether you should outsource or not, it’s good to ask yourself a couple of questions: 

• Do I have the resources to create a plan and to execute the PMCF activities? As previously mentioned, having to do post-market activities can be a burden on your team, which could also be spending their time on other projects within your company. Time is limited, so it must be spent wisely. By outsourcing the heavy lifting of a project, your team can stay committed to other high-value projects.  

• Do I have the in-house knowledge required to perform adequate PMCF? Under the MDR, it is the responsibility of the manufacturer to present the notified body with sufficient clinical evidence to support their claims. There are guidelines on what is roughly required, but determining which activity is best for your device (cost- and timewise) remains a challenge for many manufacturers. Companies like Qserve have teams that specialize in planning and executing PMCF activities. As such, they can help you to determine which activity would be suitable for your device, based on their knowledge and experience. 

• Do I have access to the relevant clinical data sources? Even with a solid PMCF plan in place, many manufacturers still face challenges when collecting their required clinical data. Getting access to the right investigators, end-users or other real-world data sources is critical, but it’s often difficult and delays in recruitment or engagement can severely impact your timelines. Meanwhile, specialized companies often bring established networks that can help you generate the data you need without the risk of facing delays. 

What are the costs? 

Of course, the elephant in the room should also be addressed: What are the costs? Outsourcing your PMCF activities would indeed involve costs which you otherwise would not have. However, one should not forget about the opportunity costs of doing in-house PMCF. While your team is committed to PMCF activities, they have less time to spend on bringing new devices to the market, which might hurt your company on the long term.

In contrast, a specialized company brings hands, expertise and established networks, which makes timelines efficient and minimizes delays. This is best illustrated when a notified body determines your PMCF activity as insufficient and you have to perform a new PMCF activity to collect clinical evidence. Setting and executing a new PMCF activity will most likely cost more time and money than paying the outsourcing costs up front and succeeding on the first try. 

What works in the end? 

Do you have the resources, knowledge, and access to your clinical data to perform your PMCF requirements? That’s great! With knowledge on the latest requirements of the regulations and a deep understanding of your device, in combination with enough time to execute your planned activities and the ability to find the people you need, PMCF can remain cost-effective while supplying your notified body with a sufficient amount of clinical evidence for your device.  

However, manufacturers often face hurdles in one or more of these areas. For those parts, outsourcing can help fill critical gaps.  

At Qserve, our dedicated teams cater to your PMCF needs. Whether you need to find the best PMCF activity for your device, create a PMCF Plan or Report, or help you find respondents for your high-level user survey, our PMCF teams will use their knowledge, experience, and networks to assist you wherever you need.

Contact us today to explore what’s possible.