How do we prevent patients from being impacted by PMCF requirements?

Post market clinical follow-up (PMCF) is now a top priority for medtech companies with the new Medical Devices Regulation (MDR 2017/745) in effect. There are pressures to collect data for products already approved for sale in Europe, but there is also the added pressure of limited resources from a time and cost perspective. This has prompted device companies to take a closer look at technology and the clinical design of these studies to help drive the post market surveillance (PMS) plan for a device.

How does the successful completion of these studies ultimately impact patients? This question was discussed during a customer roundtable at our recent MedTech Clinical Forum. As a patient myself this was a personal discussion for me. I have relied on medical devices to treat serious diseases and it made me think about how patient care may change in the future if companies are not able to collect PMCF data. I began to ask more questions to learn from the industry to see what role I could play in helping patients.

New Regulations

PMCF studies are designed to identify the potential for residual risks of a CE marked medical device and to collect data and gain clarity regarding the long-term clinical performance of the product. Situations that may require this additional data include but are not limited to confirming the safety and/or clinical performance for a new indication, significant changes made to the medical device or labeling, adjusted risk-classifications, post-marketing surveillance activity, or a request from a regulatory authority.

Unless justified by medical-scientific rationale, medical device companies need to conduct PMCF studies to collect additional information about a product already approved for sale in Europe. The new regulation officially went into effect earlier this year, but now that organizations are shifting from pandemic mode to post pandemic mode there is increased focus on ensuring they are on track to adhere to the new rules. A PMCF strategy outlined in the PMS plan is essential to satisfying the regulatory requirements and has been causing much anxiety among data management teams to figure out how to get the data. While the regulations speak about what is required to submit, they do not explain their expectation on how to collect the data.

A New Type of Study to Run

Our customer roundtable discussed how PMCF is a different type of study. Studies are typically a bit more formal in nature and proactive with pre-approved outcomes or acceptance criteria making the data that needs to be collected very specific. A common criterion for running a PMCF may be a device approved that may have longer term data gaps or unanswered questions associated with use. Of course, many class IIa/IIb/III devices are permanent implants that have not undergone long term clinical studies as part of the pre-clearance studies. The specific additional data points collected as part of PMCF study execution will supplement the existing pre-market clinical and non-clinical data.

Study design has come into play by device companies as the data points that need to be collected are specific. Feedback from participants in our forum indicated that they know very specifically the number of patients they need per demographic, device usage, follow-up period, outcomes, and criteria to support their PMS plan. What must be decided is how the PMCF is conducted, which can be a clinical study, registry, or patient survey. Ultimately the study design needs to ensure it bridges the gap of any data previously collected.

Four-Corner Approach

The simplicity of PMCF studies has stumped companies as they decide on the tools that they want to use to collect their data. Our forum discussion highlighted that decision makers are using a “four-corner approach” in selecting a system to use.

1. In order to meet regulatory requirements, they need to use compliant tools, so many technology solutions are immediately ruled out and the available tools in the market are clear.
2. Studies are complex, so design tools need to be easily adopted with streamlined training and certification for study builders; with builders frequently being inside the Medtech company to control costs.
3. The study design approach must change, and common edit checks or rules built into case report forms need to be scaled back with focus on univariate checks only to reduce the overhead required to build.
4. Study execution timelines are short in many cases so data on demand capability is mandatory, and companies need the ability to lock their database quickly. Our forum also highlighted that since the study design is not clearly understood, systems need to be able to accommodate amendments very quickly and with no downtime.

Patient Impact

I have been very focused on the time I’m inside the clinic to reduce my risk but still want to ensure I’m receiving excellent care. Device companies are working to ensure a patient centric approach in collecting the much-needed PMCF data and this has required them to focus on study design. Ease of use of systems to collect data, such as Vault CDMS, are critical to ensure that caregivers can focus on the patient while still taking advantage of precious time in the clinic to collect much needed data for PMCF. Performance is key while keeping the data collected focused on only what is needed. Visits may not require too much data to actually be collected, but most data points are critical and required for each visit. Study timelines depending on the type of CE device and type and volume of data to be collected may be as short as 2 to 3 months, so each visit is critical. I know personally that some of my real world data has been collected in written surveys that are then re-keyed by the clinicians to reduce the amount of time at the clinical site or completed in a virtual visit. Patient safety has driven the amount of time clinicians have to perform treatment, but also satisfy data collection requirements.

When I joined Veeva, I wanted to make a difference in the clinical data management space by sharing my own personal patient experience. In my own mastectomy or scull-based craniotomy surgeries I listed out all the devices needed to complete a surgery and I was stunned – it was hundreds! PMCF to me is potentially a study on any one of those devices and means something to me.

I am excited that I was able to pull together medical device leaders to talk about the ever-changing regulatory landscape with EU MDR and work to collaborate on how we keep devices on the market that are used to save lives. While PMCF seems complicated with no clear set of directions, we are slowly figuring it out, and have already demonstrated how we can reduce cost and complexity in study designs and satisfy timeline requirements. I wasn’t sure we’d get here so quickly but have seen a shift in just the past 6 months. I am very impressed with how open the MedTech industry was during our forum discussion. Everyone is committed to solving the unanswered PMCF questions to ensure that patients get access to devices that they need. I’m reassured that I will be able to get the treatment I need in the future.

Conclusion

Supporting PMCF entails a number of new challenges, but none that we can’t overcome as an industry with the right focus. With the right technology partner, medical device companies can run their studies and ensure that patients remain the focus.