It’s paramount to keep the pace of preparation activities in Post-Market Clinical Follow-Up (PMCF) planning, since the MDR has drastically enhanced the bar for supporting data quantity and quality. MILO team has identified frequent problems, each of which, if not handled, could have serious commercial ramifications. To help manufacturers leverage their competitive positioning, this article attempts to underscore those common problems. Likewise, it reminds us of the three major best practices and steps to compliance.
Sufficient Clinical Evidence: The First PMCF Potential Problem
Determining the right amount of “adequate clinical evidence” is a big PMCF compliance hurdle for businesses. It is fundamental to recognize that the interpretation of ‘sufficient’ involves a balance of quantity and quality when planning a PMCF.
When evaluating clinical articles as supporting data, ruthless rigor is necessary. The device’s risk class, indication, claims, available data to support the device, and any recent changes in clinical practice will all influence the responses to these questions. An important part of determining if the device has enough clinical evidence is analyzing outcome data from high-quality studies relevant to the device’s intended use, and comparing the results to similar devices or other therapies.
Best practice to neutralize the first problem
Ensuring that data is evaluated and identified consistently is the best practice to counteract the challenges mentioned in the previous paragraph. Also, adopting a uniform assessment process for all products can enable meaningful cross-company communications and comparisons.
A uniform data evaluation approach promotes consistency across devices, guarantees that you do not miss regions when workloads are divided, aids prioritization in subsequent stages, and presents information consistently for effective comparison. The strategy should allow clinical data to be arranged in such a way that it is evident what data is available for each device, medical indication, and target group. Before identifying all relevant data, you may need to update the clinical evaluation, so allow time for this.
Contextualizing data in a broader risk framework. This could include f.e., trends in complaints, severity metrics for complaints, adverse events, recalls/FSCAs/FSNs, sales data, changes in specific marketing regions, political risk, hazard legalities, etc.
Collaboration with Other Departments and Workflow Communication: The Second Challenge in PMCF
Getting support from other stakeholder business units is pivotal for PMCF performance and continued regulatory compliance. Failure to align early in the process with departments other than clinical, such as sales and marketing or general management, is the next big stumbling block we see in our work with manufacturers.
When PMCF planning, cross-functional connection is crucial, because this level of examination and clinical evidence applies to both legacy and new products. In fact, legacy devices that have been on the market for a long time are likely to be the most vulnerable to these hazards. Non-specialists in the industry ask, “why do we need to spend money on compliance today for widely established products?” The fact is that the new regulation requires such clinical evidence. Gathering enough data – both in terms of number and quality/relevance – can be expensive. For these operations, it is pivotal to align with device priority, submission risk, and all accessible sources of data on a product.
Key Solutions
Notified Body reviews will discover clinical data gaps or emerging problems after the manufacturer has collected clinical data for CERs, PMS and Risk Menagements evaluations for each device.
Examine data quality and appropriateness. How useful is information gathered, and literature cited? Does the data support the device’s safety, functionality, and intended use? Is this the evidence enough for risk class and the NB?
How can manufacturers fill the gaps in the most effective/efficient way? Can SOTA, risk level, compliant data, or market experience support them? Should each indicator be more specific? Is there a list of relevant outcomes to support the clinical benefits? Does any bias need to be addressed? What percentage is due to post-market surveillance? How long is product support for? Does the clinical data include all product variations and ranges?
Assign ownership with a responsibility matrix. Firstly, within product teams (TDs, IFUs, product claims, SOTA). Then across Clinical & Performance, Regulatory Affairs, Product Quality, and Sales & Marketing. Recognise full device-specific requirements exist across the product portfolio. Collaborate with PMS, Marketing, R&D, and General Management. You must allocate resources to each device and prioritise according to certificate expiration date, gap analysis, likely life cycle (Implants), sheer amount of devices requiring data clean-up, and the product’s position within broader therapeutic systems.
The system must adapt to each product’s specific needs. How would you convey the data to an auditor? How does device data differ in terms of classification, range of indications, innovation, or market history? What are the device class and clinical gaps based options? Are there exceptions to the WET rule? Is a lower data bar acceptable/advisable?
PMCF planning needs many important commercial decisions, such as whether to keep all current products on European markets. Early starters can use PMCF planning to avoid leaving the market.
Documentation is lacking in detail : 3 Potential Problem in PMCF
The third most common PMCF compliance stumbling block is a reluctance to provide adequate detail in the documentation. Notwithstanding the efforts of the Medical Device Coordination Group and the Notified Bodies to make the detail abundantly obvious, far too many businesses fail to do so. The MDR sets a considerably higher bar for clinical evidence. Even when making minor changes to existing items, such as adding an antimicrobial coating or changing the manufacturing procedure or material.
Thus, it is pivotal to ensure that the amount of PMCF necessary, as well as the explanation for it, is consistent with the suggested strategy, which is based on good scientific principles, measurable targets, and statistical planning. Document the planned facts and justification, the underlying rationale vs. the hazards, and finally the references (footnotes to EU MDR, guidance, etc). Furthermore, the statistical justifications for the level of detail and data quality supplied are frequently insufficiently robust.
Solution: Develop a PMCF Strategy that is Compliant to EU MDR and ISO 14155
Clinical literature reviews nessecitates the least effort and money, followed by patient and customer surveys/questionnaires, clinical database information, and clinical RCTs. All of this add to the development of the most robust, meticulously documented reasoning for PMCF data inclusion/exclusion, depth, and relevance. It is fundamental to understand your PCMF strategy alternatives, including the cost and effectiveness of each device type, as well as any gaps.
Further, highlight the best combination of people, systems, and talents for the most cost-effective solution. F.e. What activities should be performed in-house, and which should be outsourced? Even when adequately budgeted, skills and resources are in short supply during times of acute market pressure.
It’s important to have strong justifications for PMCF plans that will withstand examination. Justifications should be based on good scientific concepts and include explicit, measurable goals, as well as extensive documentation. The use of economic rationale (exorbitant costs) to rationalise risk-taking is never a good idea. Each PMCF activity should have its own business considerations. Timeline of the activity, available budget, risk class of the device, quality of data needed to establish sufficient proof, and whether a general or specific PMCF activity will give the data required are all factors we propose include in the evaluation.
What is the relationship between your PMCF strategy and Notified Bodies? “Consultation or guidance to the manufacturer, the authorised representative, a supplier, or their commercial competitor regarding the design, construction, marketing, or maintenance of the products under examination” is prohibited for NBs.
MILO ePRO: A Game-Changer Platform to Leverage your PMCF Plan
Milo ePro provides compliance with all relevant FDA, MDR, and GDPR requirements. With direct feedback from patients, Milo ePro streamlines your participation in clinical trials. The reduced need for on-site appointments allows patients to effortlessly incorporate the upkeep of the electronic patient diary (eDiary, ePRO) into their daily routines.
Additionally, the straightforward handling and intuitive nature of the tools contribute to increased retention and completion rates and the modern structure ensures direct feedback from a broader range of patients. Milo eCOA and ePRO solutions prioritize patient safety throughout the data collection process. Real-time data enables swift responses to adverse events, ensuring proactive intervention.
Moreover, the integration of ePro within MILO DCT enables real-time patient data collection. This means you can access and analyze health data as it’s entered by patients in the MILO DCT application. This guarantees informed decision-making, quicker adjustments to ongoing trials, and ultimately, greater success.
