Assisting in Post-market Clinical Follow-up (PMCF), involving the Protocol preparation and execution of the survey for an ophthalmological medical device targeting the global market
Background/Client Requirement:
Our client is a prominent global healthcare enterprise specializing in Ophthalmology, a leading manufacturer of ophthalmological devices, implants, solutions, and accessories. Client launched cutting-edge products designed to improve visual acuity for individuals with a specific ocular condition. The client approached Techsol to develop a protocol for their Post-Market Clinical Follow-up (PMCF) to conduct a survey for their ophthalmic medical devices, targeting the global market.
Project Objective:
This initiative aims to design a rigorous and comprehensive PMCF protocol aimed at collecting real-world data to substantiate the device’s long-term safety and efficacy profile. The protocol also ensures compliance with international regulatory standards, including EU MDR, U.S. FDA, and Asia-Pacific requirements, to maintain market approval.
Techsol Approach:
A structured, and stepwise approach was taken to develop a PMCF survey protocol for the ophthalmological device that addressed regulatory standards and practical real-world data collection needs. This included identifying data requirements from multiple perspectives such as regulatory compliance, clinical efficacy, and user experience. Ensuring the protocol met the stringent regulations from the EU MDR, U.S. FDA, and Asia-Pacific countries and include safety monitoring, efficacy assessments, and real-world usage feedback. Regionally adaptable questionnaires were created to capture clinical performance, user satisfaction, and potential adverse events. The protocol was validated and refined for clarity, relevance, and ease of execution.
- Designing a PMCF survey protocol that effectively addresses research objectives while minimizing biases and confounding factors.
- Navigating through varying regional regulatory requirements without overcomplicating the protocol.
- Designing survey questions that were relevant and culturally appropriate across various regions.
- Securing a representative sample of healthcare providers and end-users in each region.
- Managing and protecting participant data across regions with varying privacy laws (e.g., GDPR in the EU, HIPAA in the U.S.).
- To address the challenges, our expert Medical Writing team employed rigorous protocol development methodologies and bias-reduction techniques, to ensure alignment with PMCF survey objectives.
- Our Regulatory Team conducted a thorough regulatory analysis, aligning the protocol with the most comprehensive regional standards to ensure global compliance.
- Our statistical experts performed thorough literature reviews and used ctri.gov were curated to establish an optimal sample size, guaranteeing a substantial response from healthcare professionals (HCPs).
- Surveys were translated and culturally adapted with the help of in-house linguistic experts and local clinical professionals to ensure questions were universally understood to accurately capture the user experiences. Regional piloting helped to identify and resolve any region-specific misunderstandings.
- Partnerships with local ophthalmology societies and patient advocacy groups, leveraging their networks to increase participant engagement, supported by regional coordinators to manage recruitment efforts locally.
- Regulatory requirements, were continuously monitored and integrated into the protocol, ensuring compliance with evolving standards for ophthalmological medical devices and PMCF surveys.
- A centralized, encrypted data management platform compliant with GDPR, HIPAA, and other regional standards were employed, with anonymization techniques protecting participant identities.
- Techsol’s MW team strategically planned and developed a detailed timeline for survey design, implementation, and data analysis. This plan ensured the completion of the PMCF survey within one month.
Project Achievements:
The PMCF protocol was successfully delivered, incorporating all major necessary components for comprehensive real-world data collection and regulatory compliance.
Key achievements included:
The survey study was carried out with ease and efficiency.
The PMCF data met the requirements of several international regulatory bodies, including the EU MDR, ensuring continued market approval.
High Satisfaction Rates were observed with over 85% of users reported improvement in visual acuity and overall satisfaction with the device. Minimal adverse events were reported, all of which aligned with expected device performance as outlined in the pre-market studies.
The culturally adapted surveys and multi-channel recruitment strategy resulted in a strong pool of participants, increasing the robustness of data that would be collected.
Customer (HCP) feedback influenced the device’s utilization across various countries, leading to its global market penetration.
Project Outcomes:
The client’s marketing success was significantly boosted by the PMCF survey, offering insights into real-world usage and enabling tailored strategies. Drafting the PMCF protocol has successfully set the foundation for a post-market clinical follow-up demonstrated the importance of a thorough, collaborative, and adaptable approach in developing PMCF protocols, especially for medical devices targeting global markets. The completed protocol served as a critical tool, supporting the client in ensuring ongoing compliance, gathering real-world performance insights, and maintaining a high level of trust and satisfaction among users.
Our Medical Writing Capabilities:
•Rich experience across therapeutic areas and expertise in regulatory documents and scientific communications.
•Robust two-step review process for quality control and high-quality deliverables.
•Customized solutions compliant with the evolving regulatory landscape.