Human in the Lead: Insights from the RAPS Convergence in California
The Purdie Pascoe Post Market Clinical Follow-up (PMCF) team was out in full force at this year’s Regulatory Affairs Professionals Society (RAPS) conference in Long Beach, California in September.
Marcus Torr, PMCF/MDR Lead, attended with PMCF Managers, Martha Vakalopoulou and Chris Webb. The team jetted off from London to the California sunshine to eagerly set up the exhibition booth, showcase a range of new merchandise and kick-start exciting conversations with leading regulatory and medical professionals.
Following a very successful networking reception on the opening evening, the main conference got underway. The Purdie Pascoe booth was a hot spot at the conference, where the team met a variety of current clients and developed many new connections, whilst discussing all things PMCF surveys.
Marcus and Martha also presented an insightful paper on day two of the conference to delegates titled ‘Best Practices in the Use of PMCF Surveys’.
Key takeaways:
Artificial Intelligence: Ride the wave
This year’s conference theme, “Human in the Lead,” sparked a series of engaging conversations, with thought leaders taking the stage to discuss this crucial aspect of our industry. The opening plenary session focused on Artificial Intelligence (AI) and emphasised the need to balance our increasing reliance on these tools with proper human input and oversight, to ensure quality and protection of data.
The theme aligns perfectly with why our Purdie Pascoe team attended the conference. We assist MedTech manufacturers in collecting PMCF and Real-World Data through surveys and understand that controlling data is paramount for compliance. However, without proper design, quality control, and analysis, the validity and integrity of data could be compromised.
Patients at the forefront: Unmet needs
Addressing unmet medical needs for patients is a significant challenge in the medical industry. The EU Commission is making commendable progress in aiding manufacturers to develop medical devices for rare diseases. There is concern, however, that the Medical Device Regulation (MDR) has stifled innovation, particularly for unique or rare conditions. So, how can we introduce these innovative devices to the market without compromising patient safety?
To achieve this, we need greater stability and clarity, which can be realised through the principles of the MDR. This includes long-term solutions for orphan and innovative devices, improved efficiency in administrative processes, digitalisation, and consistent oversight from a global perspective. Through careful evaluation, changes will come but they won’t be immediate, MDR adjustments are crucial for enhancing patient safety and addressing unmet medical needs.
Human interaction: Critical for collaboration
Collaboration and meaningful dialogue between Medical Device Manufacturers and device users is vital to enhance communication, build trust and ensure cohesive and effective outcomes. The RAPS convergence exemplified this need for interaction and the importance of face-to-face meetings with industry colleagues. Whether asking questions in sessions, discussing ideas in the exhibition hall, or catching up at networking events, these interactions foster key advancements based on a shared common purpose, the patient perspective and improving health outcomes.
Purdie Pascoe PMCF survey expertise
Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with ISO requirements and GDPR regulations, for PMCF surveys.
We can support you with the design, implementation, data collection and reporting of your PMCF surveys to ensure you collect appropriate PMCF data to be used within your Medial Device Regulation (MDR) submissions.
