Spotlight on Post Market Clinical Follow-Up Surveys
Interview with Marcus Torr:
PMCF/MDR Lead at Purdie Pascoe
An introduction to Marcus
Marcus, tell us a bit about yourself?
I joined Purdie Pascoe in 2015, shortly after graduating with a First Class MSci in Natural Sciences (Chemistry with Pharmacology) from the University of Bath. Nine and a half years later, I’m still here, though my role has evolved from focusing on Primary Market Research to leading our Post Market Clinical Follow-up (PMCF) team, a position I’ve held for the past five years.
When you aren’t delivering PMCF insights to clients, what do you enjoy doing?
I used to spend my Saturdays playing and managing a Step 7 football team called AFC Cubo. After over 150 games across 9 years, I’ve slowed down and now focus on spending more time with my wife and one-year-old, while trying to squeeze in a game of golf.
If you could have one superpower, what would it be, and why?
Ability to fly – there’s nothing worse than being stuck in traffic or waiting around at an airport. I want to travel and see more of the world, and what better way than to do it yourself, enjoying some beautiful views along the way.
Marcus’s Perspective - Deep Dive
What is Post-Market Clinical Follow-up (PMCF)?
PMCF requires manufacturers to proactively assess the safety and performance of their devices, once on the market, and record this data throughout the product’s lifecycle for compliance with the European Medical Device Regulation (EU-MDR). PMCF data can be collected through various approaches, such as Clinical Investigations, Registries, Surveys and Literature Reviews.
Why should medical device manufacturers consider PMCF surveys?
PMCF surveys are a cost-effective method for collecting PMCF data. They require significantly less time and resources compared to other approaches, such as clinical investigations and registries, making them much more affordable. Additionally, PMCF surveys offer flexibility, enabling manufacturers to gather Level 8 data through general end-user surveys or Level 4 data via high-quality, case-specific surveys.
Could you briefly explain the post-market clinical follow-up (PMCF) survey process?
Manufacturers must first justify and provide a rationale for including a PMCF survey in their PMCF plan. It is then critical to draft a PMCF survey protocol, documenting the methodology, objectives, endpoints, sample size, and acceptance criteria. The survey questions must align with the objectives and endpoints before implementation (programming, recruitment, data collection, etc.) can begin. Throughout implementation, it is important to consider data privacy regulations (e.g., GDPR) and compliance requirements (e.g., ISO14155). Once the sample size is met, the data can be analysed, and the report outputs drafted before integrating them into the manufacturer’s MDR submission.
What are the biggest challenges surrounding PMCF surveys?
We often see manufacturers choose PMCF surveys because they are quicker and cheaper, rather than the most suitable option. Therefore, it’s crucial for manufacturers to invest proper time and resources in carefully planning their PMCF approaches. If a PMCF survey is deemed appropriate, the main challenges we have observed include:
• Determining appropriate safety and performance endpoints and acceptance criteria
• Selecting a statistically justified and robust sample size
• Identifying and recruiting end-users
What are the solutions to these challenges?
The simple answer to ensure successful PMCF surveys is proper planning, whether using internal resources or external support. For endpoints and acceptance criteria, manufacturers should leverage their clinical documentation on the specific device and review state-of-the-art (SOTA) literature. Sample sizing is tied to endpoint selection, as the calculations should be based on the primary endpoint and acceptance criteria, while also considering feasibility. Once the sample size is determined, manufacturers should assess if recruitment can be managed internally. If not, external providers, such as Purdie Pascoe, can offer extremely valuable support.
What most excites you about the work you do?
Working directly with our clients, I enjoy sharing my knowledge and expertise on PMCF surveys to provide solutions that confirm the safety and performance of their devices, ultimately enhancing patient safety. Additionally, over the past five years, I’ve built a team to help implement these surveys. Witnessing individual growth and progression within the team has been incredibly rewarding.
Can you tell us more about the PMCF expertise at Purdie Pascoe?
We have conducted over 400 PMCF surveys over the last 5 years, for a range of manufacturers, device types and risk classifications. We have expertise to help design and implement a best-in-class approach for both Level 8 and Level 4 surveys and have a team of 15 experts dedicated solely to PMCF survey support. Our flexibility allows us to provide full-service support, from PMCF survey planning to reporting, as well as assistance at specific project stages when needed.
Since you started the PMCF function, how has the industry evolved?
In 2019, with the MDR approaching, there was minimal guidance on the best methods for collecting PMCF data. Manufacturers started experimenting, often using exploratory surveys that gathered lower-level evidence with limited statistical rationale and justification. However, in the past 2-3 years, we’ve observed a significant shift towards collecting higher-level data, supported by much more comprehensive PMCF survey protocols.
What makes Purdie Pascoe’s PMCF expertise unique?
I believe no other company has a division solely dedicated to PMCF survey implementation. This focus and commitment gives our team unrivalled knowledge, enabling us to not only support manufacturers but also partner with them. The sheer number of PMCF surveys we’ve conducted speaks for itself, and we take pride in the fact that the majority of our clients are repeat customers.