PMCF SURVEYS

PMCF surveys or ‘end user’ surveys are a valid method of collecting post-market clinical data. They can be used to gain information on a device and its use from both healthcare professionals and patients by providing a set of questions to be answered.

What is PMCF SURVEYS ?

PMCF surveys or ‘end user’ surveys are a valid method of collecting post-market clinical data. They can be used to gain information on a device and its use from both healthcare professionals and patients by providing a set of questions to be answered. These questions should be carefully considered for each device. The nature of the product and the target population will inform the types of questions asked.

These are not the usual ‘marketing’ survey. This is a clinical data generation tool.

The nature of the survey can vary. They can be general or specific – for the lower-risk devices and established technologies then a more general survey on user feedback can be utilized. For products in the high-risk categories a manufacturer should consider a more specific survey activity.

General surveys tend to be retrospective design – asking the end-user to recall information on the device and its use.

Specific surveys can be patient level and case specific – this can be a single survey or a series of surveys that follow the usage of the devices (prospective). This could be direct to the patient or via a healthcare professional using patient records. The data obtained from this type of activity will be of higher quality – usually producing clinical data on the devices under review via patient outcome data and clinical indication data.

When designing and conducting a study there are some considerations:

What are the data gaps?
What is the method of analysis going to be? Are they justified?
Are the necessary consents and approvals in place?
What is the sample size needed?

Survey method – online/in person/telephone/postal – what is most appropriate for the group you wish to approach?

When are surveys a good choice?

Where a manufacturer has direct access to their end-users, either healthcare professionals or patients.

They are an agile tool, they have the potential to reach different user groups, and they are not limited by group size.

Surveys can be resource efficient both in terms of financial commitment and staff resource. In addition to this, they can be conducted in a remote setting This reduces the need for research personnel to be actively involved in collecting the data, it also reduces the burden on patients in terms of attending additional appointments. Although it should be noted, that the more specific surveys, particularly the case studies and series of surveys will likely require more time and more financial input, likewise an in-person or phone-based survey will have resource implications.

Challenges to implementing a survey

Access to the end-users – this can be limited /restricted e.g. if a distributor is used.
Bias – the structure of the survey is important in minimizing bias. More of a concern with subjective healthcare professional responses.
Lack of responses – the survey needs to be accessible and simple to complete. Users may get ‘fatigue’ in completing them if they are too long, too complicated or not relevant.

Loss of focus – as set out above the survey needs a clear direction – if too many objectives are attempted the survey may not be clear enough, and the data returned may be skewed.
GDPR compliance is critical
Ethical review and approval may be required – individual countries may have different requirements.

How to address gaps

Review the PMCF and identify the gaps in the data – seek to align the objectives and the questions of the survey with these gaps. It is important to maintain a clear focus on this activity to ensure it feeds in appropriate data to the PMCF.

There may be a need for more than one survey over time, however this should be part of the ongoing development of the PMCF plan and analysis of the data gaps identified.

How ECLEVAR Can help you:

PMCF Surveys team encompass:

Clinical project manager

Data protection officer

Data manager

Data engineers

Senior Statistician

Clinical Nurses

Medical advisors

Get 1 Hour free consulting

During 1 hour, our Eclevar experts will answer your questions and will guide you to the next steps!

Join us now

DATA CAPTURE PLATFORM ENGINEERED FOR MEDICAL DEVICE PMCF SURVEYS UNDER MDR

Collect scientifically valid and MDR compliant PMCF data using our platform:

Pre-validated and compliant data platform:
Our platform is compliant with ISO14155:2020 requirements and GDRP.

Fully documented data traceability

All data inputs automatically include automatic user identification to ensure fully documented traceability from source to sponsor via using State of The Art technology -> Blockchain.

Easy GDPR compliance

Easily comply with GDPR requirements for informed consent and data protection. Our in house data protection officer monitor the compliance for all the studies.

The EU MDR defines Post-Market Clinical Follow-up (PMCF) as a continuous process that updates the clinical evaluation referred to in Article 61 Clinical Evaluation and Part A of Annex XIV Part A Clinical Evaluation. PMCF is a proactive collection and evaluation of real-world clinical data, with the aim of confirming the safety and performance throughout the expected lifetime of the device.

There 4 main methods of PMCF activity in order to collect the data: traditional clinical studies, registries, Observational data collection, surveys.

Depending on the medical device, each method has its own considerations on data quality and PMCF design as well as risks and benefits. The Webinar below outlines the team effort, and also the pros and cons of using surveys for PMCF, how to distinguish between Marketing Surveys, Clinical Surveys and Subject Surveys, and what needs to be considered from an Investigator’s perspective. This case study will be explained from our senior clinical project manager and ophthalmologist.

Learning Objectives

Interdisciplinary team set-up

Survey based on Classification of Device:
Difference between Marketing Surveys, Clinical Surveys, Subject Surveys
Retro- or prospective Data collection,
Question of validation of survey

Investigator’s perspective

Play Video

Presenters:

MARKO LUKIC, PHD, FEBO, FASRS

Scientific Board Member, Referent Ophthalmology at ECLEVAR MEDTECH

Dr. Marko Lukic, Ph.D. FEBO FASRS is a consultant ophthalmologist specializing in retina and uveitis. He is affiliated with Moorfields Eye Hospital NHS Foundation Trust, where he serves as a consultant ophthalmologist in medical retina digital imaging clinics. Dr. Lukic completed two fellowships at Moorfields Eye Hospital: in 2016 Clinical Medical Retina Fellowship and the 2017 Clinical Research in Retina Fellowship. During his clinical research fellowship, dr Lukic participated as an investigator in more than 15 clinical trials. Dr. Lukic passed the ICO subspecialist exam in the retina in October 2020 and finished his Ph.D. in November 2021 at the Medical School of the University of Split, Croatia.

Dr. Lukic has been designated as a Fellow of the American Society of Retina Specialists since May 2022.

Dr. Lukic’s research interest is real-life data in diabetic macular oedema and wet age-related macular degeneration. His continuous research work resulted in manuscripts published in highly ranked journals like Nature Medicine, AJO, Retina, EJO, etc. He serves as a reviewer in highly rated ophthalmology journals. Dr. Lukic has been part of the team of experts who participated in a collaborative project between Moorfields Eye Hospital and Google’s Deep Mind to develop an artificial intelligence system to recognise various retinal conditions based on deep learning protocol. Dr. Lukic lectures ophthalmology at the Medical School of Zagreb and serves as a medical retina tutor to optometrists at the University College of London, UK.

Dr. Lukic is the owner and director of the European Medical Consultants, one of the leading European companies specializing in teleophthalmology. Dr. Lukic sits on the advisory board of Eclevar and serves as an external expert for Specsavers Nordic.