*The translation of this article in French and Portuguese has been made through machine translation and has not been edited yet. we apologise for any inaccuracies.
Real-World Evidence studies, which include PMCF (post-market clinical follow-up) studies, collect real-world data to evaluate the safety and performance of medical devices. This M3 Guide reveals how M3 Global Research conducts Real-World Evidence studies, how they contribute to better patient outcomes, and how healthcare professionals can get compensated for sharing their medical experience in paid studies about medical devices with M3.
Research, development, and follow-up studies of medical devices are essential to improving patient safety and patient outcomes. They make it possible for physicians to prevent, diagnose, and treat patients effectivity.
Learn more about Real-World Evidence studies:
How do Real-World Evidence Studies Impact Patient Outcomes and Safety?
Before a medical device can be legally released on the market and used for patient care, the product needs to get a CE mark in Europe, similar to an FDA approval in the US. The CE mark is a regulatory mark that indicates compliance with EU Medical Device Regulations (EU MDR). To receive a CE mark, the medical device needs to undergo an assessment to prove it complies with all essential requirements of safety and performance.
After receiving a CE mark, manufacturers must follow specific steps and ongoing processes to ensure their medical devices maintain the CE marking. After the device is released on the market, manufacturers and regulatory authorities monitor its ongoing safety, performance, and effectiveness through post-market surveillance activities. Ongoing monitoring involves collecting and analysing data on how the device is used in clinical practice and real life, as well as data on adverse events, complaints, and other relevant information.
Real-World Evidence studies are one of the essential ways for manufacturers to gather real-world evidence to assess the long-term safety and performance of their devices, both for regulatory purposes and for better patient outcomes. By collecting real-world data and feedback from healthcare providers and patients, manufacturers can detect and address potential safety issues promptly, improve device performance, and enhance patient safety. It’s an ongoing process that ensures that medical devices remain safe and effective throughout their lifecycle in the market and retain their CE mark.
How does M3 Conduct Real-World Evidence Studies?
M3 Global Research’s primary goal of a Real-World Evidence study is to gather data derived from real-life experiences with medical devices. This data is collected through paid online surveys involving physicians and other healthcare professionals, who provide fact-based feedback on the functionality of the medical device and how it’s used in their clinical practice. As always with M3, your personal data is protected at every stage of the study, from recruitment to reporting. Read more about our ISO certifications and privacy policy.
What is the difference between a Real-World Evidence study and a healthcare market research study?
Both Real-World Evidence studies and healthcare market research studies can be conducted through paid online surveys and require input from healthcare professionals. So, what’s the difference? The distinction lies in the type of feedback required. Real-World Evidence studies aim to collect fact-based data, including functionality and practical use, based on real-life experiences, specifically for medical devices. Meanwhile, healthcare market research studies concentrate on gathering opinion-based data, such as perceptions, impressions, and thoughts about various healthcare products and subjects. Both are equally vital for enhancing patient outcomes but serve different purposes.
The most important aspect to consider when participating in a Real-World Evidence study is the necessity of providing accurate and transparent information. As this data is collected for regulatory purposes, ensuring its high quality is essential.
Before participating in a Real-World Evidence study, it is recommended to carefully review the study details and confirm you possess the required real-life experience with the specific medical device in question.
Here are a few questions to demonstrate what might appear in a Real-World Evidence study. Please note, that these are example questions only. You may also be asked to provide other details about the medical device in question, such as the manufacturer.
- Within the last two weeks, have you personally used this medical device to perform any of the below actions or procedures? (select from “yes” or “no” answer options).
- Thinking about the last instance where you personally used this medical device, please indicate what indication(s) the device was used for (select from a list of answer options).
- For the following characteristics, please rate the medical device using a scale of 1 to 5, where 1 is “Performs far below expectations” and 5 is “Performs far beyond expectations”.
- Please provide more details as to why you rated the medical device as performing below expectations for the following characteristics (open answer).
- You stated a complication that was directly related to the medical device. Please provide some additional information and review your answers to ensure only those directly related to the medical device are captured and NOT related to the procedure, patient, or any other accessories.
How to Participate in Real-World Evidence Studies with M3?
As an M3 panel member, you have access to a wide variety of paid study opportunities. Depending on your profession, specialty, and medical experience, you will receive tailored study invitations matching your M3 profile.
Your M3 profile is the most important tool to utilise if you want to maximise your earnings and experience as a panel member. Follow the instructions in this M3 Profile Guide to build your profile over time and start receiving relevant and personalised study invitations.
Three steps to start participating in paid surveys about medical devices:
- Join the M3 Panel: Register here, confirm your email address, and go through the verification process.
- Build Your M3 Profile: Log in to your M3 Account and answer profiling questions to receive invitations to paid studies matching your profession and medical specialty.
- Receive Compensation: Select and complete a paid study on your survey dashboard and receive payment via the M3 Wallet.
Keep an eye out for this icon in your study invitations sent to you via email, which indicates it is a Real-World Evidence study.
Real-World Evidence studies are convenient and flexible as they are online surveys and can be taken when your schedule allows. They usually take around 20-30 minutes to complete and as always with M3, they provide competitive compensation and certified privacy protection.
If you want to discover how your medical experience and participation can impact your career, patient outcomes, and the future of healthcare developments, read what these M3 members have to say in the interview articles below:
Are You Willing to Share Your Medical Experience in Paid Studies About Medical Devices?
Be part of the M3 Panel and get rewarded when you share your opinions in paid market research studies involving real-world data in paid studies about medical devices
Get to Know Paid Studies About Medical Devices
How Healthcare Market Research Shapes the Future of Treatments and Devices
Healthcare market research shapes the future of treatments and devices through digital research methods and clinician insights.
Market Research Methodologies – M3 Study Guide
A quick guide to help you navigate through the different market research methodologies that we use.
