10 November 2020 - RQM+ experts have come up with a list of our top ten suggestions for mastering Post-Market Clinical Follow-up ("PMCF") Surveys under the European Union's Medical Device Regulation.

By: Torrie DeGennaro, CBA,  Associate Engineer and Celeste Maksim, PhD, RAC,Principal Specialist

1) Create a clinical evidence matrix.

To clearly identify gaps to clearly align survey objectives and questions with areas of Post-Market Clinical Follow-up ("PMCF") need. For clinical evidence guidance refer to MDCG 2020-6.

2) Give your survey a clear objective.

The PMCF survey should have a clear objective and not have conflicting purposes that could confuse the respondent. This can result from attempting to combine a PMCF survey with a marketing survey.

Your survey respondent can lose focus easily if you try to cover too many diverse topics, resulting in less useful data needed to meet the requirements of the Medical Device Regulation ("MDR"). This is a dilemma within many companies where marketing holds the survey budget.

3) Weigh your options carefully.

Phone or in-person interviews and online surveys have different benefits and risks that need to be carefully weighed based upon the intended respondents. For example, in a phone survey, the interviewer’s tone, pace, volume, and enunciation of words can have a major impact on your results. Whereas a risk with the online survey is that it relies heavily on question wording and design, which is too complex can result in low response rates. Choose a methodology that will optimize your scenario for success.

4) Keep it short.

The survey should be 15 questions or less and try to limit the question length to 20 words or less. If longer, consider presenting some of the background material before asking the question.

5) Keep it simple.

Each survey question should present one idea or topic, and avoid double negatives or double‐barreled questions. The simpler the better. Always keep the respondent’s perspective in mind.

6) Align questions and response options.

Choose response options/scales that make sense for the question, and do not create confusion or undue stress on the respondent. For example, a Likert type scale is a great choice for simple measurement of agreement or disagreement. Also, a frequency scale is a great approach when it is important to establish how often a target behavior or event has occurred.

When you design your clinical evidence matrix and determine that a survey can fill that need, make sure the questions and response scales will produce data that aligns with the original objectives. We recommend having a clinician review the survey before deploying it.

7) Avoid response bias.

A mixture of both positively and negatively worded items may minimize the danger of acquiescent response bias, i.e. the tendency for respondents to agree with a statement or respond in the same way to two similar items.

8) Time is of the essence.

Most studies indicate that surveys that take five minutes or less to complete tend to get the best response rate. Anything longer than 11 minutes is likely to result in higher abandonment rates and/or random answers.

9) Use close-ended response options.

Free text response or open questions allow respondents to expand upon answers and provide more in‐depth responses. However, to avoid survey fatigue we recommend reframing questions so they are closed-ended and require a simple, straightforward ‘yes’ or ‘no’ response. If required, use open-ended questions towards the beginning/middle of the survey when respondents are most engaged.

10) Use validated tools.

Additional laws outside of the EU MDR Post-Market Surveillance ("PMS") requirements apply to survey activities. Use a validated tool for data collection and respondent contact handling. Surveys require GDPR compliance and may require PHI/HIPAA compliance as well. If honoraria are being supplied to respondents, tax and Sunshine Act reporting may be applicable. Additionally, although unlikely, IRB/EC review may be required for surveys collecting detailed patient data or used for medical research purposes.

The Bottom Line: 

A PMCF Survey is not your standard marketing survey. Regulatory and clinical expertise is required at every step to ensure success and a good investment of your resources.

>> Access now: RQM+ and RAPS On-Demand Webcast - Strategies for Successful PMCF Planning and Execution

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Source::
[1] Medical Device Coordination Group Document. MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies. Published 23 April 2020. Accessed 12 August 2020. https://ec.europa.eu/docsroom/documents/40904?locale=en

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