Episode description
The RQM+ team has collected PMCF data from surveys on thousands of patients and charts on hundreds of devices, and we're excited to share our case studies. In this Live! show we will dive into our PMCF survey successes and discuss the ways that surveys have significantly helped manufacturers maintain label indications by providing a process for collecting data to support all claims, indications, and user populations. The survey approach has saved our clients significant amounts of money (in the millions) by avoiding the need to remove indications that would cause relabeling and rework of product in the field, or worse, complete removal of the product from the market.
We'll cover the four types of surveys we conduct:
- General user feedback surveys
- General user feedback surveys deployed through a panel
- Patient level surveys
- Retrospective patient chart review conducted via surveys.
Panelists will discuss details to make planning PMCF surveys for your portfolio a success including:
- Realistic survey activity timelines
- Ideal team composition and size
- Regulatory, ethics, and legal considerations
- Using survey data to address notified body review questions
This is a unique opportunity for you to ask questions on the details of what makes these surveys a success and how to apply surveys to your products.
- Celeste Maksim, Ph.D., RAC - Chief of Staff and Moderator
- Jaishankar (Jai) Kutty, Ph.D. VP, Intelligence & Innovation
- Niki Spaniel, RAC - Senior Principal Specialist
- Brian Hockett - Principal Engineer
- Torrie DeGennaro, CBA - Senior Engineer
- Ethan Elshoff - Associate Project Manager
Questions:
3:03 What risk classes of devices have we done surveys for?
3:26 Can the team provide some different types of surveys or styles, and then examples with devices?
4:39 Do you have any example of one of the patient level surveys?
8:15 Have these surveys been submitted to notified bodies? Have they been reviewed successfully? What has your feedback been?
12:23 Can the team elaborate on collecting long-term data via surveys? 14:30 -- Discussion around data quality and ranking the quality of data coming from a survey
18:40 What are some things we've learned about question design? How are you able to obtain meaningful data?
19:43 Bias when it comes to physician surveys: What if people are responding that use the device quite a bit? When doing these surveys and getting responses, if physicians are responding from memory, how is that weighted factual evidence vs. patient charts.
24:43 What do we do to improve the response rate?
26:11 What is a realistic timeline to develop a protocol, deploy a survey, analyze the data, and write a report?
27:36 Some clients don't want to ask certain questions in their survey, like adverse events or emerging risks - how do you handle that?
32:15 For devices not geared towards patient chart review, how do we do surveys for these types of devices? 34:45 - What do you mean by "panel?"
36:03 What are the regulatory requirements for a third party panel?
37:55 How important is translation?
38:43 What are you seeing as the acceptable number of responses?
40:18 For a population-based approach, what if the device has very little sales (less than 100) and it's a Class III product. What would you recommend we do?
43:09 Regarding a Class IIb imaging device... the surrogate endpoint is image quality and there is not a large install base. From a deployment perspective, what do you recommend?
44:48 Do you have any specific device related to surveys for mass market medical devices?
46:36 Any final advice or things we want to leave the audience with today?