Episode Number: 058
Release Date: April 23, 2023
Guest: David Rutledge
Connect With Guest: https://www.linkedin.com/in/david-rutledge-9291609/
Guest Biography:
In this episode, we’re going to talk about Postmarket Surveillance Studies.
In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.
To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast.
David is the President & CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations.
David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs.
David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, the author of Mythical Medical™: Revelations from a Global Product Approval Consultant.
Enjoy!
Sponsors:
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 37,000 study sites, sponsors, and CROs in 90 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
Resource and Links Mentioned:
Food and Drug Administration (FDA)
European Union Medical Device Regulator (EU MDR)
SCAAR Registry (now SWEDEN HEART))
Academy of Orthopedic Surgeons in US (AAOS)
Australian Orthopedic Registry
Manufacturer and User Facility Device Experience (MAUDE) Database
EUDAMED – European Database on Medical Devices
Medical Device Coordination Group
US Postmarket Surveillance – Code of Federal Regulations (CFR)
Books and Literature Mentioned:
Mythical Medical: Revelations from a Global Product Approval Consultant – David Rutledge (Amazon)
Simple: Conquering the Crisis of Complexity – Alan Siegal (Amazon, Barnes & Noble)
Linchpin – Seth Godin (Amazon, Barnes & Noble)
The Obstacle is the Way – Ryan Holiday (Amazon, Barnes & Noble)
The Five Dysfunctions of a Team – Patrick Lencioni (Amazon, Barnes & Noble)
Thank You For Arguing – Jay Heinrichs (Amazon, Barnes & Noble)
28 Days to Save the World – Dan Purvis (Amazon, Barnes & Noble)
Related Episodes
Becoming an Intelligent Clinical Researcher with David Rutledge
Show Notes:
[0:20] Kunal Joins and provides background on David Rutledge
- CEO of Global Strategic Solutions
- Global Consultant for Clinical Evaluations Risk Management, Regulatory Quality, and Clinical Investigations
- Previously Director of Abbott Medical Devices Global Clinical Research and Global Regulatory Operations
- Worked to submit to US FDA, Health Canada, Australia TGA, Japan PMDA, and EU Notified Bodies
- Published over 100 manuscripts and served on two FDA Panels
[3:10] Sponsor Break: Florence (https://florencehc.com)
[4:22] David joins and discusses his appearance on the first Clinical Trial Podcast episode
- Previously worked with Kunal on a book club for a book called Simple
- Additional book recommendation Linchpin by Seth Godin
[8:14] Differences between FDA and European MDR
- Post Market Surveillance broadly: process for handling complaint and analyze them over different timelines and within different regions
- Important to create Quality Management Systems (QMS) and managing them through continual maintenance and updating of documentation
- Postmarket Clinical Follow Up (PMCF): proactive approach to collecting data instead of reactive to complaints
- In Europe, this is typically required for all products
- In the US its not always required and contingent on the approvals and risk of the product
[12:57] Clinical Evaluation Plans and Reports for Post Market Surveillance
- Post Market Surveillance is big umbrella and PMS Plan fits into that
- Clinical Evaluation Plans/Reports aren’t required processes in the US but in Europe and Australia, and in Asia they are commonly a requirement
- Clinical Evaluation Plans outline what data you will be collecting post-approval
- MAUDE – US Database for volunteer submissions of complaints
- Nyquist Data – AI driven program that extracts data out of the MAUDE database
[17:57] How to keep up with FDA 483s: Notice of Inspectional Observations
- Some subscription services that give you information
- AI driven tools are helping to solve the problem of keeping up with these notices
[19:47] Clinical Evaluations and Clinical Evaluation Plans
- Data comes from both proactive collection and patient follow ups
- Data is compiled into Clinical Evaluation Report (CER)
- Surveys like Likert scales are common surveys used to collect this information
- Very robust and useful for actually generating objective and statistically significant data
- Data can be collected from patients in on-label or off-label settings. Physicians often contact Sponsors if interested in off-label studies to get access to product
- Cardiovascular registries: SCAAR, TVT, NCDR
[27:04] Challenges with Identifying Country Specific Registries
- No specific location where different disease based registries are listed
- National Joint Registry in UK
- Academy of Orthopedic Surgeons in US
- Australian Orthopedic Registry
[28:16] Resources for Identifying Surveys
- LinkedIn Articles
- QuestionPro program for developing surveys
- Greenlight Guru is another QMS system
[29:43] Differences between National/Regional Registries and Hospital Databases
- Hospital Databases are not linked like Registries
- China has divided country into quadrants with regional registries
- Typically have to work with Chinese CROs
- Sometimes within hospital systems different departments are capturing different data and you need to aggregate across them to answer research questions
[35:33] Registry Data from China
- Quadrant divisions inChina, one of the quadrants links all the patient hospital data, and potential follow up
- CROs work as intermediaries between research companies and groups running different quadrants
[38:40] Revisiting Clinical Evaluation Reports
- Clinical Evaluations/Reports are of interest to EU, Australia, and China
- Plans can be updated and are sometimes influenced by the total amount of available data
- Decision to write report is sometimes influenced by the amount of available data
- Report templates available for Europe from the Medical Device Coordinating Group (MDCG) for Postmarket Clinical Follow-up (PMCF) Plan and Report
[41:47] Sponsor Break: Florence & Calyx (https://florencehc.com) & (https://www.calyx.ai/)
[44:24] Motivating Physicains to do Registry Studies
- Sometimes younger investigators are more motivated because they want to build relationships with sponsors
- Interest sometimes diminishes the longer studies go on
- Compensation for registries sometimes presents a challenge as it is lower and makes interest lower
[48:07] Who is Responsible for Post-Market Surveillance?
- Manufacturer is responsible for what’s in the quality system of that governing country
- Regionally what is captured and how much people want to spend on Post-Market Surveillance can vary
- Some see PMS as an expense, others see it as investment in getting more information
- Some countries do get a nice amount of revenue from requiring PMS studies
- Sales of devices for post-market surveillance studies can be revenue generating in some regions
[53:39] Different Examples of Post-Market Surveillance
- Surveys
- Single arm registry study
- Literature review/ high level journals to look at on a regular basis
- Collecting hospital data
- Lower-Risk devices are sometimes the harder ones to find clinical data
- Databases such as Medline, Embase, clinicaltrials.gov, MAUDE
[58:09] Review of Different Resources David Uses for Working with Registry Data/Literature Reviews
- ProQuest Dialogue
- Distiller SRN
- Alexa
- Clarivate
- Services that help support you doing literature reviews
[1:02:08] Discussing Important Guidelines for Post Market Surveillance
- MDCG 2020 – 6: Guidance for clinical evidence needed for products on market provided by the Medical Device Coordinating Group
- MDCG 2020 – 7: Post Market Follow Up Plan template that manufacturers can use
[1:07:25] Differences Between Real World Evidence and Postmarket Surveillance
- Real World Evidence: US terminology but sometimes used in Europe
- Generally the same thing as post-market surveillance data, its just Real World Evidence stems from US regulatory terminology
[1:08:58] Discussing David Rutledge’s Book:
- Mythical Medical Revelations from a Global Product Approval Consultant
- Stemmed from David’s article writing while working as a consultant for mid to small sized companies
- Created different characters to represent the different journeys within the medical space
- Working on a second book
- The Obstacle is the Way – Ryan Holiday
- The Five Dysfunctions of a Team
- Thank You For Arguing – Jay Heinrichs
- 28 Days to Save the World – Dan Purvis
[1:19:39] Sponsor Break: Calyx (https://www.calyx.ai/)
Major Themes:
- Post Market Surveillance Requirements can vary region to region. It is important that your efforts align with the requirements and guidelines of where you are doing your surveillance research.
- Supplemental tools can greatly enhance your ability to analyze databases and publications to meet Post Market Surveillance requirements
- There is a diversity of opinion around the value of Post Market Surveillance as well what makes conducting post market surveillance challenging and exciting
Quotes:
- “There’s a difference between US and Europe in terms of how long to keep doing proactive post market clinical followup.”
- “Across the world I see different leadership, responsibilities, and interest and support for aspects of the quality management systems.”
- “That plan may need to be updated as you’re implementing the plan. You may find something that you may need to do differently. And you would go back and update and reread that plan. And then once you get all the data collected, you have to ask a question, do we have enough data to write our report?”
Audience Question:
Do you think the more structured approach to Clinical Evaluation Plans from regions like the EU, China and Australia is more effective than the US approach? What can these different regions learn from each other?
