MedCon 2023 Workshop
This in-depth, pre-conference workshop took place on April 24 at 8:00 a.m.
Theme
Risk Management: Practical Applications of Risk Management Throughout the Device Life Cycle
Jump-start your deeper understanding of RMS regulatory authority expectations!
This workshop is meant for beginner to intermediate practitioners who want to go beyond the basic understanding of risk management system (RMS) requirements. The workshop will give a brief overview of the history of regulatory authority expectations related to risk management activities and delve into these practical topics with breakout group activities and discussions:
• Value of well-established risk assessment criteria
• Traceability tables from design specifications to IFUs to market applications
• Human Factors/Usability testing over the life time of your medical product
• Understanding the global regulatory authority sensitivity regarding “use errors”
• Pulling premarket risk data through to post-market data
• Correlating RMS data to post-market IMDRF Adverse Event Codes
• Product Risk Assessments for possible escalations to Field Safety Corrective Actions/Recalls decisions.
Facilitators
Bill Brodbeck
Senior Director, Regulatory Affairs, STERIS Corporation
Shannon Hoste
President, Agilis Consulting Group
Kim Trautman
Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
Brian Siroka
Associate Medical Device Consultant, MEDIcept
Tina Krenc
Principal Consultant, KTA Compliance Consulting
Attendance at the MedCon Pre-Conference Workshop requires a separate registration
Industry
(100+ employees)
$750
Small Business
(1 – 99 employees)
$550
Start-Up Manufacturer
(a company with no product or service on the market and no investing partners)
$250
Self-Employed or Non-Profit
$250
Academic Institution
$250
Government
(email validation required)
Free
APRIL 24, 2023 / WORKSHOP AGENDA
7:00 a.M. – 4:30 P.M.
Registration
7:00 a.M. – 8:00 A.M.
Breakfast
Join your colleagues from around the globe as we kick off MedCon 2023 Workshop with a complimentary hot breakfast.
8:00 a.m. – 8:10 A.M.
Workshop Welcome
Welcome! Thank you for joining today’s workshop – Risk Management: Practical Applications of Risk Management Throughout the Device Life Cycle! We are excited for an informative day with real-world examples and applications for risk management systems!
Facilitator
Timothy Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:10 a.m. – 8:55 A.M.
Historical Overview of Risk Analysis and Risk Management Systems
This session provides a historical overview of Risk Management that includes discussions on EN 1441, FDA’s Quality System regulation/preamble, ISO 13485 & 14971, GHTF guidance, AAMI TIR48 & TIR97, and the EU MDR/IVDR. Understanding the past to meet global regulatory authority expectations in the present is an important aspect of every risk management system.
Facilitator
Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
8:55 a.m. – 9:55 A.M.
Essentials for Premarket Risk Management Systems – Hazard Analysis and Risk Acceptability
If you were building a new house, would you put up the walls without first establishing the foundation? Of course not! The thought is ludicrous. The same is true for a risk management system. A solid foundation must be built in the premarket stage to support the risk-based decisions for each medical device over the life of the device. This session will provide an overview of the essential elements that make up the foundation of a sustainable risk management system. In addition, practical examples and focus on errors to avoid will help provide structure to a sound risk management system.
Facilitator
Tina Krenc, Principal Consultant, KTA Compliance Consulting
9:55 a.m. – 10:35 A.M.
Exercise 1 – Risk Evaluation Matrix and Rationale
This exercise will focus on completing a risk evaluation matrix based on severity of harm and probability of occurrence using field data. It will also dive into the combined rationale needed to properly evaluate risk acceptability.
Facilitators
All Facilitators
10:35 a.M. – 10:50 A.M.
Break
10:50 a.m. – 11:10 A.M.
Exercise 1 Review
Review participants’ responses and discussion.
Facilitator
Tina Krenc, Principal Consultant, KTA Compliance Consulting
11:10 a.m. – 11:40 A.M.
Correlating RMS Data for a Life-Cycle Approach
This session will show how to utilize FDA databases to gather Risk Management System data. The presentation will explain the correlation between premarket searches and post-market data gathering by searching for predicate, similar, and a manufacturer’s own devices. It will touch on connecting these sets of data using the IMDRF Adverse Event Codes.
Facilitator
Brian Siroka, Associate Consultant, MEDIcept
11:40 A.m. – 12:40 P.M.
Essentials of RM Data for Design Changes and Regulatory Submissions
This session will examine best practices for how risk is assessed in design changes and how that information is used to assess whether a new 510k is needed or what information can be used in drafting the no filing memo. The session will also address assessing the risk on accumulated changes made to the design to help determine whether the risk acceptability has not changed.
Facilitator
Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
12:40 P.M. – 1:25 P.M.
Lunch
1:25 P.m. – 1:55 P.M.
Exercise 2 – Design Changes – Submissions and ‘Letters to File’
This exercise will focus on risk assessment of design changes proposed from different drivers, the decision on whether a new submission is needed, and what information can be used in a decision memo.
Facilitators
All Facilitators
1:55 P.m. – 2:15 P.M.
Exercise 2 Review
Review participants’ responses and discussion.
Facilitator
Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
2:15 P.m. – 3:15 P.M.
Human Factors and Usability Across the Device Life-Cycle
The human factors process is a risk management activity focused on use-related risk. This session will provide an overview of that process and common challenges faced in design changes and post-market activities. This presentation will explore how to systematically identify, evaluate, and address use error.
Facilitator
Shannon Hoste, President , Agilis Consulting Group
3:15 P.M. – 3:30 P.M.
Break
3:30 P.m. – 4:00 P.M.
Exercise 3 – Life-Cycle Case Studies for Human Factors
This exercise will help reinforce that use error should not be an attributable root cause — it’s an indicator that further investigation is necessary. This exercise will look at duodenoscope data in the MAUDE database to determine what actionable steps should be taken.
Facilitators
All Facilitators
4:00 P.m. – 4:20 P.M.
Exercise 3 Review
Review participants’ responses and discussion.
Facilitator
Shannon Hoste, President, Agilis Consulting Group
4:20 P.m. – 4:40 P.M
Closing Session – Key Takeaways – Resources – and Thank You!
Thank you for attending the Risk Management: Practical Applications of Risk Management Throughout the Device Life Cycle Workshop!
Facilitators
Timothy Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
Because of the generosity of our supporters, we can continue our work to improve the healthcare products industry.
Diamond Sponsor
Platinum Sponsor
Learn more about supporting MedCon 2024 through sponsorship by contacting Patrick Flynn at +1-301-770-2920, ext. 246, or pflynn@raps.org.
