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Medcon 2023 Horz Fda

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 KrencPrincipal 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.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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