DAY ONE | WEDNESDAY, JANUARY 22
8:00 REGISTRATION & WELCOME COFFEE
CLINICAL FOLLOW-UP TRACK
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 OPENING ICE BREAKER: DEVICE POSTMARKET SURVEILLANCE OPERATIONS FOR EXECUTIVE LEVEL AUDIENCE
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives on the daily challenges of executive level audiences, discussing challenges associated with preparation strategies for compliance with EU MDR regulations, best practices in data gathering from social media sources, and the impact of technological advancements on adverse event data collection. Furthermore, participants in this warm-up session are also given the opportunity to directly build contacts.
9:30 PANEL DISCUSSION: NAVIGATING THE EVOLUTION OF THE POSTMARKET SURVEILLANCE ROLE
- Impact of increased regulatory expectations of surveillance teams
- Artificial intelligence and technological advancements in data quality
- Implications on data sourcing
- Enriched data analyses
- Postmarket real world evidence as a strategic priority for submissions
John Giantsidis, INTEGRA LIFE SCIENCES
Joe Falvo, ORTHO-CLINICAL DIAGNOSTICS
Tom Middleton, SPARTA SYSTEMS
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 OPENING ICE BREAKER: DEVICE POST-MARKET CLINICAL RESEARCH PLANNING
This interactive icebreaker will open the event with an opportunity for all participants to move around the conference room with the aim of meeting participants and engaging in brief introductions and discussions. The audience is encouraged to exchange information on the types of post-market studies currently being conducted, whether structured randomized studies, patient registries, surveys or other models, as well as types of research of greatest interest.
9:30 OPTIMIZING OUTCOMES THROUGH SERVITIZATION
In an environment that is being increasingly driven by value outcomes over fee for service it is important to evaluate services that provide a positive impact to outcomes. Products provide an abundance of data, however, without actionable insight it is meaningless. This session will demonstrate the value of how services and product data can drive patient outcomes and help improve the quadruple aim.
- Describe and understand how servitization can optimize outcomes.
- Identifying and focusing on meaningful insights and data for the customer.
- Data can be utilized in creating services to improve outcomes.
- Methodology for structuring service work effort
Ray McLean, Workflow Thought Leader, PHILIPS
10:30 COFFEE AND NETWORKING BREAK
11:00 POSTMARKET STRATEGIES TO ENSURE UTILIZATION OF SEAMLESS RECALL MANAGEMENT PROCEDURES
As medical devices continue to advance in complexity, the possibility for malfunctions or quality deficiencies equally rises, it is the responsibility of postmarket teams remain vigilant in discovering any large scale product problems that might result in recalls. While the recalls involve a multitude of internal executives, the collaboration between all teams involved is critical to ensuring seamless and swift recall management strategies are employed. Postmarket teams are often engaged in pre-recall operations and it is critical for executives to utilize compliant and efficient processes to ensure timely reporting and execution of product recalls in order to mitigate any potential future adverse events.
- Risk assessments for initiating full recall actions
- Transitioning from small corrective actions to full recalls
- Compliance guidelines for recall reporting requirements
Joe Falvo, Senior Manager, Post Market Risk Management, ORTHO-CLINICAL DIAGNOSTICS
11:45 LEVERAGING TECHNOLOGY TO ENHANCE YOUR POSTMARKET SURVEILLANCE STRATEGY
As a manufacturer, you need an effective PostMarket surveillance program. One that monitors the operation of devices under real conditions,to ensure that the assumptions made during the product development process were correct and remain that way during the total product life-cycle. During this session we will discuss the importance of an effective PostMarket surveillance program along with the requirements of industry regulations and a quality system.
- Define the regulatory and quality system requirements that address PostMarket surveillance.
- Identify the data sources of PostMarket surveillance and how to create actionable insights.
- Leverage technology to streamline operations and provide visibility case study
Tom Middleton, Solutions Architect, SPARTA SYSTEMS
11:00 DISCUSSION: OVERVIEW OF VARIOUS FORMS OF PMCF BASED ON DEVICE CLASSIFICATIONS
- Various sources for postmarket data
- Balancing time & resources in data generation
- Analysis of postmarket activity initiation
- Determining if the research is sufficient
Kavita Dhamdhere, SIGHT SCIENCES
Ray McLean, PHILIPS
Ibou Diop, JOHNSON & JOHNSON
11:45 UTILIZING PATIENT REGISTRIES FOR POSTMARKET FOLLOW-UP
- Considerations in registry design & sample size
- Use of registries throughout device product lifecycle
- Securing sufficient patient follow-up & data
- Adequately capturing malfunctions & deviations
Clay Hillyard, Clinical Research & Post-Market Surveillance Manager, MICROPORT ORTHOPEDICS
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:45 – 3:00 IMPACT OF MDSAP MODEL ON RISK BASED PRODUCT SAFETY MONITORING
- Navigating the three round audit process for MDSAP certifications
- Building foundational plan for an auditing organization review
- Tailoring MDSAP postmarket plans for regional requirements
- Internal gap analyses and monitoring post-MDSAP certification
1:45 LEGAL PERSPECTIVE
Brady Mickelsen, Associate, SIDLEY AUSTIN LLP
2:15 INDUSTRY PERSPECTIVE
Paul Chiappetta, Director of Quality Systems, THERMO FISCHER SCIENTIFIC
1:45 SUCCESSFULLY CONDUCTING INVESTIGATOR INITIATED STUDIES
- Rationale behind IIS for postmarket research
- Eligibility & profiling potential investigators
- Methods of capturing adverse events
- Complying with regulatory requirements
- Effectively training and informing investigators
Goldy Singh, Vice President Regulatory & Clinical Affairs, PROFOUND MEDICAL INC
2:15 DISCUSSION: DETERMINING SUFFICIENT CLINICAL EVIDENCE TO SUPPORT EU MDR POSTMARKET REQUIREMENTS
The EU MDR requires that firms provide a sufficient level of postmarket clinical follow-up data for both new product applications as well as to support existing products on the market, but within the framework of the regulation there is difficulty in the interpretation of what constitutes sufficient clinical evidence. Interpretations of sufficient data varies among postmarket clinical professionals as there are several factors to consider such as, device classification, level of risk and expected product lifetime.
- Exploring the various interpretations of sufficient data
- Distinguishing clinical postmarket development by class
- Regulatory action taken if there is not sufficient data
Clay Hillyard, MICROPORT ORTHOPEDICS
Goldy Singh, PROFOUND MEDICAL INC
3:00 COFFEE AND NETWORKING BREAK
3:30 RISK ASSESSMENTS FOR PARTICIPATION WITH FDA VOLUNTARY MANUFACTURING SUMMARY REPORTING
- Internal risk assessment regarding voluntary reporting
- Benchmarks triggering need for adverse event data submission
- Compliance parameters for participation with FDA VMSR program
- Overview of experience and results from VMSR involvement
Rachael Hunt, Associate, HYMAN, PHELPS & MCNAMARA
4:15 SMALL GROUP DISCUSSIONS: GARNERING POSTMARKET AND ADVERSE EVENT DATA FROM SOCIAL MEDIA SOURCES
The world of social media and digital engagement offers HCPs and patients an environment to openly engage in conversation regarding medical devices; however, this open communication offers postmarket surveillance teams a variety of challenges in monitoring and data verification. In order to engage in meaningful, in-depth conversations regarding the complex nature of the sourcing and analyzing digital and social media for postmarket relevant product information, attendees will break into small groups to engage in peer to peer discussion. Facilitated by a discussion leader, participants will share recent experiences regarding which social medical platforms are monitored and how to best determine what comments are online noise compared to viable and reportable events.
Sandra Bausback-Aballo, Director, Post Market Surveillance, BOSTON SCIENTIFIC
Ladi Owolabi, Deputy Director, Medical Device Safety, BAYER
5:00 END OF DAY ONE CONFERENCE
3:30 GENERATING POSTMARKET EVIDENCE FOR LEGACY PRODUCTS UNDER EU MDR
Of considerable concern for medical device manufacturers are postmarket data requirements for legacy products under the EU MDR, many of which have been CE marked using predicate data and which do not have substantial evidence to support product safety and efficacy, but which have been successfully marketed in the European system for some time. Manufacturers must take immediate steps to generate new data to support products currently on the market, or make difficult portfolio decisions related to product discontinuation.
- Effectively developing PMCF for legacy medical devices
- Cost effective data generation for existing products
- Potential product discontinuation in the EU market
- Ramifications if data is not sufficient for legacy products
Melanie Crystal, Senior Clinical Program Manager, MEDTRONIC
4:15 GROUP DISCUSSION: APPROPRIATE STUDY SELECTION FOR POSTMARKET CLINICAL RESEARCH UNDER EU MDR
Selecting appropriate postmarket clinical follow-up activities continues to challenge manufacturers and postmarket officials due to EU MDR’s ambiguity on what constitutes sufficient data and how new MDR requirements differ from the MDD. A decision must be made on the type of study that will most quickly and effectively generate sufficient clinical evidence. Executives must also consider the class of device, time and resources needed before deciding which study methodology is appropriate.
- Aligning postmarket study by class of device
- Assessing time and cost to satisfy requirements
- Evaluation of devices length of time on the market
Avishek Mishra, CANTEL MEDICAL
5:00 CLOSING REMARKS & DAY ONE CONCLUSION