DAY TWO | THURSDAY, JANUARY 31
8:30 REGISTRATION & WELCOME COFFEE
8:55 CHAIRPERSON’S OPENING REMARKS
9:00 DEVICE CLASS SMALL GROUP DISCUSSION: POSTMARKET OPERATIONAL AND COMPLIANCE CONSIDERATIONS
Medical device and diagnostic products in today’s marketplace range greatly in the degree of complexity and the challenges associated with continuous safety monitoring can vary dependent on the device’s classification. Not only can postmarket hurdles be very specific to a device class, but regulatory scrutiny and oversight of safety monitoring operations can also be greatly impacted; this group discussion allows attendees an opportunity to engage with industry colleagues facing similar device class specific postmarket surveillance challenges and provides executives with a unique opportunity for insights from varied individuals and corporations.
- Class I Small Group Discussion
- Class II Small Group Discussion
- Class III Small Group Discussion
- IVD Product Small Group Discussion
Facilitator: Jeanette Johnson, Director, Quality Complaint Handling Unit, Post Market Compliance, CONVATEC
9:45 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 lifecycle. 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.
Tom Middleton, Solutions Architect, SPARTA SYSTEMS
10:30 COFFEE AND NETWORKING BREAK
11:00 STREAMLINING MDR FILING PROCESSES TO ENSURE REGULATORY COMPLIANCE
Postmarket surveillance executives are continually tasked with ensuring that any malfunctions or quality deficiencies that could have been a contributing factor to a product’s adverse event are properly recorded and filed with the necessary regulatory authorities. MDR filings’ underlining goal serves to develop complete transparency between manufacturers and regulators allowing for quick action to be taken when remediation is required to ensure patient safety. In order to ensure compliance with regulator expectations it is crucial for postmarket teams to explore more streamlined reporting process to decrease any internal redundancies while provided the needed information externally.
- Current regulatory expectations regarding data
- Timelines for proper submission
- Trends in reporting frequency
Mursal Sadozai, Supervisor, Post Market Surveillance, FRESENIUS MEDICAL CARE
11:45 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
12:45 SESSION NINE: PANEL DISCUSSION: IMPORTANCE OF CYBERSECURITY INITIATIVES IN SECURING PRODUCT QUALITY
- Collaboration between cybersecurity & postmarket teams
- Trends in cybersecurity product marketing initiatives
- Regulatory concerns surrounding postmarket cybersecurity
Scott T. Nichols, HCISPP, CHPSE, MCP, BECKMAN COULTER
Colin Morgan, JOHNSON & JOHNSON
Scott Shindledecker, PMP, HCISPP, BD LIFE SCIENCES
1:30 SOFTWARE PATCHING: IMPACT OF INCREASED SCRUTINY ON POSTMARKET CYBERSECURITY MONITORING
The complexity of recent medical devices offers great advancement in patient care, but for those medical product’s that rely on integrated software capabilities the need for continuous technical upgrades and patching raises a plethora of new postmarket concerns. The FDA’s postmarket guidance suggests that manufacturers have a proactive software patching process in place which was further reinforced in the 2018 Medical Device Safety Action plan; however, once the device is launched into the market addressing firmware and software vulnerabilities becomes exceedingly challenging. Postmarket and cybersecurity teams are often tasked with integrating patching capabilities to certify uninterrupted product safety while remaining compliant with regulatory expectations.
- Strategies for software patch delivery
- Validation of product following patch download
- Building seamless patching into product design
Scott Shindledecker, PMP, HCISPP, Associate Director, Product Security, Diagnostics, BD LIFE SCIENCES
2:15 COFFEE AND NETWORKING BREAK
2:25 – 3:40 INTEGRATING LITERATURE REVIEWS IN POSTMARKET PRODUCT DATA COMPILATION
- Timelines for literature monitoring, triage and analysis
- Translating literature review results into action plans
- Identification parameters for literary search
- Literature review automation methodologies
- Email alerts
- RSS feeds
- Impact of systematic literature review on PM analyses
2:25 JOHNSON & JOHNSON CASE STUDY
Evgeniya Degnera, Senior Manager Clinical Complaints, QA Complaints, JOHNSON & JOHNSON
3:55 MEDTRONIC CASE STUDY
Brandi Coffin, Sr Manager Medical Device Safety I Global Safety Office MITG, MEDTRONIC
3:25 Q&A WITH CASE STUDY PRESENTERS
3:40 CLOSING REMARKS AND CONFERENCE CONCLUSION