Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.
Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.
Build FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system.
Interact with leading minds in the industry. Attendees will get to network with the prominent decision makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities.
Deliberate the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process.
Scale factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs better understand the criterias for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses.
Enhance risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve quality management system.Why you should attend this summit
- Future Trends of Medical Device Regulation, Risk Management, UDI, Recall Complaint Management etc.
- Listen from FDA/CDRH Directors:
- What is Critical to Quality
- Get Update on FDA compliance
- Listen from FBI:
- Cyber Security Risks
- Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion
- Explore Upcoming Changes in Medical Devices under Trump Administration
- Change Management
- Criteria for Supplier Quality Agreement
- Establishing a Medical Device Security Program
- Panel Discussion
- FDA Warning Letter
- FDA Enforcement
- FDA Interaction
8:00 - 8:30 am Registration and Breakfast
8:30 - 8:45 am Welcome Speech with an Introduction of ComplianceOnline & Summit
8:45 - 9:10 am Adequate Directions for Use "in the Age of AI and Watson"
Stephen Allan Weitzman, Editor in Chief at FDA Information Repository, IRAI
9:10 - 9:40 am FDA Enforcement - Outlook & Implications - Panel Discussion
9:40 - 10:20 am Benefit-Risk: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
10:20 - 10:40 am Medical Devices under Trump Administration
10:40 - 11:10 am Change Management - Managing the Cost of Change
Pat Baird, Regulatory Head of Global Software Standards, Philips
It is said that the one Constant in life is Change. Whether it is new features, increased reliability, or cost savings, we are constantly asked to make changes to our products and our processes. However, change comes with a cost, and often this cost is either under-estimated or overshadowed by misperceptions by key stakeholders.
At this session you will learn how to:
- Evaluate the cost of change, including both local and hidden costs
- Evaluate the cost of NOT changing
- Getting stakeholder buy-in
- Propagating success
11:10 - 11:25 am Networking Break
11:25 - 12:05 pm Post-Market Compliance; No Easy Journey
Ineffective or lack of proper Complaint Handing is cited as one of the top violations in a 483 issued at time of inspection by FDA. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required. Ms Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, filing for both Medical Device Reports (MDR) and eMDR, effective and appropriate communication with the appropriate regulatory agencies in the event of a recalls and how UDI’s factor into reporting.
She will provide key factors in implementing and maintaining compliance with the regulations from real life experiences from her career in FDA for a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from an FDA perspective on achieving regulatory compliance. In addition, a brief review of the affect that the new FDA Compliance Guidance’s issued in 2016 on post-marketing have had on post-marketing.
12:05 - 12:30 pm Establishing a Medical Device Security Program
Brief Synopsis of Content: Connected medical devices are playing a transformative and beneficial role in healthcare; however, these devices also pose risks to patient safety and health information security. As innovation continues and the threat landscape evolves, securing medical devices becomes more crucial. Currently, many manufacturers and providers have an ad hoc and device-specific security approach with a lack of a programmatic approach and framework for addressing connected medical device security risks. A mature medical device security program can increase effectiveness and consistency in the execution of security mitigations, including improved collaboration and communication between medical device manufacturers and healthcare providers. This session will focus on industry leading practices related to designing, developing, implementing, and sustaining a mature medical device security program.
Learning Objectives: Following this session, the audience will have an enhanced understanding of the below topics:
- The evolution of connected medical devices
- The connected medical device cybersecurity landscape
- Recent messaging and action of the FDA around medical device cybersecurity
- Industry response to secure connected medical devices
- Medical device security program solution for both healthcare providers and medical device manufacturers
- The top risks the industry might face over the next five years, as well as some of the potential industry responses
12:30 - 1:30 pm Lunch
1:35 - 2:05 pm Off-label Promotion: Truth or Consequences
FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. This course will explain what you need to know and what you should do to survive an FDA inspection with the least possible pain.
2:10 - 2:35 pm
Track A - Sessions: Medical Device Single Audit Program (MDSAP) - Can I Really Get Down to Just One Audit?
MDSAP can potentially offer a variety of important advantages. While currently optional for FDA, it will be mandatory for Health Canada in January of 2019. Understand MDSAP inside and out and be sufficiently prepared. Successful first-hand experiences will be shared along with step-by-step practical advice on how to adequately prepare for MDSAP. Real-world case studies provide engaging examples of what to do and how to accomplish it.
Track B - Sessions: Cleaning, Disinfection and Sterilization of Re-usable Medical Devices
In order for a re-usable medical device to be safe for patient use, a strict and detailed validation for the cleaning and disinfection processes should be performed. A validated cleaning and disinfection instruction for use are the responsibility of the manufacturer that are required to prove their claims for the re-use of the product and the validation should mimic as much as possible the clinically relevant conditions. The testing laboratory encounter many challenges to meet FDA expectation for the right simulation of that cleaning and disinfection process, including – simulated use of the device, artificial contamination with blood, mucus, microorganisms and endotoxins, validated recovery processes of the contaminated devices, devices with different surfaces/materials and complex structures.
2:40 - 3:05 pm
Track A - Sessions: Documentation for Agile Development - Shared Understanding, Vacation Photos, and Compliance
Working rapidly and flexibly, and demonstrating a working product regularly, are hallmarks of the Agile approach. For medical devices, however, our development also needs to produce documentation - requirements, design, tests, hazard analysis, usability, and traceability. How do we achieve all that and remain Agile? Documenting an Agile process for medical devices needs to serve two almost contradictory challenges: allowing ready sharing, exchange, and revision to build shared understanding on the one hand (see Jeff Patton's book) and satisfying the legal / regulatory demand to prove who, what and when. Take a tour through the documentation landscape and consider with me the primary document deliverables. How can we gather these as development proceeds, while minimizing overhead? How can we assure that inputs are reviewed and approved, without getting mired in the document signoff spiral? How can we address design reviews without bogging down the team in long, droning meetings? How can we capture traceability as a natural outcome of our work? This presentation will focus on concepts rather than tools, but specific tools will be used to provide concrete examples.
Track B - Sessions: Is Your Medical Device Software Ready for a 510K?
3:10 - 3:40 pm
Track B - Sessions: Medical Device Risk Management 2017 Updates - Workshop
The last year has been active with changes around the world in Risk Management. Are you familiar with the Compliance Risk requirements of ISO 13485? Is “risk-based thinking” as required by ISO 9001 evident in your organization? Has your organization implemented elements of Enterprise Risk Management based on ISO 31000? And most importantly, the international committee for ISO 14971 is actively working on updating this key standard! Stan will bring you the latest information that will keep you abreast of the recent changes related to managing risk. He will also discuss the vector of future changes. Based on insightful analyses, Stan will present concise key considerations to help you evaluate the currency of your firm’s Risk Management program.
3:40 - 3:55 pm Networking Break
3:55 - 4:25 pm Best Practices When Interacting with FDA - Panel Discussion
4:25 - 4:35 pm Closing Mark - Next Day Plan
8:00 - 8:30 am Registration and Breakfast
8:30 - 9:00 am Cyber Security Risks and Working with Law Enforcement - Keynote Speech
9:00 - 9:30 am Medical Devices and the Future of Outcomes Centricity - Keynote Speech
Peter Pitts, Chief Regulatory Officer, Adherent Health, LLC.
9:30 - 10:00 am Medical Device Enhancements - Keynote Speech
10:00 - 10:25 am Effective Internal Auditing for Superior Quality Systems
10:25 - 10:55 am CDRH Office of Compliance Strategic Priorities and Hot Topics in Compliance - Keynote Speech
10:55 - 11:10 am Networking Break
11:10 - 11:40 am FDA Upcoming Electronic Submission Process
11:40 - 12:15 pm Is a Quality Agreement Required for All Suppliers? - Panel Discussion
12:15 - 12:45 pm Global Regulatory Landscape (US, EU and APAC): What’s on the Horizon?
12:45 - 1:45 pm Lunch
1:50 - 2:30 pm
Track A - Sessions The EU Regulations - Prepare for Implementation
Track B - Sessions Human Factors Compliance: Just Another “Hoop” or Good Business?
2:35 - 3:00 pm
Track A - Sessions Digital Health & Medical Devices
Track B - Sessions Practical Lessons from 16 years of the Agile Community
3:00 - 3:15 pm Networking Break
3:15 - 3:40 pm
Track B - Sessions Learning From FDA Warning Letter - How to Stay Out of Trouble? - Keynote Speech
3:40 - 4:20 pm
Track B - Sessions Post Marketing Safety Reporting for Combination Products
Susan Neadle, Head, Combination Products Center of Excellence, Sr. Director, Quality Engineering & Design-to-Value, Product Quality Management (PQM), Janssen Pharmaceuticals Companies of Johnson & Johnson
4:20 - 4:35 pm Vote of Thanks & Participation Certificate Distribution
Omni San Francisco Hotel
500 California Street,
San Francisco, CA