keynote presentation BY joe mullings, THE MULLINGS GROUP COMPANIES
Building Companies & Careers: Your Brand
Joe Mullings, the Chairman and CEO of The Mullings Group Companies, founded and leads the top medtech / healthtech search firm in the world with more than 8,000 successful placements partnering with more than 700 companies over the past 30 years.
Joe will be sharing the concepts and strategies you should be using to build an organizational hiring brand as well as a personal career brand that are required in the emerging world of work.
The dynamics of the workplace have changed dramatically in the past 24 months and the rate of change is not slowing down. How you position your organization to the force multipliers in the workforce and how you position yourself in the workplace requires a new point of view.
Joe will be covering subjects such as creating awareness and attention, negotiating offers for yourself and your organization, and how to use social platforms to attract individuals to your firm or organizations to yourself if you are considering a career move.
PRESENTED BY ERIC HENRY, KING & SPALDING
The Wait is Over: Assessing the Proposed Rule Aligning FDA’s Medical Device Quality System Regulation with ISO 13485:2016
On February 23, 2022, the FDA published the long-awaited proposed rule to align U.S. medical device quality regulations with international standards. This session will discuss the notable changes in the proposed Quality Management System Regulation (QMSR), the most current expectations regarding how and when the rule will be finalized and implemented, and how it will impact both industry and the FDA itself. Even firms already certified to ISO 13485:2016 will have to make adjustments to their quality systems, so don’t miss this critical update.
panel
Concept to Commercialization: Challenges, Lessons, and Triumphs in Bringing New Devices to Market
A panel of CEOs discusses the process of moving a complex medical device from “successful science project” into design and development, through regulatory hurdles, and into commercialization. The more complicated and sensitive the device, the more difficult and expensive it is to bring to market. Hence the more critical it becomes for design and development to be informed by quality, testability, manufacturability, cybersecurity, regulatory, reimbursement, marketability, and other lifecycle concerns as early as possible. There just isn't time or money available for a second chance! Come listen and engage with CEOs to discuss project successes, pitfalls, and learnings for guiding projects across the finish line.
PRESENTED BY BASSIL AKRA, AKRA TEAM
Status of EU MDR and EU IVDR after 5Y of Publication
The EU Regulations on medical and in-vitro diagnostic devices were published in May 2017 with a transition period of 3 years and 5 years. The EU Regulations have a big impact on the various Economic Operators and their business continuity strategy but also on the EU Healthcare System which needs to keep running and address patient needs. Therefore, after 5 years of publication, it is important to do a review to understand the status of their implementation and the learning which was gained during this period.
panel with chris gates, velentium | Abbas Dhilawala, Galen Data | Medcrypt | & more
Cybersecurity Governance within Medical Device Development
Join cybersecurity experts for a lively discussion about all things medical device cybersecurity, including:
- Mapping security activities and artifacts into existing lifecycle processes
- Using quality management to drive cybersecurity adoption and a security-minded culture in the organization
- Parsing the differences between regulatory expectations, customer expectations, and your own business interests
- Establishing roles and responsibilities
- Navigating the rash of recent activities in Medtech cybersecurity, including legislation, guidances, tools, and incidents
presented by mike baca, white rook consulting (former VP QA/RA stryker, medtronic)
Implementation of a Risk Management Board for New Product Introduction & Post-Market Surveillance
Managing the Risk Profile of a product from conception through obsolescence is a critical process that can determine the success, or failure, of any medical device. No medical device ever marketed has done so without some level of risk. ISO 14971 2019 and TR 24971 2019 provide the framework for the Risk Management Program. Once this framework is established, how is it implemented? Who are the stakeholders? Who provides the input? Who provides oversight? How is it maintained? Who needs to be informed? What input does the Subject Matter Expert have on the process? Ultimately, who makes the decision on going to market? How are Post Market Surveillance issues evaluated and addressed in a timely manner? The session will attempt to answer these questions and define Critical Success Factors for the process.
PRESENTED BY GARY SANER, REED TECH
The Journey Continues: What to Know for US FDA Class I and other Global Regulator Requirements
The journey of UDI continues as mile markers for US FDA Class I, EU EUDAMED, China NMPA, South Korea MFDS and other global health regulators appear on the horizon. Learn more about UDI data management and submission experiences from the experts at Reed Tech. Hear about requirements and exceptions pertaining to UDI product data submissions and device label requirements. Bring your questions as we make the following stops:
US FDA – The next stop on your UDI journey is Class I devices
EU EUDAMED – MDR and IVDR, a flight plan?
UK – Roadmap for regulatory compliance
Asia – Unpack nuances and timelines
Australia and other regions – Make future plans now
PRESENTED BY KYLE ROSE, ROOK QUALITY SYSTEMS
Best Quality Practices for SaMD, including Artificial Intelligence and Machine Learning
A panel of SaMD experts will explore in detail developments in regulating AI-based devices and share the latest updates, as well as bold predictions for SaMD, AI/ML innovation and regulation in 2022 and beyond.
Learn how to set up your QMS to maintain agile development, and about the FDA Action Plan to address AI/ML-based SaMD, created to establish a framework for evaluating AI/ML-SaMD so that this revolutionary technology can be applied to healthcare in a safe, effective manner.
presented by MaryBeth Privitera, hs design
Is Your Use Related Risk Analysis Half Empty or Half Full?
panel with michelle lott, lean raqa | damini Agarwal, infinite biomedical | & more
Regulatory Pathways and your Go-To-Market Strategy
The regulatory pathways you choose to pursue will be a major influence on your go-to-market strategy. But navigating these pathways, especially in the two largest markets for medical devices—the US and the EU—, can quickly become complicated. During this session, you’ll learn about the nuances, similarities, and differences of regulatory pathways in the US, EU, and other markets. Join regulatory experts from both sides of the Atlantic to discover how timelines, costs, and other considerations can affect the complex questions of which markets to pursue and when to make your move.
presented by Michael Drues, vascular sciences
Communicating With FDA: Is FDA hearing what you're saying? Are you sure?
The mere thought of interacting with FDA causes a great deal of anxiety for many medical device manufacturers. Right or wrong, the agency has developed a reputation for being less than accommodating and communicative over the years. However, communication with FDA is inevitable, and positive, productive interaction with FDA can make or break your product development efforts — or at the very least accelerate (or impede) your time to market.
Most if not all submission delays and rejections, as well as additional information requests, 483 observations and warning letters are due to communication or the lack thereof. In this interactive workshop, all methods of communication with the FDA will be presented with a discussion of how and when to consider each one including:
- How early to begin talking to FDA
- What to say, what not to say and how to say it
- Formal vs. Informal Mechanisms of communication
- Pre-market vs. post market communication
- Is FDA hearing what you’re saying? How do you know?
Simply put:
- If you get questions back on a submission… you’re not communicating!
- If you get an addition information request (AIR)… you’re not communicating!
- If you get a not substantially equivalent (NSE) determination or a major deficiency letter… you’re not communicating!
- If you get a 483 observation or a warning letter… you’re not communicating!
- If you’re playing ping-pong with FDA (questions, response… questions, response, etc.) … you’re not communicating!
In this workshop, participants will learn best practices for approaching – and communicating with – the FDA, specifically what, when and how. Using case studies from a variety of clinical specialties, all of these and more will be discussed in this interactive workshop.
panel with Allison Komiyama, acknowledge regulatory strategies (former fda) | michael nilo, nilo medical consulting (Former FDa) | Kate Dilligan, cooler heads | & More
Into the Unknown: A look at where your file goes when you send it off to FDA
For many medical device companies, the process of submitting to the FDA can seem like a black box. What best practices is FDA looking for? What details do they appreciate? What mistakes should you avoid at all costs? Listen as medical device professionals like yourself describe their product submission experience with FDA. Then, get a look into the world of FDA as two former FDA officials describe what happens when they get a submission. Don’t miss this peek behind the curtain!
Carolyn Guthrie, kapstone medical
Understanding the critical interdependence of Risk with Pre- and Post-Market Activities
Risk management, although a requirement, is a valuable tool to ensure the initial and continued
safety and performance of your medical device. This presentation will discuss the relationship
between risk management and the activities required prior to placing your device on the
market, as well as postmarket activities with feedback loops to risk management. We will
discuss how to incorporate risk management activities into the QMS to ensure these feedback
loops are triggered at the appropriate times, and appropriate actions are taken.
PRESENTED BY BRETT STEWART, ORTHOGONAL
This is not your grandmother's validated state!
- An appreciation for the breadth and depth of opportunities and challenges we are facing as an industry when incorporating modern software technologies into medical devices
- A technical and regulatory review of the first-ever formal industry guidance on this topic, a recent AAMI Consensus Report (510:2021) on cloud computing and medical devices
- A new systems engineering framework for appropriately seizing new technology-enabled opportunities to improve patient outcomes and the impact of medical devices, while still responsibly mitigating risks
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