True Quality 2022 Agenda
Plan your day at True Quality 2022. Get in-depth descriptions of sessions here.
*Session topics & times are subject to change!
Green Carpet Day (Greenlight Guru Users Only)
We're rolling out the Green Carpet for an event dedicated exclusively to our customer community.
The day kicks off with Breakfast and is packed full of keynotes, customer-driven panels, sneak peeks of our upcoming releases, and training sessions to take your Greenlight Guru usage to the next level.
The schedule below is subject to change!
Green Carpet Day Registration Open & Breakfast
Green Carpet Day Opening Keynote
Networking Break
All about timing: Design Controls, Risk, and more
[Breakout session]
When to get started with design and development and why it matters
All about timing: CAPA, Audit, and more
[Breakout session]
When to get started with establishing quality processes and why it matters
Design Control 101
[Hands-on Training] [By Device Type]
How to document your design with Greenlight Guru to drive efficient, risk-based product development that fuels the success of your entire project.
Automation 101
[Hands-on Training]
Learn the power of automating your quality event workflows with Greenlight Guru.
Product Showcases
[Showcase on Main Stage]
Join us as we highlight the new developments and upcoming features of Greenlight Guru's software.
Lunch
Survey Says: Achieving CAPA Excellence
[Breakout session]
Nearly half of companies rate their company’s level of competence with CAPA as average or below. And just 17% of companies feel they have achieved excellence as it relates to their CAPA process. Dive into these findings with peers and discuss ways to level up your CAPA competency.
Survey Says: Keeping up with Innovation and Technology
[Breakout session]
With 8 in 10 MedTech companies are predicting growth for 2022 and 54% are investing in advanced technologies for their products, there is a new wave of tech driving growth and innovation in the industry. Dive into these findings with peers and discuss how to balance these pressures of innovation and growth in the industry.
Building your BOM: Medical Device Product Management
[Hands-on training]
How to manage your product development work with Greenlight Guru, when to get started, best practices, and the importance of DMR documentation.
Top 10 Tips & Tricks for using GG
[Hands-on training]
To be the best, you need to use GG the best! Our product experts will share little-known tips and tricks to level up your use of the Greenlight Guru software.
Networking break
Greenlight Guru Academy Showcase
See how Greenlight Guru Academy can help you grow and learn.
Customer Panel
Customer Awards & Closing Remarks
Don’t miss this fun close of the day as we celebrate our customer community.
True Quality 2022 Welcome Reception
We're excited to welcome you to sunny San Diego! Greenlight Guru customers, event sponsors, speakers, and all True Quality registrants are invited to our opening reception. Enjoy networking, drinks, and hors d'oeuvres and get ready for what's to come.
At Paradise Point Resort on Paradise Terrace
Registration Open & Breakfast
Opening Remarks
Behind the Research: Overcoming the Barriers to Improved Quality
[Keynote] Presented by Sandra Rodriguez | Senior Industry Analyst - Axendia, Inc.
New market research reveals 87% of executives admitted to having an ineffective requirements management process. Additionally, products rarely launch by target release date; and, never get delivered at or below original budget! How can quality help accelerate the success of your product? Join the keynote for more eye-opening results.
The New Era of MedTech
Networking Break
Mindset Tools for High Performance Teams
Presented by Kevin Bailey, CEO & Founder | DreamFuel
There are few jobs in this world as important as medical device innovation... You are tasked with fighting disease, fighting poor quality, and fighting for funding. Unfortunately, many medical device startups fail, not because they lose these fights, but because they lose a bigger fight... The fight with their own minds. In this talk, mindset coach and founder of Dreamfuel, Kevin Bailey will walk you through the practical tips and tricks he uses to help CEOs, athletes, and other high-performance professionals overcome the voices in their own head to accomplish great things. BONUS: For those interested, Kevin will lead a guided visualization about the future of MedTech.
The Future of Health & Medicine: Where Can Technology Take Us?
Lunch & Networking
Building Companies & Careers: Your Brand
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.
Located in General Session Hall
Panel with: Dan Purvis, CEO at Velentium | Shri Raghunathan, President & CEO, Noctrix | James Reinstein, President & CEO, Saranas | Molly Wade, Founder & CEO, Baralogics
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.
Located in Palm Room
Panel with: Kyle Rose, President at Rook Quality Systems | Andrew Wu, Software Consultant at Rook Quality Systems | & More
Understanding the critical interdependence of Risk with Pre- and Post-Market Activities
This presentation 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.
Located in Garden Room
Presented by: Carolyn Guthrie, Director of QA/RA at Kapstone Medical
Status of EU MDR and EU IVDR after 5Y of Publication
It's been 5 years since the publication of the EU Regulations on medical and in-vitro diagnostic devices. Let's dive into the status of the implementation and discuss what we've learned over this time.
Located in General Session Hall
Presented by: Bassil Akra, CEO at Akra Team (Former VP at TÜV SÜD)
Communicating With FDA: Is FDA hearing what you're saying? Are you sure?
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.
Located in Garden Room
Presented by: Michael Drues, Ph.D at Vascular Sciences
Governance of cybersecurity program for developing medical devices
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 adoption, customer expectations, your own business interests, and more!
Located in Palm Room
Panel with: Christopher Gates, Director of Product Security at Velentium | Abbas Dhilawala, CTO at Galen Data |
Vidya Murthy, COO, MedCrypt | Jason Smith, Sr. Communications Strategist, Velentium
Regulatory Pathways and your Go-To-Market Strategy
During this session, you’ll learn about the nuances, similarities, and differences of regulatory pathways in the US, EU, and other markets. Discover how timelines, costs, and other considerations can affect the complex questions of which markets to pursue and when to make your move.
Located in General Session Hall
Panel with: Michelle Lott, Regulatory Strategist, Principal and Founder - Lean RAQA | Damini Agarwal Director of Product Development - Infinite Biomedical | Isabella Schmitt, Director of Regulatory Affairs - Proxima Clinical Research
MedTech Companies Will Never be the Same: A Quality Leader's Perspective
Located in Palm Room
Panel with: Mitch Lewandowski, Vice President, Quality - GRAIL | Amit Relia, Sr. Director, Quality - iRhythm Technologies | Patricia Setti-LaPerch, Director of Regulatory Compliance & Quality - Koios
Is Your Use Related Risk Analysis Half Empty or Half Full?
Located in Garden Room
Presented by: MaryBeth Privitera, Principal- Human Factors & Research at HS Design, Inc
Afternoon Break
CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
Located in Main Ballroom
Roundtable Panel featuring: Lishan Aklog, MD, Chairman & CEO - PAVmed Inc & Lucid Diagnostics, Justin Barad, Founder/CEO - Osso VR & Nick Mourlas, Head of Johnson & Johnson Innovation - JLABS @ San Diego,
Fireside Chat with a Medtech Living Legend
Join us for a fireside chat led by Scott Pantel with Dr. Manny Villafaña, Medtech entrepreneur and industry icon. Hear stories of how he has launched, expanded, and sold Medtech startups, including his most notable: Cardiac Pacemakers Inc. (CPI) and St. Jude Medical. We'll also learn about his newest company, Medical 21 who is on a mission to make heart bypass surgery safer, less painful, more accessible, and less expensive by eliminating the need for vessel harvesting.
Manny Villafaña has a substantial track record of founding companies that develop and deliver successful medical products to the healthcare market. Medical 21 is Manny’s eighth medical device company, and he has led his previous seven companies to an IPO financing.
As the founder of Cardiac Pacemaker, Inc. (CPI)/Guidant, he co-invented the first long-life lithium-powered pacemakers and defibrillators which revolutionized the pacemaker industry. The technology he developed in 1972 is still in use in virtually every defibrillator and pacemaker worldwide. CPI was purchased by Boston Scientific for $27 billion. He was the founder of St. Jude Medical, Inc and the co-developer of the St. Jude heart valve – an innovative mechanical bi-leaflet heart valve that dramatically reduced the frequency of blood clots. This is the most commonly used prosthesis in the world, in approximately five million patients. St. Jude was purchased by Abbott Laboratories for $30 billion.
Manny went on to develop several other companies including ATS Medical, which introduced the new generation ATS open-pivot heart valve. ATS was purchased by Medtronic for $400 million.
TQ After Dark
Registration Open & Breakfast
Opening Remarks & Keynote: Global Medtech Innovation and Regulation in the Digital Age
Clinical Evidence under the EU MDR
What should you be aware of when targeting the European device market? Moderated discussion with industry experts on how to comply with clinical evidence requirements under the EU MDR.
Panel with: Bassil Akra, Páll Jóhannesson, Isabella Schmitt, and Jon Bergsteinsson.
Networking Break
This is not your grandmother's validated state!
Into the Unknown: A look at where your file goes when you send it off to FDA
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!
Located in General Session Hall
Presented by: Allison Komiyama, Principal Consultant at RQM+ | Kate Dilligan, CEO at Cooler Heads | Michael Nilo, President and Principal Consultant at Nilo Medical Consulting
The Wait is Over: Assessing the Proposed Rule Aligning FDA’s Medical Device Quality System Regulation with ISO 13485:2016
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.
Located in Palm Room
Presented by: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice - King & Spalding
How NFTs will change Medtech
Located in General Session Hall
Presented by: Omar M. Khateeb, Head of State & Host at The State of MedTech | Henry Peck, Director of Global Marketing at Altoida
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.
Located in Palm Room
Presented by: Gary Saner, Sr Mgr, Information Solutions-Life Sciences at Reed Tech
Implementation of Risk Management Board for New Product Introduction & PMS
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? The session will attempt to answer these questions and many more and define Critical Success Factors for the process.
Located in Garden Room
Presented by: Mike Baca, White Rook Consulting (Formerly VP at Stryker, VP at Medtronic, & Senior Director at Johnson & Johnson)
Networking Break & Grab To-Go Lunch Boxes
Fireside Chat with Mike Baca on Leadership, Purpose, and Impact
Join Greenlight Guru CEO David DeRam, and Mike Baca, former Vice President, QA/RA at Stryker, Medtronic, and Senior Director at Johnson & Johnson for a fireside chat. Mike will discuss the foundation of his career and the impact quality has in Medtech and daily life. You won't want to miss his inspirational and moving stories.
Mike Baca graduated from the United States Military Academy at West Point and served as an Officer in the Field Artillery Branch of the US Army.
After the military, Mike joined Johnson & Johnson in 1981, working there for 22 years progressing through numerous assignments of increasing responsibility in the Quality and Regulatory disciplines through four operating companies and Johnson & Johnson Corporate as a Quality and Compliance Services Account Director responsible for Corporate oversight of several Medical Device Implant Divisions. In 2003, Mike joined Medtronic, serving as head of Quality in the Neuromodulation and later Cardiac Rhythm Disease Management divisions. He joined Stryker Instruments in May of 2010 as the Global Vice President of the Instruments Division, responsible for Quality Assurance, Regulatory Affairs, and Clinical Sciences. He retired in November 2017. He formed White Rook Consulting LLC in 2019, consulting in his areas of expertise.