1:00 pm: Arrival & Networking
2:00 pm: Welcome
2:15 pm: From Data to Direction: Transforming MedTech Challenges into Opportunities
A panel of seasoned medical device professionals will discuss the top challenges, strategies, and opportunities in the medical device industry in 2024 and beyond. They'll share how product development, regulatory, and quality management can address and adapt to the future.
Plus, ask the experts live questions following the discussion!
3:15 pm: Networking Break
3:45 pm: The Global Medical Device Podcast: Live
Experience a live recording of the Global Medical Device Podcast where Etienne Nichols sits down with Kevin Hacker, Director-Life Sciences Quality Management at KPMG.
As part of our ongoing commitment to fostering innovation and collaboration within MedTech, we’re bringing together the best of adjacent industries to explore the untapped potential at their intersection.
In this unique gathering, we’ll be diving deep with a seasoned Quality Management Systems (QMS) professional whose roots are in the pharmaceutical industry but whose insights are invaluable to the MedTech sphere. This isn’t just another webinar; it’s a candid conversation, designed to unearth practical wisdom and strategies from pharma that could be game-changers for medical device companies.
4:30 pm: Networking, Drinks, & Hors d’oeuvres
6:00 pm: Event Ends
NETWORKING
No icebreakers, no name games — just time well spent with MedTech professionals who are excited to network with peers while enjoying some specialty drinks and hor d’oeuvres.
PANEL DISCUSSION
A panel of local medical device leaders will share industry stories and experiences, as well as their thoughts on the 2024 MedTech Industry Benchmark Report.
Live Podcast
Experience a live recording of the Global Medical Device Podcast. Host Etienne Nichols will sit down with some of the brightest minds in MedTech for an episode full of actionable insider knowledge.
ABOUT THE ROADSHOW
The Greenlight Guru True Quality Roadshow brings together MedTech leaders in quality, regulatory, clinical, and product development to connect with their local MedTech community, learn exclusive industry insights, and find inspiration to continue improving the quality of life.
Guest Speakers
More speakers will be announced soon...
Interested in speaking at a True Quality Roadshow? Let us know!
Etienne Nichols
Medical Device Guru | Greenlight Guru
Etienne Nichols
Medical Device Guru | Greenlight Guru
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.
Kevin Hacker
Director, Advisory, Life Sciences Solutions | KPMG
Kevin Hacker
Director, Advisory, Life Sciences Solutions | KPMG
Kevin Hacker is a Director within KPMG’s Life Sciences Solution Advisory practice, specializing in Quality Operations, Quality Strategy, and Manufacturing disciplines. Kevin is based out of KPMG’s Austin, TX location. He has over 20 years of global industry and consulting experience in Life Sciences, supporting strategic and implementation projects in diverse therapeutic categories and classifications. He has held leadership roles of increasing responsibilities within industry at pharmaceutical and biotechnology companies in Quality Management, Quality Operations, Manufacturing, and Supply Chain. Kevin has considerable experience leading global quality, compliance, and operations programs for both leading and emerging life sciences companies, specializing in quality management systems transformations, compliance auditing, and Mergers and Acquisitions readiness and transaction support. He has a consistent track record of developing and implementing new foundational quality and operations processes, driving operational excellence, and collaborating across multi-disciplinary teams. Kevin’s credentials include ASQ-Certified Quality Auditor (CQE); ASQ-Certified Quality Engineer (CQE); and ASQ-Six Sigma Black Belt (CSSBB)
Alexis Bilodeau
CEO & Co-founder | CLEIO
Alexis Bilodeau
CEO & Co-founder | CLEIO
Kyle Rose
President | Rook Quality Systems
Kyle Rose
President | Rook Quality Systems
Tamas Borsai
Division Manager, MHS Customer Service and Quality - TUV SUD America
Tamas Borsai
Division Manager, MHS Customer Service and Quality - TUV SUD America
Weronika Michaluk
Principal, SaMD Lead - HTD Health
Weronika Michaluk
Principal, SaMD Lead - HTD Health
Nirav Desai
Global Vice President of Regulatory Affairs & Quality Assurance - Cynosure
Nirav Desai
Global Vice President of Regulatory Affairs & Quality Assurance - Cynosure
Currently working as a Global Quality & Regulatory Leader for a Medical Device company. Previously worked as Director Quality Engineering at Fresenius Medical Care North America, leading New Product Development, Design Controls, Sustaining Quality Engineering and Post Market Surveillance activities. With significant Regulatory and Quality Experience, I would like to take additional responsibilities and grow in the healthcare industry to serve as a Quality, Regulatory and Compliance leader in Pharmaceutical and Medical Device industry.
My goal is to grow in Quality Engineering, Compliance and Regulatory space and serve as a industry leader for Medical Devices and Pharmaceuticals.
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