2024-JUNE F2F ASQ O E (Section-701) Monthly Meeting

What are the implications of advances in computing and the rise of AI on the role of a RA/QA professional? How does one stay abreast of the changing regulatory landscape as a result of these technological advances? This session will discuss the contours of a regulatory intelligence program to monitor and stay ahead of the changing regulatory landscape that impacts the medical device industry. Additionally, attendees will gain a better understanding about the capabilities and limitations of incorporating such technological tools in their routine tasks.

Kandarp has 8 years of experience with US 510(k) and PMA applicable products, including IDE approvals and EU IVDR/MDR/CE marking as well as worldwide registrations for permanent implants and IVD products. His IVD experience includes laboratory developed tests (LDTs), CLIA high/medium-complexity tests, and CLIA-waived point of care diagnostics. He also has over 10 years of progressive experience in molecular and cellular biology, immunology, cardiovascular disease, and tissue-based diagnoses in research laboratories. Kandarp has worked with Carl Zeiss, Exact Sciences and other organizations. Dr. Shah holds a PhD in Biological Sciences from the University of California, Irvine. .

There are 4 key stages to an M&A transaction. These ateh "pre-deal", "diligence", "integration planning" and "integration execution. We will review these stages from both sides of the table and highlight the important role of Quality in the process at each stage.

Todd is approaching 40 years in the medical device industry. He began his career at cardiovascular leader Cordis in 1985 and ascended rapidly to become the site leader of their Miami 2600 person HQ at the time of acquisition by JNJ in 1995. Todd headed west to SoCal in 2000 to lead a Gynecology start up but was recruited to Edwards Lifesciences to help drive growth post Edward's spin from Baxter. Todd started as VP of Manufacturing for Edwards and later held roles as VP, Global Supply Chain and VP/GM Glucose. While at EW Todd co-founded and championed their engineering development program and he played key roles in all of the M&A activities that helped transform Edwards. In 2010 Todd was recruited to Endologix (Aortic Vascular Stents) as Global VP of Operations and #2 to the CEO and helped them grow from $0MM to $200 by 2015 when he exited to care for his terminally ill mother. In 2017 Todd joined pre-commercial Ophthalmology Ivantis Inc. As COO Todd again played the #2 role and Ivantis grew from 17 to over 180 employees after launching in late 2018 and achieving the 2nd fastest initial product growth in VC backed medtech history. Along the way Ivantis won multiple innovation awards and 3 "best places to work" awards. Ivantis was acquired in January 2022 by Alcon and at their request Todd stayed for a year to support integration. In January 2023 Todd shift his focus to his consulting firm, Sage Medtech Advisory, LLC. (www.sagemedtechadvisory/com).In October 2023 Todd was inducted to the Bellwether Foundation League's Supply Chain Hall of Fame.

Host or Publisher ASQ Orange Empire Section 0701