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We're back in action! To kick off our fall events season, the Generis team headed to Chicago for our 11th annual American Medical Device Summit.
First stop: Chicago!
From October 1-2, 2024, we celebrated the 11th anniversary of our American Medical Device Summit at the Renaissance Schaumburg Hotel. We like to give a big thank you and deep appreciation to everyone who contributed to making this incredible event possible.
Did you miss the 11th-year celebration, or are you looking to reminisce about the event?
If so, we have compiled a recap of the key moments and highlights from the two-day summit. From insightful presentations and productive one-on-one meetings to energetic networking and lively roundtable discussions and panels, we're excited to share that the event was a great success!
Table of Contents
Day 1 Highlights
Day 1 of the 11th annual American Medical Device Summit started with a warm welcome from our Room 1 chair, Jackie Kunzler, SVP and Global Head, R&D at Terumo Blood and Cell Technologies. Her opening remarks set the tone for an event filled with excitement, engagement, and innovative insights! A special thank you goes out to our emcees for the breakout rooms, including Juan Daccach, VP, Global Product Safety at Merz Aesthetics, Jack Garvey, Founder, CEO at Compliance Architects, and Patrick Jones, Senior Director, Regulatory Affairs at ShockWave Medical.
We started the event with a dynamic opening keynote from Robert Kossmann, EVP and Chief of Medical Affairs at Fresenius Medical Care. Robert took to the stage and discussed chartering best practices for bringing new products to market. He highlighted the tools, technologies, and expertise needed to cement the relationships between design, R&D, quality, and regulatory to drive production innovation; the significance of patient-centric approaches in clinical research, and more, followed by a case study.
Following the keynote was Ganesh Mayya, SVP, Software Engineering, GE HealthCare Imaging at GE HealthCare, who led a plenary on innovating medtech product design for superior clinical outcomes. He also touched on key points in enhancing product design through quality, reliability, and rapid delivery, mastering software strategies, implementing deep learning, and utilizing AI for comprehensive CT and XRAY software solutions.
Next up was a plenary session featuring Shital Patel, Chief Operating Officer, Orla Blount, Senior Director, Business Development, and Maylin Truesdell, Director, Regulatory Affairs at ECI. They discussed the best practices in successful product design acquisition integration, the benefits of pre-acquisition due diligence, tools and techniques for successful assessment of data, and more thorough insights.
Following the captivating speaking sessions, we took a break to enjoy refreshments, network, and engage in pre-arranged 1-to-1 meetings. This intermission provided the opportunity for all participants to foster new connections and explore innovative business solutions.
Day 1 continued with insightful sessions from Alind Sahay, VP, Research & Development at Pentax Medical, Kamaal Anas, CVP, Regulatory Affairs, B. Braun Medical at B. Braun Group, and Richard Rapoza, PH.D., DVP, Research and Development at Abbott. They addressed delving into product development and R&D strategies, pushing the boundaries of medical technology, leveraging data from regulatory bodies, and unveiling the future of bioresorbable technology in cardiovascular care.
Next up were some engaging workshops! On the main stage, Brett Landrum, VP, Global Innovation and Development at Phillips Medisize, led an informative workshop about sustainability in medical device product design and development. Meanwhile, Rita King, CEO, Senior Regulatory Consultant at MethodSense led a captivating workshop on developing AI/ML validation strategies that support clearance of your AI/ML medical device.
Across the hall and upstairs were two additional workshops, one led by Greg L. Palagi, Senior Consultant at IPM, and the other led by Atul Mahajan, Director, Engineering Services at IZiel Healthcare Inc. In Greg's workshop, he discussed how to take control of your product remediation efforts and keep your product on the market. Atul's workshop provided insights into effective change management and the evolving PFAS story.
Afterward, we transitioned into Lunch & Learn Roundtable Discussions, where industry experts engaged in moderated discussions about pressing issues in the field. These engaging conversations were led by executives from The Voluntary Improvement Program, 180 Engineering, Providence Enterprise USA Inc, Keysight Technologies, Ambrit Engineering Corp, BSI Group America, 1factory, ECI, Johari Digital Healthcare, CADDi Co, Prolucid, GXO, and UL.
Following the roundtables, we heard from more industry executives during their insightful speaking sessions. Mizanu Kebede, Chief Quality and Regulatory Officer at Smith & Nephew, spoke on navigating the current regulatory changes in the European medical device industry. Leading the next room was John Sutton, VP, Operations at Thermo Fisher Scientific. He highlighted building high-performance teams through effective leadership.
Robert Popp, VP, Quality at Cook Medical, simultaneously led a session on utilizing risk management methodology to assess the safety and performance of products. Meanwhile, Daniel Canos, Director, Office of Clinical Evidence and Analysis, OPEQ, CDRH at FDA, led a stream on advancing clinical evidence generation and harnessing real-world insights.
Later in the afternoon, we dove into some workshops from our solution providers. Scott Miller, EVP, Global Occupier Advisory Team, and Jordan Adams, Senior Associate, Global Occupier Advisory Team from CBRE discussed how MedTech companies have pivoted in their production and distribution strategies. Michael Corrales, Director, Sales Operations and Marketing at 1factory hosted a workshop on compliance, risk, reduction, and increased yield for medical device manufacturers.
Concurrently, another workshop hosted by Priya Paul, Founder, CEO at RegDesk, explored the path, pitfalls, and the use of RIM for managing regulatory submissions. Meanwhile, Youzhi Li, PH.D., Director, MedTech Instrumentations at Keysight Technologies, led their workshop on master risk management in wireless coexistence and cybersecurity for IOMT devices. Following these engaging sessions, we prepared for our next round of one-on-one meetings and a Networking Happy Hour, kindly sponsored by The Voluntary Improvement Program .
After the break, we dived into more insightful sessions in our four breakout rooms. On the main stage, Brian Lawrence, VP, Chief Technology Officer at Vapotherm spoke on chartering the future and navigating the evolving digital landscape in medical device innovation. Next room over, Magnus Karlberg, VP, Product Development at Arjo provided insights on utilizing data-driven decision-making in new product development.
Down the hallway, Elena Mack, Chief Quality Officer at SaniSure led a thoughtful session on implementing strategies to elevate supplier quality. Upstairs in our fourth room, Raghu Jainapur, VP, Quality and Amarjot Singh, Director, Quality, Digital Health and Innovation at Baxter International spoke on navigating the exciting world of AI/ML in MedTech.
Shortly following, we moved to an empowering panel discussion surrounding Women in Leadership. The panel brought together Kathleen Wessberg, DVP at Abbott, Andrea LaBarbera, VP, Global Talent and Engagement at Zimmer Biomet, Elena Mack, Chief Quality Officer at SaniSure, and Shelly Nash, SVP, Global Chief Medical Information Officer at Fresenius Medical Care. The panelist shared engaging insights into the most significant barriers in their leadership career, the best pieces of advice they received, organizational initiatives that are in place, and advice for empowering next-gen professions.
Concluding Day 1 of the conference, we heard from a panel comprised of Eric Rainis, GVP, Quality Management, Design Assurance at Olympus Corporation, Steve Blatcher, Product Development Director at Team Consulting, Daniel Wright, VP, Quality Assurance and Regulatory Compliance - Global at Owens & Minor, and Daniel Campion, VP, Regulatory Affairs at Becton Dickinson. The industry executives shared their expertise and strategies for navigating the path to quality and regulatory excellence.
We wrapped up the day with closing remarks, followed by a vibrant Networking Drinks Reception, bringing together our valued delegates, sponsors, and speakers for enjoyable networking. A special thank you to 1factory for sponsoring the featured cocktail of the evening, The Compliance Old Fashioned!
A special appreciation goes out to our emcees, Jackie Kunzler, Juan Daccach, Jack Garvey, and Patrick Jones for their insightful contributions and support throughout the day!
Day 2 Highlights
Day 2 of the American Medical Device Summit kicked off bright and early with a Networking Breakfast, followed by our emcee, Jackie Kunzler, providing their opening remarks to set the tone for the day ahead.
The morning started fresh with an opening keynote led by Jeff Cohen, SVP, Global Business Leader Ultrasound at Philips. Jeff shared further insights on the role of AI and the future of healthcare, furthering the discussion of industry transformation. Immediately preceding the insightful session, Jennifer Paine, SVP and Chief Quality Officer at Johnson & Johnson, led a plenary. Her presentation dug further into digitizing quality organizations to unlock value and drive business growth.
Following Jennifer's engaging session, Chris Brown, VP, Sales at CADDi Co and Brian Loushine, Strategic Development at Chamfr wrapped up our morning plenaries with their captivating session. The two spoke on optimizing R&D procurement in MedTech with similar parts.
After our initial Day 2 morning plenaries, we enjoyed our final networking break of the summit with more engaging 1-2-1 meetings and refreshments!
Workshops were then hosted across four rooms for the delegates to attend. In Room 1, Jay Crowley, VP, Medical Device Solutions and Services at USDM Life Sciences hosted a workshop on data management strategies to accelerate digital transformation. Concurrently in Room 2, Taylor Young, Chief Strategy Officer at CoLab Software, hosted a workshop next door. Taylor spoke on quantifying the impact of design review methods on NPD.
Around the corner in Room 3, Evi Cohen, Industry Leader, Life Sciences at Appian, Subodh Loknath, Senior Manager, Global IT Systems, Quality, Post Market Regulatory Affairs at Boston Scientific, and David Trang, Advisory Director, Platforms at KPMG LLP, led a workshop on revolutionizing medical device tracking at Boston Scientific and leveraging Appian and KPMG for scalable solutions. Meanwhile in Room 4 upstairs, Mark Palmer, MD, PH.D., CTO Healthcare, Lead Chief Technologist at Ansys led a workshop on accelerating innovation and quality of care through computer modeling and AI.
The dynamic workshops were followed by a series of captivating sessions. On the main stage, Robert Scott, VP, Intraocular Devices R&D at Alcon, led a session about building resilience and combating supply risk with effective and efficient contingency planning solutions on strategies for mastering product launching and development cycles. Next door, a session was led by Neeta Mhatre, VP, China Strategy, Operations at Intuitive. Neeta led the lively session on advancing patient care through digital integration in the OR.
Around the corner, another session was hosted by Dina Justice, VP, Regulatory Affairs at Terumo Medical Corporation, where he shared some great insights on global regulatory strategies and design control considerations for new products.
Following the engaging sessions, we kicked off noon with our final set of workshops. In Room 1, Jason Scherer, CEO, and Richard Thompson, VP, Engineering and Product Development at VitaTek, hosted a workshop on true vertical integration and the secret to bringing devices to market. Concurrently in Room 2, Andrey Fadeev, CEO and Sanjay Inamdar, Head of International Business at ELMAS, hosted a dynamic workshop next door. Andrey and Sanjay shared insights into regulatory affairs and market access consulting in BRIC nations (Brazil, Russia, India and China).
Then, it was time for lunch with some engaging roundtable discussions featuring Kamala Kodihally Nanjundeshaiah, Senior Manager, Quality Assurance, Software Medical Devices at Pfizer, John Mastrototaro, PH.D., CEO at Movano, Lisa K. Rose, EVP, Head of DX Core Lab Solutions Business at Siemens Healthineers, Abdulmohsen Alhajlan, Head of Clinical Evaluation of Medical Devices at SFDA, David Navazio, President, CEO at Gentell, Sean Gilligan, COO, and Rob Lavado, Regulatory and Quality Lead at AVS, Maria Moroni, Project Officer at BARDA/ASPR, and Joe Sapiente, SVP at Medical Device Innovation Consortium (MDIC).
After enjoying some delicious food and lots of valuable insights, we returned to the main stage with our final plenary, led by Daniel Campion, VP, Regulatory Affairs at Becton Dickinson. In Daniel's captivating discussion, he spoke on leveraging a more clinical look at product design for more impactful FDA submission.
To wrap up the thought-provoking discussions from the event, our final plenary was led in Room 1 by Adam Szaronos, President, CEO at Trukera, Aaron Peterson, VP, Research and Development at HeartSciences, David Navazio, President, CEO at Gentell, and John Mastrototaro, PH.D., CEO at Movano. The speakers led the discussion on visionary strategies for small to midsize companies, and lessons on leading innovation when building effective culture, and more.
As the Summit drew to a close, concluding two days filled with learning, networking, and knowledge exchange, our incredible emcee Jackie Kunzler provided their closing remarks and announced the winners of our survey prize giveaway. A special thank you again to Juan Daccach, Jack Garvey, and Patrick Jones for their remarkable support throughout the day emceeing the breakout rooms.
In celebration of our attendees' outstanding participation, we're delighted to unveil our prize champions, who've brought an extra dash of vibrancy to our event! A big congratulations to our survey winner, Aleli Scerba, Director, Executive Search, Talent Acquisition at Medtronic, and Ian Kelsey, Director, Quality at Bausch & Lomb, the networking superstar!
Conclusion
We are thrilled to celebrate the 11th Anniversary of the American Medical Device Summit! We extend our heartfelt appreciation to the esteemed experts and every delegate and sponsor who contributed to making this Summit an extraordinary experience. Your dedicated support and enthusiasm are what make our summits successful!
It's been a remarkable journey leading to this milestone, and we are excited to carry this success into the 12th annual American Medical Device Summit.
We truly hope the Summit made a lasting impression on you, just as it did on us. If you were unable to join us this year but wish to participate in this exceptional gathering next year, please express your interest. It's never too early to get excited about what's to come!
SEE YOU NEXT YEAR: 12th annual American Medical Device Summit | October 7-8, 2025 in Chicago, IL
Visit the summit's website to learn more, view the current program, and secure your pass today!
Secure your spot for next year as an attendee, solution provider, or speaker with early registration opening now! To keep yourself in the loop about upcoming Summits, explore our event calendar at generisgp.com/events.
Testimonials
We had a great first experience as a sponsor of the American Medical Device Summit. Special shout out to our sales rep who went above and beyond to deliver value for us.
Patrick Hodgdon, VP of Marketing, VitaTek
The arranged meetings were very valuable and aligned us with companies who need our product & service.
Jim Reilly, Vice President, Copley Consulting Group
My experience at the summit was incredibly enriching. It provided a great opportunity to engage with industry leaders, exchange valuable insights, and expand my professional network. The sessions were thought-provoking, and I left feeling inspired and better equipped with actionable strategies to implement in my own work. Overall, it was a well-organized event that exceeded my expectations and fostered meaningful connections.
Nasim Anbarafshan, Quality Assurance Director, Luciddx Labs
The AMD Summit has been a unique, valuable opportunity to make great connections in the medical device industry - from service providers to fellow attendees (ranging from start-ups to large corporations).
Emily Skanron, Director of Quality and Regulatory, FlexDex Surgical
Fantastic!!! Well organized with top-notch speakers in the industry. 1-2-1 meetings were well set up with individual needs
Lenny Dao, Director, Getinge
Very happy with my choice to attend my first Generis American Medical Device Summit. Excellent variety of relevant, field-specific, current content presented by industry experts with facilitated Q&A by your industry peers.
Jarod Markley, Director, Quality & Regulatory Affairs, Recovery Force Health
The summit was an incredible experience! It was inspiring to connect with so many like-minded professionals, share ideas, and gain new insights. The sessions were engaging, and the networking opportunities were invaluable. I'm leaving with fresh perspectives and excitement for what's to come.
Abdulmohsen Alhajlan, Head of Clinical Evaluation, Saudi FDA
It has been an amazing learning and networking event. The organizers did a great job ensuring that all attendees made the most out of this experience. They have done an excellent job facilitating such an event. Met some really amazing people and found many useful resources and tools that we will be looking into getting, which will streamline the process, and increase efficiency and productivity.
Lakshmi Rajan, QA Manager, Gentell
Very collaborative atmosphere and good connections. Great event- love the app!
Shalene Thomas, Manager Emerging Contaminants, Battelle
Learn more about our upcoming North American events and secure your spot today:
- 6th annual American Food Manufacturing Summit | November 7-8, 2024
- 9th annual American Automotive Summit | November 12-13, 2024
- 8th annual American Pharma Manufacturing & Outsourcing Summit | November 18-19, 2024
- 10th annual American Aerospace & Defense Summit | December 4-5, 2024
- ...and more 2025 events!
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