This studio session explores how a quality-first mindset can drive success across an organization, from product development and operations to supply chain and manufacturing. Key topics include leveraging risk management to focus on high-priority areas, balancing speed to market with cost and quality considerations, and creating robust feedback loops to adapt and evolve processes. The discussion also highlights the importance of fostering a culture of quality through communication, accountability, and integrated performance objectives.
Hosted by Joe Sapiente, head of MDIC’s Science and Technology Group, the session features insights from Al Crouse, Head of QA/RA at CVRx, and George Serafin, CEO of NanoDX, who bring their extensive expertise to this engaging and practical conversation. A must-watch for MedTech leaders committed to operational excellence and innovation.
In this studio conversation, Joseph Sapiente, MDIC’s Senior Vice President of Science and Technology, discusses the critical role of quality assurance in shaping regulatory and clinical strategies. Joined by Al Crouse, Head of Quality at CVRx, and George Serafin, CEO of NanoDX, the panel explores essential topics including product classification, preclinical and clinical strategies, and the growing role of simulation and modeling in development. They also highlight the importance of risk management and enterprise-wide approaches to ensuring data integrity, biocompatibility, and cybersecurity in clinical trials. Learn how QA strategies can align with regulatory requirements and drive success from development to market. A must-watch for MedTech professionals striving to integrate quality into every stage of the product lifecycle.
This interview hosted by Joseph Sapiente, MDIC’s Senior Vice President of Science and Technology, explores how quality assurance (QA) can drive competitive advantage in the medical device industry. Featuring expert perspectives from Al Crouse, Vice President of Quality Assurance and Regulatory Affairs at CVRx, and George Serafin, CEO of NanoDX, the discussion covers essential topics such as the distinction between quality and compliance, building a culture of quality in early-stage companies, and linking quality outcomes to business success. Learn how early investment in quality, post-market surveillance, and enterprise-wide approaches can optimize regulatory and clinical strategies while aligning with business goals. A must-watch for leaders aiming to elevate quality practices and impact the healthcare ecosystem.
Join Domhnall Carroll, CEO of Digital Manufacturing Ireland, in an MDIC Studio Session as he dives into the transformative role of advanced manufacturing for product, supply chain, and quality management innovation. Carroll discusses how digital tools like digital twins and data integration can make manufacturing processes more agile, efficient, and responsive to market challenges. He also shares insights on overcoming adoption barriers, emphasizing the importance of aligning corporate strategy with advanced manufacturing projects to enhance operational excellence and ensure long-term success. This session is essential for MedTech leaders looking to drive meaningful innovation in their manufacturing practices.
In an era characterized by unprecedented change and technological advancement, the message from industry leaders is clear: digital transformation is no longer optional but a critical necessity for survival and growth.
In this MDIC Studio session, hear from Daniel Matlis, President and Founder of Axendia, as he describes the current state of advanced manufacturing in the life sciences industry and what is yet to come. Matlis offers a comprehensive overview of how novel and innovative applications of existing technologies are reshaping manufacturing processes to enhance product quality and improve patient outcomes. Drawing from Axendia’s extensive primary research and interactions with regulatory officials, industry executives, and clients, Matlis discusses the current landscape and the critical need for broadening the adoption of advanced manufacturing technologies throughout the total product lifecycle.
“We’re living in the age of continuous disruption as and as organizations. We need to realize and prepare for that. And as a result, digital transformation. It’s not a nice to have. It is an imperative for our industry.” As the pace of technological change shows no signs of slowing, the importance of digital transformation will only grow. Companies that embrace this shift will be better positioned to navigate disruptions, meet customer needs, and drive sustainable growth.
Daniel’s insights serve as a reminder that in the age of continuous disruption, digital transformation is not just a strategy but a fundamental requirement. Organizations that recognize this imperative and act accordingly will be the ones that thrive in the digital future.
We invite you to learn more about the Advanced Manufacturing Clearing House and reach out to us with questions about how you can participate at AMCH@MDIC.org.
Join industry leaders Domhnall Caroll, CEO of Digital Manufacturing Ireland, Garth Conrad, Vice President of Quality at Flex Health Solutions, Daniel Matlis, CEO and Founder of Axendia, and Francisco Vicenty, Case for Quality Program Manager at the FDA CDRH in a compelling discussion on the adoption of advanced manufacturing in the medical device field. Discover how companies are tackling barriers such as ROI and internal expertise, common fears and misconceptions industry has on advanced manufacturing, and how regulatory agencies are evolving their approach. Watch the panel and discover how participating in the Advanced Manufacturing Clearing House can improve overall quality and product safety.
How do I do it? How will the agency react? How do I sell it to my leadership? An answer to your questions about advanced manufacturing—and road map over the peskiest hurdles to getting there—exist on the other side of simple change in perception. Join Joe Sapiente, Senior Vice President of Clinical Science and Technology at MDIC, and Fransisco Vicenty, Program Manager for Case for Quality at the FDA, as they discuss the evolution of the Advanced Manufacturing Clearing House initiative at MDIC.
In this MDIC Studio Session, Garth Conrad, Vice President of Quality at FLEX Health Solutions, discusses the company’s approach to enhancing quality through advanced manufacturing techniques. These innovations not only keep FLEX competitive in the medtech marketplace but also enable them to consistently deliver high-quality products to their customers. The session features real-world examples of advanced manufacturing techniques in action.
Are you working on an advanced technology project that supports digital transformation? Don’t miss out on the opportunity to apply for funding through the Advanced Manufacturing Clearing House (AMCH) program at MDIC. By submitting an application through the AMCH application portal, you open doors to a world of possibilities. Successful applicants will not only receive funding of up to $300,000 USD, but also gain recognition for adopting advanced technologies and receive valuable project feedback from the U.S. FDA and the Medical Device Innovation Consortium (MDIC).
The advantages of participating in the AMCH program are numerous., You’ll have the opportunity to collaborate with the Advanced Manufacturing Clearing House team, and Subject Matter Experts (SMEs) in your area of technology. After completion of the project you agree to share your learnings and benefits gained through implementation of the project and include in the Clearing House portion of the AMCH Program.
Furthermore, the Project Selection Team, comprising members from MDIC, FDA, and Advanced Manufacturing SMEs, will determine the funding amounts awarded to approved projects. You could receive up to 30% of the total project cost not to exceed $300,000, giving you the financial boost, you need to bring your vision to life.
To help you understand how to include critical components of a successful application and make the most of this program, we invite you to watch this informative webinar.
Hosted by the Advanced Manufacturing Clearing House Program Director, Prakash Patwardhan, and the Sr. Program Manager for AMCH, Steve Zera, this webinar will provide insights into submission criteria, eligibility requirements, and the ability to ask questions during this live event.
