Accelerate Updates to AI Algorithms with PCCP: Webinar

We in MedTech are learning how to more rapidly evolve the software in our connected medical devices and Software as a Medical Devices (SaMD) while maintaining our quality standards for device safety and effectiveness.

Historically, it has been a challenge to minimize the regulatory burden of a full resubmission each time we’re ready to release a new software version. However, when compared with software’s ability to rapidly evolve, AI and Machine Learning (ML) algorithms take it to an entirely new level. These algorithms can continuously improve every time they are used based on real-world feedback. Regulators and manufacturers need to reconcile the instantaneous speed of AI learning with our methodical approach to updating devices.

As a first step in this process, the FDA has created Predetermined Change Control Plans (PCCP), giving manufacturers more latitude to make post-market algorithm changes without resubmission as long as they fall within specific guardrails and scope parameters established during the original device submission. How can the industry work with regulators to leverage this new regulatory framework so we can “move faster and break nothing” with AI/ML algorithms and medical device software in general?

Join Orthogonal on June 28th, 2024 at 11 AM CDT for a webinar looking at the potential impact of PCCP on software-enabled medical devices and SaMD. We’ll discuss the challenges organizations face when embracing PCCP, emerging best practices and the possibilities it opens up for medical device manufacturers going forward.

This webinar will build on a recent white paper developed by a group of seasoned industry professionals co-convened by Orthogonal titled “Making the Significant Insignificant: Implementing a Predetermined Change Control Plan (PCCP) for Class II SaMD Products Beyond AI/ML.”

You’ll leave the webinar with:

• A high-level understanding of PCCP and its rollout.
• Advice on how to craft a PCCP based on submissions from manufactures who have successfully had PCCP approved by regulators.
• A framework for thinking about how to apply PCCP to your current and future medical device software and SaMD products.

Speakers

Yu Zhao, Founder and President, Bridging Consulting LLC

Yu Zhao leads a cutting-edge regulatory, quality, and clinical consulting firm dedicated to servicing AI startups and medical device companies. With a dedicated team of over 20 expert consultants, he provides invaluable services to clients across North America, Europe, and Asia Pacific. With over two decades of leadership experience in the medical device industry, Mr. Zhao’s career also includes a 16-year tenure at Medtronic. During this time, he held successive leadership roles, including that of director and interim vice president for several multi-billion-dollar business units.

Throughout his career, Mr. Zhao and his teams have secured more than 150 U.S. FDA approvals and clearances. Their success extends across diverse device classifications and submission categories, encompassing PMAs, PMA supplements, IDEs, 510(k)s and De Novos, including submissions for many AI/ML-enabled SaMDs and recent ones with Predetermined Change Control Plans.

Mr. Zhao’s academic background includes a BS in Electrical Engineering from Zhejiang University in China, complemented by an MBA and an MSc from Washington University in St. Louis, U.S.

Ashley Miller, Senior Director of Regulatory Affairs, Digital Diagnostics

Ashley Miller is the Senior Director of Regulatory Affairs at Digital Diagnostics, a medical device company that designs AI systems that can diagnose disease by analyzing high-quality images and received the first-ever FDA clearance to market a fully autonomous AI diagnostic platform. Ashley has over a decade of experience in regulatory affairs in the medical device industry and developing regulatory strategies for a variety of device classifications across the globe.

Ashley has extensive knowledge supporting software as a medical device, including AI/ML-enabled SaMDs, and imaging systems, and has led cross-functional teams throughout the product life cycle, from design and development through regulatory review, to ultimately gain market access.

Ashley’s academic background includes a BS in Nuclear, Plasma, and Radiological Engineering from the University of Illinois at Urbana-Champaign.

Bernhard Kappe, CEO and Founder, Orthogonal

Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.

Moderator

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).