Closing the gap between Regulatory and Development with Milton Yarberry
Mar 5, 2024
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Medical device product development specialist Milton Yarberry discusses bridging regulatory and development mindsets in the medical device industry, automating GUI testing, balancing compliance and efficiency in software engineering processes, rethinking rules and regulations for Agile transformation, and navigating the gap between regulatory and development teams in product development.
Collaboration between engineering and regulatory teams is crucial for successful product development.
Automating checks and documentation processes is essential for ensuring product safety and efficacy.
Deep dives
Understanding the Gap Between Engineering and Regulatory Teams
The podcast delves into the perceived gap between engineering and regulatory teams in product development. Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions, shares his experience working with medical device software. He emphasizes the importance of bridging this gap to ensure product success.
Challenges Faced in Product Development
The discussion highlights challenges such as process lag and ambiguous regulatory processes that impact startups. Milton advocates for a collaborative approach, focusing on incremental process rollout and simplifying procedures to ensure safety and efficacy.
Automating Processes and Ensuring Product Safety
The importance of automating checks and documentation processes is stressed for product safety. Suggestions for incremental process changes and risk mitigation strategies are discussed, emphasizing the value of early and continuous testing in product development.
Building Collaborative Relationships for Product Success
The need for collaborative interactions between engineering and regulatory teams is essential for successful product development. A shift towards regulatory support instead of burden is suggested, promoting shared responsibility and clear communication to deliver safe and effective products.
ICS offers medical device product development services, with their: - Proprietary low-code prototype system - Free Cybersecurity and Architecture gap analysis offerings
Get in touch with Milton Yarberry at: - email: myarberry@ics.com - LinkedIn: https://www.linkedin.com/in/milton-yarberry-06a2311