Streamlining Medical Device Development: An Integrated Approach to Compliance, Quality, and Agility

Medical device development is facing increasing challenges due to rising complexity, emerging cyber security threats, and evolving regulations. The development of new and innovative medical devices requires companies to navigate a complex and constantly changing landscape, balancing the need for speed, agility, and cost-effectiveness with the need to meet rigorous standards for quality and compliance.

This presentation outlines a comprehensive engineering lifecycle solution designed to address the challenges faced by medical device development companies today. The solution aims to achieve three key objectives: (i) enabling the speed of innovation, (ii) reducing the cost of meeting medical device regulations across different geographies, and (iii) assuring quality and avoiding recalls effectively.

The solution is based on an integrated engineering approach that creates digital threads across engineering disciplines and domains, from requirements management and risk analysis to product design, implementation, and verification and validation. This integration also includes domain-specific applications for electrical and mechanical engineering, as well as common software development tools such as Git platforms. The integrated environment provides a foundation for quality engineering, ensuring data consistency and integrating verification and validation activities with requirements and design artifacts.

To address the challenges of regulatory practices such as ISO 13485, ISO 14971, and IEC 62304, the solution includes a central review and change management system, including a central reporting system that leverages cross-domain engineering data to automate all necessary evidence for the engineering process. This includes traceability to requirements, testing coverage, and review, configuration, and change control activities. The system provides continuous visibility into progress and quality trends, resulting in more trustworthy and accurate reporting compared to manual reporting and documentation. This device history data is automated across all disciplines, including software, electrical, and mechanical.

Finally, to support the speed of innovation, the solution integrates an agile planning and tracking system that includes agile planning boards, online dashboards, and continuous work prioritization and tracking. The system also supports digital collaboration across all engineers and disciplines, including discussion threads and personal dashboards related to all engineering artifacts and activities. This integrated approach to medical device development supports the goal of delivering high-quality, compliant, and innovative medical devices to patients.

Was lernen die Zuhörer in dem Vortrag:

Wir zeigen auf wie Digital Engineering hilft

• das Qualitätsmanagement zu verbessern
• agil zu entwickeln
• Auswirkungen von Änderungen schnell zu beurteilen.

Referenten: Peter Schedl, IBM Deutschland GmbH und Eran Gery, IBM Israel

Peter Schedl befasst sich seit mehr als 20 Jahren mit Themen im Bereich der Entwicklung von mechatronischen Systemen. Bereits frühzeitig lernte er den Mehrwert eines ganzheitlichen Vorgehens bei der Erstellung von System-, HW- & SW-Architekturen schätzen. Im Rahmen von verschiedensten Projekten z.B. im Automobil, Bahn, Medizin und Luftfahrt Umfeld konnte er erst Erfahrungen mit der Einführung von methodischen Vorgehensweisen sammeln und später als Berater weitergeben. Aktuell befasst er sich insbesondere mit den Herausforderungen, die die digitalen Transformation an Entwickler von Produkten und Services stellt, und wie diese mit Hilfe von künstlicher Intelligenz gemeistert werden können.

Eran Gery is a World-Wide solution lead for IBM Engineering Lifecycle Management (ELM). Eran leads the engineering practices and solution architectures for IBM ELM for regulatory industrial domains, With special focus on Medical Devices, Aerospace and Defense, and Automotive. Eran’s expertise includes Systems and Software Engineering practices, Model Based Engineering, Product Line Engineering, and Automation of regulatory practices. Eran has over 25 years of experience within the complex systems domain working on digital and tool practices with major customers worldwide in the abovementioned industries. Eran is also an active member of the SysML V2 specification team in the OMG and was part of the SysML and UML founding teams.