PLM in Medical Devices
A Complimentary CIMdata Educational Webinar with Vinu Gurukar, Executive Consultant, CIMdata
February 13 2020
11:00 EST | 08:00 PST | 17:00 CEST
Are you facing any of the following challenges?
- A lack of understanding as to what PLM is
- PLM ownership and governance challenges
- Poor business systems architecture
- A nonexistent “golden” product record
- A reliance on documentation for compliance
Every medical device company wants to get to market faster to benefit from the “first-mover” advantage. On the road to commercialization, not everything is within the company’s control. Needless to say, regulatory bodies around the world hold companies accountable to standards and requirements that are getting tougher by the day. As a result, medical device manufacturers have to balance speed to get to regulatory submission and commercialization with the need for regulatory compliance. Regulatory compliance requires “production” and “assembly” of a significant amount of data and documentation during the entire lifecycle of the product. Production and assembly of data take time, effort, and resources, adding cost and extending timelines.
While subject matter experts engaged in the development of new products, features, and functionality are mindful of compliance requirements, they are typically not excited about producing documentation for compliance. So, how do we make the production and assembly of documentation for compliance during product development, manufacturing, distribution, and maintenance less onerous on resources, and free up their time to do more creative work so they can develop more lifesaving products and improve patients’ quality of life? In other words, how can we automate the production and assembly of documents and data for compliance as an effortless by-product of product and process development and manufacturing? The concepts of “digital twin” and “digital thread” can be applied and leveraged to accomplish this, which not only makes it less onerous on resources, but also enables the reuse of data and documentation for the next generation and next iteration product development—thereby accelerating product development.
This webinar focuses on the typical challenges associated with PLM in medical device companies and how they can be overcome.
What will I learn by attending this webinar?
- You will improve your understanding of PLM at all levels of the organization.
- You will gain an understanding of how PLM ownership and governance should be established and maintained.
- You will recognize the importance of business systems architecture for PLM.
- You will learn why defining and governing a product record (and data architecture) is important.
- You will find out how to lessen the burden of producing and assembling documents for compliance
- You will understand how PLM can help accelerate product development and compliance.
- You will be able to determine how to prepare an organization for PLM.
- You will be able to recognize the dependencies of people, process, and technology for PLM.
Who should attend?
- Executives, directors, and managers engaged in product development, quality, regulatory affairs, manufacturing, supply chain, and IT.
- PLM team leaders and team members
- Business analysts
- Systems architects, data architects, and solution architects
- Organizational change management experts
- Software validation experts
- Anyone who wants to learn about how PLM can be beneficial for medical device companies.
During the webinar you’ll also have the opportunity to ask questions about the topics discussed.