PLM as the Foundation for Digital Transformation in Medical Device

Enterprise PLM: The Backbone of Medical Device Digital Transformation

Fueled by an urgent need to address the challenges of quality, risk, and an evolving regulatory environment, digital transformation initiatives are underway across the medical device ecosystem, which includes design and manufacturing partners. The goal is to meet regulatory reporting requirements and improve time to market for the sake of patient outcomes. Every program has been tasked with getting their digital ‘house’ in order to reduce the risk of non-compliance and drive down the costs with traceability of CTQs (Critical to Quality) over the entire product lifecycle. However, change of this magnitude is not easy and the impacts of COVID-19 have strained even the best of organizations. Typical challenges encountered include:

• New product introductions – time to market delays
• Adverse events/response – risk to patient outcomes
• Gaps in audit ready data – risk of non-compliance
• Do more with less – projects with quicker time to value/ highest value with lowest risk.
• Additional strain from COVID-19 – remote workforce/changing safety rules
• Additional strain from regulators – region-specific requirements (i.e. EU-MDR)
• Non-traditional competition – open sourcing of designs and increased pressure for right to repair