At the recent European Medical Device Summit, leaders from EssilorLuxottica and Edwards Lifesciences shared their perspectives on accelerating patient access to high-quality medical devices by leveraging technology.
The panelists discussed the most significant challenges and opportunities facing the medtech industry today. Dr. Norbert Gorny, chief scientific officer at EssilorLuxottica, explained that in the light of the ongoing changes at the FDA, medtech companies need to assess how they’re working with the regulator so as not to lose time and efficiency. Hence, EssilorLuxottica supports an alliance to bridge the gap between FDA, private companies, and universities so they can collectively work on innovative solutions.
Dr. Wendel Smith, global senior vice president for quality and product safety at Edwards Lifesciences, expressed similar concerns regarding the FDA uncertainty but agreed that building relationships and focusing on direct communication is crucial. He also noted that medtechs should prioritize automation to streamline internal processes, but that they’ll need to allocate substantial time and resources as the shift from spreadsheets to AI is even more significant than from paper to digital tools.
AI has tremendous potential, agreed Dr. Gorny, citing one McKinsey study that estimates it will drive $14-55 billion per year in productivity gains, with the greatest impacts in critical but repetitive workflows like regulatory documentation, contract compliance tracking, and customer support.1 However, in order to unlock this value, medtechs must ensure they’re investing in high quality data and leveraging accessible repositories like data lakes to feed AI-driven dashboards and proprietary algorithms.
In addition to underlying technology, Dr. Gorny and Dr. Smith also discussed how collaboration among teams, specifically quality and medical affairs, can improve closed-loop patient safety and speed to market. At Edwards quality and medical affairs are interacting more closely in response to events and need access to the same cloud-based data. This is also the case at EssilorLuxottica where they are using blockchain technology and decentralized ledgers to improve data visibility across teams. By setting clear targets and timelines for patient outcomes, quality and medical affairs teams can stay aligned while still having the autonomy to decide how best to achieve goals.
Looking ahead, both companies are optimistic that these factors will expedite efforts around personalized medicine and eventually predictive, preventative medicine. For example, Dr. Smith shared that a recent thoracic imaging study leveraged advanced technology to process around 150,000 images from patients already dismissed from hospital. They found roughly 1,000 nodules and caught 14 cancers, seven of which were still in stage 1 and most receptive to treatment.
1. McKinsey, Scaling Gen AI in the Medtech Industry, 2021↩Read more about AI’s impact on medtech, including how Zeiss is using AI to optimize commercial content generation.