Balancing sustainability with patient safety in medical device design
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PA Consulting life sciences and regulatory expert Maggie Chan, Ramsay Black, a mechanical engineer at PA, and Emanuel Wasson, a medtech expert at PA, authored an article for Med Device Online explaining that medical device manufacturers must build in sustainable practices and approaches to device design to stay competitive in the market, and highlighting data from PA’s Reimagining sustainable medtech report.
Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on manufacturers to make devices that combine safety and effectiveness with sustainability. PA Consulting’s Reimagining sustainable medtech report shows leaders the steps that they can take to design for sustainability when developing medical devices, based on research that was conducted into the sustainability impact of six continuous glucose monitors (CGMs), as a real-life example. The pressure comes from increasing regulatory requirements but also from public opinion. Consumers of medical devices are becoming more alert and critical for the sustainability of the products they use.
Increased legislation on sustainability of medical devices
The focus on environmental impact has been progressively strengthened within the medical devices industry in the last 20+ years. Both EU MDR 2017/7451 and IVDR 2017/7462 incorporate environmental elements into the medical device life cycle implicitly, along with EU regulations and directives to provide additional guidance on hazardous substances and waste management in promoting sustainability, reducing environmental impact, and fostering a more circular economy throughout the medical device life cycle.
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