Quality operations is an essential function of the life sciences industry. Drug manufacturers must thoroughly test materials, processes, equipment, techniques, environments and personnel in order to ensure their final products are consistent, safe, effective and predictable. Of the medicines that are tested on people, 90% don’t reach the market because they are unsafe or ineffective.
Even when a drug does make it to market, there is no guarantee it will succeed. From January 2013 to October 2018, approximately 8,000 medications were recalled by pharmaceutical companies across the United States and abroad, following concerns over quality. While every year, $5bn is wasted due to expired, lost or uncaptured medical device charge costs. To avoid operational inefficiencies, information needs to be kept up-to-date and products captured at point of use to enable intelligent healthcare and purchasing decisions.
Research by McKinsey Global Institute (MGI) reveals that major recalls or other quality events can mean medical device manufacturers risk losing up to 11.7% of market segment revenue or around $300m in less than 12 months. Companies are all too aware of the risk, according to research, 67% of executives consider cost of quality essential to competitive success. Quality issues can be the result of a slip up somewhere along a complex supply chain or during the design, testing and manufacturing process. A single error can have severe consequences not just for patients, but shareholders too - one major quality event can mean a ten percent drop in a manufacturer’s share price, according to MGI.
A new phase in the industrial revolution has the potential to revolutionize the quality process. Industry 4.0. is ushering in a new era of interdisciplinary research and practice that focuses heavily on interconnectivity, automation, machine learning, and real-time data. According to a report by Pharma Manufacturing, the first real-life cases of implementing such innovations have delivered a 50% reduction in overall quality control costs. Digitization and automation will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and effective resolution of problems. Test cases have demonstrated incidents with over 90% faster closure times.
In Deloitte’s Global Life Sciences Sector Outlook, research points to “an evolving regulatory and risk environment” heightening the need for skilled life sciences professionals. As the demand for this talent continues to grow, organizations such as the ASQ, headquartered in Milwaukee, Wisconsin, helps provide ongoing training and certifications to quality professionals in more than 130 countries global. As the life sciences industry continues to grow, so too will the medical device and pharmaceutical quality assurance sectors.
