As companies work to comply with changing regulations in the Medical Device industry, there is an opportunity to improve production and revenue for the savvy manufacturer.
By Anthony Cuilwik, CEO of CIMx Software
Change is happening across the Medical Device Manufacturing industry.
Additional standards are being implemented at an accelerated pace across the industry. There is a push for electronic medical records to increase collaboration and improve patient care. Hospital facilities and medical treatments are under increased scrutiny. In addition, globalization of medical device production, the rapid development of new treatments, and a focused push to lower the cost of treatment are just a few of the reasons the industry must adapt and adjust to new regulations, standards and processes.
In fact, in a recent survey, 43.3% of medical device manufacturers reported changing regulatory environment as the biggest challenge they face in the future. Companies are looking at cost efficient ways to, “… navigate the increased regulatory burden,” according to another industry report. New standards require more detailed and careful labeling, dating, use-by dates, sourcing, detailed manufacturing records, and accountability, resulting in tightened production constraints and record requirements. To comply, manufacturers must adopt new processes and utilize new tools.
At the same time, changes in the medical device industry are pushing manufacturers to lower cost and standardize production for a global market, while absorbing a new tax on medical devices. As the population ages and the cost of healthcare increases, everyone must look at ways to make healthcare cost effective and more available. To meet these goals, manufacturers must adjust their operations to improve production, lower cost and increase quality, while accommodating new regulations.