Impending European regulations on medical testing have medical device makers around the world hopping. The European Union is expected to implement its In Vitro Diagnostics (IVD) Directive by December 2003. It will require calibration of medical devices for measuring specific substances in IVD samples, such as cholesterol or glucose, to be traceable to a national standard. Manufacturers will have to comply with the regulations in order to do business in EU member countries. Stakeholders worldwide recently gathered in Gaithersburg, MD, to discuss how to meet the EU directive. The U.S. National Institute of Standards and Technology, meanwhile, is developing a database of reference materials that the IV industry can use. The database will serve as a benchmark for developing individual diagnostic tests for IV samples. E-mail email@example.com.
Cost, product development rigor, the patient-as-a-user movement, and consumer electronics that include wireless connectivity are just a few hot topics swirling around medical devices. Each brings challenges that create innovation opportunities. If we briefly look at each one, we can see that one common need will be innovation in simplicity.
The supply chain will change significantly over the next 10 years as industry 4.0 technology enhances supply chain performance, according to the 2015 MHI Annual Industry Report, “Supply Chain Innovation — Making the impossible possible.”
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