Top five forces shaping life sciences in the future--#1 Regulations: A Top-of-Mind Concern

New white paper from PMMI Business Intelligence outlines the top five forces shaping the pharmaceutical and medical device markets. Regulatory compliance drives all conversations.

#1 Regulations: A Top-of-Mind Concern
#1 Regulations: A Top-of-Mind Concern

As the pharmaceutical and medical device industries continue to evolve, one topic sits prominently in all manufacturers’ minds: regulation. Government regulation has presented new hurdles to the pharmaceutical and medical device industries within the last decade, requiring manufacturers to adapt their processes to meet changing production demands of speed, flexibility, and safety while continuing to comply with regulations.

For the pharmaceutical industry, the track and trace requirements involved with serialization (and eventual aggregation in 2023) require new sensors, software, and automated machines, as well as new integrated systems to track, monitor, and verify products throughout the supply chain.

For medical device makers, the Unique Device Identification (UDI) requirements have imposed new class-based regulations on medical devices, with each class outlining mandatory changes to development, testing, reporting, and marking requirements.

Complying with these regulations can often require a significant investment in machinery and software systems, with two out of three companies reporting that they will be spending more on capital equipment in the next two years. Adhering to regulations is particularly burdensome for smaller manufacturers with less capital to expend.

Healthcare manufacturers are looking to OEMs to help with regulation compliance strategies by adapting their machines to meet data acquisition and storage requirements for marking and tracking products which includes coding and vision inspection systems.

When evaluating a future machine purchase, manufacturers report they are most concerned with the speed and flexibility of changeovers, the efficacy of the preventive maintenance features, and the ability to automate cleaning processes.

Many of the leading suppliers of machinery and materials for pharma and medical device packaging and logistics teams will be exhibiting at Healthcare Packaging EXPO in Las Vegas, September 25-27, 2017.

See all five top business drivers here.

Source: 2016 PMMI Pharmaceutical and Medical Devices – Trends & Opportunities in Packaging Operations.

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