As a medical device manufacturer, you cannot ignore Industry 4.0 in order to remain competitive in this new era. The impending age of the global ‘smart’ or ‘digital’ factory will have a particular relevance for the sector, as the demand for increasingly sophisticated and rigorously regulated products continues to intensify. Products that are less than precision-perfect simply will not make the cut in the age of digitization.

Although there is an acknowledgement across the device industry that companies must become ‘Industry 4.0 ready’, many, especially smaller organizations, simply do not know where to begin. While there is a degree of awareness that new software and technology is needed, many shy away from the investment. The good news is that a lot of the new software and systems necessary can be scaled to size for an operation, and a return on investment is possible in as little as three months following implementation. However, the true revolution does not reside within the technology but within the processes and methodologies that are enabled by the technology.

For a clearer picture of how Industry 4.0 will look in practice, this article reviews the top factors you need to consider as a medical device manufacturer.

1. Manufacturing Execution Systems (MES) will be necessary to remain competitive. Advanced manufacturing technologies and software will be mission critical in Industry 4.0. Regardless of the size of the company, a failure to adopt these technologies and integrate them into operations will prove devastating in an Industry 4.0 world. For medical device manufacturers, MES is the software that will ensure you remain relevant, compliant and competitive in this new era without sacrificing quality. Put simply, MES is a comprehensive system that enables integration and communication of real-time data from the ‘shop floor to the top floor’, all while systematically enforcing your device manufacturing requirements at the point of use to prevent errors and immediately detect defects. MES will result in the following benefits:

• Reduction in costs
• Enhanced productivity
• Improved quality control
• Enforcement of regulatory compliance
• Elimination of the paper trail
• Improved manufacturing culture
• Enablement of manufacturing excellence

2. The Internet of Things (IoT) will be central. Industry 4.0 in a nutshell will be comprised of a combination of advanced software, sensors and communication technology. Machines on the shop floor will be connected to wired and wireless networks via embedded sensors used to not only extract, but analyze data in real time. This valuable data, accurate and precise with reduced potential for human error, will be shared and communicated with other machines on the floor, as well as with every department across the manufacturing organization. This will allow medical device manufacturers to have better quality control over their processes, better visibility into their “Critical to Quality” parameters, and will ultimately lead to making better informed, timely and effective decisions. In turn, this will lead to superior products at a reduced cost of goods sold, a necessity for the future.

3. Manufacturing processes must support Cyber-Physical Systems (CPS). Medical devices will effectively be CPS that can communicate with monitoring systems and with medical professionals. Therefore, manufacturing operations and processes have to be optimized to support this capability, as it will spawn a new generation of products that enable the manufacturer to directly monitor the use, status, issues and effectiveness of their products by the consumer. This feedback loop will enable unprecedented access to the real-world use of products so that the manufacturer can better understand consumer needs and challenges. For serviced products, manufacturers will have the ability to enable advanced notifications of potential issues with products and proactively notify consumers of the need for service.

4. Industry 4.0 is a good thing! Just as the three industrial revolutions that have preceded Industry 4.0—steam power, mass production and information technology—have benefitted the world immensely, so too will Industry 4.0. The advanced technologies and unprecedented improvements in how products are manufactured and even designed will mean patients can benefit from superior medical devices. For manufacturers, the benefits can be realized with real time, accurate data stored in centralized systems that can be accessed by everyone within a company from designers to engineers to business managers, enabling the cost-effective production of better products. Costs associated with re-designs and paper storage will be eliminated and time to market will be dramatically reduced. Ultimately, customers will receive superior products at no extra cost to the manufacturer.

There is no question but that Industry 4.0 is on the horizon—the question is whether manufacturers have the foresight to take the required action now that will position them as the leaders of the new age before their competitors beat them to it.