Manufacturing execution systems with fully digital device history records get life-saving and life-improving products to patients faster.
Brian Curran, MasterControl
Medtech manufacturers’ goal of delivering more product faster, at lower costs, and with fewer quality issues is hindered by a continued reliance on paper or a traditional manufacturing execution system (MES) to manage production processes. Digital technology can accelerate processes, increase visibility and flexibility, and bring life-saving products to market sooner for patients who need them.
In a 2021 Deloitte survey on digital transformation, executives said the top reasons for investing in digital transformation were to innovate faster, to modernize to keep up with the times/, industry changes to become more resilient, because competitor moves require it; and to comply with regulations.
A modern MES solution meets these needs by reducing production errors, improving cycle times and efficiency, enhancing line performance, integrating manufacturing and quality management, and accelerating product release. These are all critical factors for medtech manufacturing organizations that must get their products to market faster while upholding the highest levels of quality.
A modern, cloud-based MES solution is fast to deploy, simple to configure, easy to use, and scalable across every production line and site — all contributing directly to accelerating time to market of medical products.
Digitize fast with a light MES solution
Depending on the complexity of a traditional MES, it can take years to roll out a complete MES, considering internal requirements gathering, budgeting, selection, and actual MES implementation. While you can customize an off-the-shelf traditional MES, almost everything is hard-coded, and making changes requires time-intensive process re-engineering. A traditional MES’s machine-centric design and complexity also tend to make the barrier to acceptance quite high, making user adoption and usage even more challenging.
A cloud-based MES solution can be implemented fast, from planning and discovery through building, testing, and launch. For example, MasterControl’s light MES, Manufacturing Excellence, can be implemented in less than six months for a single-site solution, including parallel pilot and system validation. A global medical imaging manufacturing customer took its U.S. and China sites paperless in six months. The no-code configuration of a modern MES solution lets manufacturers configure quickly while supporting existing processes and workflows. A modern MES solution’s pick-up-and-use simplicity is focused on the operator and their ability to quickly adopt the software.
The rapid deployment of a light, configurable MES solution means medtech manufacturers can quickly digitize and automate their shop floor and get users up to speed, which leads to faster process improvements.
Streamline manufacturing production processes
Paper-based systems are generally time-consuming and prone to error because they rely heavily on manual data input. Likewise, the time-consuming implementation and rigid process configurations of a legacy MES means it is often deployed on a limited number of product lines, so all production capacity that isn’t automated using the MES still has paper-based device history records (DHRs). This paper creates an offline data gap that slows production, quality review, and product release.
A modern MES solution with fully digital eDHRs is designed to connect every step of the manufacturing process, eliminate the documentation burden, and automate the labor-intensive steps in production. For example, automated data integrity checks and error-proofing features streamline the DHR process. Automated real-time quality review at every step on the production line helps ensure lots are right the first time (RFT), improving cycle times and efficiency. Closing the offline paper gap with a modern MES solution lets medtech organizations capture the real-time data and insights they need to optimize production, reduce deviations and corrective actions/preventive actions (CAPAs), improve RFT metrics, and accelerate good manufacturing practice (GMP) review and product release.
The significant process and operational improvements provided by a modern MES solution can reach across all product lines and sites.
Quickly scale up and out across lines
While manufacturing leaders believe digital technologies create huge opportunities for their organizations’ ability to improve processes, project complexity and overall cost often limits the ability to implement a traditional MES across all of an organization’s products and production lines. With most traditional MES implementations, the system gets rolled out onto certain lines or at certain sites, and then cost justification becomes an issue. The result is that the MES is rarely deployed across all product lines and sites.
In the face of changing environments and markets, a configurable, cloud-based MES solution can quickly scale up and out across production lines and sites to deliver varying products faster. The no-code configuration discussed above allows for the flexibility to adjust processes, material, and equipment changes for varying products. When an MES solution leverages a configurable no-code master template builder, manufacturers can quickly create an eDHR with minimal training as well as simplify building subsequent master templates. An integrated product family tool simplifies the management of product variations, substitutions, and change control from a single master template to quickly scale operations and create new products for existing or new markets. Scalable templates enable consistency, mitigate change control, and provide real-time updates.
Through fast digital implementation, greater efficiency, and easy scaling, a modern MES solution with fully digital eDHRs will allow medtech manufacturers to dramatically accelerate the speed at which they get their life-saving and life-improving products to the patients who need them.
Brian Curran, SVP of Manufacturing Excellence success at MasterControl, has more than 30 years of experience leading the direction for enterprise and entrepreneurial software development companies. He has an MBA with an information systems emphasis.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.