“Corporate innovation – and indeed any kind of innovation – is never the result of spontaneous ideas appearing for no reason. Rather it is a process that begins with a problem or a goal and ends with the implementation of one or more ideas deemed to offer value to the organization.”www.creativejeffrey.com
As a Medical Device Manufacturer, the number one barrier to scaling appears to be the slow speed of the medical industry. Device complexity, regulatory concerns, enterprise size, and more contribute to this relative slow – but steady – industry. As Medical Device Manufacturers adapt to life with – and post – the Covid19 pandemic, the utilization of digitalization will be vital for success and competitiveness in our increasingly digitalized world. Challenges require new ways of thinking. Although implementation of new technology and new processes may seem daunting during this difficult time, it may be an ideal time for manufacturers to take a deep breath, analyze their current status, evaluate challenges and opportunities, and plan next steps in moving forward in the “post COVID19” economy.
Manufacturing Execution Systems (MES) manage and employ data to enable paperless manufacturing, capture Device History Records electronically, and enforce compliance. Beyond these immediate benefits that MES provides, there is also substantial evidence that rapid scaling of production is possible through the utilization of MES Rapid Implementation Methodology.
What are the Most Impactful Business Challenges Facing Medical Device Manufacturing?
Challenges that have faced manufacturing for years continue to be magnified as digitalization comes to the forefront of the industry. These challenges include:
- Improving and Controlling Quality
- Maintaining or Reducing TCO (Total Cost of Ownership)
- Keeping Manufacturing Processes Lean and Efficient
- Reducing Errors and Increasing Manufacturing Excellence
- Streamlining Regulatory Compliance
- Enabling Rapid Scalability to Support Expansion
What is Needed – Especially Now?
“When you’re in manufacturing, it’s common sense that there be an emphasis on production systems as you evolve. Experiencing a glitch in the production process is a real possibility when you’re looking to expand sales and demand. Although such an occurrence may indicate that your product is popular, it also means it’s one additional headache to deal with. These problems are easily avoidable by investing in your production process and turning to technology. Having technology-based equipment in place can further alleviate potential inefficiencies in the production line, thus preventing a breakdown in the scaling-up progression.”Michael Deane, Thrive Global May 27, 2019
When addressing quick implementation to transform a manufacturing facility to paperless, Medical Device manufacturers must look to reduce the upfront investment and realize a return on investment (ROI) more quickly – without negatively impacting quality or compromising future developments.
How Does Siemens Opcenter Execution Manufacturing Execution System Aid in Rapid Scale-Up?
Siemens Opcenter Execution Medical Device & Diagnostics (SOE-MDD) creates a paperless manufacturing environment, enforces industry best practices and compliance, eliminates non-value-added activities, and creates a self-auditing electronic Device History Record (eDHR) and electronic batch record (eBR) – leading to a more efficient and effective production.
How Can Siemens Opcenter Be Implemented through Rapid Implementation Methodology (RIM)?
Rapid Implementation Methodology (RIM) is based on state-of-the-art cloud software technology to remove the typical time spent on IT infrastructure lead and set-up time.
In Rapid Implementation Methodology,
- A Pre-configured Solution template can be implemented within 4-6 weeks (vs. 6 months + for custom implementation),
- Out of the box (OOTB) capabilities can enforce Good Manufacturing Practices (CGMP) and enable remote auditing in order to achieve accreditation more quickly,
- A fully secured network is used via Amazon Web Services to provide a Cloud environment for production licenses,
- Flexible licensing options are available to suit individual business requirements, and
- Remote deployment and support are provided, allowing for rapid deployment and response should issues arise.
It should also be noted that RIM is independent of architecture – and can be applied to a centralized, locally installed, or managed services environment. The key benefit of a RIM approach is greater efficiency for quick implementation and scale-up. Additionally, faster development and more effective communication are a by-product.
What are the Key Pillars of Rapid Implementation Methodology (RIM)?
- Validation Support:
All the out of the box (OOTB) functionalities are already tested by Siemens, and scripts are available. Opcenter MDD is not a tool-kit; it is a fully functioning OOTB solution. This OOTB solution and associated industry experience allows for an optimized validation process.
- Top of Class Industry OOTB:
In Opcenter MDD, there are
- 170+ OOTB modeling objects available
- 75+ OOTB UI available
- 20+ OOTB Reports available
- Zero Code Configuration
- We usually cover 70+% of the projects OOTB
The manufacturer, then, receives an integrated solution, including: MES Best-In-Class solution, an opportunity to shorten the validation process, and a host of OOTB capabilities such as ERP Integration, Self-auditing eDHR/eBR, Work Order Dispatch Management, Material Management, Tracking & Tracing, Sample data collection, Non-Conformances Management, EWI, and more!
3. Pre-Configured Functionalities:
The OOTB Solution comes with pre-figured functionalities including Product Download, Inventory Download, Work Order Download, Consumption Upload, Component-Remove Upload, and Step/Order Completion Upload.
It should be noted that although RIM does not allow for customization – it leverages only in OOTB, we have found that we are typically able to deliver over 70% of the project utilizing strict OOTB functionality. Additionally, although RIM does not allow for 3rd party integration beyond the ERP it is INDEPENDENT of architecture, so can be applied to a centralized, locally installed or managed services environment.
Why Pursue Rapid Implementation Methodology Now?
- Access to the Best-in-Class MES with a limited investment
- Achieve first implementation running within 3 months
- Achieve RIM measured results similar to those who have
already utilized this methodology:
- Reduction of the overall total cost of implementation by 66%
- Reduction of the level of client resources for implementation by 75%
- Reduction of time to implementation by 50%
We have been thrust into uncertain times, however manufacturers can experience also great benefit in a time like this. When Rapid Implementation Methodology is utilized, medical device manufacturers of all sizes can to stay competitive. Exploring rapidly-implemented paperless manufacturing is an opportunity for small-to-medium manufacturers to increase their competitive advantages. Stepping into the paperless revolution creates a more secure and more accurate process, while leading the way to greater revenues…which can now be done quickly and efficiently utilizing RIM.
Questions about paperless manufacturing and RIM? We at Seabrook Technology Group are happy to walk you through pain points and address challenges that may arise during this time of uncertainty. Seabrook Technology Group consists of a team of global manufacturing experts and industry thought leaders. As Connected Manufacturing experts, we bring end-to-end manufacturing solutions (people, processes, technology) together in a harmonized fashion to enable operational excellence for medical device manufacturers.
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