Disruptive market conditions caused by COVID-19 pandemic, self-sufficient manufacturing policies, personalized medicine, value-based care and the new FDA and EU MDR updates have led Medical Manufacturers from large enterprises to small- and medium-sized businesses (SMB) to require a flexible digital infrastructure specific for the MD&D industry to increase speed-to-market, improve cost-efficiency, and maintain high quality necessary to achieve regulatory compliance. On this topic James Thompson, explains why digital infrastructure is leading the way in medical device manufacturing advancements and innovation.
How did COVID-19 change the MD&D Manufacturing Industry and which challenges did you face and how?
The COVID-19 pandemic has disrupted global supply chains on a monumental scale, therefore MD&D manufacturers had to quickly adapt and respond with an increased speed to market, while still managing the arduous process of regulatory approvals. The impact on the medical manufacturing process has resulted in more complexity in tracking and tracing, as well as introduction of quality processes to new suppliers.
Another change, in countries such as the United States, is governmental directives and investments for their domestic manufacturing supply chain, to respond to the semiconductors shortage, and ensure high-quality and ready-to-use products are available domestically for a future crisis. Also China, with its “Made in China 2025” program is aiming at improving their own R&D capability so that they can achieve domestic manufacturing and technological innovation capabilities independently from Western countries. Thus, medical device manufacturers from outside the country are facing more challenges and barriers to enter the Chinese market.
On the other side, in Europe, the new European Medical Devices Regulations (MDR) came effective in May 2021 including new significant requirements that MD&D manufacturers need to meet to be compliant.
Taking this all together, in the future, MD&D manufacturers will face an increase in the number of new product development and introduction (NPDI) processes, as well as increased competition in the upcoming years. This means that MD&D manufacturers will be facing new challenges and require the right technological partner to meet the highest standard quality regulatory authorities request.
As a MD&D Expert, how can Siemens support with its solutions in these special times?
Siemens has responded to Medical Devices & Diagnostic market needs and has developed solutions that allow MD&D manufacturers to meet their critical technical, regulatory and business requirements, enabling cost reduction and faster implementation time.
Siemens Opcenter™ EX MDD software is the leading manufacturing execution system (MES) used by medical device manufacturers to meet their challenges in the industry. The solution enables a rigorous detailed manufacturing operations traceability, parallel processing to reduce queue and times, and systematically controlled process controls to enforce product quality and ensure “First-Time-Right.”
Moreover, Medical Manufacturers can furtherly rely on “Operational Excellence through Smart Manufacturing”, which means a digital infrastructure using production digital twins to design and simulate manufacturing scenarios in advance to optimize quality and efficiency, detailed production planning & scheduling to optimize factory resource utilization, shop floor workflow automation and electronic Device History Record (eDHR) creation that enforces routing through both automated and operator work cells, including quality inspections to deliver high quality devices.
Siemens Opcenter™ EX MDD is critical for MD&D manufacturing. What are the key pillars of Opcenter™ EX MDD and how does it fit to the Siemens Digital Enterprise portfolio?
For the MD&D industry, Siemens Opcenter™ EX MD&D can be considered as the best-in-class MES as it builds quality into the manufacturing process at every step, rather than relying on testing quality into the device during production. From incoming raw materials and supplier shipments, to finished goods, the entire manufacturing process is controlled with support of automation. This includes quality assurance processes, and when appropriate, rework process routes are enforced.
Implementing such a solution means digitalizing manufacturing operations, enforcing efficient manufacturing processes that accelerate the delivery of innovative products, at the highest levels of quality.
Opcenter™ EX MD&D eliminates paper from the shop floor and reduces non-value-added activities by automating the control of the 5Ms:
Further, it provides self-auditing eDHR and eBR, enforces good manufacturing practices (GMP) and regulatory compliance, and accelerates and controls change management processes.
Taking this all together we can clearly identify 6 key pillars of Opcenter™ EX that MD&D manufacturers can benefit from:
- Accelerate time to market
- Support regulatory compliance in the manufacturing processes
- Improve product quality with paperless manufacturing
- Reduce time and cost of implementation
- Scale efficient production
- Expedite the change management process
The Siemens Opcenter™ EX MD&D solution has been deployed with impressive results in a variety of medical device industry segments, including diagnostics, orthopedics, cardiovascular, hospital and wound care, diabetes care, renal, blood care, vision and imaging. Here’s a sampling of the benefits our customers have achieved:
- Reducing lead time across all products by 15 to 20%
- Reducing device history record (DHR) review time by 80%
- Reducing nonconformance reports (NCRs) by 80%
- Completely eliminating paper costs
- Taking only two months from project rollout to measured benefits
Looking to the future, to make the platform more accessible to Small- and Medium-Sized businesses who are emerging as MD&D leaders, Siemens developed the Opcenter™ EX MD&D Rapid Implementation package, which is already the leading solution for this market segment because it’s tailored to meet the needs of resource-constrained smaller companies, and it can serve as an extensible platform that grows as the manufacturer grows.
James B. Thompson, Ph.D.
Siemens Digital Industries Software
Sr. Director, Industry Strategy
Medical Device & Pharmaceutical
Jim Thompson has worked in the engineering software industry for 30 years, in various leadership and management positions. Currently, at Siemens Digital Industry Software, Jim is responsible for the global business strategy for the Medical Device & Pharmaceutical industries.
Prior to Siemens, Jim worked for IBM in software development & consulting, and for GE as a mechanical engineer. Jim received his doctorate from the University of Illinois at Urbana-Champaign, where his research focused on AI-based engineering decision making.
Sponsored content by Siemens Digital Industries Software