Accelerating growth for emerging Medical Device Manufacturers

Realizing the digital infrastructure for growth

Medical Device and Diagnostics (MDD) manufacturing is a challenging industry for all players. Not only are technology and products becoming more complex, but regulatory and supply chain factors increasingly compound the requirements baring down on businesses. The FDA is rewarding manufacturers that implement critical-to-quality practices in design and production, shifting their focus to quality first versus compliance first. Today, competing in this industry necessitates the proper digital manufacturing foundation to address these growing requirements.

Larger, more entrenched MDD manufacturers have the capital and the experienced human resources to implement a digital foundation that improves both quality and cost, creating the most efficient environment for bringing innovation to market. Siemens has been a leader in developing that proper digital infrastructure, having worked alongside the FDA throughout their Case for Quality program.

Now, small- to medium-sized businesses (SMB) in MDD are looking to create the same infrastructure to get their own innovation to market – rapidly, cost-efficiently, and at high quality that achieves regulatory compliance. They are realizing that the MOM foundation is not a nice to have, it is a must have to compete in this complex industry. For the SMB, the emerging leaders in this market, there are additional factors that create urgency around speed, efficiency, and the path to regulatory approval.

• Resource constraints,
• Less-experienced users and fewer support staff
• Speed in the compliance process and
• Acceleration of growth

Siemens has recognized this market need and has developed a solution that gives access to the SMB with a scope that meets their critical competitive requirements while reducing the cost and time for implementation and maintenance. The result is a solution that expedites the realization of digital manufacturing, while achieving significant near-term benefits.

At its core, MOM creates a digital foundation for enabling paperless manufacturing. For MDD, this digital infrastructure creates a self-auditing eDHR/eBR to support regulatory compliance. Using a digital representation of the manufacturing processes, or the digital twin, MOM enforces the 5Ms of manufacturing – man (operator), machine, material, measure, and method. It puts in place safeguards that direct all of these factors of the production process, ensuring products are built as intended. That enforcement builds quality into the product from end to end.

5 Key Capabilities of MOM for the SMB

1. Orchestration: MOM provides the orchestration and planning of manufacturing and quality operations
2. Vertical Integration: MOM bridges the gap between enterprise systems and shop-floor automation
3. eDHR/eBR: MOM automatically generates the eDHR/eBR, supporting more rapid compliance processes
4. Digital Twin: MOM implements the Digital Twin of the physical production realm, creating a digital representation of the manufacturing process.
5. Analytics: MOM transforms big data into IoT actionable information (smart data) and provides the intelligence for continuous improvement and innovation.

MOM capabilities are essential for any MDD manufacturer, given the complexity of both products and the regulatory environment. Opcenter Execution MDD, built on the long-time leading MES platform for MDD, Camstar Medical Device Suite, is the MOM leader in the industry. In order to make the platform more accessible to emerging MDD leaders, Siemens created the Rapid Start package to address the challenges unique to these companies. Opcenter Execution MDD Rapid Start is the leading digital infrastructure for the SMB segment, tailored for quick and efficient implementation and maintenance, while serving as an extensible platform as the manufacturer grows. The three key pillars of Opcenter Execution MDD Rapid Start, includes:

• Standard, pre-configured modules: The pre-packaged software configuration that provides the core MOM functionality critical for MDD manufacturers.
• Rapid Implementation Model: An accelerated implementation approach created specifically for a rapid adoption of the MES solution.
• Validation package: a proven methodology to expedite the validation phase
• Cloud support and maintenance: The option to use Siemens’ infrastructure and/or managed services.

SMB MDD manufacturers are proving the value of digital manufacturing. Some of the results from these manufacturers leveraging the Siemens solution – Siemens Opcenter Execution MDD – include

• 15-20% lead time reduction across all products
• 80% reduction in DHR review time
• 80% reduction of non-conformance reports (NCRs)
• 100% Elimination of paper costs
• 2months timeframe from project rollout to measured benefits

Siemens is championing product quality in the medical device industry. With a strong alliance with the FDA and other regulatory bodies across the world, Siemens brings longstanding expertise to their customers that give them confidence in their journey towards digital manufacturing.

For emerging medical device companies, Siemens is providing access to the same world-class product that leading MDD manufacturers are using to increase efficiency, reduce cost, improve product quality, and ensure compliance – all while improving their overall customer experience.

At Siemens, we are dedicated to the success of every customer, and the value realized by patients worldwide.

An ebook with detailed contain on this subject will be published soon.

If you want to get an overview of the products you can visit our website.