Emerging Medical Device and Diagnostics Manufacturing

By Sergio Bellisario

Part 1: Overcoming resource constraints to accelerate time to market

Today’s Medical Device and Diagnostics (MDD) manufacturers face a host of challenges as they work to bring potentially life-saving products to market. Accelerated innovation and customization of products in this industry are adding complexity to the manufacturing process, while the regulatory environment continues to increase compliance risk for the manufacturing enterprise.

The risk is much greater for emerging MDD companies that are struggling to bring new products to market in their resource-constrained environment. Often the survival of the company is contingent on successful new product introduction (NPI). These companies struggle to shorten the time to market, and are often racing against a resource and funding clock, as well as a small market window to gain a leadership position with their innovation.

It is clear the support of a digital manufacturing infrastructure, in particular a manufacturing operations management (MOM) solution, is required to ensure product quality, rapid NPI, and regulatory compliance in this complex environment. Yet the emerging MDD company is challenged across several fronts as they seek to derive the benefits of digital transformation. They have fewer process and engineering resources for the required configuration and process definitions. They have fewer IT resources for system implementations. And they have lower budget availability for a MOM platform.

That’s why Siemens, the leader in MOM for MDD, has addressed this emerging market specifically. We have developed a MOM solution that fits the needs of this critical area of manufacturing that promises tremendous value to patients and healthcare workers worldwide.

Our Opcenter MDD for SMB (Small and Medium Businesses) is pre-configured for emerging manufacturers to rapidly deploy a digital infrastructure in a cost- and resource-efficient way. The solution was developed to meet these specific needs:

Compliance: The solution must reduce the time and resources required to validate high-risk devices.

Core functionality: The solution must provide the key capabilities that MDD manufacturers need to deliver their products to market rapidly, safely and with quality. The key capabilities that need to be delivered out of the box include:

  • Paperless manufacturing operations management
  • Self-auditing eDHR/eBR
  • ERP integration
  • Work order dispatch management
  • Material management
  • Tracking and tracing
  • Sample data collection
  • Nonconformance management
  • Electronic work instructions

Easy-to use, mobile interface: The solution must accommodate users with various operational functions and skill levels, with minimal training requirements.

Scalability: The solution must be able to scale as the business expands.

Total cost of ownership:  The solution and the required resources must be financially accessible to the SMB during implementation and continuing through lifetime maintenance and support.

Siemens Opcenter MDD SMB is built on the leading MOM platform for MDD, tailored to these unique needs of the SMB. In addition, we have developed a rapid implementation package that shortens the deployment timeline and provides the necessary expertise to support the needs of the internal IT team.

Read part two here and find out more about Siemens Opcenter MDD SMB by registering on the on-demand webinar!

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This article first appeared on the Siemens Digital Industries Software blog at