Small-Medium-Sized-Business, the emerging Medical Device manufacturer leaders

By Thomas Bell

In the MD&D manufacturing industry Siemens and its Opcenter Execution Medical Device and Diagnostics (Opcenter EX MDD) can be considered as the best-in-class manufacturing execution system (MES) needed by all medical device manufacturers to meet their challenges in the industry, with particular regard to the small- to medium-sized businesses (SMB).

SMB are the emerging leaders in the MD&D market, and they need to face several additional factors to succeed in the market compared to their large competitors such as:

  1. Constrained resources. SMB manufacturers need to get their products manufactured “right-at-first-time”, complete the regulatory process and place their product on market faster than their competitors.
  2. Less experienced users and fewer support staff. SMB operators need to quickly implement new technology with minimal training.
  3. Speed in the compliance process. Validation process for high-risk medical devices is both time-consuming and resource-intensive.
  4. Acceleration of growth. SMB manufacturers must have their product to market quickly to establish a market position and but to bring potentially life-saving products to patients.

That demands an urgency around creating a digital infrastructure that supports them increasing their product quality and ensure “right-first-time” product along with rigorous detailed manufacturing traceability to reach regulatory approval.

Opcenter Execution Medical Device and Diagnostics (Opcenter EX MDD) is the leading solution that helps MD&D companies accelerate innovation for small- to medium-sized businesses, reduce cost and achieve the highest quality. Opcenter provides self-auditing eDHR and eBR, enforces good manufacturing practices (GMP) and regulatory compliance to a “right-first-time” product. It also eliminates paper from the shop floor and reduces non-value-added activities by automating the control of the 5Ms (Material, Man, Machine, Measure, Method).

Are you a small- to medium-sized businesses MD&D manufacturer? Learn more about digital transformation, download our eBook here and discover how Siemens can support you building up your digital enterprise.

Also, sign to our dedicated webinar to discover more on how to accelerate your digital transformation in the MD&D industry.

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