Emerging Medical Device and Diagnostics Manufacturing

Part 3:  The Path to FDA Approval for Medical Device – The Importance of the eDHR

In parts 1 and 2 of this blog series, we discussed the challenges of small- and medium-sized Medical Device and Diagnostics (MDD) manufacturers operating in their complex environment – specifically addressing constraints in resources and skillsets. We discussed how technology can allow these companies to scale amidst these constraints.

Speed to market is an essential outcome for these companies. Getting their innovation to market rapidly is often more critical than their larger competitors. With smaller companies, their future depends on the ability to commercialize their products fast enough to fund future operations. The agility of the smaller competitor can be a competitive advantage, but when complex regulations are part of the landscape, their compliance requirements are exactly the same as their larger counterparts. Earlier stage companies often have less mature processes and systems to ensure regulatory compliance, as well as less experience navigating the FDA approval for medical device process in the US – or other regulatory processes in other countries.

This is another area where systems support is crucial for emerging companies. Siemens developed Opcenter MDD for the small- and medium-sized business (SMB) to give them access to mature processes that expedite FDA approval for medical device – using the same systems as many of the largest MDD manufacturers in the world. Built on the leading MOM solution for MDD, our SMB solution provides MDD SMB companies the digital infrastructure that can help accelerate this key milestone in getting their products to market.

The reality is that an MDD manufacturer is producing two things – products and DHRs/BRs. Both must be perfect. Paper-based processes are simply not sufficient in the complex world of MDD. Opcenter MDD creates a digital infrastructure that builds quality in from end to end, and produces compliance as a natural output.

The Opcenter SMB solution provides mature processes on which emerging companies can rely to ensure a smooth FDA approval for medical device process. There are 3 pillars of the solution that pave the way for this access:

  1. MDD industry configuration out of the box
  2. Pre-configured processes, functions, and reports
  3. Validation support to accelerate the path to FDA Clearance/Approval

The risk-based validation package leverages out-of-the-box functionality and broad industry expertise to optimize the process. Validation documentation is comprehensive, while giving manufacturers the ability to add and remove content. Siemens provides the protocols, and the manufacturer updates and executes reports. The output includes:

  • Master Validation Plan
  • FRS
  • FMEA
  • IQ Testing
  • OQ Testing
  • PQ Testing
  • Trace Matrix
  • Master Validation Report

The FDA is increasingly looking at the underlying quality processes in place as the ultimate measure of compliance. Opcenter MDD is the best-in-class system for quality manufacturing, including:

  • Paperless manufacturing and self-auditing eDHR and eBR
  • Single as-built track and trace record
  • Manufacturing enforcement and quality
  • Identification, analysis, and prevention of errors
  • APS and EMI integration
  • Closed-loop manufacturing environment for continuous improvement

Using this foundation, emerging medical device manufacturers have a process that automatically generates the eDHR as a part of the production process. Exception-based reporting requires the manufacturer to review the eDHR only when necessary, in case of non-conformances, conserving precious human resources. 

Siemens Opcenter MDD SMB is a perfect MOM solution for the emerging medical device manufacturer looking for a smooth FDA approval for medical device path. Siemens’ tight relationship with the FDA maintains current best practices and provides manufacturers the most expeditious support for a smooth approval process. Through its expert validation support, Opcenter provides access to mature systems for SMB companies to accelerate the FDA Clearance/Approval process and become market leaders.

Find out more about Siemens Opcenter EX MDD.

Did you miss post1 and post2? Find it out!

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