Next month in Chicago, the Institute of Validation Technology hosts its 2nd Annual Forum on Manufacturing Execution Systems (MES) for the Medical Device and Diagnostic Industry. The Forum’s theme is “Improving Quality, Efficiency and Compliance with Paperless Manufacturing through eDHR and eBR Systems.” A host of industry experts will give presentations during the two-day session. One presenter, James Eric Miller, senior quality systems analyst at Roche Diagnostics, was kind enough to answer a few questions as a preview to his upcoming presentation.
Q: Why is MES important for medical device manufacturers such as Roche?
A: From my standpoint, I’m seeing a trend being driven by the FDA: if you make sure your products are being manufactured within their validation constraints, it will be very helpful to your ongoing operations. MES exists to make sure that manufacturing occurs within those constraints.
Q: In your upcoming session at the IVT Forum, you’ll be talking about using post-market data in conjunction with MES data. Why is that something that medical device manufacturers should be considering?
A: In the August/September timeframe, the FDA announced a post-market surveillance initiative that will use all the post-market data available—the whole electronic medical record dataset as well as internal MDRs—for real-time analysis, now or in the not-too-distant future. So there is going to be a drive by the FDA regarding products on the market that are behaving poorly; they are going to ask you to prove that you have manufactured products within validation guidelines. An MES is a super tool to be able to do that.
Q: What’s the potential regulatory impact if a company fails to bring in post-market data?
A: If you don’t have a well-documented feedback loop between your compliance data, MBR data, and your MES, then you’re missing an opportunity. If you can prove that you’re within your validation guidelines and that your manufacturing system is under control, that’s going to help you keep manufacturing in control while proving to the FDA that you’re in compliance with their regulations. Further, if you have that feedback loop, you should also experience a significant reduction in rework and scrap costs.
Q: That being the case, what suggestions do you have for medical device manufacturers as they look to better leverage their MES data?
A: They should begin with a list of their most frequent and critical complaints, and start doing studies to ensure that they have good linkage in their MES to identify and monitor the cause of those complaints. If they do this, the complaints will cease. So they need to be able to trace from the complaint to the root cause by having data fields or sensors set up in MES so they can see when those issues arise. Then they can stop issues from becoming problems in the field.
Q: How does that translate into leaner processes?
A: As you develop these kinds of systems, you gain much tighter control of your processes. Scrap and rework will be reduced. You also can scale your regulatory compliance processes to match the nature of your complaints.
James Eric Miller’s session at the IVT Forum in Chicago, “Leverage MES Data to Analyze Trends and Optimize Post Market Business Intelligence,” will be held on Thursday, March 7, at 2:15 pm.