By some, the threat is called a ‘purpose designed’ system or a variation on that theme. Sometimes they are benignly described as ‘integrated packaging management systems.’ Here’s what they really are: they are healthcare product-oriented, special purpose and single purpose silo systems with run-of-the-mill labeling capabilities built around a proprietary single function Content Management System (CMS). In all cases, by whatever name or description, they can bring a healthcare products manufacturing company to a standstill, or worse:  render it significantly hobbled, if not ultimately insolvent.

How can that possibly be true? In advance of the longer answer in subsequent sections to follow, the short answer relates to two event possibilities at the healthcare product manufacturing company: something goes wrong with the product or something goes wrong with the label on the product even if the product is flawless. Yes, as far as the Food and Drug Administration (FDA) is concerned, the label and the product on which the label sits are, for regulatory purposes, one and the same. Bad label means bad product. It’s not hard to see why. Label mistakes lead to the accidental misuse of healthcare products which can lead to serious patient injury or death.

In either event – bad product or bad label on a good or bad product – a mandated regulatory process sweeps into effect.  Universally considered arduous at best, it’s called CAPA, for Corrective and Preventative Action. Lots of companies commit to their own routine set of voluntary CAPA procedures. But a CAPA mandated by the FDA is not voluntary. They are enforced every time and any time the FDA identifies differences or deviations from given standards in the business or production processes or non-compliance to production validation guidelines. And, at any time whatsoever, thanks to a regulatory requirement known as Title 21 CFR Part 11, the FDA expects the healthcare product manufacturer to have, and gain quick access to, everything involved in the development and manufacturing… and labeling… of any product.

More to come…

UDI Adoption Methodology White Paper >>

And he has set new strategic priorities for 2010 and beyond for all companies who manufacture, repackage, relabel, and/or import medical devices. The deadline: September 30th, 2013. His goal is to implement a total product lifecycle approach, enhance communication and transparency, strengthen its workforce to implement this strategy and provide agile feedback and innovation on unmet public health needs.

If you’re involved in labeling, this is very important to read:

Priority 1. Fully Implement a Total Product Life Cycle Approach

Our public health responsibilities span the entire life cycle of medical devices, from early product development to long-term experience with the marketed device, from manufacturing to market use. At any stage of a device’s life cycle we must make well-supported regulatory decisions, taking into consideration all of the relevant information available to us.

To fully implement a total product life cycle approach, we will: (1) enhance and integrate premarket, postmarket, and compliance information and functions, in order to enable each part of our organization to meet current and anticipated challenges, and work together with a unity of effort toward our mission. To do so, we will: improve the quality and consistency of our science-based decision making by strengthening premarket review and aligning our use of scientific resources across the Center; make better use of information by enhancing our systems and processes for collecting, analyzing, and sharing information to support day-to-day Center needs; consider ways to better integrate our work across Offices by re-examining our organizational structure; and prepare to meet the demands of the future by addressing challenges associated with globalization and establishing mechanisms to incorporate new scientific information into our decision making. We will also: (2) improve guidance and regulation development, in order to convey current expectations and requirements to our external constituencies in a clear and timely manner; and (3) develop a cross-Center compliance strategy, in order to more effectively identify and address compliance issues across the total product life cycle.

–CDRH FY 2010 Strategic Priorities, Executive Summary

Okay so the important thing to note here is: change. The nature of compliance standards mean constant change. Your barcode labels reflect the ebb and flow of regulation. If your ERP system, whether it is SAP. Oracle, or another, is not set up to be agile, scalable, and responsive to the wave of scientific information that will affect your product’s lifecycle, your business will suffer.

There is a way to adapt to compliance easily and efficiently. Visit our healthcare page.

As you are aware, the Unique Device Identification (UDI) system is the FDA’s proposed system for identifying medical devices in a standardized way. This will help any recall efforts, post market surveillance and adverse event reporting, and electronic health record documentation. Another bonus is for the supply chain management to help improve it’s ordering and distribution of products. At the end of the day, though, the main driver is patient safety.

The FDA will be publishing the proposed UDI system regulations in 2010 for all medical devices. This will create an analogous, standardized identification system for all medical devices and promote the use of data that can help manufacturers manage their products.

For those manufacturers of medical devices in the Class 3 category, you will have one year after the final ruling, for those with Class 2 will have three years, Class 1 up to five years. This will have a significant impact on your supply chain. The good news is more efficiency through standardization and product tracking. The bad news is the short implementation curve.

As most IT managers know, changing how products are labeled becomes a nightmare to manufacturers with decentralized, standalone and multi-regional labeling systems. It may require a complete programming overhaul of your existing ERP system that may take up to 4 years and unforeseen budget increases. Although the FDA is trying to be sensitive to this tight timetable, there is still the healthcare market demanding a system of standardization (GS1 for example) and forcing the issue of manufacturers getting up to speed.

So, is there hope? If you’ve been reading this blog, then you know where I’m driving this. There is a proven methodology of adapting your enterprise labeling system to the UDI standards. It’s easy. It’s efficient. And it will save you a lot of time and money. We’ve written a white paper on it. We’re experts at this. It’s a quick read and well worth 5 minutes of your time.

Yes. There is hope.

Our validation process is quite direct. With old solutions still running in the background, our services professionals go through the equivalent of a pre-flight check list, including the writing and use of test scripts to validate the installation. In the next phase of production qualification, the labeling solution is tested under the pressures of the real world. Then, once completed validated and tested, new label templates and new data are put through the actual approval processes that drive the manufacturer’s operation. This makes sure that new templates can be reliably routed for approval and electronic sign-off from marketing, regulatory, legal, engineering, and other departments.

To read the entire methodology on UDI adoption for your Enterprise Labeling System, click here >>

This approach is a super win for healthcare IT professionals for a variety of reasons. Automating enterprise wide on existing business applications is less costly. Instead of fifteen departments and fifteen different methodologies to support, there is one. IT is in a better position to both control the solution and to train everyone once and to one set of directions. In essence, intelligent automated systems simply minimize operator decision-making. His makes the labeling process faster, more reliable, more accurate, and significantly easier to manage, document and control.

At Loftware we have developed a portfolio of ‘Connector’ solutions tailored for virtually all of the major enterprise applications. In short, these software bridges integrate seamlessly to enterprise applications and with Loftware print servers for template development and label printing anywhere in the world. This gives IT professionals a centralized solution over which they have direct command and control of every label, and every label event can be captured.

A reluctance to integrate in this way with known, proven, and familiar applications and to impose new applications with inescapable redundancies at some level, results in what we call a “swivel chair” solution. These require people to log in, on, and out of separate applications to handle a label requirement when these same requirements can be met within the existing infrastructure already well-known and understood. Moreover, swivel chair solutions like this – and an overall reluctance to integrate processes in general — heighten the risk of human error. In healthcare products, a label error of course is more serious than in any other industry because the label is the product, or considered a part of the product. Bad label: bad outcome, since it can halt production, freeze shipments, and drive a recall.

Facing this reality but still not yet seeing the benefits of consolidation, some medical products manufacturers are contemplating a half-way solution that substitutes the current disarray with single-function stand-alone black box alternatives. If there is a benefit to this, it is that at least technology consistency can be achieved: all the silos everywhere will be of the same variety and vintage.  But that’s where the benefit, such as it is, ends. The boxes are empty of data; they must be populated with the data; everyone has to be retrained on these new systems; these solutions are not tied to any centralized system, control or authority; and, they don’t leverage existing enterprise applications used to drive virtually every other aspect of every manufacturing operation.

But the most significant flaw of this approach is that once it has been implemented, the medical products manufacturing is still left with a dispersed array of department, plant, warehouse, and distribution center solutions, just to name a few. This approach, for example, leaves manufacturers with 10, 20… even fifty or more separate solutions. Instead, forward-thinking medical products manufacturers are telling us they want one way to solve the problem, once, that applies consistently across the enterprise, which will scale through inevitable future changes in labeling requirements, and which can be monitored and controlled from a central location and by all the appropriate label authorities. Of course, they still want the flexibility and efficiency of printing product labels anywhere, at any time, and to any volume. But with the right consolidated solution, this becomes a function of remote printers versus remote, standalone label systems ripe for error, tampering, and downtime.

Haven’t started yet? — you’ll need to. Much of the healthcare products and services world, including many GPOs, are ahead of the curve already and demanding that their manufacturers adopt and adapt to GS1 product identification and labeling standards by 2011, in anticipation of this FDA ruling. Major device manufacturers should not delay…although 2013 seems far off, the actual time it takes to implement exceeds that narrow window already set.

For example, one Loftware contact admitted that it took them four years to make the transition. Not much time is left. There is a methodology, which this blog will explore in more detail soon.

Until now, many healthcare product manufacturers have adhered to what they see as a sensible, cost-effective philosophy: if the current labeling system isn’t broken, even if it may be byzantine, hard to manage and unpredictable, why fix it? But as healthcare CIOs, IT directors, packaging engineers, quality engineers, corporate regulatory compliance officers and manufacturing professionals look to the near horizon of new FDA UDI mandates, many are questioning if the current patchwork of incompatible, siloed, redundant, remote or standalone labeling solutions can get them from here to there. This question is the essence of this next series of several blog posts. Specifically, can you get from here to there with existing solutions; what are the significant pain points you can anticipate in that process; and what is the best approach – the best methodology –to instead use this time to implement an enterprise-wide, wholly-compatible, and more permanent architecture to achieve a more streamlined, more secure, more automated, and more centralized and centrally-controlled solution that leverages and exploits core applications already in place that are both proven and well-known.

Next post: Step 1: Consolidating Your Labels