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Finding process improvement opportunities in new eMDR regulations.

It would be difficult to fault medical device manufacturers for sometimes .seeing shifts in the U.S. Food and Drug Administration's (FDA) regulatory practices as obstacles that divert time and resources away from new products, sales and customers. However, when approached a different way, regulatory shifts also present opportunities for examining, automating and improving existing quality control processes in ways that benefit the business, increase efficiencies and enhance revenues.

The FDA's proposal to mandate the use of electronic medical device reporting, which could pass into law later this year or in early 2011, is a case in point. The new rules from the FDA's Center for Devices and Radiological Health would require medical device manufacturers, distributors and reprocessors, as well as hospitals and physicians, to establish internal processes for submitting XML-based medical device reports electronically via the agency's Electronic Submissions Gateway. XML is set of rules for encoding documents in machine-readable form.

For many companies, preparing for the inevitable electronic medical device reporting (eMDR) requirements may necessitate a thorough examination of the organization's entire complaint handling process, rather than simply MDR submission, as well as increased automation to make the process less time consuming. While this process is an investment, it's also an invaluable opportunity for a thorough examination that likely will uncover process inefficiencies and redundancies. In addition, it's a chance to discover ways to extend automation technologies and software from one set of processes to others or to implement new software that can improve efficiencies across quality processes. The result often can be more efficient complaint handling from end to end, which means better customer relationships and more resources available for functions that build the business. Proper complaint handling also can help companies identify and prioritize potential design changes to ultimately produce better products.

For organizations that have considered automating quality processes but weren't sure when or how to begin, eMDR just may be the catalyst that jumpstarts the process and sets the course for the continuous improvement necessary to support a rapidly growing, maturing medical technology business.

Here are four ways companies can use eMDR and other regulatory shifts to their best advantage.

1. Evaluate

In many companies, quality control processes are manual, decentralized and inconsistent, with effort expended on steps that may be redundant or outdated. The best way for a company to understand the full scope of necessary changes to comply with a new regulatory requirement is to examine the entire process behind it from end to end. In the case of eMDR, for example, organizations must examine the entire complaint-handling process, including new software and hardware requirements. Since eMDR requires XML output that conforms to strict regulations, many companies also will want to examine current processes for storing, retrieving and generating reports from relevant data.

A full review of the entire complaint handling process also will require getting the right people in a room--those on the frontlines of quality assurance, validation and regulatory areas of the company who know those processes most intimately, as well as representatives of information technology who understand any of the systems those processes depend on. As various departments discuss their use of technology, other departments likely will start to understand how these technologies can be applied to their own processes. For example, if one part of complaint handling harnesses an enterprise quality management solution (EQMS) system, there is bound to be an opportunity to extend the use of EQMS across other parts of the process as well as other departments and functions in the company.

In the case of eMDR, medical technology companies can choose between manually entering into the FDA's system or building an automated interface, which requires both EQMS and electronic data interchange (EDI) software packages. In many cases, it is possible to extend an EDI system already in use elsewhere for eMDR, rather than purchasing a completely new system. Extending a current complaint management, reporting, or other data system to cover eMDR also may be the simplest and most economical way to achieve compliance and process acceleration.

As improvements to data handling and retrieval are considered, it is critical to think about how such improvements could simplify compliance with future regulatory changes. This also is the time to examine the common forms of MDR rework, whether they be supplemental reports, requests for additional information, or even outright rejections, as this can lead to additional improvements in your current data retrieval and reporting systems that benefit other quality processes as well.

2. Planning

Planning for the eMDR submission processes also has potential for general process improvement. This is where it is possible to harness the information gathered from stakeholders and begin discussing timelines and strategies for making improvements. Will a legacy com plaint management system be extended, or should the migration to an entirely new system be planned because of its expected benefits? If so, take the time to plan out the implementation timeline with an eye on future changes as well. The current priority might be to achieve FDA compliance, but it also can be the time to start preliminary steps for automating other parts of the complaint handling process as well. For example, improvements to reporting necessary for eMDR compliance can be extended easily across other reporting processes as a single effort.

This also is where the risks and decision points of these processes that could be improved, alleviated and applied elsewhere will be discovered.

3. Design

Mapping process flows, security aspects and integration strategies with corrective and preventive actions and other quality systems, as well as designing interfaces for forms, dashboards, queries, reports, and other components, should be executed with an eye on how these tools might be able to automate other aspects of complaint handling.

This also is the time to research vendor capabilities. Work with potential vendors to understand the use of their products for a broader complaint handling and reporting system as well as for any international compliance requirements. Make sure to discuss training and ongoing support and maintenance. Evaluate the security aspects of the software to determine if they're sufficient for other aspects of quality control that may have stricter security requirements.

Does the system integrate easily with your other systems? Is it able to handle high numbers of reports? And most importantly, does the vendor have experience actually implementing these systems? These are considerations that will apply future integration and automation efforts.

4. Testing and Implementation

Testing and validation can be undertaken with future developments in mind. Every process in a quality system has inputs and outputs, which are all interconnected. By thinking of any change in the context of a larger system, it is possible to focus testing and implementation as part of a larger strategy to use those resources most effectively. The more the process is automated, the more there are resources available for other business functions.

Implementation will involve migrating to a production platform, commonly in a phased approach based on location or business unit that keeps legacy systems running while users are brought up to speed on the new system. These legacy systems are then ultimately retired when the entire company is live on the new system.

Moving Forward

Just as moving from one house to another provides the opportunity to "de-clutter," making changes to processes to accommodate new regulations also presents the opportunity to automate, consolidate and make the entire process more efficient.

The relationships that are formed can be harnessed later to make numerous improvements in other processes as well.

Many life-sciences organizations have made great improvements to their processes simply because regulations required them to do so. In the end, many companies have regulations to thank at least partially for their success in the face of rapid growth,

Tim Mohn is industry principal in Sparta Systems" product management group. He previously served as manager of Worldwide Quality Systems at Ortho Clinical Diagnostics, a Johnson &Johnson company. He is a recognized expert in the field of business process engineering and IT system implementation.
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Title Annotation:IT Intelligence
Author:Mohn, Tim
Publication:Medical Product Outsourcing
Date:Sep 1, 2010
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