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Continuing to innovate in a changing regulatory landscape.

The medical device industry has been making headline news recently as the U.S. Food and Drug Administration (FDA) re-examines its regulation and oversight for medical device manufacturers. Regulations haven't changed dramatically--yet--but the agency has become more conservative, with existing 510(k) processes under tighter scrutiny and an increased emphasis on post-market surveillance. Recently, Congress allocated $100 million to strengthen FDA regulation of medical products. At the same time, however, medical device manufacturers are looking at an increased excise tax starting in 2013, as a result of national health reform legislation.

How will these regulatory and financial pressures affect innovation in the medical device industry? Some analysts fear that increased time to market and taxes will limit resources for the research and development required for product innovation.

Rather than viewing these trends strictly as threats, however, device companies can take the opportunity to gain competitive advantage by improving operational efficiencies. Now is the time to enhance and invest in quality systems in ways that both increase productivity and demonstrate that the company is operating in a state of control. By streamlining, standardizing and automating critical processes, companies can continue to innovate in the face of increased regulatory scrutiny and uncertainty while the FDA continues to seek out new ways to keep consumers safer and healthier than ever before. When innovation and regulation coexist peacefully, everyone benefits.

The shifting regulatory landscape also provides medical device manufacturers with an opportunity to cut internal costs and transform quality management processes to more easily meet the regulatory and financial challenges that lie ahead. By controlling what's within their control, companies more easily can adjust whatever external changes come along down the road.

People, Processes and Technologies

As with many other business processes, the key to efficiency in quality management lies with people, processes and technology. A good first step on the road to increasing efficiencies is to assemble a team of experts for a thorough review of current quality control processes across the enterprise, including customer complaint handling, non-conformances, change control and supply chain management functions. If that sounds like too much to undertake at once, companies may begin with a single quality function, such as change management, recognized to be a particular challenge or pain point in the organization.

It's important to include the right people in the review process, including those on the quality front lines in various departments who understand the details of disparate quality processes, as well as representatives from IT who understand the current systems involved in quality management and opportunities for further automation and consolidation.

The assembled team should choose a process or group of processes and map out their individual steps in detail, with an eye toward standardization and elimination of redundancies and wasted effort wherever possible. It's amazing how many glaring inefficiencies and inconsistencies can jump out at everyone just by examining these processes in detail. In one company, a representative reported coworkers shaking their heads in disbelief and asking, "Why do we do it this way?"

Mapping out processes and underlying systems requires an investment in time, but the results are well worth the effort. Standardization across the enterprise--when it's designed to meet the needs of individual processes and departments as well can have a dramatic impact on enterprise efficiency and process visibility.

Time to Automate

In addition to mapping out manual processes, medical device teams striving for efficiency should examine the software technologies the company currently uses to determine if they enhance or inhibit efficiency and effectiveness. A global medical technology company that manufactures and sells medical supplies, devices, laboratory instruments, antibodies, reagents and diagnostic products examined its corrective and preventive action (CAPA) processes and technologies only to discover that its existing software, while expensive, was having little impact on efficiency because it couldn't integrate with other company processes and lacked multi-language and help desk support. At the other end of the spectrum, management and quality teams also may discover software used for some processes or departments could easily be expanded to have a very positive impact on other processes as well.

Medical device manufacturers frequently leave nonconformance, design control and supply chain functions decentralized, with many different manual, localized, departmental systems and processes--especially in companies that have grown by acquisition. The result often is a lack of enterprise-level visibility into quality control processes, unnecessary process and system redundancy and overlap and, in some cases, a lack of readiness for new regulatory requirements such as electronic medical device reporting.

Dedicated enterprise quality management systems (EQMS) represent one way that medical device manufacturers can automate and centralize quality processes at an enterprise level. The most effective solutions integrate easily with existing systems such as ERP, Laboratory Information Management Systems, Manufacturing Execution Systems, and Document Management Systems. They also overlay automated workflows for scores of quality processes, including customer complaint handling, change management and supply chain management.

At a human resources level, EQMS's benefit employees by cutting out scores of time consuming manual steps and providing enterprise-wide access to relevant documents and centralized on-demand reporting capabilities that can be invaluable for audits and other regulatory functions. That enterprise level visibility can also be extended outside the enterprise to partners and suppliers, with manufacturers better able to monitor changes on the supply chain required for innovations, and suppliers empowered with automated change notifications and easy access to the information they need to make the right changes at their end.

Strive for Continuous Improvement

When choosing a quality system, it's important to look for an architecture that can help a company drive continuous improvement. Rather than making all improvements at once, organizations are likely to find ways to tweak and transform quality processes year after year as they develop more experience with enterprise processes and technologies. Solutions should have the flexibility, scalability and easy integration with existing systems to let companies tweak, change and reconfigure automated processes when they need to, rather than being forced to wait for the vendor to catch up to their needs. This flexibility also makes it easy to adjust to new regulatory developments rapidly.

With faster quality processes, medical device companies can also drive out the costs of rework and scrap by attending to nonconformance issues at a much more rapid pace than was previously possible. And with enterprise-level visibility into quality processes (such as global change control), organizations have the information to prioritize risk and focus resources on the design changes that create the most value for the business. Better visibility also helps to prevent situations in which product design changes and innovations coming out of incident management conflict with changes coming from sales and marketing.

Increased regulation and financial pressures don't have to stifle innovation. By driving out the costs of quality control and improving visibility and efficiency in processes such as noncompliance and change control, medical device companies can continue to innovate while adjusting to whatever new regulatory requirements come along. The right combination of people, processes and technologies can position a company for a future of continuous innovation and competitive advantage.

There's no reason for medical device manufacturers to reinvent the wheel every time a new regulation comes along. An enterprise-wide approach to quality management can position firms not only to tackle new regulations with minimal disruption, but to slash costs and resource requirements for quality management, reduce the incidence of wasted materials, and focus precious resources on areas of innovation and risk that enhance their competitive advantage.

Tim Mohn is industry principal in Sparta Systems" product management group. Previously he 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:Jul 1, 2010
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