Medical Device Technology

According to Zacks Equity Research (ZER), the global medical devices industry is fairly large, with annual worldwide sales in 2010 in excess of $220 billion. The U.S. accounts for approximately 41% of this market, with division of the industry into different categories such as cardiology, oncology, neurology, orthopedic, aesthetic devices, healthcare IT, etc. ZER sees the most growth potential in companies involved with cardiovascular devices, neurology, blood-related, and disposable products.

Companies that deliver solutions to manage the life cycles of their medical products are better poised for growth and have a greater capability to withstand a downturn in the economy. ZER takes it one step further in stating the Product Lifecycle Management (PLM) of life-sustaining products will see the most growth of all in the medical devices market. An example of this is with PLC Medical Systems Inc., who worked closely with cardiac surgeons to pioneer the CO2 Heart Laser System that performs CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC Medical Systems used the latest in innovative product life cycle management technology from Omnify Software to achieve compliance.

According to Dick Slansky, the principal author of ARC’s “Product Lifecycle Management Worldwide Outlook” study, “The medical device manufacturing sector is re-focusing the strategic direction of their companies toward innovation and new product development to gain critical market share and grow top line revenues. While innovation, new product concepts and design are necessary to a company in order to maintain its competitive edge, getting the right product, at the right time, to the right market sectors will often determine a company’s profitability.”

ARC Advisory Group’s recent study further supports this stating that the demand for increased efficiency and productivity, a continuing need for collaboration across a global manufacturing lifecycle, and the rapidly growing need for product re-invention and innovation shows the expanding adoption of a more holistic end-to-end PLM solution set. This will contribute to growth in the worldwide PLM market, especially affecting the medical device industry.
 

Validation Achieved
Another real example is seen with Solta Medical Inc., a global leader in the medical aesthetics market. Solta implemented Omnify Empower to transition to electronic processes and streamline its product development processes. This meant Solta Medical had to comply with 21 CFR Part 11 requirements and validate the software. In this case, Empower is used.

Andy Kuver, Sr. document control specialist for Solta Medical adds, “Omnify provides a controlled environment to manage all of our product data and design processes as well as the capabilities to support our FDA compliance requirements.”

The validation supports the meeting of FDA (Food and Drug Administration) Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) compliance requirements for electronic product data management for the Thermage solution. As a Class II medical device manufacturer, the company is required to meet stringent FDA guidelines and comply with 21 CFR Part 11 requirements as well as validate the software.

For medical devices manufacturers, ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

PLC Medical System primary objective of achieving ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for its quality management system. ISO 13485:2003 requirements are specific to medical device organizations, regardless of the type or size of the organization.

According to Jeff Steward, IT director for PLC Medical Systems, “Omnify is the core of our quality management system. In our most recent ISO compliance audit, Omnify Empower was noted as a significant enhancement and a demonstration of our commitment to continuous improvement.”

PLC Medical System’s validation of Omnify Empower show they chose wisely when selecting the right PLM product for a medical device environment.

“Quality, purchasing, and manufacturing have easily adopted the FDA 21 CFR Part 11 compliant electronic signature process, and are capitalizing on both the workflow-driven change process and the speedy distribution of approved changes. Our development team is taking great advantage of the online Device Master Records and searchable Design History Files,” says Ern Damon, document control manager at PLC Medical Systems Inc.
 

Tying it all Together
Various solutions are available for software automation in the medical device industry. However, the ideal solution should reach across departmental barriers, allowing information sharing and process automation across the enterprise.

The development and manufacturing of a medical device is an increasingly difficult endeavor as competition grows stronger and regulatory constraints broaden. Device companies must look for ways to increase efficiency in their processes in order to remain competitive and in compliance with the various regulatory bodies governing the world markets.

One potential method for increased efficiency is the use of software solutions as outlined by both PLC Medical Systems and Solta and their successes in automating the various processes contributing to the development, manufacturing, and lifecycle of a medical device. Software that ties together the information sharing requirements of the various departments within a device company shows to reduce development costs by as much as 25% and reduce time to market by a staggering 40%.

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