Despite heavy investment in quality systems and personnel, the medical device industry is plagued with manufacturing waste, product recalls, and FDA violations. This exclusive report explains how implementing an eDHR solution enables medical device manufacturers to lower their cost of compliance and improve profitability.

Medical device manufacturers, such as those involved in the manufacture of pacemakers, need automated and cost-effective solutions that allow them to quickly address customer and regulatory issues as well as reduce liability exposures, while still managing a complex manufacturing environment optimized for throughput, quality, and efficiency.

• Problems with paper

• Risks of custom solutions

• Benefits of new applications

• Thinking ahead

Bharat Nair is director of the high-tech and life sciences industry segments at Brooks Software, a division of Brooks Automation, 15 Elizabeth Dr., Chelmsford, MA 01824. His career has spanned the design, development, and deployment of leading-edge technology solutions and products for a diverse set of industries including medical device, semiconductor (front and back end), opto-electronics, chemical, and aerospace/defense. He has experience with equipment and transport automation, ERP implementation, financial systems, inventory, and costing and has provided program execution leadership for implementing real-time applications across global supply chain nodes.

By Bharat Nair
Product innovation and operational efficiencies are critical elements of maintaining product and market leadership. Medical device manufacturers, like manufacturers in other regulated industries, are faced with a third element—validation and compliance to standards and guidelines set by the FDA and other regulatory agencies. One of the most significant regulatory requirements facing medical device manufacturers involves collecting detailed manufacturing information that traces a device through its entire product life cycle as well as defines, controls, and tracks product configuration. As traditionally practiced by device manufacturers, however, this data collection process is a laborious, paper-based, manual procedure.

Collecting data during manufacturing—"as-built configuration"—is only part of the challenge. Device manufacturers must also provide "as-maintained information" as well. The use of a paper-based system to store and handle the volumes of manufacturing data needed to meet compliance is time-consuming and very costly since paper-based systems are vulnerable to information loss and prone to human error.

Until recently, a cost-effective solution that eliminates paper from the factory floor (as well as product development and quality assurance processes) and supports regulatory compliance has eluded manufacturers. This has led several manufacturers to develop custom solutions, which pose several unintended risks. First, the cost of ownership of custom solutions increases as the complexity and frequency of products grow in response to changing market and regulatory dynamics. Second, instead of focusing on their core competencies of product innovation and operational excellence, medical device companies have to spend precious resources maintaining custom solutions and hiring external consultants to ensure that validation and compliance are maintained. In spite of all this effort, compliance violations continue to grow and become commonplace.

In order to successfully compete in this highly regulated industry, device manufacturers need to start with a solution that focuses on addressing the immediate needs — eliminating paper from internal processes such as manufacturing, product and process innovation, quality assurance, auditing, and reporting. From there, companies can build on this foundation to analyze the data collected and use that information to help improve the product development and manufacturing processes to help lower the costs of both compliance and operations in real-time. The objective is to turn the burden of compliance into a benefit that improves the bottom line.

Medical device manufacturers need automated and cost-effective solutions that allow them to address customer and regulatory issues as well as reduce liability exposures quickly, while still managing a complex manufacturing environment optimized for throughput, quality, and efficiency.
Industry Challenges
Failure to comply with quality control standards and regulations such as FDA cGMP and 21 CFR Part 820 or Part 11 comes with serious consequences. High levels of manufacturing precision and conformance control are the differences between quality-manufactured products and financially damaging recalls. In addition to the direct financial impact, the damage can extend to the company's brand, trademark, and business reputation. To safeguard against such damaging consequences, companies today are forced to implement costly redundancy within their operations to ensure compliance and quality control. Yet, a recent InformationWeek research survey reported that 80 percent of respondents found it challenging to know with certainty whether they are in compliance or not. The reason is simple: paper systems require more resources to maintain and are inherently susceptible to human error. Today most quality control and assurance programs are paper-based and disconnected from manufacturing. Despite heavy investment in quality systems and personnel, the medical device industry is still plagued with manufacturing waste, product recalls, and FDA violations.
Cost of Compliance
Electronic Device History Record (eDHR) solutions are able to provide complete product genealogy and maintain audit trails to meet FDA regulatory requirements. These new applications provide complete visibility to the "as-built configurations" and can easily be extended to support "as-maintained information" by offering secure access to field technicians and service providers. In fact, eDHR solutions provide current status of work in process on the shop floor while taking into account human factors to greatly reduce processing errors. Manufacturers that use eDHRs, as opposed to manual paper-based solutions, will reduce the cost of compliance through the automated online capture of necessary data and the creation of audit trails that meet FDA regulatory requirements.

An eDHR allows manufacturers to capture "as-built manufacturing information" in real-time, ensuring operators are adhering to the specified device configuration and providing manufacturing audit trails for compliance. This new paperless operation improves production efficiency, avoids rework by "getting it right the first time," and supports lean manufacturing initiatives by eliminating redundant tasks and reducing documentation efforts. Real-time eDHRs enable medical device manufacturers to quickly and easily achieve the following:

• Cost-effective device history tracking

• Shorter time to new product introductions and part substitutions

• Online capture of compliance data and creation of manufacturing audit trails that meet FDA regulatory requirements

• Reduced exposure to costly liability
Beyond Paperless Manufacturing
Many device manufacturers looking to implement paperless manufacturing may not be ready to move to a full-featured manufacturing execution system (MES). As device manufacturers gain more experience, eDHRs must enable them to add incremental functionality such as equipment or process control automation. In addition, eDHRs should allow a manufacturer to expand the functionality or integrate it to a broader enterprise quality management solution, which can include audit management, supplier quality management (SQM), NC/CAPA management, customer returns, failure mode engineering analysis (FMEA), and more. Choosing an eDHR that allows communication between various applications gives decision makers the real-time event-driven data they need to make better business decisions.

World-class device manufacturing requires an adaptive real-time manufacturing organization that thrives on constant change in an environment that demands complex and repeatable manufacturing processes. Since conformance to growing regulations is not an option, low-cost solutions that provide complete product life cycle traceability while facilitating manufacturing efficiency and productivity are a requirement for survival and competitive advantage.

Implementing an eDHR is an important first step that enables medical device manufacturers to lower their cost of compliance and improve profitability. Current paper-based systems lack the superior data collection, verification, and computer-enforced compliance required. Real-time electronic applications increase quality conformance while reducing the overhead costs associated with paper-based systems. With foresight, electronic solutions can also connect to other manufacturing applications and help manufacturers continue their evolution to real-time enterprises.
For additional information on the technologies discussed in this article, see Medical Design Technology online at or Brooks Software at
Advantages of a Real-Time eDHR
• Eliminate process paper from the factory floor

• Provide manufacturing instructions and steps to the operator

• Link demand from ERP, product definition, and process step instruction to create build profiles

• Collect and analyze "as-built configuration data"

• Prevent bad parts from getting processed through real-time validation of test data and results

• Attach test files and details related to the product manufacture

• Create FDA and other regulatory audit and compliance reports online

• Provide access to suppliers for improving quality and reducing time to resolution for part problems

• Provide access to the field for capturing "as-maintained data"