Compliant Design and Manufacturing 4042

Originally Published MX July/August 2006

INFORMATION TECHNOLOGIES

Increasingly integrated software systems are helping medtech companies improve regulatory compliance, from design through postmarket surveillance.

Steve Halasey

Compliance with regulatory and market requirements is an important factor in both the design and manufacture of medical devices. In order to beat competitors to market and maintain a financial advantage, however, medtech companies are equally challenged to streamline their operations for both product development and manufacturing. Balancing these competing priorities can be a challenging task for the leaders of start-up companies new to the industry—but there is light at the end of the tunnel.

Medtech suppliers and information technology vendors are continuing to develop new software systems designed especially to meet the needs of the medical device industry. Such integrated software systems are playing an increasingly important role in helping medtech companies to meet all of these needs at once.

Varied Design Needs

The wide array of technologies employed in medical products can be a challenge to medtech product designers, sometimes requiring advanced capabilities in mechanical, electrical, hydraulic, and other types of engineering. As a result, product designers often use a number of different software systems to meet their varied design needs.

Some idea of the variety of design software packages in use by device manufacturers comes from the practice of Welch Allyn Inc. (Skaneateles Falls, NY). According to Richard A. Tamburrino, engineering manager at Welch Allyn, the company uses Pro/Engineer Wildfire for mechanical design, OSLO for optical design, ANSYS for mechanical analysis, and Trace Pro for illumination analysis.

Design consulting firms face the same challenges and use an equivalent variety of software systems. "Our primary 3-D solid model computer-aided design (CAD) systems are SolidWorks and Pro/Engineer Wildfire, but we use a variety of different software packages depending on where the product is within the development path," says Tor Alden, principal at HS Design Inc. (Gladstone, NJ). "As product design consultants, we need to be as flexible as possible so that we can dovetail into our clients' design process."

Robert Howard, principal of the recently formed medical engineering and design practice at Lunar Design (San Francisco), says that his firm's experience has been similar. "We serve a broad variety of clients—from start-ups to the big guys—so we see an equally broad variety of tools in use. For the most part, the industry uses SolidWorks and Pro/Engineer for mechanical development, in conjunction with a wide range of product data management (PDM) and enterprise management tools."

According to Suchit Jain, vice president of analysis products at SolidWorks Corp. (Concord, MA), the major advantage of CAD and computer-aided engineering (CAE) systems is that they enable product designers and engineers to create and optimize their product designs virtually—on a computer—before ever building a single prototype. "Since a product may need to be tested for many types of physical behaviors—such as strength, temperature resistance, and flow—there are many types of analysis software," says Jain.

"There is no question that Pro/Engineer and SolidWorks are the two main mechanical platforms of choice for about 98% of our client base," says Craig Scherer, senior partner at Insight Product Development (Chicago). "In addition, Pro/Mechanica offers an excellent integrated finite element analysis (FEA) package, and SolidWorks has followed suit by purchasing Cosmos and integrating it seamlessly into its main mechanical package."

Products that require significant software engineering can present their own set of challenges, says John A. Verrant, vice president of engineering at Immunicon Corp. (Huntingdon Valley, PA), a maker of diagnostic instrumentation. "From a software engineering perspective, it is always best for all of the team members to have the same development environment so that the engineers can cross-develop different projects, reduce the number of different development tools (and associated expenses), and enhance the speed of design reviews and validations. Modularity of the software architecture is paramount for the ability to make changes during the early stages of development and later in the life cycle of the product," he says.

Talking Points

In an ideal world, all of the varied software systems used by medtech companies and their suppliers would communicate flawlessly and effortlessly with one another whenever necessary. But the reality of intercommunication is often quite different. Medtech companies must often concern themselves with the ability of their software systems to integrate with one another.

To resolve such communication issues, the Cosmos analysis systems produced by SolidWorks are all fully embedded inside the core SolidWorks CAD products. "This means that any changes to the CAD design are also automatically reflected in the analysis model without having to import the geometry again," says Jain. "All of the Cosmos analysis products interact with one another so that data from one system can be automatically imported to the others."

"Our primary CAD systems can be made to share data fairly cleanly, but the trick is in knowing how to accomplish this," says Lunar's Howard. "In theory, CAD data from electronic design (Gerber) and industrial design (Alias and Vellum) systems can be easily integrated via industry-standard data conversion protocols like the initial graphics exchange specification (IGES) and the standard for the exchange of product model data (STEP). But sometimes, industry standards aren't so standardized."

Sometimes manufacturers must take matters into their own hands to ensure that communications are executed correctly. "Pro/Engineer is integrated with SAP," says Welch Allyn's Tamburrino, "but not with OSLO, ANSYS, or TracePro. Files can be transferred by creating a STEP file, however, and this makes it possible to generate a file in a program such as OSLO and use it in Pro/Engineer."

"Today, most if not all software systems have built-in translators that permit them to easily integrate with one another," says HS Design's Alden.

But not everyone is satisfied with the communications capabilities typically available in off-the-shelf design software systems. "To ensure accuracy and efficiency, we have created a proprietary centralized database to meet our own specific needs," says David C. Robson, development director for Ximedica (Providence, RI), a wholly owned subsidiary recently formed by the Item Group to specialize in the design, development, and supply of medical devices. "As a result of working with and relying on our own unique system, our single-database environment eliminates the need for us to transfer information from one system to another."

The Regulatory Challenge

With all the difficulties that software systems present for everyday communications and data transfer, it's sometimes easy to forget that one of their key functions should be to help companies comply with regulatory requirements. Many of today's systems offer very strong packages that correspond directly to FDA's quality system regulation (QSR) and other agency requirements. Nevertheless, system capabilities vary widely, and not all such systems are equally robust or flexible in all areas.

Scherer reports that both Pro/Engineer and SolidWorks offer modules for PDM—respectively, Pro/Intralink and PDMWorks. "These packages have proven to be quite valuable in helping us comply with FDA's design control requirements. They enable us to work together more collaboratively."

"To meet FDA's design control requirements, companies must manage and track all design documentation," observes SolidWorks' Jain. "PDMWorks data management software enables the design team to search and optionally reuse existing design documents at any time throughout the development process, as well as to manage newly created documents and versions."

"PDM software can be very useful for tracking latest revisions, dates, change orders, and bills of materials items," agrees Alden. "But these systems still have a way to go toward permitting the user to exercise greater control over which parts or assemblies should have a revision rollover instead of doing it automatically."

"We use our CAD tool's integrated PDM capabilities to maintain a clear path for design control," says Lunar's Howard. "However, our experience has shown that no amount of automation is a substitute for diligence and care, since any system run by a person is subject to human error, automated or not."

Expanding regulatory control over a variety of company functions can require companies to use a number of different systems. "To maintain configuration and change control for software, Immunicon uses StarTeam," says Verrant. "But for overall instrument development and operations configuration management, the company utilizes an EtQ system. Design history file documents are released through EtQ and tracked in a Microsoft Excel spreadsheet, using the hyperlinks to released documents residing in EtQ."

On the Manufacturing Edge

Over the past decade, software vendors have done a great deal to develop and elaborate on advanced IT systems for medical device manufacturing operations. Today, such systems are generally well coordinated with their corresponding FDA regulations, and they are increasingly being offered as fully integrated suites of modules devoted specifically to compliant manufacturing of medical products.

One such system is the Medical Device Suite by Camstar Systems Inc. (Charlotte, NC). According to Camstar director of marketing Chris Parsons, the suite is the only such software solution that provides out-of-the-box functionality to support compliance with FDA's QSR. "Camstar's Medical Device Suite provides the manufacturing control needed to help eliminate scrap, rework, paperwork errors, and redundant checks; and the real-time feedback needed to quickly identify and resolve issues that inhibit product and process improvement," says Parsons.

A similar strategy is being pursued by Brooks Software (Chelmsford, MA), a division of Brooks Automation, which has a long history of providing software solutions for complex manufacturing systems and environments. Although Brooks is a newcomer to the medical device field, the company has hit the ground running with its Manufacturing Enterprise Device and Drug Intelligence and Compliance (MEDIC) Solution Suite for medtech manufacturers. According to Milan Bhalala, director of life sciences, the Brooks suite creates "a manufacturing compliance framework that brings together all of the key compliance functionalities from across the organization in order to help automate cross-application, cross-functional processes."

Agile Software Corp. (San Jose) offers product life-cycle management (PLM) software designed especially to support the medtech industry. The Agile system enables manufacturers to record, track, and access all product-related information. Todd Hein, Agile's senior director of life sciences, says that access to product-related information is important to medtech companies. "Having all of this content synchronized in one system enables medtech companies easy access to information, which improves business performance and ensures compliance integrity as required by FDA regulations."

Apriso Corp. (Long Beach, CA) develops enterprise operations execution software that spans manufacturing execution, maintenance management, warehouse management, time and labor (including operator certification), quality execution, and supply-chain visibility and traceability applications.

Solutions for the Future

Improving communications is high on the list of issues to be addressed in future generations of design and manufacturing software. "We have yet to come across a good method for linking 2-D and 3-D CAD specs to the document control process," says Ximedica's Robson.

"Currently, our established partners share similar software systems and development processes to our own. But with the trend in product design and development going toward larger, multidisciplinary teams, there is an increased need for compatibility," says Alden.

"The ability to easily transition a project from one party to another regardless of the systems they are running would be ideal," says Scherer. "One could imagine a system that would trace user input into design output, provide access controls for collaboration, and track document versions and work flows as well as compliance issues—but it would be one complicated piece of software. Transferring a project from one party to another is tricky if their software packages are different. Some agreed-upon way to format such data so that one system can pick up where another left off would be an improvement."

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