Compliant Design and Manufacturing

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.

With greater industry experience also comes better understanding of accepted methods for meeting regulatory requirements while maintaining a competitive advantage. At the same time, 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.

This article looks at the types of software systems currently in use for designing and manufacturing high-end medical products, with special attention to the ongoing integration and connectivity of such systems. Experts discuss the strengths and weaknesses of existing systems, and the directions being taken for the development of future systems.

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). "In the early development cycle we do not constrain designers to a specific program, but allow them to utilize multiple software packages. When the product is in the middle to end of the design cycle, we match our software as closely as possible to our clients' systems.

"As product design consultants, we need to be as flexible as possible so that we can dovetail into our clients' design process," adds Alden. "This can be much more challenging with Fortune 100 firms than with start-ups. Start-ups tend to utilize our internal 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. Lunar must therefore be 'pan-gnostic' to support all popular systems."

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. "SolidWorks makes CosmosWorks software to perform structural and thermal analysis, CosmosMotion to perform motion simulation, CosmosFloWorks to perform CFD (flow analysis), and CosmosEMS to perform electromagnetic analysis."

"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."

Scherer emphasizes the need for product designers to use additional software tools as needed for the task at hand. "Early in the development process, our industrial design team uses software packages such as Rhino and Alias to create the initial forms of the product being developed. These 3-D packages allow for quick exploration and configurational analysis. We use these data to create rapid-prototype models using methods such as fused-deposition modeling, Polyjet, or CNC machining. These prototypes are taken into the field to help ensure that we are going down the correct path and meeting both FDA requirements and the needs of the users.

"In addition to mechanical design, Insight provides extensive human factors and ergonomics engineering to help our clients meet the ever-evolving FDA requirements related to human factors," says Scherer. "We use a wide variety of software, including Visio and other systems, for documenting task analyses and workflows. For interface testing, Macromedia Director and even Microsoft PowerPoint can be very effective tools for usability testing to verify that the user interface requirements are met."

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."

When developing an instrumented in vitro diagnostic assay, the use of scripting languages enables other disciplines to interact with the software developer while the functionality of the instrument is still being shaped, says Verrant. "Changes must be made and compiled quickly so that the same specimen can be analyzed on a range of instrument operating parameters. This is most important in diagnostic instrumentation where assay chemistry has to be integrated with the functionality of the instrument's hardware and software. Ideally, the instrument under development should not reside in an engineering or software development laboratory, but in a clinical laboratory where researchers can test the assay and instrument in their own environment."

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. And sometimes extraordinary measures are needed to overcome the challenges involved in data sharing among systems that are not integrated.

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. In addition, SolidWorks offers CAD and analysis data communication tools such as eDrawings, which can create accurate representations of 2-D and 3-D models that everyone can understand."

"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. In practice, expertise is crucial to ensure that data import correctly, and are oriented and scaled to match the data structure at the destination."

To ensure quality transfers, says Howard, Lunar includes an experimental conversion, transfer, and review step in every new program kickoff. This test enables the firm to verify that the data it receives, creates, and delivers will be trustworthy and useful. Learning from the test, Lunar then uses the transfer protocol that works best to minimize compatibility problems for each client.

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. "The drawback to this is that most data files will lose their parametric features and be uneditable, with the exception of adding new features. On the other hand, there are times when this limitation works in our favor, as it prevents downstream users from changing design or component specifications once they have been released to production."

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 innovative new 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. It is a constantly evolving system that is best designed and managed by the people that are designing and manufacturing the product."

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.

"Requirements traceability is the cornerstone of our regulatory support activities for clients," says Insight's Scherer. "Tracing decisions and changes made during the design and development phases back to the core user requirements has been made easier to coordinate, and error-free, by using requirements-tracing packages such as Rational RequisitePro and Caliber. With these systems, every decision is traced back to a single user need in a detailed and organized way. It is really the glue for the entire development and decision-making system."

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. We can check parts in and out of a library and not worry about writing over a file someone else is working on. More importantly, the software makes it much easier to track changes to the design. We are able to quickly determine who made what changes to the design, when the changes were made, and the reason for the changes."

"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. The system can also be used to generate manuals, assembly instructions, maintenance documents, catalogs, and marketing materials. And again, all changes to the design data are automatically reflected, guaranteeing that such documents will always be up-to-date with the latest revision."

"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 human 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."

To make sure that regulatory requirements can be met, medical device designers must sometimes overcome the limitations of proprietary systems. "The problem for a consulting firm like Insight is that most PDM packages are platform-specific," says Scherer. "But platform-independent packages, such as Teamcenter Express by UGS (maker of Solid Edge, another engineering CAD package), work across different CAD programs as well as other types of documents. They include requirements-tracing and layered security capabilities, and also have specific FDA-related modules to meet the needs of medical product developers."

Another concern, especially among emerging device manufacturers, is the cost of purchasing and implementing a broad-based software system. "In order to contain costs, we have purchased a limited number of options offered by EtQ," says Verrant. "At our present size, these semiautomated systems are sufficient. But looking ahead, we will need to purchase more options, which is a strong point for EtQ—expandability."

Over the (Virtual) Wall

One of the long-standing failures of traditional manufacturing systems was the tendency of research and development personnel to design products in isolation and then throw the plans 'over the wall' to manufacturing. Companies gave little thought to production issues until the plans landed on the desk of the process engineer whose job was to figure out how to make the product. The waste, rework, and poor product quality that resulted from such practices constituted a major underpinning for the transition to a quality systems approach to design and manufacturing that began to take hold of the medical device industry nearly two decades ago.

Although medtech manufacturers are thus well aware of the dangers of faulty integration between the design and manufacturing aspects of their business, adequate integration between the software systems used in each area is often difficult to detect. Medtech companies—especially those using outside design or contract manufacturing firms—must be continually vigilant to ensure that the software systems used for product design will interface with those used in manufacturing. Ensuring the accurate transfer of data among design and manufacturing systems can be a major undertaking—but not one that most product developers consider insurmountable.

"We started out taking photographs of assemblies and then writing the assembly scripts," says Immunicon's Verrant. "For the next product, we used CAD models with exploded views that allowed engineering changes to be reflected in the manufacturing documentation. To ensure accurate transfer of data, we imposed traceability to the level of 'were used' notations. To date, such practices have not been a problem because each of our instrument systems has been unique. However, as we expand our product line and begin to use common parts this will become a challenge, as it has in most companies."

"Lunar employs various validation checks during file transfer, as well as tight revision control and file ownership," says Howard. "When clients use the integrated PDM tools built into the same CAD systems we use, our files typically transfer cleanly and maintain traceability and design history. In these cases, we check the data received by our client to verify that they transferred cleanly into their corporate data management systems.

"If clients do not use an integrated PDM," adds Howard, "we offer a number of solutions ranging from hand-tracked file databases (traditional document control), to working on-site with the client to bring up a compatible PDM system of their choice and ensure it is integrated correctly with their internal systems."

According to Jain, SolidWorks software automatically maintains bills of materials, which can be exported in a variety of formats for use with materials resource planning (MRP) systems. "This information can help companies save time and avoid errors during the purchasing process," says Jain.

SolidWorks Corp. partners with industry-leading computer-aided manufacturing (CAM) software companies to deliver a variety of powerful computer numerically controlled (CNC) programming solutions for milling, turning, and electric-discharge machining. "Since certified CAM solutions read native SolidWorks geometry and are fully associative, design changes are also reflected in the CNC program," says Jain. "Certified gold solutions also provide single-window integration with the SolidWorks model, enabling generation of the CNC program path within the familiar SolidWorks environment."

The SolidWorks Manufacturing Network (www.solidworks.com/pages/partners/mfgnetwork.html) enables companies to locate contract manufacturers who can utilize native SolidWorks files to eliminate manufacturing errors.

Alden agrees that the most commonly used design platforms create no difficulties for transferring data to manufacturing personnel. "Using SolidWorks and Pro/Engineer Wildfire, we have no problem at all interfacing with the hundreds of manufacturing houses we deal with. Normally we will provide manufacturing with an IGES or STEP file accompanied by a PDF of a control drawing. The fact that these files cannot be altered by manufacturing groups helps to control data with these releases."

"Pro/Engineer and SAP integration provides a common database for the product development team and manufacturing," agrees Welch Allyn's Tamburrino. "We ensure the accurate transfer of data by manual and automated means. A review of the design input and output is part of the product development process."

Such careful reviews are especially important with respect to outsourced manufacturing, says Verrant, in order to detect and eliminate differences between internal and external product design, configuration, and assembly. "Software companies that provide these applications have to shed some of their proprietary interest in having companies purchase their entire package," he adds. "The industry has to adopt a common interface—such as that occurring in the CAD industry—so that the systems used for file transfers from different development environments can communicate with one another."

"We always design for manufacturing as well as for reliability, functionality, and performance," says Samuel Prabhakar, director of the medical solutions practice at IBM Engineering and Technology Services (Rochester, MN). "Most often we create the manufacturing test software as well. Hence, the hooks are there in the functional code of the product to provide the data needed for manufacturing testing."

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), an enterprise production and quality management system created specifically for medical device and diagnostics manufacturers. 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.

The Medical Device Suite is powered by Camstar's InSite manufacturing execution system (MES), which uses a service-oriented architecture. "InSite employs Web services, a flexible data model, and a configurable user interface that dramatically decreases the time and effort needed to deploy and validate the solution," Parsons adds.

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." The system uses a service-oriented architecture to coordinate key medtech-specific modules, including an MES, a quality management system (QMS), and applications for manufacturing process optimization, asset management, and radio-frequency identification.

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 information belonging to a product's design history file (DHF) and device master record (DMR); all information related to regulatory submissions; and all events related to the company's quality management system, including corrective and preventive actions (CAPA), customer complaints, and medical device reports (MDRs). 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. According to Tom Comstock, the company's senior vice president for marketing and product management, "Apriso's systems can be deployed individually or as a comprehensive suite tightly integrated with business systems, including enterprise resource planning (ERP), CAPA, and PLM."

As might be expected, all of these companies boast that their own modules operate seamlessly within their own integrated environment. But the companies have also put a lot of work into making certain that their systems can communicate with other software systems. "Agile routinely integrates with other enterprise software solutions that manage transactional or authoring events for the organization," says Hein. "Examples of integration include ERP systems, MES systems, customer relationship management (CRM) systems, and CAD systems. Data sharing is accomplished through common application program interfaces that provide real-time, accurate transfer bidirectionally between Agile and the other systems."

At Ingenuus (Frisco, TX), a provider of business process automation software, communication involves both internal links and middleware. "Our processes run on a common platform we call the Process Orchestrator," says Ingenuus founder and president Christopher Williams. "Our unique process-linking technology allows for processes to be linked rather than nested, providing ultimate flexibility, which is crucial in today's global manufacturing. We also provide integrated middleware to enhance process-based data exchange between different systems."

Although interfacing with design software systems has not been a high priority, most manufacturing IT firms believe that their systems can accept and manage product design data. "Product designers typically use a PLM or document management system to create documents that describe the characteristics of a product and how to build that product," says Parsons. "Camstar's Medical Device Suite turns the 'how to build' information into structured manufacturing instructions that it uses to track and enforce the manufacturing process."

Solutions for the Future

Although today's advanced design and manufacturing software packages offer capabilities that are light-years ahead of their predecessors, they remain a collective work in progress. Future developments will almost certainly continue to improve the capabilities and connectivity features of such systems. The experience of today's users will help to guide the enhancement of systems in directions needed to meet the needs of the medtech industry.

Dealing with communications missteps is high on the list of issues that current users would like to see 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. "While there have been a lot of attempts by all of the major and even by some of the secondary CAD companies, the systems are still very limited and need to be perfected."

"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. "Proprietary protections adopted by each software developer make it difficult to share data across multiple platforms. Open-ended translation to native files would help, but my guess is that we will have to live with IGES and STEP files for the time being."

Lunar Design's Howard agrees that software providers should aim for "better integration of the various PDM and corporate data management tools to minimize proprietary or inconsistent 'standards' that exacerbate intercommunication problems."

According to Verrant, making a company's materials resource planning (MRP) and PDM systems work with one another is presently the most important issue for efficient design transfer from engineering to manufacturing. "To ensure traceability between engineering PDMs and operations MRP systems there needs to be a universal or common file format conversion so that the various systems can communicate with one another. The configuration of bills of materials for engineering is changed when transferred into manufacturing; the challenge is to provide traceability and the ability to track changes on both sides.

"The third leg of this traceability function should involve the company's field service personnel, so that they are aware of changes originating from either engineering or manufacturing," says Verrant. "There are systems out there, but systems suitable for smaller companies have been a long time coming. We're looking for an automated system inexpensive enough for our size company."

"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 an entire 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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