Originally Published MX July/August 2006
Originally Published MX July/August 2006
During the past year, FDA has increased its scrutiny over the safe use of new medical products in the period immediately after their market launch. Such increased vigilance is in part a response to public concern that arose with Merck's 2004 withdrawal of its Cox-2 inhibitor Vioxx and was transferred into the device industry as a result of the many product recalls issued in 2005 by Guidant Corp.
In theory, software systems used for product design could interface with a company's systems for postmarket regulatory complianceincluding such areas as corrective and preventive actions, complaints management, and adverse event reporting. Such a closed-loop system would increase the likelihood that design changes identified during postmarket follow-upincluding those required to improve patient safetywould make their way back to product designers for rapid implementation.
Growing into Automation
Although manufacturers may be closing the postmarket loop, automation usually has little to do with the process. "Our software systems are used to track customer complaints and corrective actions," says Richard A. Tamburrino, engineering manager at Welch Allyn Inc. (Skaneateles Falls, NY). "Changes make their way back to product designers by execution of standard operating procedures."
Automating such procedures can improve a company's ability to handle customer complaints, log each complaint and corrective action for regulatory purposes, and dispatch personnel or parts to a customer as needed to resolve the complaints. But most medtech firms need to grow into the need for an automated system. "As we grow, we will look into packages to expand this capability," says John A. Verrant, vice president of engineering at Immunicon Corp (Huntingdon Valley, PA).
"We are presently using two different software packages, and the regulatory software package is different from the business package for manufacturing resource planning and customer service," Verrant explains. "There is a need to tie business-related software to regulatory compliance management software. The regulatory package by EtQ has the right idea, but we as a company will eventually have to decide to combine all that we have into one database."
Although current design software packages offer some functionality that can be useful for regulatory compliance, integration with other systems for regulatory purposes isn't their strong suit. Document control is one area in which such programs are typically quite strong. "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," says Suchit Jain, vice president of analysis products at SolidWorks Corp. (Concord, MA). "All changes to the design data are automatically reflected, guaranteeing that such documents will always be up-to-date with the latest revision."
Integration a Plus
On the manufacturing side of the equation, the software packages available to device manufacturers are much more sophisticated. By virtue of their connection with FDA's quality system regulation, many existing manufacturing software packages already include modules devoted to postmarket regulatory compliance, including such areas as corrective and preventive actions, complaints management, and adverse event reporting.
"Camstar provides a closed-loop system to receive issues and data from manufacturing and from customers, perform full root-cause investigation and analysis, determine the scope of the problem, implement effective and timely resolutions, and return the improvements to the design system," says Chris Parsons, director of marketing at Camstar Systems Inc. (Charlotte, NC). "Then, automatically, the manufacturing system ensures that employees have been retrained and recertified, and automatically enforces the process or material changes necessary to prevent the problem from recurring."
A similar approach is used in the Manufacturing Enterprise Device and Drug Intelligence and Compliance (MEDIC) Solution Suite by Brooks Software (Chelmsford, MA). "When field information is brought in, the manufacturing execution system (MES) provides all of the root-cause analysis information required to ascertain where the problem occurred," says Milan Bhalala, director of life sciences at Brooks. "Once this is determined, and an engineering change is created in the design system, the MES ensures that the change is implemented immediately."
When it comes to sharing a product's postmarket performance data, such integrated manufacturing IT systems often have the advantage of already including all of the original design information belonging to the product's design history file. Data typically on file include a product's verification and validation results, clinical testing results, regulatory submissions, manufacturing qualification and transfer information, and records of all corrective and preventive actions. "Having all of this data in a single system provides easy reference to assess the impact of postmarket events," says Todd Hein, senior director of life sciences at Agile Software Corp. (San Jose). "Any postmarket changes or quality events can be easily associated to the original design information to assess their impact on the original design intent. This synchronized visibility and reporting capability improves management decisions and compliance integrity for postmarket management requirements, including annual reports."
On top of the capabilities of such in-house systems, some vendors offer systems that have been designed with field use in mind. "Apriso provides maintenance management applications to support the field service technicians who maintain equipment and to manage the 'as-maintained' history of the equipment," says Tom Comstock, senior vice president for marketing and product management at Apriso Corp. (Long Beach, CA). "The system provides graphical mark-up via annotations, free-form comments, or customer-specified reason codes. And because it is a Web-enabled application, data can be entered directly into the system and evaluated immediately, allowing for detailed understanding of problem histories of medtech equipment in the field."
Hands and Feet
However well such systems may be tracking postmarket events, however, data-sharing typically remains a fairly localized function. Even in well-integrated systems, individual modules do not necessarily communicate outside their local system, and they do not automatically direct postmarket data back to the product's R&D personnel so that design changes can be considered. Communicating information about a product's postmarket performanceespecially to outside design firmsremains mostly an operation of many hands and many feet.
"Normally, we design within our clients' computer-assisted design (CAD) system and try to deliver the data in a format that they can revise and manage once released for manufacturing," says Tor Alden, principal at HS Design Inc. (Gladstone, NJ). "If there's a need for engineering change orders, they are usually done in writing and filed with the revised database when complete."
"We do not currently use any client-collaborative software, but we do imagine a time when we will install client-based data privileges," says David C. Robson, development director for Ximedica (Providence, RI). "Today we rely on our most important and valuable resourceour peopleto do it right with constant communication and diligent reporting."
"Basically, this requires good project management and documentation to meet FDA's good manufacturing practices requirements and other guidelines," agrees Samuel Prabhakar, director of the medical solutions practice at IBM Engineering and Technology Services (Rochester, MN). "We conduct frequent reviews with the client, and handle change management through formal product change request processes."
When outside design firms are recalled to assist with product changes, special care should be exercised to ensure that change control procedures are not violated. "Clients often retain Lunar throughout compliance and testing specifically to take advantage of our familiarity with the systems we design and our clean data-management procedures," says Robert Howard, principal of the medical engineering and design practice at Lunar Design (San Francisco). "When inevitable changes are needed, Lunar verifies and only works from the latest file versions, whether those are our own files or ones imported back from our client's product data management (PDM) system."
"From the clients' standpoint, open-ended involvement by us can get expensive," says Craig Scherer, senior partner at Insight Product Development (Chicago). "As a result, we are typically retained for a fixed scope of work, which means at some point the ownership of the project and engineering data is transferred to the client's staff. Design changes beyond that point are typically going to be handled by the client unless the company chooses to retain us for that work. Ultimately, it is the client that is responsible for the outcome and regulatory compliance of products that it introduces into the market."
But Scherer emphasizes that it's usually a good idea for a product's original designers to be involved in making postmarket changes. "One of the things manufacturers need to be careful of is making one change that causes a number of other problems down the road," he says. "As the organization responsible for the design of the product, it makes sense that we are consulted on proposed changes to the design. Since we are familiar with the decisions that went into the initial design, we are usually able to develop a variety of solutions that do not have any adverse effects on the rest of the design."
Many of the design and manufacturing software systems used by medtech manufacturers offer sophisticated capabilitiesincluding very detailed and carefully crafted modules for regulatory compliance. But in practice, such systems still have a long way to go to create a closed-loop environment in which patient safety issues can be detected and resolved rapidly and without hesitation. FDA's increasing vigilance over postmarket safety issues may stimulate further systems elaboration to achieve that goal in the very near future.
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