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Aligning Product Development Processes to Meet Compliance Demands

Wed, 05/03/2006 - 6:04am
The Project:  Streamline the document management and retrieval processes to enable a more efficient regulatory compliance protocol.

The Solution:  Implement an electronic product lifecycle management solution to manage product-related information.

By Sam Zawaideh and Tim Anderson
Medical device companies face significant challenges in developing life-saving products. Quality is vital, market demands change quickly, competition is fierce, regulatory pathways are often long and expensive, and the need for continual design innovation is relentless. Compounding these complexities are requirements to comply with strict FDA regulations including Title 21 CFR Part 11 that prescribes the use of electronic records and signatures, and Part 820 that outlines quality system regulations.

Possis Medical believes its project to manage product development will lead to more efficient multidisciplinary team collaboration for different groups during this cycle, which will ultimately get Possis' leading products in the hands of doctors and hospitals more quickly.
Compliance with these regulations entails preparing and maintaining accurate sets of extensive documentation: design history files (DHF) demonstrating that the product was developed in accordance with an approved design plan, device master records (DMR) with specifications and procedures defining how the product is to be manufactured, and device history records documenting all steps actually performed in fabricating the product. Preparing these and other documents, as well as managing underlying data, is a monumental task.

In the case of Possis Medical, a developer and manufacturer of advanced medical devices for the large and growing cardiovascular and vascular treatment market, DMRs for a single product, such as a catheter, typically contain 500 different specifications and procedures. Often, manufacturers must quickly produce a few specific pages of data out of the thousands of documents requested by the FDA during on-site audits.

Like many other medical device manufacturers, Possis previously met these requirements using a paper-based process. After release, hardcopy prints, drawings, and other records were scanned as electronic files into the company's computer system and managed by a central document control group where clerks archived, cataloged, and copied relevant data and documents as needed. Time spent locating information and synchronizing paper and scanned online copies added to the inefficiency, especially with the growing volume of files and continual improvements resulting in frequent changes. Folders of hardcopy documents were manually routed through the organization, creating further delays.

"A paper-based system made it more time-consuming and difficult to maintain a smooth workflow and to allow workers and managers to share information quickly and work collaboratively," explains Possis Document Control Manager Rob Oveson.

To better meet these challenges, Possis implemented the MatrixOne product lifecycle management (PLM) solution to manage product-related information. Rather than relying on paper documents and manual data searches, PLM captures and manages information in an integrated system that facilitates quick online access to data, streamlining of processes, and collaboration between enterprise groups.

As part of its PLM system, Possis is implementing MartrixOne Accelerator for FDA Compliance software with built-in templates, phase-gate process structures, and best practices to help comply with federal regulations throughout their product lifecycle processes. The system electronically manages product-related information to easily generate required compliance reports and extract information as needed for FDA audits and regulatory requirements.
Building an Integrated System
"PLM is enabling us to build an integrated system for managing information and processes throughout the product development cycle with all necessary FDA compliances. It's more than controlling engineering drawings and technical documents," says Oveson. "The power of PLM is in managing corporate knowledge."


To speed the development of products, like the drive unit of Possis Medical's AngioJet Thrombectomy system (seen here), the company is piloting a project to manage overall product development activities from start to finish with MatrixOne Program Central software.
The plan at Possis is an overarching system for people to perform broad contextual searches across a unified company database in finding information that now resides on separate lists and files. This "one-stop data shop" will link all information about a particular part such as supplier information, specifications, qualifications, and preventive maintenance information. On their way to this type of knowledge management system, Possis is in the initial stages of phasing PLM into their operations and are already seeing significant benefits.

"Compiling all the information and documents required for a DMR took up to two to three days under the old paper-based procedures," says Oveson. "With the MartrixOne Accelerator for FDA Compliance, a DMR report can be created automatically in just five minutes. The ability to retrieve information immediately for the FDA will make the audit process go much more smoothly."

Having access to DMR documents online is of particular value in the cleanroom production area, where hours were previously spent copying documents, sealing them in plastic, assembling notebooks, and wiping them down to remove contaminants. With workers able to access the DMR drawings, procedures, and forms on networked computers inside the cleanroom, production staff can focus more on manufacturing activities. Moreover, costs are lower by eliminating the need to physically reproduce the volumes of production documents, many of which are color copies costing 50 cents each.

Possis is piloting a project to manage overall product development activities from start to finish with MatrixOne Program Central software, which works in conjunction with the Accelerator for FDA Compliance in generating DHFs. Whereas hardcopies are now typically contained in three-ring binders in the program manager's office, moving forward, the files will be available online to everyone on the project team including R&D, quality, engineering, design, marketing, production, regulatory affairs, and anyone requiring access, including senior management.

The system gives Possis immediate access to information it needs throughout the product development lifecycle from start to finish. These capabilities allow Possis to be more efficient and facilitate multidisciplinary team collaboration where people in different groups get a "heads up" on projects coming down the pipeline and have the opportunity to provide input early in the cycle. The ability to work collaboratively and productively enables Possis Medical to demonstrate compliance with FDA regulations more efficiently and without delay.
Online
For additional information on the technologies and products discussed in this article, see the following websites:Sam Zawaideh is the senior vice president of product solutions and customer support at MatrixOne, 210 Littleton Rd., Westford, MA 01886. He is responsible for the development and execution of the product strategy for all of MatrixOne's products and integration offerings. Zawaideh can be reached at 978-589-4000 or sam.zawaideh@matrixone.com.

Tim Anderson is the director of engineering at Possis Medical, 9055 Evergreen Blvd. NW, Minneapolis, MN 55433. The company is a manufacturer of advanced medical devices for the cardiovascular and vascular treatment market. Anderson can be reached at 800-810-7677 or tim.anderson@possis.com.
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