Managing the Total Product Life Cycle
The changing face of medical device product development.
Daniel R. Matlis, President, Axendia Inc., and David Rubin, Director, Vertical Market Strategy Medical Devices, PTC
Medical device manufacturers face intense financial and competitive pressures. In this highly complex business landscape, they must boost innovation while managing global product development, outsourcing of design and manufacturing and the need to update product development technology—while continuing to meet the strict regulatory requirements imposed by government agencies around the globe.
Figure 1—This medical device product development landscape shows the processes in which most companies engage when developing new products, the stages through which a product advances (horizontal axis on top) and the functional departments responsible for each stage (left vertical column).
This article provides an in-depth look at the impact of an integrated Product Life Cycle Management (PLM)/Quality Management System (QMS) framework and describes how organizations can take a
Figure 2—The Waterfall Design Process 2offers design control guidance for me
The Waterfall Effect
On March 11, 1997, the FDA issued a document titled “Design Control Guidance for Medical Device Manufacturers.”1 This guidance document focused on key issues associated with the design control requirements set forth in 21 CFR 820.30 and described the Waterfall Model (Figure 2) as a tool to illustrate the design control process.
With respect to the industry’s strict adherence to the Waterfall Model, Al Taylor, director of the Division of Electrical and Software Engineering Office of Science and Engineering Laboratories and a primary contributor to the design control guidance, commented:3“Subsequent to publication of the guidance document, a lot of people have told me that they interpret this diagram as FDA’s endorsement of the Waterfall approach to design—this, in spite of the fact that the guidance document talks explicitly about the use of concurrent engineering and other models of design process.”
Despite clarification from the agency, some in the industry continue to follow the Waterfall model nearly a dozen years after it was first introduced.
One major consequence of the Waterfall Effect is the proliferation of rigid, sequential and unidirectional product development models void of continuous feedback paths for the individuals and departments responsible for each phase. The result is a reactive approach to product design, quality and compliance.
Tilting at Silos
Another key factor contributing to the reactive approach to product design and quality is the existence of standalone and siloed development processes. This problem is compounded by the fact that many departments utilize separate and distinct systems to support their functional needs. These systems include:
• Requirements Management
To support compliance in today’s new business landscape, medical device manufacturers need a closed-loop, integrated change control and QMS, which supports proper traceability between quality events, design and development activities such as engineering changes and risk assessments.
Proactive Product Development
Figure 3—Total Product Life Cycle (TPLC0) model created by FDA's Center for Devices and Radiological Health (CDRH).
In recent years, the FDA has further encouraged device manufacturers totransition away from the rigid Waterfall paradigm to the more suitableTotal Product Life Cycle (TPLC) model (Figure 3), which suggests that stages of a product not only overlap, but are interdependent.
Furthermore, knowledge acquired while developing one product should be applied to future generations of products that a company develops. TPLC represents the centerpiece of the Center for Devices and Radiological Health Strategic Plan in which the stated vision is: “Ensuring the health of the public throughout the Total Product Life Cycle—It’s Everyone’s Business.” 4
The TPLC model is more representative of the design process. In TPLC, product development is iterative and incorporates the required interactions between stakeholders as well as the contribution and input of every group involved in the development process.
A TPLC approach focuses on sharing information among the various product life cycle stages, and by extension, between different departments.
TPLC also encourages the use of preventative actions over corrective actions, an approach that shifts focus away from rapid event closure in favor of developing solutions that prevent the occurrence of a problem in advance of its manifestation.
Preventive actions often involve the continuous monitoring of processes that affect the design and production of a product to ensure it is properly documented, executed and closed.
Medical device manufacturers must concentrate on reducing the sources of variability, which lead to corrective action, in favor of a proactive approach to product design and quality.
For example, device development teams should conduct design of experiments to determine critical process parameters and establish process set points and upper and lower control limits. Then, the team should thoroughly exercise the manufacturing process by producing parts made at the extremes of the process settings to ensure adherence to acceptance criteria. Should the product fail to meet specification, preventative actions should be taken to modify either the product or the process until acceptable results are obtained. In the true spirit of TPLC, the knowledge gained during these exercises must be transferred to manufacturing to help manufacturing engineers and quality engineers better understand the process.
In order to be proactive, device manufacturers should seek technology solutions that not only archive and manage data, but also facilitate the sharing of product and process data throughout the enterprise, including development (mechanical design, electrical design and software design), manufacturing, sales, marketing, quality and regulatory.
It is extremely difficult to assess the impact and then execute a change when each department stores important product and process information in separate siloed, disconnected systems.
Quality, clinical, manufacturing and field use data must play a key role in the product development process, as well as support quality by design initiatives. These sources of data provide critical inputs that give designers visibility into variables that are not often available if information resides in isolated quality or study management systems. This approach fully supports the TPLC model.
Integrating Systems and People
Figure 5—It is difficult, if not impossible, to manage the TPLC using disconnected and unstructured systems and processes. Graphic courtesy of PTC.
Figure 6—An integrated product development/QSM system as shown above enables organizations to move away from "testing quality into products"toward a proactive strategy of "designing quality into products and processes." Graphic courtesy of PTC.
Today’s PLM software systems have become key enablement tools that are helping manufacturers and suppliers solve design and quality challenges—and their associated visibility and traceability. With the increasing popularity of outsourcing, it is the underlying coordination, integration and visibility that is most critical to how well any product is designed.
It is difficult, if not impossible, to manage the TPLC using disconnected and unstructured systems and processes, as shown in Figure 5 on page 119. Without an integrated system that can be accessed from anywhere in the world (that is, web-based), a design engineer will face a tremendous challenge in determining the impact that an engineering change may have on other components, assemblies or sub-assemblies.
A better solution is to work within an integrated, closed-loop product development and quality system. With the complexity of today’s products, and with the rise of outsourcing, PLM systems and the management of data and knowledge are critical to medical device manufacturing.
With the current move away from “testing quality into products” to a more proactive strategy of “designing quality into products and processes,” the ability to control the TPLC process has become a critical factor to ensuring product quality. An integrated Product Development/QMS system—as represented in Figure 6 on page 119—provides a solid foundation to achieving this goal.
The rapid pace of advancement in medical technology, coupled with intense financial and competitive pressures, has thrust product innovation to the very forefront of competitive advantage. As a result, medical device manufacturers are faced with a new set of challenges associated with developing increasingly complex products, while working with antiquated processes and facing intensely competitive markets.
By replacing disparate, standalone product development applications with a cohesive Product Development System, manufacturers can ensure that the right version of the product data is available to the right people at the right time.
This efficient and convenient storage of product information, coupled with the ease of its retrieval, and the ability to better manage changing information, are just a few of the advantages of an integrated platform for product development and quality.
To facilitate compliance, medical device manufacturers today need a truly closed-loop, integrated change control and quality management system, which will help ensure proper traceability between quality events and engineering activities such as engineering changes and risk assessments.
As the FDA increases its emphasis on a TPLC model, those medical device manufactures working within an integrated Product Life Cycle and Quality Management infrastructure will be able to meet even the strictest requirements for product development.
In addition, an integrated PLM/QMS framework enables organizations to take a proactive approach to product development, while facilitating transparent compliance with quality system and regulatory requirements.
This integrated framework will allow medical device manufacturers to meet tomorrow’s toughest business challenges while decreasing time to market, improving product performance and reducing compliance costs.
Daniel R. Matlis is the founder and president of Axendia Inc., an adviser to life-science executives on business, technology and regulatory issues. Matlis’ 18-year experience in the life-sciences industry has included projects in research and development, manufacturing, regulatory compliance, business development and information technology. Prior to founding Axendia, Matlis was vice president and general manager at Stelex Inc., a leading consultancy to life-science companies. He started his professional career at a Johnson & Johnson’s Ethicon Company. There, he was the technical owner for computer integrated manufacturing, automation and IT engineering standards and computer system validation and compliance. Matlis holds degrees from Polytechnic University (B.S. in Electrical Engineering) and New Jersey Institute of Technology (M.S. in Management.) Matlis is the chief contributor and editor of Life-Science Panorama, a publication covering business, regulatory and technology issues facing industry executives. David Rubin is director of vertical market strategy for the medical device industry for PTC in Needham, Mass., where he is responsible for ensuring that current and future product releases address the needs of the life-science community. Prior to joining PTC, Rubin served as a worldwide group product manager and program manager at Millipore Corporation in Billerica, Mass., where he was responsible for all TFF products used for protein purification and concentration in the pharmaceutical and biotech industries. Prior to this, Rubin served nearly 10 years as vice president-general manager of the Separations Technology Division of ACS Industries in Houston, Texas, a design and manufacturing company that supplied separation equipment to the chemical processing industry. Rubin is a member of PMI and AAMI, and is a certified associate in Project Management. He graduated with distinction from Worcester Polytechnic Institute with a BSChE and has completed post-graduate courses in business administration.
Methods for Choosing Parts
Consider a scenario in which a design engineer is tasked with changing a part to improve performance, add functionality or reduce cost. Upon accessing the part from the global repository, the engineer can view a complete history of all changes, nonconformances, complaints and corrective and preventative actions (CAPAs) associated with the part—in the true spirit of TPLC (See Figure 8). No doubt, the new design is sure to incorporate lessons learned throughout the part’s life, thus helping to reduce risk of failure and/or to improve performance.
Implementing Total Product Life Cycle
To reap the benefits of TPLC, device manufacturers must implement an integrated PLM and QMS solution. This technology framework enables organizations to bridge rigid process structures and to connect dispersed functional areas into highly efficient, fully integrated teams.
Real-world scenarios benefiting from integrated PLM/ QMS solutions:
1. Product manager creating design inputs. The product manager, responsible for creating design inputs for a product-line extension, is able to produce a report from the QMS that lists all the customer feedback along with all the product trends to be considered as future design inputs. With this information, the product manager can create a more complete and practical set of requirements.
2. Development engineer designing next generation device. In addition to reviewing design inputs from product management, the engineer must review previously identified complaints, nonconformances and CAPAs attributed to the current product in order to improve quality and performance in the new product. Here, the engineer is able to access results of postmarket studies, which contain important input from end users.
3. Quality engineer requesting change. In this scenario, a CAPA has been created in response to a series of nonconformances and complaints. Instead of being forced to “open the loop” and transfer information regarding a required change to a co-worker who in turns will initiate a change request, the quality engineer can initiate the change request directly from the CAPA system, ensuring the request is made accurately and in a timely manner.
4. Manufacturing engineer issues ECN. When the change control process is complete, the ECN number can automatically be added to the CAPA record, thus ensuring complete, end-to-end traceability.
5. Supplier quality engineer conducts impact assessment. Upon receipt of a nonconformance describing an out-of-specification situation for a raw material, the supplier quality engineer can immediately run a “where-used” report directly from the QMS system to quickly assess the impact of the nonconformance and determine if raw materials, WIP or finished goods must be quarantined. Additionally, the engineer can assess the impact on current design control projects, as encouraged in the TPLC model.
6. Complaints manager conducts impact assessment. Upon receipt of a complaint, the complaints manager searches the product information stored in PLM directly from the QMS system to determine both the effectivity of the particular design, as well as a complete change history for the item.
7. EVP quality, clinical and regulatory ensures appropriate regulatory reporting of product adverse events. Knowing when and what to report to regulatory authorities is often a challenge. An integrated product development, quality and study management system uses decision trees—in conjunction with sophisticated monitoring, tracking and trending algorithms—to ensure accurate and timely regulatory reporting.
8. IT director reduces efforts supporting multiple, disparate systems. A vendor-supported, integrated product development, study and QMS relieves the IT department’s burden of creating, supporting and maintaining expensive custom integrations.