No FDA Guidance or Specific Regulation but Don’t Overlook the Criticality of Product Life Cycle in Medical Device Design Control

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Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

After a discussion of the short FDA CFR 21 Part 820 Quality System Sec. 820.30 and Sec. 820.40 on Design Control, even with the expanded FDA ‘Design Control Guidance For Medical Device Manufacturers’, there is not any mention of controlling the device lifecycle as part of the design controls. With the high degree of findings in the Design Control regulation, an important piece not discussed is the state or status of a product and definitions surrounding the Life Cycle of products. An important distinction and critical element of any Design Control fully defining a Product Life Cycle (PLC) and assigning stages of a product through a design process supplies a critical element in any general product management and can play a critical role in Medical Device audit and FDA Design Control compliance. Development of a Product Life Cycle (PLC) along with a solid Product Development Process (PDP), a topic for a later discussion, provide the provide the necessary corner stones for a complete Design Control and Device Management compliance. In this article we’ll explore the basics of a PLC to provide the basics, each manufacturing and development environment may need to adjust the model to meet the needs of the given environment but meshing the PLC with a solid PDP that align and complement each other provide a very solid Design Control base platform.

General Cradle to Grave Product Lifecycle

A simplistic product lifecycle has some very basic phases of life: research, development, production and end of life. These can certainly be expanded as needed by a specific device design & manufacturing complexity, or simplicity for that matter, as well as device class, category and classification. There can be sub-phases in the product development (prototype, engineering build, alpha, beta, archived, etc., level of product status, for example) but the main concern is to define the lifecycle that best meets the overall objective while being able to track the various product and versions of product in development, in the marketing place and archived after manufacture discontinuance (still have to support those products in the market place even though the selling cycle has ended).

The diagram below provides the basic PLC model and a generalized flow of life. A good deal of the life cycle flow should be overlaid with a device development process so while the PLC is discussed here remember that both the PLC and PDP for a given manufacturing environment should be developed in conjunction so that the two mesh well and complement each other as part of the total design control of devices.

Source: Expandable Software

Source: Expandable Software

As a Product Manager each of these phases of a product are of concern. The FDA defines some flexibility is design control as to when those controls should engage somewhere in the gray area between Research and Development mainly in an attempt to loosen up compliance a bit to help encourage research of new technologies and device for the medical industry. While the FDA being somewhat flexible in the front end research, for a Product Manager managing products even in the research phase needs some definition to help define when technology can be developed for the market place and further defined as viable for the business, market and developed into a marketable device. With the remaining PLC, the FDA will certainly want solid design controls and tracking of the device history from development through to product end-of-life (EOL) although for all purposes the EOL of products doesn’t mean that they disappear, rather they are product designs that gets archived for any reason that they might need to be revisited for support of product in the market. Here again the other end of the PLC spectrum may have deeper EOL process depending on the device(s) a manufacture is delivering to the market and how those devices live beyond the final sales.

Key points to consider in the development of a specific product life cycle (PLC) are:

  1. General enough to apply to finished product as well as supply chain components
  2. Define a solid definition between a research phase and development phase that will meet the definitions of controls for a particular product. Note: the FDA can be a bit more flexible with the research phase as far as hard and fast design documentation but best to make sure there is a clear distinction and definition built into a PLC and PDP and assure adequate regulatory coverage
  3. Perform a clear and clean hand off between Development and Production with all associated documentation approved and release. Be sure there is a process built into the PLC to review current product for meeting needs (both marketing and business) and allow for adjustments/changes as the product traverses it lifecycle
  4. Design a process around the End-Of-Life of a product both from a business perspective (not to strand any inventory, leave customers without solutions, etc.) but also from a regulatory perspective in that no product really “ends” – it rather gets archived and stored so that design history is retrievable (very much like Levi’s…they “never die they just fade away” but the history must endure). Note: although the general case of the PDP provided in previous sections has been focused primarily on the R&D and production phases of this PLC, the EOL Process is equally important to define and put in place so that product is properly archived for future reference, retrieval and audit compliance.

This short article can never do full justice to defining a full Product Life Cycle (PLC), there have likely been many books written on the topic, but the key point here is that there is not a whole lot of FDA regulation or guidance for Design Control that discuss PLC. A basic product management tool like a well-defined PLC can play a huge role in compliance to Medical Device Design Control and overlaid with a well-defined Product Development Process can help avoid design control issues, FDA finding or even worse warning letters or other punitive action. From a Product Managers perspective the earlier in the startup device manufacture and earlier in the product life that these principles can be applied the better managed the overall product can be managed both from a compliance perspective and from a business perspective. Regardless of the FDA compliance managing the product from a business perspective can pay big dividends in determinate time to market when managing the PLC married to a well-defined and practiced PDP. These PLC and PDP topics along with a perspective of FDA Design Control normalization and enterprise tools that manage the process and can accelerate time to market are discuss together in an Expandable Software white paper: “Quality System for Startup Medtech Companies: Design & Documentation Controls”.

Get the full detailed White Paper here.

About the Author

Dennis Payton is executive director of product marketing with Expandable Software Inc. He has 23 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

 

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No FDA Guidance or Specific Regulation but Don’t Overlook the Criticality of Product Life Cycle in Medical Device Design Control
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No FDA Guidance or Specific Regulation but Don’t Overlook the Criticality of Product Life Cycle in Medical Device Design Control
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After a discussion of the short FDA CFR 21 Part 820 Quality System Sec. 820.30 and Sec. 820.40 on Design Control, even with the expanded FDA ‘Design Control Guidance For Medical Device Manufacturers’, there is not any mention of controlling the device lifecycle as part of the design controls.
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AssurX
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