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Quality By Design, Total Product Life Cycle, and Seven Ways to Improve Design Controls for an FDA Inspection
by Lori Carr, Regulatory Consultant


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With the unsteady economy and the ever-changing regulatory world that we find ourselves in, strong design controls within the medical device and biotech industries are a necessity. When faced with a multi-million dollar recall, no medical device company wants to wish it had instituted more robust design controls. Therefore, having a solid design control system is a must in the world in which we live.

Medical device designs are viewed in this industry as a pipeline of innovation and offer room for continual design improvements.

Quality by Design

Quality by Design (QbD) provides a medical technology company with an enhanced understanding of product quality and a strong basis for risk management. With the increased regulatory flexibility that FDA has been showing in the past several years, this facilitates design of products and processes that maximize the product's efficacy and safety profile. Additionally, using QbD may also enhance product manufacturability. The fundamental approach to QbD understands the relationship between the quality attributes of the product and their impact on the safety and efficacy of the device.

By instituting QbD within the design control area potential impacts may include a flexible regulatory process which may be applicable, the offering for timely manufacturing process improvements, and a high mitigation of risk.

TOTAL PRODUCT LIFECYCLE: All new medical devices start out in the concept phase. Questions which are asked typically include:

  • What is the device intended to do?
  • Does it meet the FDA definition of a medical device?
  • Is it a pharmaceutical or a biologic?

Increasingly, new product launches have become combination products. In order to facilitate any FDA issues, the question needs to be answered in relation to what makes the product different or new to the marketplace: are the indications for use going to be new to clinical applications? There may be older features of the new product that have already undergone an FDA regulatory submission. The onus on the developers is to ensure a safe and effective device design via reasonable controls within the critical performance specifications.

If a new material is to be evaluated, there may be standards from international organizations or from FDA that deal with specific biomaterials or provide a model for the evaluation of a new material.

FDA's policy has historically been to provide medical device companies with the least burdensome path to market for both PMAs and 510(k)s. As medical device designs approach marketing, the specifications of manufacturing become more important during the course of the design project. The total product cycle components overlap and interconnect. Medical devices are "multigenerational." Information is gathered from one part of the life cycle and may be applied to the redesign of a next generation. Many types of medical devices have very short life spans on the market and are replaced by the next version of the device which may offer enhanced functionality, improved user interface, faster response time, etc. Medical device designs are viewed in this industry as a pipeline of innovation and offer room for continual design improvements. The sheer nature of this ever-changing design environment provides a backdrop of a very different regulatory challenge aside from regulating a pharmaceutical with a long patent life and very few, if any, changes to the original formulation.

FDA (QSIT) DESIGN CONTROLS PERSPECTIVE: Why are medical device companies interested in design controls? Simple. Within the FDA QSIT Guide, there are specific references to the purpose and importance of Design Controls. Additionally, objectives, flow chart, and narratives for Investigators are included within the QSIT Guide. Who is ultimately in the middle? Management is. Design Controls are one spoke of the wheel with Management in the center. The other spokes of the Regulatory QSIT wheel are CAPA, P&PC, Material Controls, Equipment/Facility Controls, and Records/Documents/Change Controls.




FDA looks for specific design control responsibilities to address all aspects of the project. Typically, these responsibilities include Marketing and Sales Departments to conduct market research to establish user needs. Engineering is responsible for implementation of design controls and all employees, within multiple levels of the company, are involved in developing new products or modifying existing products.

A Design History File (DHF) is created and maintained for each new development project and describes the design history of the finished device. The DHF demonstrates that the device was developed in accordance with the design plan, requirements, and the established Design Control Standard Operating Procedure. The DHF may be modified to meet the needs of the development project.

Seven Ways to Improve Design Controls for FDA Inspection

There are several things that medical device companies can do in order to improve design control documentation presentation for FDA during inspections. Listed below is a summary of some things that will help a company to better comply with the design control regulations.

  1. Establish a Design Team within the Design Plan. This will allow the FDA Investigator to know, up front, the individuals who are to participate within aspects of the design project. These individuals should actively participate throughout the design project.

  2. Ensure that Design Team participants are included in all applicable design reviews. Since these individuals have been identified as integral parts of the design project, the FDA Investigator will look for documentation to support their involvement in both Design Reviews at specified phases and throughout the design project in milestones.

  3. Establish an Input/Output Matrix to outline and summarize verification and validation activities. This I/O Matrix will allow the FDA Investigator to be able to easily navigate through the DHF in order to determine that the outputs have, in fact, met the inputs. The I/O Matrix will act as a road map to be able to clearly see the applicable design verification and validation activities associated with inputs and outputs.

  4. Close the loop on all open and ambiguous action items. This includes all design input, output, verification, and validation activities. FDA Investigators will review the DHF in order to ensure that all open action items have been resolved at the time of design transfer. Documentation needs to exist within the DHF to support the fact that these items have been addressed, acted upon, approved and closed. There need to be clear and understandable mechanisms in place to capture these activities.

  5. Conduct a Regulatory Evaluation on all new designs and changes to existing designs. This evaluation is to be clearly and thoroughly documented within the Design History File. There are guidance documents which exist to aid medical device companies in making these decisions. A flow chart is typically used by industry to document this decision. FDA Investigators will review the DHF in order to determine whether the company has been duly diligent related to any regulatory submission that may be necessary as a result of the design project.

  6. Ensure that all Engineers who have participated in any of the design control activities found within the DHFs are trained regarding applicable and established Design Control Procedures. FDA Investigators will determine whether or not all members of the Design Team have had adequate training in all applicable and established Design Control procedures associated with the design project on which they performed activities. This training is to be documented at the company and not within the DHF. Companies need to ensure that the training has been conducted related to the applicable revisions of the procedures.

  7. Document, document, document. After all, if it is not documented, then it has not been done, according to the FDA adage. Documentation omissions and errors account for the majority of design control issues that FDA Investigators note on FDA-483s. Not much credit is given to companies that have incomplete design control documentation within DHFs. Therefore, ensure that the documentation is complete, accurate, and understandable and an FDA-483 may be avoided.

In summation, by implementing Quality by Design, understanding the Total Product Lifecycle, and developing medical devices in accordance with the FDA Design Control regulations, a medical device company will be on the road to providing the American people with safe and effective products in this ever-changing technology arena.

Lori Carr has more than 14 years' experience in the medical device industry. As a Medical Device Specialist FDA Investigator in both the Cincinnati and Denver District Offices of FDA, she conducted international and domestic inspections of medical device facilities and trained FDA investigators in conducting medical device inspections. As an FDA regulatory compliance consultant, she performed numerous quality assurance audits for medical device companies. She has created and implemented quality systems and provided guidance on quality, regulatory, and compliance issues throughout the world. Her clients include companies that have received FDA Warning Letters, are under FDA injunction or have had product seized by FDA.

In her capacity as a Medical Device Specialist, she conducted numerous domestic and international inspections to ensure compliance with applicable FDA regulations including routine GMP, Pre-market (PMA), 510(k), and directed inspections from the Center of Devices and Radiological Health (CDRH) while working in both the FDA Denver and Cincinnati District Offices.

She can be reached at 720.981.9594, loriacarrinc@comcast.net or http://www.linkedin.com/in/loriacarrinc.


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FDA Link

Do It by Design: An Introduction to Human Factors, http://www.fda.gov/cdrh/humfac/doit.html

Additional Article

Rubin, David. "Integrating Quality and the Product Life Cycle into a Single System." MedicalDeviceLink.com, August 2007. Accessed 3-4-09. http://www.devicelink.com/mddi/archive/07/08/014.html