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Design Controls: A 17-Year Learning Curve

Remember that a quality management system that has been implemented effectively, monitored to identify and address existing and potential problems, and has an integrated risk management process utilizing risk-based decision-making is more likely to produce medical devices that function as intended. 

Note: The documentation and control of changes begins when the initial design inputs are approved, and continues for the life of the product. Design change control applies to changes to inputs or outputs as a result of design verification or design validation, changes to labeling or packaging, changes to enhance a product’s performance, changes of production process(es) and changes that result from the analysis of quality data. Change can be acceptable as long as it is controlled.

To just have data is not good enough. Effectively using the data is paramount.
The appropriate sources of quality data must be identified for input into the design controls process at all stages of this life-cycle approach, including customer complaints, feedback, service records, returned product, internal and external audit findings, adverse events, data from the monitoring of products, processes, nonconforming products and suppliers. Data derived from your competition is always understated but so very important (as you compare the issues versus your own devices). It is imperative that you confirm that data from these sources are accurate and analyzed using valid statistical methods to identify existing and potential product and quality management system nonconformities that may require redesign. As a manufacturer, you must make effective arrangements for gaining experience from the post-production phase.

Utilize information from the analysis of production and postproduction quality data to amend the analysis of product and process risk, as appropriate. You may choose to enact new or more stringent controls to maintain an acceptable level of product and process risk.

Some other sources of quality data that may be useful in identifying potential problems are acceptance activities, such as component, in-process or finished device testing; environmental monitoring and statistical process control (SPC). Results of acceptance activities may indicate an unfavorable trend that left unattended may result in product nonconformity. 

The requirements for delivery, installation and servicing of a particular device should have already been evaluated and addressed by the organization during design and development and planning for product realization. If risk control measures were identified involving the delivery, installation and servicing for a particular device, you must confirm in continuum that the necessary processes have been implemented to ensure the risk control measures are in place. As related, multi-use medical devices are becoming more important from a costing standpoint in the operating room. Service reports can be an important source of quality data for input into the organization’s design process. When necessary, you must confirm that data regarding service reports is analyzed for possible corrective action/preventive action and design changes. Service reports must also be analyzed to determine if the service event represents an adverse event that is reportable to regulatory authorities. Measured trends in this area of medical device reporting show that in the majority of cases the design is suspect. 

Verify that design and development changes were controlled, verified (or where appropriate validated), and approved prior to design change have been identified and mitigated to the greatest extent practical. 

Human Factors: Yes, design controls are all about safety and effectiveness for human use.
You must establish and maintain a continuous process of risk management that covers the entire life cycle of the product. Possible hazards must be identified in both normal and fault conditions, including those arising from human factors issues. Your design process must have procedures in place to determine how much risk is acceptable. Determining an acceptable level of risk depends upon the intended use of the device, including the particular health concern of the patient population, the training of the users involved and the use environment.

Design validation must address the needs of all appropriate parties, such as the patient, healthcare worker, biomedical engineer and storage clerk. Consideration must be given to the environment in which the device will be stored, transported and used. Design validation needs to be performed for each intended use. Design validation must also confirm that user needs and intended uses associated with the device’s packaging and labeling are met. These outputs have human factor implications, and unless they are adequately considered during design validation, they may adversely affect the device and its use. Confirm that design validation data show that the approved design met the predetermined user needs and intended uses. The intended uses must include the purpose of the device, patient type (adult, pediatric or newborn) and the environment in which the device is to be transported and used (domestic use, hospitals, ambulances, etc.).

Where are we going? We’re going to continue to get better.
The planning exercise and execution of the plans is complex because of the many areas and activities that should be covered, but are not covered during the urgency to get the device to market.

Risks cannot always be removed from medical devices, but they should be known and controlled to the extent feasible with existing technology. There are human factor and validation process techniques that can be used in developing a risk analysis.

All risk evaluation results should be reviewed by manufacturing, as well as product development personnel who compare these results with specifications, including safety and performance standards, to make certain that the desired level of essential quality has been designed into the device.

The appropriate design of manufacturing processes, including validation where appropriate, is needed to assure that production can achieve the level of quality designed into the device. As mentioned earlier, if there is one over-arching, negative aspect of this QS Regulation in relation to design over the past 16 years, it’s that companies fail to link Part 820.30 with the rest of Part 820. They manage design controls separately, rather than incorporating the inter-relational architecture into the grand scheme of the whole QS Regulation.

We should be going in the direction that joins the design and manufacturing effort together on a daily basis to assure that process controls actually work, and that medical devices are safe and effective for human use. 

John Gagliardi has had success over the past 43 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. John can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC


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