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Is Your Medical Device Manufacturing Process Safe & Secure?


As medical products increasingly become a part of the daily lives of patients and consumers, ensuring the growth of the medical device market is continuing to be a core focus for companies developing advanced technologies across many areas of healthcare. Innovative medical product development necessitates efficient and robust risk management coupled with effective safety management procedures that can help mitigate potential risks associated with using these devices.

Medical device manufacturers and developers must integrate risk management processes into their design, development, and post-commercialization efforts to pass regulatory scrutiny and demonstrate that their products do not compromise public health or trust. Medical device developers will continue to be required to improve manufacturing processes and design robust quality systems in the coming years as regulatory bodies worldwide enact stricter guidelines for product approval and mandate increasingly rigorous testing for increases in adverse events.

Medical device product recalls, fines for data breaches and adverse media coverage are the signs of an unsafe and insecure manufacturing process. Below are ways to improve medical device manufacturing processes to ensure safe and effective use of medical devices for patients and users.

1. Conduct a risk analysis of your medical device manufacturing process that includes identifying hazards, estimating risks, and assessing controls in place.

A hazard can be any activity or condition in your manufacturing environment or process that can cause injury, illness or damage. Estimate the severity of each risk and the probability (frequency) of its occurrence. Severity is defined as how intense the harm can be, whereas probability refers to how often harm occurs. Identify controls that may eliminate or reduce the identified hazards, and assess the adequacy of control measures already in place. Document all relevant information relating to your risk management plan, including identifying and evaluating risks, the rationale for selecting controls, and results/outcomes from monitoring.

2.Conduct validation of your quality management system, including all applicable processes, procedures, and methods to ensure product quality. The test plan should include, as a minimum:

  • Data integrity/security requirements and testing
  • Results from ongoing monitoring
  • Data from calibration and maintenance of equipment
  • Define how out-of-specification results will be handled
  • Documentation of process validations for critical processes

3.Incorporate appropriate acceptance criteria into your quality management system, including acceptance criteria for procurement activities, production process control, incoming inspection activities and final inspection/test activities.

The FDA defines acceptance criteria as “the characteristics of a product or process that must be met for the product or process to be accepted.” Acceptance criteria should be based on the results of the design input requirements and design outputs and should include specifications for safety and effectiveness.

Consider implementing a process that ensures that you are notified of any changes to the raw materials or services used in the manufacturing process prior to their use. This can help identify issues with a supplier’s processes before impacting your devices. Take steps to ensure that your quality management system effectively identifies and addresses any deficiencies in the manufacturing process.

Establish a system to collect and analyze data from all stages of the manufacturing process and the finished product. This will enable you to identify problems in real-time and take corrective action before the problem spreads.

4.Adopt a state-of-the-art approach to design validation and verification testing (e.g., incorporating computer modeling into verification testing) to ensure device performance over time.

CM technology does this by combining computer models with actual physical device testing, enabling the manufacturer to access real-time data from various aspects of device performance. CM technology includes computerized modeling, advanced sensing techniques, signal processing algorithms, control methods, and data acquisition systems.

Another way CM technology can reduce product development time is through its ability to create virtual prototypes of a medical device. This cuts down on the number of different physical prototypes that need to be made during the development process by allowing manufacturers to conduct several tests on one virtual prototype.

5.Implement an appropriate change control program for your medical device manufacturing processes

A change control process is a system that enables project managers to manage change requests effectively and justify or reject these changes. This is because any difference between the original design and the final product could mean severe health risks for the end-users of your products.

As with any aspect of medical device manufacturing, documentation is critical for effective change control. A standard operating procedure (SOP) should be established to outline the steps in the process clearly:

  • identification of the need for change
  • evaluation of the risk associated with implementing or not implementing the change
  • development and implementation of a plan for addressing issues related to manufacturing, regulatory compliance, training, personnel requirements and more
  • verification that actions were taken as planned
  • communication of results
  • review by management

Outsourcing Your Medical Device Manufacturing

Once you have decided that your new device is a good idea, the next step is to determine if it will be manufactured in-house or if it will be outsourced. Consider the advantages and disadvantages of each approach.

In-house manufacturing may seem expensive, but it can yield significant savings in time and money. The biggest advantage is ensuring that your product meets all applicable regulatory requirements before the product is distributed. You will also be able to make sure that your production process is reliable and repeatable to scale up as needed quickly.

Outsourcing medical device manufacturing means hiring experts who know their way around the medical device industry. Outsourcing may also lead to lower costs than in-house manufacturing, but it could also mean fewer quality assurances. A turnkey contract manufacturer will have an established process for creating prototypes and will be able to handle FDA testing, which may not be an option in-house.

The Bottom Line

Risk management is a crucial part of any medical device manufacturer’s workflow. It is an ongoing activity, not something that you only do once at the beginning of your process, so you must keep track of what risks surfaced while you were developing your medical device and how they were resolved. It allows companies to minimize their liability and avoid running afoul of costly regulation. Additionally, each new employee who will be working on your device needs to be trained on the plan and the documentation. These actions help ensure that your company stays safe and secure as it manufactures devices for patients, users and third parties.

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