Combination Products and RM: Human Factors Approach

Combination Products and RM: Human Factors Approach

Combination products are medical products that combine drugs, devices, or biological products to achieve a therapeutic effect. These can be challenging to develop and manufacture due to the complexity of the product and the regulatory requirements. One important aspect of combination products is the human factors considerations in their design, development, and use. Human factors engineering aims to optimize the interaction between humans and technology by considering the user’s needs, abilities, and limitations. Human factors play a vital role in designing and developing combination products. Incorporating risk management ensures safe and effective use.

Key Points about Combination Products

Combination products are a growing field in the medical industry that combine different types of medical products to provide more effective and efficient treatments. Here are some key points to know about combination product:

  • Combination products combine two or more different types of medical products, such as drugs, devices, or biological products, to achieve a therapeutic effect.
  • Combination products can offer advantages such as targeted drug delivery, increased patient adherence, and improved therapeutic outcomes.
  • The FDA regulates combination product and has established guidelines and regulations to ensure their safety and effectiveness.
  • Combination product have gained significant attention in recent years due to their potential benefits in providing more effective and efficient treatments for various medical conditions.

Examples of combination products include drug-eluting stents, inhalers, and insulin pens.

Human Factors Approach in Combination Product Design

The importance of human factors engineering in the design and development of combination products.

  • Human factors engineering aims to ensure that the device is safe, effective, and easy to use by the intended user population.
  • Usability testing is an important aspect of human factors engineering that involves evaluating the device’s performance in a simulated or actual use environment.
  • Identifying any design issues impacting device use, usability testing uses surveys, observations, and interviews.
  • The consideration of user instructions and labeling is also crucial in human factors engineering.
  • Clear and concise instructions and labeling are important for the safe and effective use of the device.
  • Instructions should be written in a way that is easy to understand by the intended user population, and labeling should be prominently displayed on the device.

Risk Management for Combination Products

Risk management is an essential component of the development and use of combination products. Here are some important aspects of risk management:

Identification of Hazards

  • Various methods, such as hazard analysis, FMEA, and FTA, identify hazards.
  • The identified hazards should be evaluated to determine their severity and likelihood of occurrence.

Evaluation of Risks

  • Once the hazards have been identified and evaluated, the risks associated with the device’s use should be evaluated.
  • The evaluation should consider the device’s intended use, user population, and potential risks associated with the device’s use.

Implementation of Risk Control Measures

  • Implement risk control measures to mitigate device use risks.
  • The risk control measures should be designed to reduce the likelihood or severity of harm associated with the device’s use.

Examples of risk control measures include design changes, labeling updates, and training programs.

Continual Assessment of Risks

Effective risk management is a key component of the regulatory process for combination products. Manufacturers must identify potential hazards and evaluate associated risks, as well as implement risk control measures to mitigate those risks. Continuous risk assessment throughout the product lifecycle is also necessary to ensure that the product remains safe and effective over time. By adopting a comprehensive risk management approach, manufacturers can minimize the likelihood of adverse events and ensure that their combination products meet the high safety and efficacy standards required by regulatory bodies. Ultimately, this can improve patient outcomes and drive innovation in the development of new combination product.

  • The device’s use risks require continual assessment throughout the product lifecycle.
  • As new information emerges, update the risk assessment. And adjust risk control measures as needed.


In addition to incorporating a human factors approach, the development of combination product also requires close collaboration between the different regulatory agencies responsible for drug, device, and biological product approvals. This coordination ensures that combination products meet the necessary regulatory requirements for each component of the product. Combination products may also require unique manufacturing processes and quality control procedures to ensure the safety and efficacy of the final product. Combination product are increasingly common in medicine. They can treat complex conditions effectively. Technology and medical knowledge will continue to advance. Developing combination products will improve patient outcomes and quality of life.