How can you engineer medical devices to improve patient safety?

Patient safety is a crucial aspect of medical device engineering, as any malfunction, error, or defect can have serious consequences for the users and the providers. As a sales engineer, you need to understand how to engineer medical devices that meet the highest standards of quality, reliability, and usability, and how to communicate their value to your prospects and customers. In this article, we will explore some of the key factors and methods that can help you engineer medical devices to improve patient safety.

1 Define the user needs and requirements

The first step to engineer medical devices that improve patient safety is to define the user needs and requirements clearly and comprehensively. You need to identify who will use the device, how they will use it, what problem it will solve, what benefits it will provide, and what risks it will pose. You also need to consider the regulatory, ethical, and legal aspects of the device, and how it will comply with the relevant standards and guidelines. You can use various tools and techniques, such as interviews, surveys, observations, focus groups, and personas, to gather and analyze the user needs and requirements.

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Ron van Oudenallen

Manager of Operations and Technology & PRRC
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Before you start, make sure you have a clear picture of the clinical needs and market. Define an intended purpose. Step 3 should be the first step in my opinion. When setting up requirements, assess regulatory requirements and standards too. Perform risk management and add risk controls to the requirements.

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Erika Coburn

SPD Manager bei Complete Surgery Mesquite
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Find out if the devices can be used and do you have a market for it. I'm speaking Instruments, cleaning products for sterile processing. Ask the people that work in the field

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2 Design the device with safety in mind

The next step is to design the device with safety in mind, using the user needs and requirements as the basis. You need to apply the principles of human factors engineering, which is the science of designing products that fit the capabilities and limitations of the human users. You need to consider how the device will interact with the user, the environment, and other devices, and how to minimize the potential for errors, misuse, or harm. You need to use design methods, such as prototyping, testing, simulation, and verification, to evaluate and improve the device's safety features and performance.

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Ron van Oudenallen

Manager of Operations and Technology & PRRC
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Involve all (future) stakeholders in the design process. Including manufacturing in an early stage. Assess your competitors.

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Erika Coburn

SPD Manager bei Complete Surgery Mesquite
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Design a device that it is easy to use, easy to clean and easy to sterilize. Keep the end user in mind when creating anything.

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3 Implement a quality management system

The third step is to implement a quality management system (QMS) that ensures the device's safety throughout its lifecycle. A QMS is a set of policies, procedures, and processes that control how the device is planned, developed, manufactured, distributed, maintained, and disposed of. A QMS helps you to monitor and measure the device's quality, identify and correct any defects or deviations, prevent and mitigate any adverse events, and comply with the regulatory requirements. You need to use quality tools and techniques, such as audits, inspections, reviews, feedback, and documentation, to implement and maintain a QMS.

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Erika Coburn

SPD Manager bei Complete Surgery Mesquite
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Devices used for medical use should not only consider patient safety but also people working in Sterile Processing. It is of he utmost importance that devices are designed to so techs in Sterile Processing can clean the device accurately and with not a lot of steps. Sterile Processing is very busy any given day and a lot of times to turn over sets is time sensitive therefore the devices should be designed to make it easy for cleaning. A lot of times these steps are overlooked. If new sets are designed, they cannot weigh more than 25 found including the tray, Sterilization perimeter should be either 4-minute sterilization time and 20-minute dry time or 4-minute sterilization time and 30-minute dry time. This is also overlooked at times.

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4 Educate and train the users and stakeholders

The fourth step is to educate and train the users and stakeholders on how to use the device safely and effectively. You need to provide clear and concise instructions, manuals, labels, and warnings that explain the device's features, functions, limitations, and precautions. You also need to provide hands-on training, demonstrations, and support that enable the users and stakeholders to operate, troubleshoot, and maintain the device. You need to use communication skills and methods, such as listening, questioning, explaining, and demonstrating, to educate and train the users and stakeholders.

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Erika Coburn

SPD Manager bei Complete Surgery Mesquite
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Education is the key; any device should come with Instruction for use. Material on the device should be easy to find on the Manufacturing website.

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5 Collect and analyze the feedback and data

The final step is to collect and analyze the feedback and data from the users and stakeholders on the device's safety and performance. You need to solicit and respond to the feedback and data, such as complaints, suggestions, testimonials, and evaluations, that reflect the user's satisfaction, expectations, and outcomes. You also need to analyze and report the data, such as incidents, errors, malfunctions, and failures, that indicate the device's reliability, usability, and risk. You need to use feedback and data collection and analysis tools and techniques, such as surveys, interviews, observations, statistics, and root cause analysis, to collect and analyze the feedback and data.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How can you engineer medical devices to improve patient safety?

1

2

3

4

5

6

1 Define the user needs and requirements

2 Design the device with safety in mind

3 Implement a quality management system

4 Educate and train the users and stakeholders

5 Collect and analyze the feedback and data

6 Here’s what else to consider

Sales Engineering

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How can you engineer medical devices to improve patient safety?

1

2

3

4

5

6

1 Define the user needs and requirements

2 Design the device with safety in mind

3 Implement a quality management system

4 Educate and train the users and stakeholders

5 Collect and analyze the feedback and data

6 Here’s what else to consider

Sales Engineering

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