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Last updated on 2024年7月23日

How do you design safe and high-performing biomedical devices?

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Biomedical devices are electronic systems that interact with the human body for diagnosis, treatment, or research purposes. They range from simple sensors to complex implants and prosthetics. Designing safe and high-performing biomedical devices requires a combination of electrical engineering skills and knowledge of biological and medical aspects. In this article, you will learn some of the key steps and challenges involved in biomedical device design.

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Charu P.

Electrical and Electronics Engineer | Software Engineer

1 Define the problem

The first step in designing a biomedical device is to define the problem that the device aims to solve or address. This involves identifying the target users, their needs and expectations, the clinical or research context, and the relevant regulations and standards. You also need to consider the feasibility, cost, and market potential of the device. A clear problem definition helps you to set the goals and specifications of the device and to evaluate its performance and impact.

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Sheng Qiu (Wendy) Liu

Senior Marine Electrical Design Engineer, P.E.
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I think accuracy is an important parameter in designing biomedical device. Factors such as temperature and humidity Iin application environment could affect accuracy and result in decreased performance of the device.

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2 Understand the interface

The second step in designing a biomedical device is to understand the interface between the device and the human body. This involves studying the anatomy, physiology, and pathology of the relevant body part or system, as well as the biocompatibility, bioelectricity, and biosignals of the device. You need to ensure that the device does not harm or interfere with the normal functioning of the body, and that it can reliably measure or deliver the desired signals or stimuli. You also need to account for the variability, noise, and artifacts that may affect the interface.

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3 Select the components

The third step in designing a biomedical device is to select the components that make up the device. This involves choosing the appropriate sensors, actuators, power sources, circuits, microcontrollers, communication modules, and software for the device. You need to balance the trade-offs between performance, size, weight, power consumption, durability, and safety of the components. You also need to test and verify the functionality and compatibility of the components and their integration.

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4 Design the system

The fourth step in designing a biomedical device is to design the system that controls and coordinates the components of the device. This involves developing the algorithms, protocols, and interfaces that enable the device to perform its intended tasks and to communicate with other devices or systems. You need to ensure that the system is robust, reliable, secure, and user-friendly. You also need to optimize the system for speed, accuracy, efficiency, and scalability.

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5 Evaluate the device

The fifth step in designing a biomedical device is to evaluate the device in terms of its safety and performance. This involves conducting preclinical and clinical trials, simulations, and validations to assess the device's functionality, usability, effectiveness, and impact. You need to follow the ethical and regulatory guidelines and standards for testing and reporting the device. You also need to collect and analyze the data and feedback from the device and its users.

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6 Improve the device

The sixth step in designing a biomedical device is to improve the device based on the evaluation results and feedback. This involves identifying and addressing the issues, limitations, and opportunities for enhancement of the device. You need to implement and test the changes and improvements in the device and its components and system. You also need to update and document the device's specifications, features, and functions.

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7 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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Charu P.

Electrical and Electronics Engineer | Software Engineer
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Designing safe and high-performing biomedical devices begins with defining the problem comprehensively. Beyond the predefined steps, it's crucial to consider ethical implications, patient privacy, ensure user-friendly interfaces and prioritize user feedback. Rigorous testing and continual improvement helps to focus on sustainability and adaptability in the evolving medical practices. Working closely with medical experts and regulatory agencies ensures that biomedical devices are effective and safe and also help to meet the needs and expectations of patients and healthcare personnel.

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Karina Vieira

Engenheira clínica na SESPA- Secretaria de Estado de Saúde do Pará | Mestrado em Engenharia Elétrica
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Projetar dispositivos biomédicos seguros e de alto desempenho é fundamentalmente guiado por diversas áreas, s?o exemplos: normas rigorosas e a experiência de usuário. As normas, como as especifica??es ISO e as diretrizes da FDA, estabelecem os padr?es de seguran?a e eficácia que devem ser seguidos desde a concep??o até a produ??o. Essas regulamenta??es garantem que os dispositivos atendam aos requisitos essenciais de qualidade e seguran?a. Além disso, a experiência do usuário desempenha um papel crucial na aceita??o e eficácia do dispositivo. Incorporar feedbacks dos usuários desde as fases iniciais do design até o lan?amento final permite ajustes contínuos que melhoram a usabilidade, a ergonomia e a eficiência dos dispositivos.

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How do you design safe and high-performing biomedical devices?

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3

4

5

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1 Define the problem

2 Understand the interface

3 Select the components

4 Design the system

5 Evaluate the device

6 Improve the device

7 Here’s what else to consider

Electrical Engineering

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How do you design safe and high-performing biomedical devices?

1

2

3

4

5

6

7

1 Define the problem

2 Understand the interface

3 Select the components

4 Design the system

5 Evaluate the device

6 Improve the device

7 Here’s what else to consider

Electrical Engineering

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