Medical Device Product Design

Medical product design is a stage in the lifecycle of the development of a medical device where the design is created taking various input factors into account.

What is Medical Product Design?

Medical product design is a stage in the lifecycle of the development of a medical device which focuses on the human factors, like aesthetics, functionality, ease-of-use, fitness for purpose, and quality.

The aim of the product design stage is to specify requirements for an effective medical device that addresses all feature specifications for the device’s intended use, all applicable compliance requirements (regulatory and standards) as well as addressing the device’s usability and any necessary risk mitigation.

Therefore, the designer creates requirements that take all of these factors into account. These requirements are gathered from various sources, e.g. asking customers directly, market research, academic research into relevant fields, domain knowledge, regulations, standards and best practices, and a bit of intuition/foresight. The output of this stage is a set of specifications which is used as the basis for determining how the device will be built such that it satisfies all the requirements in the product engineering stage.

How do you design a medical product?

You can design your medical product in-house (if you have the expertise) or you can partner with experts in medical product design and engineering, who can speed up your development time because they bring their experience from having developed other medical devices.

Medical Device Design Process

There are different types of design processes and we present the phases of three of the most common processes.

The 4-Step Design Process

The 4-step design process presents a workflow for how to solve a simple problem.

  1. Problem Definition

  2. Design Exploration

  3. Design Optimization

  4. Design Communication

The 8-Step Design Process

The 8-step design process presents a workflow to solve a general problem.

  1. Identify the problem

  2. Identify the criteria and constraints

  3. Brainstorm possible solutions

  4. Generate ideas

  5. Explore possibilities

  6. Select an approach

  7. Build a model or prototype

  8. Refine the design

The 12-Step Design Process

The 12-step design process presents a workflow to solve a more complex problem, such as that for designing a medical device.

  1. Define a problem

  2. Brainstorm

  3. Research and generate ideas

  4. Identify criteria and specify constraints

  5. Explore possibilities

  6. Select an approach

  7. Develop a design proposal

  8. Make a model or prototype

  9. Test and evaluate the design using specifications

  10. Refine the design

  11. Create or make a solution

  12. Communicate processes and results

At ArrowFast, we do not focus on a single design process because we understand that each medical device is unique. So, we choose the best methodology for your specific needs.

Who designs medical devices?

Medical devices are designed by medical device engineers and medical device engineering companies.

What does a medical device engineer do?

Medical device engineers contribute to two parts of the medical device product development process: the design and engineering stages. They understand the nature of medical systems and have the wide range of expertise necessary to solve the problem of creating a medical device that does what it is supposed to and looks like it needs to.

For more information, read the full glossary entry on Medical Device Engineer.

ArrowFast is your go-to company for help with your Medical Product Design. Don’t hesitate to contact us at and our expert engineers will be happy to help you out.

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