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When can I start prototyping my medical device?

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Question:

When can prototyping begin in medical device product development?

Some of my colleagues say I can’t use prototypes until I am under design controls and have all my design inputs defined. On the other hand, I can’t generate my design inputs until I use prototypes to better understand the user and the problem I’m trying to solve.

Answer:

This is a common question we hear from our clients. It depends on the intent of the prototype. Often we find that companies have instituted design controls as their new product development process, rather than integrating design controls within the product development process. While design controls contain elements of engineering practices, they are not a replacement for a systematic product development process.

Product Development

Product development, at the highest level, consists of 1. Discovery, 2. Development, and 3. Commercialization.

Some companies use a phased and gated process to manage their product development projects. Regardless of the process you follow, it most likely contains some form of these 3 main elements. Within each of these main elements, the core product development functions (product management, engineering/R&D, operations, and quality) each have different activities to make the product successful.

During Discovery, activities include collecting customer needs or early usability information, so we can understand how a concept might work in the customer’s hands. Since users respond better to tangible items, prototypes may be used to collect the needed information. An outcome of this work is the ability to generate the design inputs.

Technical feasibility is another important component of Discovery. When it is unclear whether the product concept can be developed using the technical knowledge available, product development teams need to learn about the technology and demonstrate technical feasibility prior to transitioning into development. Prototypes should be used to understand the technology and if it provides a solution for the customer. Technical feasibility is done prior to entering design controls.

Later in the project and under design controls, prototypes have a different objective. They enable the product development team to make design choices, obtain feedback from user groups, and study product or subsystem performance including usability.

The bottom line is that prototypes can be used prior to initiating design controls. However, the intent of the prototypes should be focused on understanding user needs and technical feasibility.

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