HDE

Medical Device Design And Development

Table of Contents

Before we embark on the medical device design and development journey, you will already know that developing a medical device is a long and complex process. In recent times, the tightening of regulatory requirements worldwide by agencies such as the FDA and the EU has made this already costly process even more so. Poorly executed development projects can overrun cost and time and ultimately have to be aborted at huge financial and opportunity costs. In the case of small businesses and start-ups, this can threaten the future of the entire company. The agile development methodology, which is more popular among technology companies, does not necessarily work in the field of medical devices, where regulations require all the details and documents before a product can go to market or be tested with users.

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How to Design and Develop a Medical Device?

Medical device design and development is more than creating a concept, developing the product, creating a prototype and launching mass production. From our experience, the specification is the most crucial phase for your success. It is about scrupulously complying with health regulations and reaching the market with technical and safety guarantees for public health. Furthermore, the value chain is critical, as if we forget to meet the needs of any major player, it will suffer from lower market adoption compared to a well-designed product.

Conceptualization Phase

Like other industries, any business strategy must begin with the analysis of the competitive environment, the identification of opportunities and the validation of potential clients. It does not have to be a physical product, for example it can be a new procedure to monitor a specific pathology or ailment, improvements in the care service, devices, technologies or any solution that improves the health and well-being of people. We propose three steps:

Identify Market Needs

 identify the need for demand by narrowing the gap between the target market need and what the development team perceives as the need. The best briefing is achieved by interacting with the market and the main players in the value chain.

Device Classification

The classification of medical devices is based on the risk associated with their use and must be complied with by law. In addition, we must ensure that we do not infringe any right of any pre-existing intellectual property.

Innovation and Conceptualization

it is about creating the initial design and an iterative prototype plan. As a result, we will obtain a product development path.

Design Phase

Before launching a medical device, it must go through specific regulatory requirements, subject to national and international regulations. There are standards used to specify and evaluate design and performance parameters. In addition, they make it easier for public organizations, product manufacturers, laboratories and others to audit and guarantee quality and performance of the medical device.

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Device Design & Development - What to Avoid?

Before launching a medical device, it must go through specific regulatory requirements, subject to national and international regulations. There are standards used to specify and evaluate design and performance parameters. In addition, they make it easier for public organizations, product manufacturers, laboratories and others to audit and guarantee quality and performance of the medical device.

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