Medical Device Product Development

Medical device product development is the complete process of developing a medical device that starts with seeing an opportunity for a medical device to actually selling the final tested and certified product.

What is Medical Device Product Development?

Medical device product development describes the complete process of developing a medical device that starts with seeing an opportunity for a medical device to actually selling the final tested and certified product. This process encompasses many stages, including opportunity identification, market analysis, idea generation and selection, product design, product engineering, manufacture commercialization and post-market surveillance.

What are the stages of medical device development?

The development of a medical device follows general stages to ensure that the device is effective and safe for use:

  • Identify a customer need (i.e. intended use), explore the opportunity and identify the risks.

  • Generate ideas that address the need, perform a feasibility (market) analysis and select the solution for further development.

  • Create a budget and business plan.

    → For example, it can cost up to €1 million to develop a simple medical device.

  • Design the product (medical product design) by specifying requirements based on intended use, usability, customer needs and regulations/standards applicable to your target market. This stage focusses on the what aspects of the device. This means what functions the device must perform, what it must look like, what it must cost, etc.

    → This is an iterative stage that works closely with the product engineering team.

    → You may do this in-house or outsource to medical device design specialists.

  • Engineer the product (medical device engineering) by taking the requirements identified in the design stage and translating them into clear technical specifications that describe a system which conforms to these requirements. This phase focuses on the how aspects. This means how to get the device to do what it needs to, how to get the device to look like it needs to, etc.

    → This is an iterative stage that works closely with the product design team.

    → Depending on your target market, you will need an established quality management system.

    → You may do this in-house or outsource to medical device engineering specialists.

    → You may have to create prototypes.

    → You will perform verification and validation of the design in this stage.

  • Certify the device for your target market.

    → Since you took all compliance requirements into account in the product design stage, the certification of the device should be relatively straightforward.

  • Manufacture/implement the product according to the technical specifications.

  • Put your device on the market.

  • Perform the post-market activities required for your target market, e.g. post-market surveillance to verify that your device is achieving its intended use and to identify any risks found from your device being in regular use.

Medical Device Development Timeline

Developing a medical device is a more complicated process than developing a general product because of all the extra regulations and standards that you need to comply with.

Therefore, it is difficult to exactly specify how long it will take to take a medical device from idea to having a certified device, as this depends completely on the complexity of the device. It can take years to implement all the stages that we have described. However, if you also take into account that you might need to find investor funding or you might need to do lengthy clinical trials, then these can add more time to overall development.

Even the simplest medical devices have times to market measured in years.

However, if you find the right partners, then you can significantly shorten the development time because your partners will have the experience of developing medical devices.

How do you develop medical products?

You can implement all these stages in-house, if you have the expertise, or you can partner with experts in medical device development, who can speed up your development time because they also bring their experience from having developed other medical devices.

What are the key roles needed to develop a medical device?

Some of the key roles that are involved in the development of a medical device are:

  • Product/project manager: This role oversees the entire product development process. They understand the customer need, the business strategy, the intended use and features, and are ultimately responsible for the business success of the product. They manage the resources, finances, and schedule.

  • Market researcher: This role is responsible for identifying the needs of the target market, identifying who the customers are, evaluating the market size and identifying the competition.

  • Medical Device Engineers: The medical device design and engineering tasks are often performed by this role. The medical device engineer specifies requirements for the solution device by taking all necessary inputs into account, e.g. intended use, requirements from applicable regulations and standards, usability, cost, required features, etc. Then they turn the requirements into a detailed technical specification that can then be used to guide the implementation or manufacture process.

  • Marketing/Sales: This role is involved with getting the medical device to the target market.

ArrowFast engineers have more than 20 years of experience in developing medical devices and having us on your team means you can shorten your time to market. Email us at so we can start the conversation.

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