Skip to content

Iterations in Medical Manufacturing

Posted in Medical Device Development

Iteration is a process used by manufacturers in many different industries to create a bulletproof product. By developing a design in separate stages, engineers can harness the strengths and weaknesses they discover along the way and refine a prototype before it’s sent to production. How does that play out in the medical device industry? Read on to learn more about iterations in medical manufacturing.

What is iteration?

Generally speaking, iteration is the repetition of a process to generate a series of outcomes with an end goal in mind. One cycle of that process is known as an iteration. When applied to manufacturing, we may call this cycle “iterative testing.”

What does iterative testing have to do with medical manufacturing?

Medical manufacturing is an iterative process. Engineers will perform repeated rounds of analysis during the design phase so they can ensure the device meets their client’s exact specifications before it’s sent to production. They may make small modifications to different parts of a device without changing the material or design through major operations like new extrusion or tooling, which results in additional costs – usually quoted separately. With each product iteration, a newly improved prototype emerges. The iterative design process goes something like this:

  1. Learn, build, test
  2. Design, build, verify
  3. Build, measure, improve
  4. Repeat

With iterations, engineers can determine the effectiveness of a design and work with clients to make alterations until no more changes are needed before it moves to production. Iterative testing is documented in a Design History File (DHF) so the device can be proven effective and safe. Once engineers have created a model with all necessary iterative improvements, they’ve reached a design freeze, and the product is sent on to manufacturing upon approval from the client.

What benefit does an iterative cycle give?

An iteratively developed prototype reduces product, project, and technical risks. Changing the design after transferring a device to production can waste time and money for the manufacturer and their client. A well-planned testing process improves the overall project schedule and documentation. The iterative method ensures that a device will safely and effectively treat a problem or condition. In this way, iterations protect the manufacturer, the distributor, and the end user.

Via Biomedical’s engineers are dedicated to creating an effective device that meets your specifications within your timeline, no matter how many prototypes it takes. Our experienced team can recommend test plans, create protocols specific to your device, manage test activities, and prepare submission-ready test reports. Contact us to learn more about our iterative process.