Medical Device Prototype Standards

From designers to executives and funders, it is crucial to have a shared understanding of the project result. Medical device prototype standards at each stage of prototype development can help to make this happen.

On the other hand, a medical device prototyping is not just a necessary cost to cover, but a trustful source of knowledge for stakeholders about upcoming Medtech innovation – Paweł Zieliński – Marketing Manager Consonance.

Prototyping in Medical Devices

Before we move deeper into mentioned standards let’s bring the essence on top. A medical device prototype is a streamlined, but frequently already operational, representation of a future item or service.

Prototypes allow for rapid and inexpensive testing of product concepts. You may use this to test the usability and operational safety of your medical products early in the medical device prototyping process, and then utilize the input you receive to iteratively improve and further develop your product. 

Because of our bodies complexity and also medical regulations it’s impossible to develop a medical device without prototypes. Well, no one has ever built something perfect from the beginning, right?

3 Phases Of Product Prototyping

In the Medtech space there are phases of the prototyping process, which are very similar in other industry sectors:

1. Alpha Prototyping

“Alpha” in the engineering field is often considered insecure and immature. “Alpha” refers to a non-functional component used to test the specifications of a physical device’s design.

Because we are working on a piece you can touch, move, design dimensions must address the product’s intended application. On the other side, we get the chance to assess the interface and determine whether it meets end-user requirements.

2. Beta Prototyping

Beta prototypes are typically one step further developed than Alpha prototypes. At this point, testing procedures look for mechanical or electrical component strengths and weaknesses.

This enables the replacement of non-compliant components and demonstrates this “mistake” to the project’s participants and stakeholders.

3. Pilot Prototyping

Pilot prototypes are essential for clinical trials or the introduction of a small batch for testing when we intend to bring a medical innovation that has not yet been used in the market or for which the literature does not provide sufficient information or scientific support.

In certain instances, we may see a product at this level that may soon be accessible to customers, but scaled manufacturing still needs the last polishing.

4. Final Product

Most eagerly awaited step that allows for large manufacturing. Keep in mind that you are at a point in the project when additional change would be significantly more expensive, occasionally impossible to perform, and from the standpoint of a medical certification, even undesirable.

Steps Of Creating A Prototype

Creating a medical device prototype is both difficult and exciting at the same time. Well, we build something to help people, right?

To move your project further, after doing your study and figuring out the finest technique to build it, we need to take your idea off the computer screen and translate it into something real. Several techniques come into play:

  1. 3D printing has excellent functionality and is revolutionizing the medical industry.
  2. Injection using mold tooling will save you from wasting resources on the material you’ll be using by ensuring that all the pieces fit together in your new gadget.
  3. CNC Milling: Produces incredibly exact components for designs with precise angles and offers a tested, fully functional item.
  4. Making your part flexible during casting will enable it to emulate the bend and twist you’ll need the finished part to execute.

The Importance Of Safety Standards in the Prototyping Process

Making a future invention visible is, in my opinion, the prototype outcome that has the greatest influence. It is quite simple to talk about something and have everyone picture a different outcome since our imaginations function differently.

Misunderstandings between designers, engineers, and financiers can be corrected via prototyping. It would be challenging to accelerate time to market and identify the ultimate product without a prototype that we can see, touch, and use.

How important is quality? Q1 2022 ended with over 300 million medical devices recalls in the US alone. 90% of cases were a result of a single component failure.

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