Steps in medical device prototyping

Did you know that steps in medical device prototyping aren’t something we would describe as a linear process? In fact, getting medical device development phases done makes designers and engineers’ work more cyclical. Think, design, prototype, test, back to the drawing board and again. Prototyping is all about delivering the first proof to visualize the initial idea in the shape of a physical, touchable device.

What is medical device prototyping?

Medical device prototyping is a process, which involves an engineering team, and designers to address product purpose and human factors in a functional, proof of concept model which defines future medical devices. How much time or money you put in this process depends on the prototype’s purpose. Do we build it to check basic functionalities or do you need a fully functional prototype, beautifully polished to attract investors?

I think it would be wise to consider this matter before starting the prototyping stage. The initial definition of done will save a lot of money, time and stress on the part of both the contractor and the product owner.

Well, regardless of the level of “done” most projects move through four stages:

  1. Alpha Prototyping
  2. Beta Prototyping
  3. Pilot Prototyping
  4. Final Product

I’ll describe them later and focus on the results of each stage.

How does medical prototyping improve manufacturing?

Product manufacturing doesn’t forgive mistakes. Producing a big volume of units also means huge expenses. You wouldn’t want to get stuck with product development because you made mistakes in product design? Prototyping helps you to address not only product requirements, human factors, and legal but also business expectations and this means there is a narrow margin for mistakes. Prototyping is a tool to limit the risk you undertake with a new endeavor. That’s why prototyping is divided into stages which allow engineers and designers to split a big project into smaller chunks that are deliverable and impact one another.

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Stages of medical device prototyping

1. Alpha 

Everything “Alpha” in engineering is associated (mostly in software-related fields) with something underdeveloped and unstable. When creating a physical device “Alpha” means a non-functional piece that tests the dimensions of the product design. Because we work on a device, design dimensions must answer the intended purpose of the device. On the other hand, we have a possibility to evaluate the interface and it complies with the end-user needs.

2. Beta

One leap ahead of Alpha, Beta prototypes are usually more advanced. Testing methods applied at this stage seek for strengths and weaknesses in mechanical parts or electronic components. This allows the rethinking and replacement of non-compliant elements and showcases this “error” to project members and stakeholders.

3. Pilot

When we plan to introduce a medical innovation that has no reference on the market yet, or the literature doesn’t reveal enough facts or scientific evidence, pilot prototypes are indispensable for clinical trials or introducing a small batch for the test. In some cases, we can see at this stage a product that soon could be available for customers, yet still, final polishing is required to manufacture on a scale.

4. Final Product

The most anticipated stage opens the door for mass production. Mind that you’re at a project stage when further modification would be even more expensive, sometimes unfeasible to implement and from a medical certification point of view, even inadvisable.

Benefits of medical device prototyping

The product development process with the prototyping stage is more likely to become successful and allow to gently step into full-scale production. Our experience gave us an insight into the benefits that you can get when working with a prototyping expert: 

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Design refinement – which is the ability to improve the final product design when it’s essential. To make that more agile, it’s better to test and look for design flaws on a 3D-printed model, instead of a more expensive sophisticated prototype.

Materials build the first impression of a product. You should test your sketch or computer model in real conditions to check how chosen materials look and perform together.

Tough conditions mean tough testing. Your prototype must assure mechanical reliability and design will meet even the most extreme forms of use in the planned spectrum.

Prototype for manufacturing validates the process of production. Well, we need to test it, right? Manufacturing processes should be as smooth as possible to deliver a quality product and simplify scale to production.

Regulatory compliance and device safety – imagine a medical device, which is harmful to the patient or medical staff. One of the prototyping goals is to build a medical device as secure as possible. Legal compliance and device certification allow avoiding potentially dangerous products available on the market.

Cutting production expenses is possible however sooner modifications are implemented, the better. There is no such thing as a perfect product from the very beginning. You can modify design, materials, or manufacturing processes because the prototyping stage is for.  On the other hand, you minimize the risk of product recalls which usually lead to legal or financial problems.

Prototyping stage summary

I think the most impactful result which comes from prototyping is making a future innovation visible. Our imagination works differently so it is very easy to talk about something and everyone could imagine a different result. Prototyping is a remedy for misconceptions between designers, engineers and investors. Without a prototype that we can see, touch, and use it would be difficult to speed up the time to market and determine the final output.



Originally posted 2022-08-09 00:05:17.