3D Printing: Separating Fantasy from Reality in Medical Device Development.

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Author: Peggy Fasano
Date: Sept-Oct 2021
From: Medical Product Outsourcing(Vol. 19, Issue 7)
Publisher: Rodman Publishing
Document Type: Article
Length: 1,668 words
Lexile Measure: 1340L

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Fantasy: Your startup company's initial fundraising efforts were successful, and you are making admirable progress on your product concept with the seed funding you received. A smart engineer spends several hours with a CAD drawing program, sends the resulting file to a 3D printer, and comes up with a slick-looking model for an upcoming presentation. The model awes investors, and they clamor to get a jump on the competition by suggesting (demanding) you move quickly into production.

Reality: Today, it's very possible for a person skilled at using a computer-aided design program to produce something flashy to show investors. It works well for that purpose. But in any industry, developing a 3D model is a very different operation from developing a product that is ready for market launch. In the medical device industry, the differences between a prototype and a saleable product are much greater, more significant, and have much larger consequences.

The Pareto Principle

The Pareto Principle states, for many outcomes, about 80 percent of consequences come from 20 percent of causes. Startup medical product companies can interpret the principle as, "It will look like you're 80 percent of the way done, when you're really only 20 percent of the way there." The availability of 3D printed models has made the Pareto Principle a great deal more relevant in the industry.

Creating an impressive concept model is a terrific milestone in product development--in the proper context. 3D-printed models are excellent tools for trying out different aesthetic approaches, and can be key in both human factors and preliminary market studies. The advent of 3D printing has made it possible to create several variations of a product for usability engineering sessions and focus groups, for instance.

If your audience--investors or others--understands the 3D-printed model they are admiring is only for visualization purposes, proof of concept, and early-stage testing, 3D has a well-earned place in your business. If there is any chance your audience does not understand the context, they may well assume the product is close to production, given the finished look a 3D model can present. For medical devices, this lack of understanding can easily turn into disappointment and frustration, and lead to significant management and funding consequences.

The Inherent Problems with Production

Many medical device companies try to move directly into production with 3D-printed parts to accelerate the time to market and avoid upfront costs with injection molding. A good grasp and appreciation of the issues in doing so will save resources in every way.


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