Realizing the Value of a Medical Device Design Through Manufacturing

By Joe Arruda, Manufacturing Manager

Here at Ximedica, we research, strategize, brainstorm, design, verify, redesign, test, and validate medical devices…as well as manufacture them on-site.

So why do we manufacture too? Why not skip it altogether? Many design firms hand over the prototype and the plans and send their clients off to find a contract manufacturer, saving everyone the cycle time and grief. The answer: because manufacturing is as critical to the product development process as the initial research that goes into unearthing user needs. Manufacturing on-site has distinct advantages for designers—be it the industrial designers, design engineers, or the design team as a whole.

To start with, manufacturing helps us to understand the robustness and utility of the design in everyday use. Anyone can make one of anything; prototyping technology has made incredible advances. However, to truly deliver value to the masses, you have to make many copies of the same thing.The value of a design is only realized when it is manufactured in volume. Nothing validates a design more than “real world mud on the tires” experience over a range of users and conditions. Everything looks like it will work when viewed in 3D CAD model, zoomed in at 100:1, but reality is another story.

Secondly, the reach and societal impact of an elegant design can only be realized when manufactured in volume. Can you imagine if Bill Gates made only one PC? Or if Steve Jobs stopped after one iPhone? True—elegant “one off” designs are important, but they serve more of a demonstrative role than a functional one. A beautiful prototype can be shown in museums or utilized in the classroom. These “one off” designs do not have the visceral, personal impact of something you use every day.

Manufacturing is also important to the product development process. Scrutiny of a design and the process that develops the design are valuable exercises. We learn from doing and making. If the product development process ended with a CAD model and a few prototypes, what have we really learned? Coming up with a great design is easy enough – the real test comes when you have to make it again, thousands of times over, in bulk quantities.

Compared to the mass manufacturing of smart phones and iPods, our manufacturing services are actually somewhat low in terms of sheer volume. More and more medical product companies today (particularly start-ups) have no factories, no manufacturing capability whatsoever. It might not be their core competency, or they just can’t afford the addition. But, the medical device industry can benefit from high value-added, lower volume manufacturing.

With the overwhelming evidence in favor of on-site manufacturing capabilities, professional service companies like Ximedica understand the value. And with these capabilities we are provide clients with well-run, easily accessible “virtual” factories on top of our design and development services.

A hidden benefit of the on-site “virtual factory” is repeat business. Where does a company go when they need more products? The answer is easy; back to the place that got their product launched. The same is true for services associated with capital devices. Who can handle refurbishment, software upgrades, physical repairs, spare parts, (all potential revenue streams), better than the manufacturer? Tech support and product training are services a manufacturer can also provide. These residual business opportunities and customer engagements often result in deeper client relationships and repeat business. As these partnerships grow and flourish, it becomes harder for competition to engage with your customer. These strategic partnerships result in “sticky” business—business that, as long as you perform, is hard for your firm to lose.