Designing for Excellence: How Design for Manufacturability is No Longer Enough

“Design for manufacturing” is a buzz phrase well known in the medical device industry. Innovative design is always desirable and valued, but unique and groundbreaking design doesn’t mean anything unless it is manufacturable, replicable, and producible en masse.

MPO’s recent feature on medical device design tackled the question of complexity. In a 2006 Quality & Safety in Health Care (now Quality & Safety) article, J.W. Senders asked, “How does one design something that is complex?” The reality of complexity, he explained, is that it is a perception or philosophical observation rather than a reality. Blood glucose meters are a good exampled of this paradox. Today, such meters are electronic, automatic, and function much like the average smartphone. They have touch screens and sometimes hundreds of components. Yet, they are made to be easy to use—the easier the better—because they are meant to be functional for the average home user. Medical devices are moving more and more into homes and away from hospitals in order to save cost, time, and improve patient care. Therefore, simplicity is key—but to achieve such simplicity, complexity in design is paramount.

But how does a manufacturer consistently produce complex devices that are simple to use? SMTC Corporation, a global EMS (electronic manufacturing services) provider of end-to-end product solutions, takes the term “end-to-end” very seriously. Rather than designing for manufacturability, the company has a culture of “design for excellence,” known to their customers as DFx, designing for every stage of the device supply chain. According to Value Engineering Manager Brian Morrison, B.A.Sc., P.Eng., the company has an acronym for each component of the device production life cycle: DFSC (design for supply chain), DFA (design for assembly), DFT (design for test) and DFM (design for manufacturing). 

“For a medical device customer, the biggest concern they are going to have is from an architectural point of view,” Morrison explained to MPO. “The first thing they are going to ask me is, ‘Here is the block diagram, this is what I want the product to do, we are trying to find components that basically provide that functionality.’ I call that the architecture. That basically means we are going to be making the major component selections, we’re going to be selecting the processor or the memory chip etc. These are the major decisions. The next question they’re going to ask is, ‘what is the reliability of these chips or components?’ Manufactures in most cases will have published test reports that show what the predicted long time reliability of the components are, what the failure rates are, and what kind of failures those are because one factor is whether the processor can do it, and the other one is whether the processor is reliable. So we spend a lot of time making sure that whatever component they pick is not end of life and that they wont have to redesign their products. We call that design for supply chain.”

Trends have a lot of influence on the way in which a medical device designer approaches their job. Morrison pointed out wearable technologies and miniaturization coming to the forefront in the medical device market, causing manufacturers to consider ways not only to make devices easier to use, but also smaller and more compact. But thankfully, materials science has kept pace with electronic advancements, providing unique solutions to the new design problems posed by mobile and tiny technology. For instance, materials that provide more flexibility makes flexible circuitry possible; and alloys that create different melt points or heat resistance allow for lower processing temperature during manufacturing.

“A lot of customers are coming to us with unique problems and the new technologies and materials out there are helping us solve problems that maybe we would have struggled with a number of years ago with traditional methods,” Morrison said. “But with some of the new materials we have, the problems that we’re seeing now are much easier to solve, the solutions are much more elegant, and the devices are much more manufacturable. This helps us and helps our customer come to market with a cheaper, better and more reliable product.”

“The biggest driver in medical device design that I have seen is really focusing on earlier engagement,” Morrison added. “I get a lot of feedback from marketing and sales—they’re really my ears and eyes in the marketplace. The feedback we’re getting from medical shows is that OEMs are really focused on manufacturing and outsourcing but they’re not really focused on a manufacturer that has the design. And the more we listen to them in terms of already having a design, the more it makes sense. The earlier design engages with those customers, customers start to see it really makes sense to engage a supplier really early in the medical product development cycle because of the value it brings up front. I’m seeing a lot of the medical device companies breaking from the ‘I’m going to design it within my four walls and then I’m going to engage my suppliers’ attitude. Those traditional views are breaking down and OEMs are opening their eyes and saying, ‘I can drive so much more value and get my product to market so much faster if I leverage my supply chain and my manufacturers and suppliers to have a collaborative input.’ Our medical customers are starting to see that that value we bring drives so much cost out of their development cycle and they say, ‘Why didn’t we do this before?’”