Manufacturing technology
that type of seal is laser welding. But while “everybody goes ‘woah, laser welding, sexy new technology, love it’”, McClannon says it’s “really expensive and has a really slow cycle time, so it kills efficiency”. It’s this cost and the often-unproven nature of new technologies that leads McClannon to avoid them, specifically telling Jabil’s designers to stick with what’s proven. “Anytime our designers are talking to me about design for assembly, I tell them the more you can stay with the mainstream technologies, the more reliable and economic [the manufacturing] is to implement. Healthcare doesn’t want to be at the cutting edge of technology, we want to be second, not first.”
Quality and assurance
The evolution of automation has predominately been around the ability to assess devices visually and functionally.
down.” A scalable production line is easier to achieve with a more flexible automation system, rather than the fixed automation machinery McClannon is most used to. But those alternatives come with higher investment costs due to more sophisticated technology, and also output lower volumes. When much of the reason to automate is the rate of production bringing down the cost per unit, the decision of whether to make the process scalable becomes “a question of economics, not technology”, McClannon adds.
The cost of technology
Creative problem-solvers are coming up with new medical devices all the time, but if McClannon’s experience is anything to go by, their go-to-market vision is often far from the reality they encounter. He says start-up companies often have had brilliant ideas for wearable insulin pumps and have poured significant time and money into developing them, but then expect manufacturers to establish the capacity to produce them in as little as a year for a fraction of the cost. “They completely underestimate what’s involved when you get up to that level of product complexity. I’ve had situations where a company has budgeted a certain amount, and we’ve come back and said it’s four times that. That’s been the difference between them having the money to launch and not being able to, and I’ve seen companies fail because of it.” What adds to that frustration for start-ups is that the tightly regulated nature of the medical device industry necessitates a level of product standardisation that forces companies to choose automation because manual processes can’t give the same level of quality on a repeatable basis. McClannon says there’s also an issue of device makers wanting the benefits of new technology without realising it has disadvantages – the most obvious being cost. The shell of a wearable pump, for instance, needs to be water-tight, and one of the ways you can achieve
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Automated medical device manufacturing may not have undergone any sea-change moments in McClannon’s 19 years at Jabil. But he originally started his career designing vision systems – a key component of product quality and assurance – and says much of the evolution in automation has been around the ability to assess devices visually and functionally. “When I was in vision systems, I would sit at my desk with a pile of maths books on one side and a pile of C programming books on the other side.” In these early days, McClannon would create the algorithms required so that an automated vision system could measure, for instance, the diameter of an object. He’d then translate the algorithm into code for the machine to understand. The growth of the automation industry has since led to companies that specialise in medical device manufacturing, and huge libraries of algorithms that can be adjusted simply by setting the custom dimensions of parts. The result is far greater reliability, McClannon says, with one of the automation lines he oversees having 48 vision systems to check a product made of ten parts. “To put 48 vision systems on a line 20 years ago would have taken a bunch of PhD guys probably years of development.” It’s quality and assurance McClannon expects to see the most development in the future too. There’s already a growing trend of serialisation allowing for products to be tracked through the supply chain. But he believes adding the capability to collect data as parts run through the automation process could be a valuable next step in determining if errors have occurred. “I’ve seen a situation where a new device has been developed and had a 0.1% functional failure rate,” he says. “At that failure rate, the FDA wouldn’t have approved it.” What followed was a four-month systematic root cause investigation in which 72 experiments were performed to eventually narrow down the issue and fix it. “If we were automatically collecting data, we could have run statistical tools on it that would have spotted the anomaly very quickly and we wouldn’t have had the stoppage.” ●
Medical Device Developments /
www.nsmedicaldevices.com
Click and Photo/
Shutterstock.com
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