Sometimes it’s hard to reconcile one facet of reality with another – like when an elite athlete has a heart attack. Medical devices can help save his life – yet see a parallel in the contrast between the high speed of product innovation and the sluggish information flows through medical device manufacturing companies. It seems unsustainable over the long haul. In the face of that disconnect, it’s a mystery to me how companies make sound decisions on which to base their innovation process – or to evaluate its success.
The core process to understand how you are doing is to collect data, analyze it, make the information visible, show it as a performance metric, and then further analyze possibilities and take action. My latest research shows that most people in medical devices need over two days to get through that data-to-decision process. That might be fine for high level executives who are working on more strategic issues.
However, someone on the staff makes decisions every hour in regards to products in the manufacturing process. Still, information flows slowly if at all. Fully 64% of medical device respondents are satisfied with operations staff seeing performance metrics less than once a month. This compares with 20% of other manufacturers satisfied with that speed. My take away is that many companies don’t even know how big a problem they have.
It’s like they have a bad heart but don’t know they need a strong one to compete as an athlete! Information must pump through a manufacturer quickly for the products – and thus the cash – to flow quickly. What I’ve seen is that medical device manufacturers are so focused on regulatory compliance and paperwork that they miss out on opportunities to be more profitable.
When you depend on innovative new products, complexity in the plant soars. The production staff must be armed to make quick and informed decisions that push profitable new products out into the market.
Let’s take just one example. To make the best of their innovations, companies must quickly ramp up new products to volume and quality and be able to run a high mix of existing and new products through their manufacturing processes. Paper and spreadsheets in the plant threaten a company’s ability to make, document, and sell the wonderful new products they design. There is an approach that works. Medical device companies using manufacturing execution systems (MES) are more than twice as likely to be improving on those measures.
I’m not the FDA, so I’m not going to dwell on the possible consequences of poorly analyzed decisions on the long-term safety and efficacy of medical devices. Until the plant has the information it needs pumped through it, the prognosis for a long and profitable life of new products – and the company – is not as good as it should be. From my vantage point looking at manufacturing effectiveness and profitability, this industry is on borrowed time.
Redefining Performance Goals to Unlock Business Improvements - A New Focus for Medical Device Manufacturers