Contract manufacturing
along the way that reveal the likelihood that a bad part was built at some point.”
“I think that kind of data capture and analysis is something they should do themselves,” he adds. “It will come in time. It is part of doing business. As a contract manufacturer, if I want to be good at building stuff I should be getting that data for myself.”
Breaking the chain
Progress towards a leaner and more agile manufacturing cycle has been accelerated by the Covid-19 pandemic, which emphasised the need for agility and, above all, faster time-to-market for medical devices.
Dodd argues that quality assurance processes are too often focused on the end result than the manufacturing process.
planning and can ensure production is managed in a more flexible and agile way with contract manufacturers. Time-to-market can be improved, even though regulations may slow the process down.
“All factors are equally important in optimising the supply chain,” says Dodd. “Quality control is important in medical devices, which needs to move more towards the kind of QA processes seen in other industries rather than measuring each product with a microscope once it is complete. It is behind the other industries in that regard.” “But in terms of time-to-market, a lot of my work is done on a just-in-time basis and I have the supplier hold the inventory,” he adds. “That gets lead times down. I do a lot of purchase orders with contract manufacturers and I set up kanban systems with them.”
Kanban is a lean workflow management method for defining, managing and improving processes to deliver maximum efficiency. For Dodd, there is a need for constant improvement in contract manufacturing processes, though this seems to go against the grain of established practices.
“It is mainly about mindset and culture. The tools are great (…) But I have to pay contract manufacturers to put in place systems to capture data along the way that reveal the likelihood that a bad part was built at some point.”
“It is mainly about mindset and culture,” he remarks. “The tools are great and they are moving forward throughout the industry. For example, IoT is helping measure processes across the supply chain and providing data. But I have to pay contract manufacturers to put in place systems to capture data
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According to KPMG, changes in the regulatory environment – typified by the European Medical Device Regulation implemented in 2020 and Chinese regulations designed to encourage local innovation – will start to chip away at margins for medical device companies that rely on major investments in R&D. So, too, will the influx of new players from other industries that are used to harnessing data to gain market share and deliver highly efficient manufacturing processes. For established players in the medical device sector, there is a clear need to have a transparent view of the supply chain to improve planning, head off potential problems before they emerge, and speed up innovation. Improving data gathering and analytics will soon become a priority for medical device companies and their partners in the manufacturing cycle. For Dodd, a key component will be changing how medical devices are sold to end users. “The sales rep gets 30% of the sale price, so their relationship with doctors and hospitals is important,” he remarks. “That relationship pushes up costs. The focus in this industry is not on operational excellence in the same way as in the car industry, as you won’t go out of business if you don’t maximise efficiency, so why bother focusing on efficiency and lead times rather than just getting the minimum regulators require?”
“I’ve worked hard at a couple of start-ups and found that even if my medical device might be cheaper and better it does not change the doctor’s mind,” he adds. “At Ignis, we focused on very short lead times for knees and hips, which means people get quality and cost advantages, but the relationship between sales rep and doctor is really tight and it is hard to get in.” Nevertheless, Dodd feels that the tide is turning. It is becoming easier to capture data on inventory, deliveries, quality control and much more. As governments – which are major purchasers of medical devices through public health institutions – increasingly relate quality to cost, the need for better and cheaper medical devices will increase. That will inevitably make device manufacturers thirsty for efficiency. ●
Medical Device Developments /
www.nsmedicaldevices.com
Party people studio/
Shutterstock.com
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