The World Health Organization estimates that are over two million types of medical devices spanning 7,000 categories currently in use around the world – from life-saving ventilators and EpiPens to highly specialized intra-ocular lenses and medical implants. Lots of medical devices are produced in high volumes too. More than one million cardiac pacemakers, for example, are fitted to patients every year.
To protect patient health, every medical device must be made to extremely precise specifications – and tight manufacturing tolerances. To maintain safety and efficacy, and keep regulators satisfied, there’s no room for error.
For the most precise tasks that demand faultless consistency, cobots (collaborative robots) are a cost-effective and reliable solution. They’re suitable for a wide range of medical device manufacturers – from niche firms to multinational pharmaceutical companies. But what exactly can they do?
Understanding medical device manufacturing
In the US, medical device manufacturing is a complex process. Developing new devices involves a five-step process overseen by the Food and Drug Administration (FDA), which includes extensive research, testing and reviewing. The process is a little different depending on the device’s classification. For Class 3 devices, which the FDA classifies as those that sustain or support human life, or prevent impairment of health, all manufacturers need to obtain Premarket Approval. This step involves inspections of manufacturing labs and facilities to make sure they’re following good manufacturing practices.
Once approval is secured, and the actual device has been cleared by the FDA, it’s vital that the manufacturing process meets the FDA’s Quality System Regulation. Essentially, this means every task, from assembly, kitting and machine tending to packaging and palletizing, has to be carried out in a way that consistently meets strict specifications. Manufacturers will also have to satisfy the FDA’s stringent post-launch safety monitoring requirements. This can include unannounced inspections, which can lead to facilities being shut down if they don’t meet the FDA’s high standards.
Consistency is an area where cobots excel – and it’s what makes them well suited to environments that can be challenging for humans to maintain.
Sterility and precision are two of the most important aspects in medical device manufacturing. Using a cobot for processes like injection molding, machining and surface finishing makes compliance simpler. They can be programmed to complete precise tasks with incredibly slim error margins. And, unlike humans, who are at risk of contamination with unavoidable bathroom and cafeteria visits, cobots never have to leave their sterile stations.
Cobot use cases for device manufacturers
There are lots of compelling use cases for cobots – but machine tending, and assembly and kitting, are two of the most commonly adopted. Learn more about cobots in medical manufacturing here
In manufacturing, machine tending refers to a range of tasks around the loading and unloading of industrial machines. It could be as simple as manually unloading an injection molding machine or as complex and potentially dangerous as handling hot, sharp or fragile parts. Whether a task is a tedious and inefficient use of operators’ time or too risky for humans to carry out, cobots can take many machine tending tasks off their hands.