Common challenges when medical device manufacturers automate high-precision assembly
Modernizing production to handle the world’s smallest devices
An automated high-resolution line scan inspection.
Researchers at the renowned Brigham and Women’s Hospital recently made a miracle advancement in brain cancer treatment. Researchers at the Boston-based hospital developed a grain-size implant that delivers nano-doses of anti-cancer drugs directly into a patient’s brain tumor. To do so, clinicians implant the MicraTM, a pacemaker the size of a vitamin capsule, directly into the heart, and then place the world’s smallest medical implant, the iStent inject®, into the eye during cataract surgery to relieve inter-ocular pressure.
The clinicians and their suppliers are now confronted with the challenge of producing these microscopic devices and the specialty tools involved in the procedure.
Fortunately, that help is here.The increasingly complex geometries of micro-medical devices present manufacturers with new challenges. When a final product is only millimeters wide, the components inside must be made at the microscale and are often invisible to the naked eye. The diameter of a wire within the device may be .002 inches and may weigh as little as 1/10 of a milligram, with tolerances as small as 1/1000th of an inch. Other drug delivery devices and different products like point-of-care test units, hypotubes, implant and wearable medical devices may have other, more demanding production requirements.
Producing components with such extraordinary precision, at a cost that makes sense for the manufacturer, requires specialized automation equipment and techniques. That’s where Invio Automation comes in. For 65 years, the company has designed, implemented and sustained automation for the largest medical device and life sciences operations in the world. They pride themselves in truly partnering with manufacturers to solve big challenges by exploring, testing and customizing the latest manufacturing technology.
“The world of microdevices is relatively new to everyone. Even top medical OEMs don’t have a lot of in-house experience to rely on, let alone emerging or smaller manufacturers,” says Charlie Shortridge, Sales Engineering Manager at Invio Automation. “Because the level of up-front commitment is so high, investing in manufacturing technologies and equipment to produce these devices focuses on risk. This also explains why early production relies on manual processes — because the cost/risk ratio is lower. When demand grows, manual processes are no longer possible and so custom automation systems are brought in by necessity. With high investment costs and long lead times for custom equipment, the stakes associated with this transition are extremely high.”
Automated medical device component processing and assembly for needles and wearable drug delivery devices.
Inside the Invio difference
A high-volume production process can be the most capital-intensive step in the lifecycle of bringing a medical device to market. During initial development, the focus is often on material selection, component costs, process validation and even software development for many new medical devices. It is easy to underestimate manufacturing and assembly costs of the device without having direct experience with similar products, components and processes.
While innovation and new automation companies are a huge part of driving the industry forward, nothing beats the value of having met similar and specific requirements in the past. Companies like Invio Automation are in demand because they can reach back to past projects and leverage experience to help their customers plan for the right costs as well as stagger and defer investment in an intelligent way. Capital efficiency is the name of the game for scaling micro-assembly operations.
Invio accurately estimates the costs of developing, testing, prototyping, and delivering new automation systems and presents options to maximize capital efficiency. Drawing on patented process technologies allows for significantly faster and lower cost solutions than truly starting from scratch. Even when starting from scratch, Invio has been able to develop processes and automation systems to manufacture products ranging from in vitro diagnostic (IVD) products to test kits to blood glucose monitors.
Faster TTM and ROI through automation partners
When a manufacturing process introduces a defect to a medical product, the costs can be enormous. The amount of regulatory oversight, financial impact and public perception concerns mean that quality is the single biggest factor for commercial success. A quality issue likely dictates the overall Time To Market (TTM) and Return on Investment (ROI) for the development of any medical device.
In an effort to mitigate the outsized impact of a quality issue, all automation includes impressive amounts of cameras and inspection systems, to the point that most automation companies have in-house experts and labs used to ensure these systems perform as required. New technologies are introduced every day to make the inspection process faster and more accurate.
Internal resources like vision labs and dedicated experts make companies like Invio Automation essential partners for manufacturing technology selection and integration. This includes ultra-HD cameras that collect visual data and use AI and advanced algorithms to analyze images for irregularities or specific attributes. Implementing these technologies can impact manufacturers by allowing for 100% inspection of high-volume products, as is the case for single use devices (such as syringes or catheters) as well as the more complex implantable devices (such as protheses or cardiac devices).
In this area, the right automation partner will bring experience with testing, proof-of-concepts, and validating all type of inspection and test systems as they collaborate with manufacturers to plan out an automation roadmap.
“Invio Automation has the deep expertise that comes with more than 65 years of automation across our locations, and thousands of successful installations,” Shortridge says. “We specialize in custom automation solutions for medical and life sciences manufacturers — dealing with the exact areas where manufacturers have trouble.”
To learn more about Invio’s capabilities, please email charlie.shortridge@invioautomation.com
