The medical industry stands out from other aspects of manufacturing. The inspection rates are often higher, quality is paramount, and the products could be implanted into the human body.
Not to mention, the U.S. Food & Drug Administration (FDA) is working behind the scenes to make sure the health and safety of patients is the highest priority. Medical device quality is not left to chance.
Medical device quality is in everyone's best interest. According to the FDA, “Medical device manufacturers can reduce costs and increase their profits by focusing on quality measures during medical device design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages.”
With such a focus on quality, manufacturers need a sophisticated metrology solution. A wide variety of measuring solutions for medical manufacturing are available to prove product quality. These solutions can help guide your company through the entire manufacturing process — from concept to commercial product.
Challenges for Medical Manufacturers
A commonality to the medical market is the tendency to wait to adopt new technology. A frequent occurrence is that a certain inspection method is validated and used for specific components. Once this happens, OEMs often continue using this manufacturing process, even after more modern options become available with better throughput.
Meeting the FDA’s requirements for a range of documentation and validation of the measuring system is also a major concern. Those components are an element that sets regular manufacturing apart, where you might not necessarily be beholden to outside forces when producing your part. Thus, manufacturers may be reluctant to adopt the latest technology when the previous one is already in place.
At the same time, customers across the board are concerned with reducing time to market. “ZEISS has a reputation for accuracy,” says Bart Newman, medical key account manager at ZEISS Industrial Quality Solutions. “But throughput is probably the biggest target to hit.”
While speed is critical, he says more and more companies are also looking at the cost of inspection and how to streamline their processes. Since most manufacturers in the medical field measure every single one of their parts, this requires reliable data and reports.
But not every metrology methodology is one-size-fits-all. “Big OEMs and their suppliers all approach things differently from one another,” says Newman. “Some still prefer the technology that’s been around more than a decade or two decades, such as CMMs with touch trigger probes doing single point measurements.” Others are using scanning and more modern technology.
ZEISS Strengthens Quality Inspection
ZEISS’ portfolio covers the gamut for medical parts manufacturers — including solutions for insulin systems, knees, hips, injectables, medication deliverables, surgical instruments, 3D-printed parts and more. “We’re involved in a lot of different areas in the medical community,” says Newman.
ZEISS can fulfill all these needs with a range of non-contact inspection methods — from coordinate measuring machines (CMMs) to X-ray and industrial computed tomography (CT) to microscopy. “White light technology along with blue light lasers for CMMs are also some recent options,” says Newman. In addition, new sensors and systems are on the way.
ZEISS CMMs are critical for qualifying medical components, such as those used in robotic and prosthetic functions, as well as testing the functionality of medical devices. They strengthen a manufacturer’s quality inspection process and ensure that parts meet precise requirements and specifications, both for customers and regulators.
The orthopedic market — including knees, hips, shoulders, bones plates and screws — is a major focus for ZEISS, benefiting not just from CMMs but also CT. “CT is definitely a trend in medical inspection,” says Newman. “It’s growing more popular as more of the applications come forward. It’s a great tool for the geometry of a component, also porosity and detecting flaws within the component itself, even things like insulin pens and delivery systems with springs or a trigger component.”
Medical manufacturers want higher quality materials and materials of a certain grade, which are often inspected with particulate analysis. Newman explains, “ZEISS’ line of X-ray-based microscopes can not only determine the quantity and size of particles on a medical device but also provide important insights into 3D structure characterization.” ZEISS high-magnification microscopic measurements and visual measurement devices provide a comprehensive non-destructive testing (NDT) solution to qualify devices, such as inhalers and epinephrine autoinjectors, with small, complex moving parts.
ZEISS’ comprehensive measurement portfolio allows the company to provide a variety of solutions for medical manufacturers.
ZEISS Consultancy Optimizes the Customer Experience
ZEISS can also take on a consulting role to help customers optimize their quality control and assurance processes. The customer decides to what extent they wish to be involved and specifies the degree of transparency required.
“Most customers in the medical community know what they want,” says Newman. “It’s our job to provide data, and a solution to look at.”
ZEISS possesses the experience and methods to carry out complex projects successfully, and ensures that each development is individually tailored to the needs of the customer.
The future of medical applications is an exciting thing to consider. There’s always something in the works in the manufacturing world — from R&D to product delivery. What will improve our health and wellness next and how will ZEISS contribute to those improvements?
“It takes a lot of different types of measurement systems to support the medical manufacturing industry,” notes Newman. “I do see it starting to change and modernize. The older methods are taking too long and are too costly. It’s a small trend but it’s there.”
The medical field and the patients involved both benefit from these advancements that ZEISS facilitates. To your health!