Quality is the Differentiator for the Medical Industry
ZEISS Industrial Quality Solutions
Manufacturers of medical component parts and equipment are encountering increasingly stringent requirements for the quality of their products. Customer requirements to reduce risk through fewer part rejects and defects are escalating and, consequently, tolerances are becoming tighter and tighter.
To support the increasing demands for high-quality medical parts, manufacturers need to have a sophisticated metrology solution, with a reputation above reproach, one that provides quality assurance for every stage in the lifecycle of a medical product — from research and development, through prototyping and on to production. Critical failures are not an option in this industry.
Measuring Solutions for the Future
Accelerated adoption of new technology and techniques continues to result in production constraints for medical component manufacturers’ ability to keep up. If this cycle repeats, machining work for medical applications will continue to become more specialized, and the advantages of these technologies and techniques will compound the complexity of the parts.
This current evolution has seen a particularly extreme transition.
As Matt Danford, Senior Editor of Modern Machine Shop, explains:
“If there’s data to be had, customers want to see it. If analysis reveals that a fit could be tighter, a feature location more exacting or a surface smoother, they’re liable to demand it, particularly if the change unlocks a better design possibility.”
Consequently, industrial metrology will be a necessity to prove a company’s efficacy and quality as more stringent specifications and comprehensive quality control become the new normal.
When it comes to selecting a metrology system, original equipment manufacturers (OEMs) and their top-tier suppliers in the medical industry will need to meet this challenge head-on. In this increasingly diverse and complex environment, a manufacturer in the supply chain must find a way to make their services and products stand out.
Establishing a reputation for superior quality can be accomplished in two primary channels — in the equipment you utilize and ultimately, in the quality of the products you deliver to your customers.
A company benefiting from using ZEISS is FUTEK Advanced Sensor Technology, Inc. A U.S. Manufacturer of load cells, torque sensors, pressure sensors, multi-axis sensors and related instruments and software, the company’s component products are used in robotic and prosthetic functions in the medical industry, as well as used to test the functionality of medical devices. As a maker of high-quality sensors and testing tools used throughout the medical supply chain, FUTEK stakes its reputation on quality.
Part of this reputation is based on their use of a ZEISS MICURA CMM in their quality inspection process. Says Thomas Bowles, Director of Quality at FUTEK Advanced Sensor Technology, Inc.:
“Our sensors are used in the most accurate applications, so they have to be manufactured to precise requirements to meet specifications…. We explored and found a number of systems out there. We looked at all of the competitive units that were available to us and we have decided on the ZEISS MICURA.”
Equipment: Technology and Reputation
In the face of technological innovation and a changing landscape, metrology is a must-have for medical suppliers and manufacturers that want to stay competitive and in compliance. When selecting the right equipment for your quality assurance needs, it’s important to start with the application — what requires inspection, what is critical to quality and which technology provides the best data for quality assurance.
Selecting a metrology partner that delivers diverse technologies and an extraordinary reputation for precision can serve as a differentiation for your company’s quality assurance program and your company overall.
According to Ilene Wolff, Contributing Editor to Advanced Manufacturing Magazine, ZEISS will be leading the way in the medical industry:
“With the growing use of alternative manufacturing methods like AM and the adoption of mixed materials in the medical industry, industrial CT scanners like the METROTOM from ZEISS may be more important than ever for performing non-destructive metrology on parts’ complex geometries and layered construction.”
Products: 100% Inspection
Most industries require components to be thoroughly examined for surface imperfections. Medical manufacturers, however, must ensure every product meets all product specifications.
A 100% quality assurance inspection means all parts of a batch must be tested or inspected against predetermined tolerances of defined features and judged to be either conforming or nonconforming.
The key to ensuring 100% inspection is having the right equipment and expertise for each of your applications.
A wide variety of metrology solutions can be utilized in each step of the assembly process, from first article inspection to in-line quality control to final inspection.
CardioBridge, a German medical technology company, purchased an O-INSPECT when it needed 100% inspection of a device that could be a gamechanger for cardiac patients. The Reitan catheter, implanted in the aorta via the femoral artery in the upper leg, helps the heart regenerate and supports circulation. The pump also has 50 parts, all from different suppliers that must be produced with exact precision to meet required specifications so they can interact with each other seamlessly.
CardioBridge measuring technicians use the O-INSPECT, along with ZEISS CALYPSO measurement software and the ZEISS VAST XXT scanning probe system, for incoming inspection of each component of the pump depending on the size, geometry and surface finish. “Thanks to the two sensors on ZEISS O-INSPECT, we can precisely measure all of the different parts,” says Klaus Epple, Research and Development Manager for CardioBridge.
When your company purchases ZEISS metrology equipment, you’ve made the decision to purchase the best machines in the market for precision, accuracy and reproducibility. You and your customers will have a high confidence that everything inspected on the machine is within the required parameters.
ZEISS’ reputation is unparalleled in the manufacturing world. If your company has the ZEISS logo in their lab, you will be recognized as having a superior quality assurance program — giving you a key differentiator from your competition.
Contact us for a demo of ZEISS measuring solutions for medical manufacturing.