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Artificial Hip Joint Manufactured For Precision Fit

Artificial Hip Joint Manufactured For Precision Fit

Artificial hip joints must be manufactured with high precision, especially in the area where the hip stem and the ball joint connect. CERATIZIT has developed an economical production solution for precise interface between hip stem and ball joint.

If a hip joint is affecting quality of life by restricting movement and causing chronic pain, and if conservative treatment methods are no longer helping, the only option is to have an artificial replacement joint implanted – over 200,000 such operations are performed in Germany-alone each year. Those who take this route are hoping for long-lasting improvements. In order to make this hope a reality, as well as a good surgeon and first-rate care, the highest quality ‘spare parts’ are needed.

Prosthetics like this usually consist of a hip stem with ball joint, a hip socket and an intermediate piece to ensure movement is as smooth as possible. Particular attention must be paid to the connection between the hip stem and the ball joint. For the conical surfaces to fit together perfectly, they need to be produced with the highest precision and surface quality. Therefore, the tools used play a crucial role when manufacturing these components. 

“An artificial hip joint consists of difficult-to-machine materials, which not only need to be machined within the narrowest tolerances but also as economically as possible. Ultimately, an artificial hip replacement should be affordable for as many people as possible. We work with great dedication to find suitable tool solutions for these tasks,” explained Dirk Martin, Application Manager Medical at CERATIZIT and member of Team Cutting Tools. 

Meeting Machining Requirements

CERATIZIT is a full-range provider in the machining sector that has a wide range of standard and specially-made tools as well as in-depth machining expertise at its disposal. “With our huge product range and the expertise of our application specialists, we are extremely well equipped for tasks like machining the area where the hip stem and joint ball connect,” stresses Martin. “With our range of tools, we can test all manner of approaches to ultimately find the optimal solution.”

In the case of the artificial hip joint, the customer has particularly demanding and varied requirements. For the hip stem, made from high-strength titanium alloy Ti6Al4V, an angle tolerance of just +/-5‘ must be achieved in the conical connection area. Other tolerances are 3 µm for straightness, 8 µm for roundness and 60 µm for the diameter. It is also important that the specified contact ratio for the cone is achieved and a precisely defined groove profile produced.

The ball joint is made from a cobalt-based alloy (Co-Cr-Mo). Its conical hole must have the same shape, angle and dimension tolerances, as well as the specified contact ratio. However, there must be no marks, ridges or grooves made during machining. Martin mentions another crucial factor: “We need a production solution that is suitable for mass production. This means the machining must be process-secure and require as little monitoring as possible.”

Flexible u-Axis and Special Conical Reamer

To produce the conical outside profile, CERATIZIT’s application specialists opted for pre-machining with a solid carbide conical milling cutter. The subsequent roughing and finishing are then completed using a CERATIZIT u-axis system. 

“This is an interchangeable, freely programmable NC axis for machining centres, which can be used to machine contours or for turning.” explains Martin. 

“Attachment tools and indexable inserts can be used to create contours in holes and external machining work. This usually means that production times can be reduced considerably, while providing optimal surface quality and higher shape accuracy than usual,” he continued.  

This means the desired groove structure can be produced on the stem cone even on a machining centre. This has the benefit that all machining processes can be done on a single machine. Using the conventional process, a lathe and a milling machine would be required, which means additional clamping, aligning, time and money.

To make the conical hole in the ball joint, CERATIZIT’s solution involved the following steps being carried out on a lathe: First, the part is faced to provide a flat surface for the subsequent special solid carbide 180 deg drill with four cutting edges. This is then used to make a hole with a flat bottom. After this an EcoCut Classic drill and turning tool is used to produce the cone with close-contour boring, while a special solid carbide conical reamer ensures the ideal contact pattern and perfect surface quality and tolerance is achieved. The regrinding capability also saves the user further production costs. 

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3D Metal Printing In The Medical Industry

3D Metal Printing In The Medical Industry

Fast manufacturing and high precision of medical implants are crucial. Metallic additive manufacturing is opening new possibilities for medical and dental application. Article by CADS Additive GmbH.

The medical and dental industry face complex challenges. Fast manufacturing and high precision of medical implants are crucial.

First and foremost, the manufacturing of these implants requires a multitude of preparation and process steps, starting from capturing of patient-specific data using imaging techniques, through creation of implant geometries and their preparation for 3D metal printing, up to post-processing and finishing. New technologies and innovation drive these industries but also the companies themselves. Different demands call for different approaches and solutions.

Here, metallic additive manufacturing opens new possibilities for medical and dental application as well as for partners and suppliers of these industries. Nevertheless, one has to create and manage a large amount of data and map these as efficiently as possible through the whole process. To be successful, efficient data preparation for metal 3D printing is fundamental.

Software for Medical and Dental Technology

Founded as a Joint Venture in 2016, CADS Additive GmbH today is a fully owned subsidiary of the company CADS GmbH, both based in Perg, Austria. CADS Additive stands for developing outstanding software components and intuitive software solutions for 3D metal printing. As a manufacturer of high-performance data preparation and data management software solutions, CADS Additive is an innovative and competent partner in the field of industrial metallic additive manufacturing worldwide.

With the knowledge and expertise in developing intuitive software for medical as well as dental technology, they work with various companies to problem solve and deal with challenges, as well as find new opportunities within the industry.

“Our high-performance software solutions and components are game-changing for their decision on 3D metal printing software. What is further crucial for their 3D printing success,” Daniel Plos, Sales Director at CADS Additive, continues.For other exclusive articles, visit www.equipment-news.com.

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Integrating 3D Printing In Orthopaedic Implants Manufacturing

Integrating 3D Printing In Orthopaedic Implants Manufacturing

Matt Smith, New Technologies and Process Engineer at Corin Group shares how the company has integrated 3D printing into its orthopaedic implants production. Article by Markforged. 

The human body is all different shapes and sizes so for companies who specialise in making implants, streamlining the process for handling variants is important. 

Being involved in implementing new technology and creating new processes at the same time is an exciting role for any engineer. Ask Matt Smith, New Technologies and Process Engineer at Corin Group—an orthopaedic medical device manufacturer in the UK, who is well underway with his additive manufacturing programme. Matt began his project in early 2020 with a printer justification based on several new product introductions. 

Manufacturing Challenges

Matt and the team set about the task of introducing a new ‘stem’ and ‘femur’ and decided to see what new technology was available to help them do it in a timely manner. Each time a new product is introduced to manufacturing there are a large number of associated fixtures that come with it. Being able to make these in house was a clear benefit and offered some very reasonable cost savings, so it was the obvious place to start. 

“We decided that we needed to look at additive as a means of helping us be more agile when introducing new products. We believed there were many areas where we’d benefit, however as we progressed with the project, and more colleagues got involved, we began to realise the huge potential we had,” said Matt.

As the project was getting underway the world fell victim to the COVID-19 pandemic and almost overnight facilities closed, including many of the supply chain at Corin Group. Matt and the team were faced with the almost impossible task of ensuring their new project was still delivered on time, whilst having to work with no raw materials, no sub-contract manufacturing and limited internal resources. As they sat and mused over the creation of all the machining and inspection fixtures required, for the 48 variants of their new stem, and 24 variants of femur they quickly identified a new challenge, their raw material deliveries of forgings and castings would also be delayed. Without the raw material it would be impossible to even test the developed fixturing. 

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SHINING 3D And TechMed 3D Offer All-In-One Solution For Human Body 3D Scanning

SHINING 3D And TechMed 3D Offer All-In-One Solution For Human Body 3D Scanning

SHINING 3D, a leading global provider of technologies for 3D digitisation and TechMed3D, a leading provider of software measuring solutions for the human body, has announced the collaboration on a powerful duo: The EinScan H by SHINING 3D and MSoft by TechMed 3D.

“We are excited that, together with TechMed, we are now able to offer an all-in-one body scanning solution for medical applications. For us, working with proven software partners not only is enriching the potential of our 3D scanners, but far more helping our customers to continually progress in their 3D digitising endeavours,” said Rebecca Khoo, Product Manager EinScan , SHINING 3D.

“At Techmed 3D, we are impressed to see the evolution of the products that Shining 3D can bring to market. The Einscan H, by its ease of use and its speed, allows us to expand our digitisation offer and access to other growth markets,” said Michel Babin, Founder and CEO, TechMed 3D.

The EinScan H is a handheld 3D scanner that human body 3D acquisition can be performed efficiently and safely. This scanner in combination with TechMed 3D’s MSoft solution unlocks the potential for clinicians to get access to clean scans within minutes. The scanner has been integrated with white light technology, which makes 3D acquisition secure and eye-safe. The scanner has a Body Scan Mode ideal for orthotics and prosthetics applications. This mode offers high movement tolerance and its alignment algorithm is set to process non-rigid objects. That being said, clinicians can 3D scan all body parts including the head with the EinScan H. This versatile and portable scanner weighing only 703 g and is easy to operate for clinicians at any level of 3D scanning expertise, including first-time scanner users.

In combination with TechMed 3D´s MSoft software, EinScan H is able to deliver powerful results. MSoft is specially designed for 3D scanning of the human body. With this solution, clinicians can easily and quickly obtain ready-to-use files to modify, carve, 3D print, design and fit. Using the software with the EinScan H allows clinicians to see what they are scanning in real-time directly in MSoft due to the built-in camera on the scanner.

 

 

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3D Printing And Titanium — A Life-Changing Combination

3D printing And Titanium — A Life-Changing Combination

3D printing is delivering customisation options that make it possible to create almost any shape using additive manufacturing (AM) technology. In fact, the possibilities of 3D printing are so game-changing, it is even possible to create carbon copies of our own skulls. Sandvik’s additive manufacturing and metal powder specialists are exploring the potential of AM in the medical field, and are preparing for the future of medical implants.

Life-threatening accidents, vertebral damage, chronic osteopathic conditions and side-effects from medical treatment can all cause irreparable damage to patients. The consequences can be painful, debilitating and even fatal, so we must develop solutions to help the human body overcome challenges, enhance the healing process and improve patient prognosis. Medical implant technology has developed vastly over the years, and one of manufacturing’s most disruptive technologies is set to transform the way we treat patients.

Medical implant developers require a manufacturing technology that delivers speed, individualisation and the ability to produce complex designs. 3D printing, paired with bio-compatible materials like titanium, is demonstrating its evident potential as the medical industry’s manufacturing technology of choice for life-changing solutions.

In the past, surgeons used metal mesh to replace areas of the body such as skull bones, which tended to be weak and lacked precision. 3D printing eliminates these flaws because it uses medical imaging to create a customised implant, shaped exactly according to the individual’s anatomical data. This means that the patient can be fitted with an exact match to replace the lost or damaged area of the skull.

In Sandviken, Sweden, lies one of the world’s most cutting-edge titanium powder plants. At the plant, Sandvik’s experts are unlocking the potential of 3D printed titanium devices for the medical industry. “Titanium, 3D printing and the medical sector are the perfect match,” explains Harald Kissel, R&D Manager at Sandvik Additive Manufacturing.

“Titanium has excellent properties and is one of few metals accepted by the human body, while 3D printing can rapidly deliver bespoke results for an industry where acting quickly could be the difference between life and death.”

In addition to titanium’s material benefits, AM can help overcome some of the challenges when producing medical implants and prosthetics. Typically, the process of being fit for a prosthesis involves several visits to create a device that fits a patient and their needs. As a result, the time between a patient’s life-changing surgery and them receiving their device can be painstakingly slow.

“If a patient undergoes a serious accident, one that destroys areas such as the skull or spine beyond repair, they simply do not have time to spare to ensure their reconstructive devices fit correctly. Instead, they’re given solutions that work, but aren’t tailored to their bodies,” Kissel explained.

“Long waiting times and a lack of customisation can really impact how a patient feels after they’ve undergone a life-changing event or procedure. Even in 2020, there are still prosthetic patients using devices that do not move, or are simply just hooks.”

“Using computer tomography, it is now possible to optimise designs that simply cannot be produced using other manufacturing methods. What’s more, we can make our designs lighter, with less material waste and in shorter lead times. Patients could receive a perfectly matching device, in less time and using a high-performing, lightweight material.”

In summer 2020, Sandvik’s specialist powder plant was awarded the ISO 13485:2016 medical certification for its Osprey titanium powders, positioning its highly automated production process at the forefront of medical device development. As AM disrupts many areas of manufacturing, it’s clear that its potential in the medical sector will be life changing.

Sandvik is also part of one of the most ground-breaking research projects within the medical segment to date, contributing with its extensive material expertise. The Swiss M4M Center in Switzerland is a public-private partnership initiated by the Swiss government, aiming to evolve medical 3D printing to a level where patient-specific, innovative implants can be developed and manufactured quickly and cost-effectively.

“The Swiss M4M Center is intended to build up and certify a complete end-to-end production line for medical applications, like implants. Being able to facilitate this initiative through the unique material knowledge that is found within Sandvik is an empowering experience. Joining forces with an array of experts to reinvent the future of medical devices as well as the lives of thousands of people — is an experience out of the ordinary.”

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A Remedy To Uncertain Times

A Remedy To Uncertain Times

Medical manufacturing company Straits Orthopaedic delivers on diverse medical applications with their flexible ANCA CNC grinding machines. Article by Duncan Thompson, ANCA.

If manufacturers have learned anything over the recent months, it is that you can take nothing for granted. Circumstances can change quickly and how you are set up to respond can be the difference between your business flourishing or folding. Recognising this, Straits Orthopaedic has been investing in ANCA machines as part of their strategy to be a flexible manufacturer in the medical tooling and component market. 

The events of COVID-19 this year are perhaps the most extreme example of rapid market change and resulting uncertainty. But, even after more normal circumstances return, manufacturers need to be constantly vigilant, watching and responding to changes in the market that provide new opportunities or necessitate a pivot in their business. 

ANCA CNC grinding machines have long been recognised in the industry for their flexibility. It is this kind of flexibility that allows ANCA users to produce parts for diverse applications, so they are not limited to just one customer or one application. Powerful software allows users to create programs for a broad range of cutting tools and components. While modular machine design means features can be easily configured to suit the varying needs of different applications. 

The medical industry offers exceptional and diverse opportunities for manufacturers, with ANCA grinding machines supporting international markets in the production of complex bone rasps, long rotary reamers and tiny dental drills and burrs, just to name a few. 

Straits Orthopaedics, based out of Malaysia, is a case-in-point of a company taking advantage of ANCA’s diverse capabilities. Already well established for contract manufacture of medical components, Straits Orthopaedics’ first tool grinder was an ANCA FX5.

Senior Process Development Engineer Vidyadhiraj Vidyadharan comments, “Custom made tools have become a significant part of our growth in the medical tool market. We need the ability to make special tools to varying customer requirements and to be able to do it quickly. ANCA’s FX5 with its flexible tool programming software has certainly allowed us to meet this need. Demand for our diverse range of medical drills, reamers and planers easily justified our second FX5.”

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Screws For Endoprosthetics

Screws for Endoprosthetics

Machining high-tech materials such as high-strength aluminium and titanium alloys, implant steels and superalloys like cobalt-chromium require high-performance tools. Here’s how Hymec Fertigungstechnik GmbH are dealing with all that for its medical products. 

“When machining cobalt-chromium alloys, we demand very high performance from the tool due to the high material costs,” explains Tibor Veres, managing director of Hymec Fertigungstechnik GmbH. Which is why the company relies on tools from Paul Horn GmbH to machine superalloys. The precision tools from the company are also used for shaping the hexagon socket of an implant screw made of cobalt-chromium. Together with HORN Technical Consultant Thomas Wassersleben, they transformed this demanding machining task into a reliable process.

“We see ourselves as a manufacturer that is able to accomplish high-precision machining to the highest quality,” says Veres. 

The company specialises in medical products, custom-made solutions and demanding low-volume production. Machining high-tech materials such as high-strength aluminium and titanium alloys, implant steels and superalloys like cobalt-chromium (CoCr) are part of Hymec’s day-to-day tasks. The range of activities includes the production of precision-engineered components and complete assemblies as well as providing technical advice from concept and design to quality audits.

Close Collaboration

Hymec has been working closely with HORN for 30 years. “The cooperation has been outstanding because they are always able to provide a cost-effective solution for our applications,” explains Veres. He attaches great importance to the selection of tools on offer and is always looking for the best tool solution for his machining tasks. He approached Wassersleben for technical support in the production of a hexagon socket in a screw made of CoCr. 

The screw is an implant and forms part of an artificial knee joint. Hymec manufactures the screws in various widths across the hex flats of 2.5 mm (0.0984″), 3.5 mm (0.118″) and 5 mm (0.197″). The hexagon socket is machined to a tight  tolerance so that the screw sits firmly on the hexagon key during insertion. The surface finish also needs to be of high quality as even small grooves and ridges can be a breeding ground for germs. The company produces around 5,000 screws like this every year. 

Broaching is Virtually Impossible in Series Production

“Machining a hexagon in titanium is relatively easy by profile broaching. Broaching in series production in cobalt-chromium is virtually impossible, however, due to its high strength, and the tool wear is significant,” says Veres.

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SLM Technology Opportunities For Healthcare Applications

SLM Technology Opportunities For Healthcare Applications

Find out why selective laser melting is the ideal production technique to integrate function into medical device components. Article by Gary Tang, SLM Solutions.

Medical device manufacturers are increasingly adopting metal additive manufacturing technology of SLM Solutions—the pioneer and one of the inventors of selective laser melting (SLM) technology—to produce a wide range of medical and dental parts.

In the healthcare sector, SLM technology is used to manufacture functional prototypes for the serial production of surgical implants, to manufacture new designs of instruments and equipment, or utilized for mass customization, i.e. the production of patient-matched implants and prostheses on a large scale. Dental prosthetic components, and orthopaedic, spine and cranio-maxillofacial implants are all common applications of the SLM technology, with clear benefits to patient outcomes. 

Selective laser melting is the ideal production technique to integrate function into medical device components, such as printing surgical implants with lattice structures for enhanced osseointegration and reduced stress shielding. Designs optimized for SLM process, and those custom to patients’ anatomy, often create complex, bionic geometries only able to be manufactured with selective laser melting. The technology thereby provides productivity and cost advantages to users.

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3D-Printed Medical Devices Can Remedy Supply Bottlenecks In Times Of Pandemic

3D-Printed Medical Devices Can Remedy Supply Bottlenecks In Times Of Pandemic

During the coronavirus pandemic, the 3D printing industry has successfully set up on-demand production facilities. Medical devices are subject to strict quality requirements and must conform to an array of legal regulations. In addition, there is a shortage of contract manufacturers able to fulfil these conditions. To mitigate the situation, TÜV SÜD has drawn up a range of checklists for production processes and is providing them to manufacturers. The company is also involved in numerous initiatives.

“When borders are closed to stop the spread of COVID-19, companies are forced to adjust their supply chains”, says Gregor Reischle, Head of Additive Manufacturing at TÜV SÜD. Additive manufacturing sites using 3D printers quickly reacted by concentrating resources and reducing the pressure on supply chains. 3D printing technology was one area of focus as an option for filling gaps in supply chains, most urgently concerning nasal swabs, ventilator components and personal protective equipment (PPE). At present, additive manufacturing is also boosting supplies of key products such as face visors, ventilator valves, filters, pressure sensors and X-ray tubes for applications ranging from general healthcare to high-precision personalised devices for even the most niche markets.

The benefits of additive manufacturing in a growing market

Even before the current pandemic, analysts had forecast that the market for additive manufacturing in the medical sector would grow to be worth at least US$ 20 billion. The market for AM in dentistry is set to reach US$ 9.7 billion by 2027 with impressive annual growth of 35 per cent.

Additive manufacturing offers the significant advantage of being able to close supply chain gaps by promptly ramping up capacities in series production when needed. The technology enables complex fully functional designs to be manufactured as a single piece, eliminating the need for subsequent assembly of individual parts. This can often result in higher-quality products. It also offers the capability of creating cost-effective prototypes while shortening development lead times. The pandemic has proved that both these methods can succeed – but also revealed the extensive array of device-specific provisions and regulatory requirements which apply to the products.

Medical devices must be high-quality, high-performance and safe. Proof of their compliance with numerous conformity and safety standards must be furnished before they can be placed on the market. The products may also be subject to further specific purpose-related requirements. Personal protective equipment must protect the wearer from particles, droplet aerosols and similar (Regulation (EU) No. 2016/425). Particularly rigorous conformity and safety standards apply to face masks and visors for use in hospitals and clinics. The necessary conformity assessment takes time, which is at a premium during a pandemic.

Checklists smooth the way for market access

Guidelines help manufacturers to implement regulatory requirements reliably and promptly. To assist them in this, TÜV SÜD has drawn up checklists for the main requirements addressing additive manufacturing, both general and specific, in key standards and regulations, and has been supplying these checklists free of charge to manufacturers in the coronavirus crisis. The lists are a boon for testing laboratories, healthcare specialists and the public. In addition, international standards organisations such as ASTM International and ISO provide free access to the relevant standards concerning the manufacture and testing of personal protective equipment and medical devices.

Additive manufacturing therefore is playing a useful role in battling the pandemic and is fostering willingness to innovate, which is impacting positively on the medical and healthcare sector in general. “There are many indications that fast, integrated supply chain networks with local production operations will become the new normal”, says Gregor Reischle. But the support provided by TÜV SÜD as an impartial third party is not confined to checklists. The technical service provider also develops specific tests for additive manufacturing operations which assure the quality and consistency of industrial additive series manufacturing. With the help of the tests, contract 3D printing companies can verify their conformity with the requirements set forth in the MDD and MDR.

Initiatives and projects for combating the pandemic

Governments and industry associations, multinational companies and start-ups are turning to platforms aimed at closing knowledge gaps in the industry. Siemens has provided its 3D printers to doctors, hospitals and manufacturers in need of development of medical devices or components. In addition, the company is networking its entire supply chain from the design and simulation phases through to production.

Singapore’s AM accelerator, National Additive Manufacturing Innovation Cluster (NAMIC), has set up a website containing a comprehensive list of COVID-19 resources for medical institutions, hospitals and medical device suppliers, which can then work with 3D printing hubs to design, optimise and print parts for vital healthcare equipment.

In Singapore, TÜV SÜD participated in an inter-agency collaboration between the Health Science Authority, Nanyang Technological University (NTU) and NAMIC, aimed at guiding manufacturers through testing requirements to fulfil them reliably and rapidly. Checklists for face visors and nasal swabs are available free of charge from NAMIC’s COVID-19 response platform.

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Ensuring That A Propeller Keeps A Heart Beating

Ensuring That A Propeller Keeps A Heart Beating

A mini propeller for the aorta will support weak hearts in patients suffering from cardiac insufficiency. German medical technology company, CardioBridge, is working on the market launch of the tiny pump. A multisensor measuring machine from ZEISS is accompanying the development and ensuring the quality of all components.

READ: Driving the Next Industrial Revolution

A multisensor measuring machine from ZEISS accompanies the development of the Reitan catheter pump on the road to market approval and ensures the quality of its components.

The Challenge: 50 exact single parts

In almost 10 percent of heart attack patients, there is a risk of cardiac shock: the blood no longer circulates properly and can lead to organ failure. The solution for many patients in the future could lie in the Reitan catheter pump.

“This pump helps the heart regenerate and supports circulation at the same time,” explains Klaus Epple, Research and Development Manager at CardioBridge GmbH.

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When folded, the device has a diameter of only around three millimeters, unfolded 15. It is implanted in the aorta via the femoral artery in the upper leg. Once in place, the propeller unfolds and pumps blood with a speed of 13,000 rpm. For everything to work properly, the device must not deviate by more than 15 micrometers from the ideal dimensions. Furthermore, the 50 different parts that go into the pump must be produced with exact precision and interact with each other seamlessly.

The company receives the parts – primarily cast, turned and milled parts just a few micrometers in size – from different suppliers. This made reliable incoming inspection that much more vital: “We can only assess the results of our developments if we know the accuracy of our components,” explains Epple.

The Solution: O-INSPECT multisensor measuring machine

CardioBridge purchased an O-INSPECT multisensor measuring machine from ZEISS to ensure that all the parts of the pump comply with the specifications. Measuring technicians use O-INSPECT to measure each component – with the optical or contact sensor depending on the size, geometry and surface finish.

READ: Precision For Guaranteed Stability Using 3D Scanners

The Benefit: precise, flexible, user-friendly

“Thanks to the two sensors on ZEISS O-INSPECT, we can precisely measure all of the different parts,” says the satisfied head of development. The user-friendliness of O-INSPECT is also vital to ensuring that the measuring results are available shortly after a part is received. As a result, the reliable and practical measuring machine is playing a big role in bringing the pump to market in the near future – and ensuring that patients’ hearts keep beating.

 

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