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Sandvik AM Achieves Medical Certification For Its Titanium Powder Plant

Sandvik AM Achieves Medical Certification For Its Titanium Powder Plant

Sandvik’s new powder plant in Sweden has received the ‘ISO 13485:2016’ medical certification for Osprey titanium powders, now approved for use in the additive manufacturing of medical applications. “This standard will reassure our customers that Sandvik has the necessary quality management systems in place to meet the stringent requirements of the medical industry”, says Keith Murray, VP and Head of Global Sales, Sandvik Additive Manufacturing.

Additive manufacturing (AM), also known as 3D printing, is already playing a significant role in the medical segment. With additive manufacturing, implants and prostheses can be manufactured directly from an individual patient’s anatomical data. This allows these customized products to be manufactured quickly, significantly enhancing the healing process and improving the prognosis for the patient.

“Achieving the ISO 13485:2016 medical certification will allow our medical customers to complete the necessary regulatory supplier approvals when bringing a medical application to market, utilising Osprey titanium powders from Sandvik,” says Keith Murray, VP and Head of Global Sales at Sandvik Additive Manufacturing.

The properties of the metal powders used, directly impact the reliability of the performance of the AM-process, as well as the quality and performance of the finished product. This medical certification ensures that best practices and continuous improvement techniques – including the company’s development, manufacturing, and testing capabilities – are leveraged during all stages of the powder lifecycle, resulting in a safer medical device.

Complete traceability – from titanium sponge to finished powder

Product traceability is especially important in the medical industry. Sandvik offers a complete traceability for its titanium powder, made possible by having the full supply chain in-house – from titanium sponge to finished powder. The new titanium powder process uses advanced electrode induction melting inert gas atomization technology to produce highly consistent and repeatable titanium powder with low oxygen and nitrogen levels. The production facility also includes dedicated downstream sieving, blending and packing facilities – integrated through the use of industrial robotics.

Titanium has exceptional material properties, being strong yet light and offering high levels of corrosion resistance. At the same time, it is biocompatible. However, the cost and complexity of machining from titanium billet have historically restricted its use. Additive manufacturing opens up new opportunities.

Powder metallurgy is also labelled a ‘recognized green technology’ – and the net-shape capability of technologies like additive manufacturing not only means that material waste is minimized, but also that great energy efficiency can be achieved, by eliminating manufacturing steps.

The first two powders produced at the plant will be Osprey Ti-6Al-4V Grade 5 and Osprey Ti-6Al-4V Grade 23. Other alloys are available on request. In addition to the ISO 13485:2016 and AS9100D certifications, the new titanium powder plant is also certified according to ISO 9001, ISO 14001 and ISO 45001.

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OGP: Prosthetic Devices Inspection With ShapeGrabber Scanner

OGP: Prosthetic Devices Inspection With ShapeGrabber Scanner

Prosthetic Device Manufacturer Relies on ShapeGrabber for Measurement and Inspection

DePuy Orthopaedics, Inc., a Johnson & Johnson company, designs, manufactures and distributes orthopaedic devices and supplies including hip, knee, extremity, trauma, orthobiologics and operating room products.

Components like knee implants are checked with laser scanning, because of the complex sculptured contours required for proper functioning.

As DePuy developed more complex, sculpted medical device components, implants, and prosthetics, it found its measurement capabilities were limited by the low point density and relatively slow speed of traditional touch probe technologies.

Because its devices were being used by human patients, DePuy needed dramatically higher density of point coverage to accurately capture the form and dimensions of these complex shapes, and the ability to compare them directly to CAD designs.

To obtain the high point density necessary for accurate measurements, DePuy selected a ShapeGrabber 3D laser scanning system. The ShapeGrabber solution proved to be faster and more versatile than other laser probe systems that DePuy evaluated, and the ShapeGrabber scanner was able to measure the complex, compound curves of DePuy parts quickly and accurately.

Since choosing the ShapeGrabber system, DePuy has found that it can reconfigure the scanner quickly to accommodate parts of different sizes and can perform the quality assurance inspections it requires to ensure its low volume parts are properly formed and sized.

“For complete inspection of our anatomical implants, we opted for the touchless approach of laser scanning. Our first laser probe system was very slow and had limited function, because it could only acquire one point at a time and could only measure diameters. We moved to a ShapeGrabber 3D laser scanner, a much faster and more versatile alternative,” said Roger Erickson, DePuy Orthopaedics, a Johnson and Johnson subsidiary.

Learn more about the ShapeGrabber here.

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Traceability In The Medical Sector—Technical Challenge

Traceability In The Medical Sector—Technical Challenge

Accuracy, efficiency and safety are the key words of an industry at the cutting edge of technology. Governed by numerous standards ensuring the reliability of its components, the medical sector has implemented numerous traceability processes over the last few years.

Thanks to the markings applied to the various components, it is possible to obtain information about the manufacturer, but also the component reference number or their expiry date. All this data complies with the UDI (Unique Device Identification) and MDR (Medical Device Regulation) standards, which are essential for exporting devices to the USA and Europe.

The components to be marked are as diverse as the professions that make up the medical sector. There are, for example, many cases of marking on surgical instruments such as scalpels or bistouries, but also on prosthetics or orthoses, made of steel, cobalt, ceramics or biomaterials, dental implants, often made of titanium, or hearing aids or pacemakers.

In order to ensure optimal identification throughout their distribution and use, these multiple devices must have a marking composed of different elements. In order to comply with the standards mentioned above, it must contain a machine-readable barcode or Datamatrix as well as several alphanumeric codes that can be identified by humans. Quite often a logo is applied, meeting a need that is more aesthetic than practical.

In addition, there are many constraints linked to the complexity of the marked components and the sector of activity. For example, the materials with which the various devices are made are complex and varied (steel, titanium, stainless steel, ceramics, various alloys, biomaterials, etc.) and require real technical expertise when marking. Precision objects and medical tools are often small and leave very little space for marking. Despite the small marking windows, the identifiers must be contrasting and visible to allow reading via a vision system and a human.

Another challenge is not to weaken the part nor to change its surface state (essential for bone prosthetics which undergo important efforts throughout their life span). It is also important to take into account all the surface treatments and sterilization cycles that medical instruments undergo. This is why it is essential that the marking carried out is resistant and durable over time.

Laser marking, the most suitable solution for the medical sector

All these constraints make the traceability of medical tools a real technical challenge. SIC MARKING’s aser marking solution consists of emitting radiation from a source, amplifying it and directing it towards the part to be marked. The beam creates a chemical reaction on contact with the workpiece.

This traceability solution, thanks to its many advantages, is becoming more and more widespread in the medical industry. It offers great flexibility of use and is able to mark barcodes, Datamatrix codes, alphanumeric characters and logos. All this while adapting to any material. The high-contrast and durable result obtained allows perfect reading over time for optimal traceability. Finally, Laser marking ensures faultless security because it doesn’t weaken the part and doesn’t degrade its hygiene, a crucial factor in the medical sector.

“Today, the medical sector is a sector where traceability has become essential and necessary. SIC MARKING’s experience in this sector enables us to provide our customers with the most interesting marking solutions from a technical and economic point of view. The wide range of laser marking solutions from SIC MARKING enables us to offer our customers a marking system that meets the requirements of the various types of applications: permanent, non-destructive marking, resistant to the sterilization process, etc,” said Nicolas Louison, Technical Sales Representative at SIC-MARKING.

 

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Fight Against Corona: TRUMPF Retrofits Mini-Lasers For Ventilators

Fight Against Corona: TRUMPF Retrofits Mini-Lasers For Ventilators

In the fight against the lung disease Covid-19 high-tech company TRUMPF retrofits Laser diodes which usually come to play in industrial fields.

The mini-Lasers are so far being used to measure the amount of oxygen while refueling planes or in petrochemistry. There, they measure the air composition in order to prevent explosions. Now, they are supposed to be incorporated into oxygen sensors for ventilators.

READ: HP Inc. And Partners Battles COVID19 With 3D Printing Solutions

“As a high-tech company, we are now able to include our development and production expertise into this one-time project. Even though components for ventilators aren’t usually part of our business- Corona concerns all of us”, says Berthold Schmidt, CEO of TRUMPF Photonic Components.

The Laser diodes shall be exported end of May to be fit into 3500 ventilators. In the course of the corona-crisis, they are additionally being manufactured by a US-American producer.

Laser Analyses Breathing Air

With the Laser diodes, the TRUMPF subsidiary Photonic Components provides the core of the oxygen sensors. The mini-Lasers are to analyse the breathing air of the patients. They emit light which absorbs the air more or less strongly – depending on the amount of oxygen it contains.

READ: Renishaw Ramps Up Production Of Ventilator Components

“A measurement in the medical field has to be most reliable and precise. Therefore, our Laser diodes are well suited for this project.” says Schmidt.

TRUMPF Photonic Components supplies the smart-phone and auto mobile industry as well as others. Worldwide the company employs around 280 people having its Headquarters in Ulm, Germany.

By Dr. Manuel Thomä, Head of Media Relations

 

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Renishaw Demonstrates Additive Manufacturing Capabilities For Spinal Implants

Renishaw Demonstrates Additive Manufacturing Capabilities For Spinal Implants

Renishaw has collaborated with two advanced technology companies to demonstrate the advantages of additive manufacturing (AM) in the production of spinal implants. By working with Irish Manufacturing Research (IMR) and nTopology, the project shows how streamlined the transition from design to AM can be when working with the right partners.

Manufacturing research organisation IMR designed a representative titanium spinal implant, aimed at the cervical spine (c spine), using advanced manufacturing software company nTopology’s generative design software. IMR then manufactured the implants using Renishaw’s RenAM 500M metal AM system.

“AM can be used to manufacture spinal implants with lattice structures, which cannot be achieved with conventional manufacturing techniques,” explained Ed Littlewood, Marketing Manager of Renishaw’s Medical and Dental Products Division. “An implant with a lattice structure is lightweight, can be optimised to meet the required loading conditions and has a greater surface area, which can aid osseointegration. Therefore, AM implants can be designed to mimic the mechanical properties of bone, resulting in better patient outcomes. But all of this comes to nothing if you do not have the tools to create the design.”

“Traditional CAD tools weren’t built to design complex lattice structures; the job would be difficult or even impossible.” Explains Matt Rohr, nTopology’s Application Engineering Manager. “nTopology was designed to complement existing workflows and make the job easier. We cut the design time of complex structures from days to minutes which was a crucial component in helping this project run to schedule.”

“Renishaw worked tirelessly with us on improving the AM process for producing the spinal implants,” commented Sean McConnell, Senior Research Engineer at IMR. “Together, we designed a set of experiments that yield the most appropriate parameter settings for the product. As a result, we reduced the amount of post processing required on key features of the implants by a factor of ten.”

Patients with medical conditions including degenerative disc disease, herniated disc, spondylolisthesis, spinal stenosis and osteoporosis can require spinal implants to restore intervertebral height. The improved implant design made possible by AM means patients may require shorter surgery time and fewer revision surgeries, saving healthcare resources and costs.

 

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Femtosecond Lasers For Unmatched Micromachining

Femtosecond Lasers for Unmatched Micromachining

Klaus Kleine and Michael LaHa of Coherent Inc review a new type of cutting laser, femtosecond and the ultra-short pulse (USP) industrial laser, which can cut feature sizes of tens of microns, with virtually no heat affected zone.

There is an increasing need to produce high precision, miniaturised components across several industries such as medical devices, automotive manufacturing and microelectronics. In many cases, traditional cutting methods cannot deliver the required combination of feature resolution and cut quality for these applications. Even lasers, which have historically offered the highest level of cutting precision, sometimes produce an unacceptably large heat affected zone (HAZ), that is, a region where melting or microcracking in surrounding material degrades part quality and/or performance. This article explores a new type of cutting laser, the ultra-short pulse (USP) industrial laser, which can cut feature sizes of tens of microns, with virtually no HAZ, and presents some specific examples of the use of this technology in medical device manufacturing.

Figure 1: Laser micromachining; in drilling, cutting and texturing applications, the use of lasers with shorter pulse widths avoids some of the limitations associated with longer pulse widths, including thermal effects and recast debris and surface micro-cracking.

USP Laser Advantages

Most precision micromachining lasers have pulse durations of 40 to 60 nanoseconds (10-9 seconds).  But, when cut quality is of primary importance, such as for producing very smooth HAZ-free edges, or when processing thin or delicate substrates, these lasers are not always optimum.

In these cases, even shorter pulse durations, in the picosecond (10-12 seconds) realm, can offer superior results.  This is because with this very short pulse duration, this is an athermal process which doesn’t cause unwanted heat to spread into surrounding material and cause a HAZ. And, the fact that the ejected material consists of very small particles (eg: as atoms) means that picosecond laser pulses do not produce recast, therefore leaving clean, smooth surfaces.

USP lasers are typically characterized by much lower pulse energies than nanosecond lasers, but with very high pulse repetition rates – usually in the 1 to 50 MHz range. So, each pulse removes a minute amount of material with minimal thermal damage, enabling unmatched depth control. Yet, the high pulse repetition rate delivers sufficient overall material removal speeds for many tasks.

Figure 2: A nitnol stent, cut with the Coherent Monaco femtosecond laser, shown at two different magnifications.  Notice the precision, edge quality and clean smooth surfaces in each case.

Femtosecond Lasers

Recently, interest has grown in using lasers with even shorter pulsewidths, specifically in the femtosecond (10-15 seconds) domain. In medical device manufacturing in particular, three factors have driven this trend. The first is the growing need for increased miniaturization, superior edge quality and surface smoothness. The extremely short pulse duration of femtosecond lasers further increases the advantages of athermal processing described previously. This is particularly valuable when processing thin films and delicate materials where no HAZ can be tolerated.

A second reason is the increasing use of mixed and layered materials, eg: bioabsorbable plastics on metal, or polyimide on glass. Femtosecond lasers produce very high peak pulse powers, which, in turn, drive non-linear (multiphoton) absorption in the material. Unlike traditional (linear) absorption, this is less dependent upon wavelength; the femtosecond laser can process virtually any material, even if it is transparent, such as glass. This allows coated and laminated substrates to be processed in a single step, enabling streamlined and lower cost fabrication in many cases.

Finally, femtosecond lasers are becoming increasingly attractive to industrial users because of recent improvements in their performance, lifetime, reliability and cost of ownership characteristics. Originally, femtosecond lasers were used exclusively for scientific applications. But, in the last few years, femtosecond laser manufacturers like Coherent have implemented a new laser material, ytterbium-doped fibre, which is scalable to much higher power. And because the laser material is in the form of a fibre, this new generation of industrial femtosecond lasers has simpler internal design and construction, leading to lower costs and significantly increased reliability.

For example, the Monaco series from Coherent provides up to 60W of processing power in a compact (667 mm x 360 mm x 181 mm) sealed package, which, given its lower capital cost and increased reliability, makes femtosecond laser processing economically competitive for a host of enabling applications in a variety of industries.  Moreover, these capabilities these lasers bring are available at several levels of integration. Options include standalone lasers, laser sub-systems (light “engines”) with scanning/focusing optics, complete machines with integrated part handling, and even complete solutions with custom software pre-optimized for a specified set of results for particular applications.

Figure 3: Three examples of stainless steel surface texturing produced with the Coherent Monaco femtosecond laser.

Cutting Precision Medical Devices

Many medical devices are formed from tubular blanks; common tasks are to make cylindrical cuts as well as produce intricate patterns for cardiovascular and peripheral stents. Testing has shown that femtosecond laser cutting delivers superior feature consistency and residual strength. For this application, the laser is typically integrated in a workstation in which the blank is mounted to a moving stage with 4-axes of motion, (three translation and one rotation). The use of a femtosecond laser allows for kerf cutting of tube stock or flat stock material with micrometre-scale precision and tolerances. Processing is sometimes accompanied by high-pressure co-axial assist gas to help remove vaporised ablation debris when cutting thicker-walled materials.

For surface texturing of contoured materials, such as catheter balloons, or surface ablation of flat stock materials such as stainless steel, another approach is used. Here, a 2D scanner workstation is usually the optimum solution, employing a high-speed 2-axis galvanometer scanner to cover a 20cm radius. The use of a femtosecond laser enables highly precise results with sub-micrometre depth control.

Yet another approach has been optimized to perform tasks such as precision hole drilling in irrigated ablation tip catheters with controlled wall taper, precision placement of slots and grooves, or to create complex shapes in tubes or flat stock material. In this case, the workstation contains a 5-axis trepanning scan head with co-axial assist gas along with a 5-axis motion control system. Again the femtosecond laser provides sub-micrometre dimensional precision and clean surfaces with typically no need for post-processing.

Conclusion

Many industries face a challenge to produce ever smaller and more precise components, while simultaneously reducing cost. Ultra-short pulse laser micromachining supports this trend in several ways, since it naturally delivers small features without damaging, heating, cracking or otherwise affecting the bulk material, while its minimisation of debris and recast material almost completely eliminates the cost of post-processing cleaning.

 

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Global Metal 3D Printer Market Outlook

Global Metal 3D Printer Market Outlook

The global metal 3D printer market is estimated to value US$0.8 billion in 2017 and is projected to register a CAGR of 24.7 percent in terms of value over the forecast period till 2026, according to a report by Market Research.

3D printing is a method of making three dimensional hard substances from a digital file. It is the process of laying down successive layers of material until the object is shaped in the desired form, in an additive manner. Each layer can be seen as a thinly sliced flat cross-section of the eventual object and it is an extremely high-precision manufacturing procedure.

Metal 3D printing offers various advantages over conventional manufacturing processes. With metal 3D printers, a range of products with varying designs can be printed and less materials are used which eliminates waste. Industries like aerospace, automotive, construction, medical device and consumer electronics are increasingly using this technology to produce components and parts.  3D metal printing provides aerospace and automotive industries with lightweight components which increases fuel efficiency and enable customisation in medical device manufacturing. Furthermore, Asia-Pacific is forecasted to be the fastest growing market for 3D printing metal due to rapid industrialisation and economic growth which drives the automotive, medical device, aerospace and defense industries. All these factors contribute to the rising popularity of metal 3D printers.

Key Players in the market include EOS GmbH, General Electric Company, SLM Solutions Group AG, 3D Systems Corporation, Arcam AB, Renishaw plc., DMG MORI AKTIENGESELLSCHAFT, The ExOne Company, Wuhan Binhu Mechanical & Electrical Company Limited, Xi’an Bright Laser Technologies Co Ltd (BLT), Wuhan Huake 3D Technology Co Ltd, Optomec Inc.

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