Malaysia Sets Its Eyes On Medical Devices Manufacturing Market
Apart from semiconductors, Malaysia extended its ambition to medical devices. At least, for Plexus, an electronic manufacturing services provider, has broken ground for its sixth manufacturing manufacturing facility in Penang, Malaysia, Bernama reported.
What Is Next For Medical Device Companies?
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Internet of Medical Things(IoMT), Disrupting and Democratising Healthcare Sector
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Growth in the global orthopaedic devices market offers an attractive diversification strategy for the CNC tool cutting industry.
Additive Manufacturing Standards For Medical Production
Dedicated standards for medical devices produced using Additive Manufacturing are already in preparation. Gregor Reischle, Head of Additive Manufacturing at TÜV SÜD highlights the importance of additive manufacturing standards for medical devices and what manufacturers need to consider before they start.
Gregor Reischle
Dedicated standards for medical devices produced using Additive Manufacturing are already in preparation. In future, they will smooth the path for the implementation of new technologies as well as their assessment for approval. In this interview with Asia Pacific Metalworking Equipment News (APMEN), Gregor Reischle, Head of Additive Manufacturing at testing, inspection and certification services provider TÜV SÜD, shares what aspects need to be considered against this backdrop.
Why do we need standards to help us use AM technology for medical production?
Gregor Reischle (GR): Items that are already produced using Additive Manufacturing, such as protective face coverings, masks and visors or products for radiation treatment, are subject to particularly rigorous conformity and safety standards. However, assessment procedures for approval of these products take time – and time is of the essence in a pandemic. Standards help to ensure regulatory requirements are implemented reliably, promptly and cost-effectively, thus minimising risks. They also represent state-of-the-art solutions and serve to concentrate specific knowledge.
There are still no Additive Manufacturing standards designed specifically for medical devices. Where can manufacturers seek guidance in the meantime?
GR: We have drawn up checklists for all the most important requirements in the main standards and regulations relating to Additive Manufacturing, covering those that set out more general terms as well as the first more specific requirements. We are currently providing the checklists free of charge International standard organisations such as ASTM International and ISO are likewise providing access to relevant standards free of charge at the moment, for items such as personal protective equipment and medical devices. This benefits testing laboratories, healthcare specialists and the general public.
How widespread are 3D-printed medical devices?
GR: Conventionally manufactured products still make up the majority. Anyone using 3D printing today is pursuing strategic aims and is willing to invest a lot of time in such products. Additive manufacturing is only widespread in specific areas of medical engineering, like prosthetics and dental technology. In fact, probably all the major manufacturers in the dental industry now supply 3D printers, some of which can even be used in medical practices.
What changes will the MDR introduce in this respect compared to its predecessor, the MDD?
GR: Under the Medical Device Directive (MDD), these “custom-made products” can be used without the need for CE marking. Although the same will apply under the Medical Device Regulation (MDR), manufacturers of class III implantable custom products will now need to call in a Notified Body to perform conformity assessment of their quality management system. Many products will fall into a higher class under the MDR, and this may require the involvement of a Notified Body in some cases. Custom-made products will be replaced by a common basic model which is customised for patient-specific use.
How will upcoming standards support the requirements to fulfil regulatory requirements such as MDR conformity? And which existing standards could already be useful?
GR: The requirements of the MDR state that a Notified Body must assess the manufacturer’s quality management system and verify compliance of its processes with the state of the art. DIN SPEC 17071—the specification for requirements concerning quality-assured processes at additive manufacturing centres—can usefully be applied here. The guideline is aimed at minimising risks stemming from parts and components produced using Additive Manufacturing, irrespective of the industry or sector. A project to transfer these findings to medical engineering is already under way, and a white paper on the subject will be published very soon. The DIN SPEC 17071 will also be advanced to reach the international ISO/ASTM level; the upcoming ISO 52920 and 52930 represent state-of-the-art quality assurance for AM production.
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The 3D Printing Market Will Reach $51 Billion In 2030
3D printing has the potential to significantly disrupt traditional manufacturing, as it is increasingly being used beyond prototypes, moulds, tools, or other one-off parts. The total 3D printing market will reach $51 billion in 2030, driven mainly by growth in production parts, according to new data from Lux Research.
Lux’s new report, “Will 3D Printing Replace Conventional Manufacturing?” highlights the 3D printing market size and growth by application and material, provides an outlook on what 3D printing means for the future of manufacturing, and discusses how strategies and business models will evolve as well.
“3D printing will be a key in the future manufacturing landscape thanks to benefits that it can bring over injection moulding, machining, casting, or other conventional methods,” explains Anthony Schiavo, Research Director at Lux Research and one of the lead authors of the report. “These benefits include customisation and personalisation, the ability to create complex geometries, part consolidation, and in some cases lowering costs.”
The value of 3D-printed parts will rise at a 15 percent compound annual growth rate (CAGR) over the next decade, from $12 billion in 2020 to $51 billion in 2030. “The largest share of this growth will be in end-use parts, which are just 23 percent of the market today but will reach 38 percent share in 2030,” notes Schiavo.
“The medical and dental industries will account for the largest share of end-use parts, reaching $4.5 billion in 2030, followed by aerospace at $3.9 billion.”
As 3D printing for manufacturing matures, strategies will shift. Vertical integration is critical today, but horizontal specialists can capture more profits in the future. Due to the relative immaturity of 3D printing as a manufacturing technology, complete well-integrated ecosystems are needed to help make it competitive.
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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
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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