Volume Graphics is enabling statistical evaluation of computer tomography (CT) scan data by extending data export from its non-destructive testing (NDT) to Hexagon Manufacturing Inteligence’s Q-DAS qs-STAT statistics software.
Volume Graphics is enabling statistical evaluation of computer tomography (CT) scan data by extending data export from its non-destructive testing (NDT) to Hexagon Manufacturing Inteligence’s Q-DAS qs-STAT statistics software. Volume Graphics already had an option for data export to Q-DAS in Release 3.3 of its VGSTUDIO MAX software, but the updated service tightens data exchange between CT and statistics.
Users can export 3D representations of components or measured features to Q-DAS software, an option introduced with version 3.4.3 of VGSTUDIO MAX, VGMETROLOGY, and VGinLINE. Users simply mark the relevant box in the export mask and the software adds the corresponding part image to the data to be exported. Reports become more transparent, defined, and accessed with Q-DAS qs-STAT, so users can immediately see which measurement series belongs to which detail.
One hurdle for medical devices is that they can only come to market once they have complied with all regulatory standards and then, at best, be manufactured automatically, since manual handling is cost intensive.
Best practices are for companies to holistically embed medical device manufacturing processes and systems, accounting for the entire value chain from delivery of raw materials and parts to assembly and finished device delivery.
Adhesive joint advantages
Adhesive bonding technology has become a popular joining method for medical device assembly, a trend that could gradually replace laser welding. The electronics and automotive industries were the pioneers as they recognized the advantages of bonding, and medical technology has now followed suit.
Special attention must be paid to assembly of medical devices because of high regulatory requirements and because the processes often take place in clean room conditions. Bonding benefits include:
Thermal load on the joining materials is low or non-existent; preferred materials are UV adhesives or cyanoacrylates; thermally curing adhesives can be used in special cases
Surface, microstructure of components being joined remain unchanged during bonding
Adhesive bonds can have sealing properties; assembly processes can be streamlined; costs reduced
An entire spectrum of component sizes can be bonded
Active alignment enables component repositioning during assembly; only UV light hardens the adhesive
Preeflow eco-PEN and eco-DUO dispensers for application of fluids and pastes in the µL range.
PHOTO: VISCOTEC
Adhesive dispensers
Purely volumetric dispensers, such as ViscoTec and preeflow, allow continuous and pulsation-free dosing to automate joining. The process is gentle and low shear with all materials, regardless of the viscosity of the adhesives being processed.
This is particularly important for medical devices used in the body, which require smooth and sterile surfaces, the bases of which are superimposed over the bonding and subsequent sterilization. The volumetric dosing unit can reverse its conveying direction, allowing precise adhesive thread breakage. In addition to the exact thread breakage, it prevents material from dripping.
The ability of preeflow systems to convey and apply adhesive with ±1% accuracy in the microliter range allows bonding of tiny, difficult-to-assemble medical devices. Without tearing, the smallest amounts of adhesive are applied to the tubes and provide pinpoint accuracy throughout the entire production cycle. The delivery rate can be changed if required by a specific component of the catheter such as balloon, cuffs, or connectors. Systems are usable for automated, semi-automated, and manual processes with one dosing technology. The dispenser is designed for all areas of application.
In fully or partially automated processes, the dispenser can be connected to the higher-level control system via a controller (foot switch). The operators have both hands free, making work more efficient and the process more secure.
“The focus of industrial manufacturers was and still is on precision and the shortest possible cycle times. This know-how was incorporated in the development of dosing solutions for medical devices,” says Annemarie Brandstetter, medical technology engineer and deputy head of the Hygienic Solutions department at ViscoTec.
The corresponding regulatory framework conditions that medical device manufacturing requires was supplemented so manufacturers could have dosing technologies developed and certified specifically for their needs and products.
A U.S. FDA compliant ViscoTec Pharma Dispenser VPHD in Hygienic Design.
PHOTO: VISCOTEC
The full ViscoTec system.
PHOTO: VISCOTEC
Sterilization after bonding
In addition to sealing, the right adhesive must allow for sterilization after bonding and must be safe for human use. Finally, the adhesive must be suitable for a fully automated process.
An alternative to bonding is component micro-encapsulation. It insulates and protects components from temperature fluctuations and ensures long-term stability during permanent or selective use in the human body. Whether microencapsulation or bonding, the combination of dosing technology and official approval of the elastomers used forms the basis for reliably serving the medical device market of the future.
Ultimately, when developing new adhesives and application technologies, component qualification and process validation are important. This begins with fluid management and emptying the container in which an adhesive is delivered, including degassing and the technical system for application. With the knowledge of these basic conditions, medical device manufacturers can automate dosing, bonding, and micro-casting, closing a gap in many places from partially automated to fully automated production processes while considering national and global specifications by the relevant authorities.
Harald Kissel is the R&D manager at Sandvik Additive Manufacturing.
PHOTO: SANDVIK
3D printing’s customization strengths enable the creation of almost any shape using additive manufacturing (AM) technology – even replicating our own skulls. Sandvik’s AM and metal powder specialists are exploring AM’s medical applications potential and preparing for the future of surgical implants.
Life-threatening accidents, vertebral damage, chronic osteopathic conditions, and side-effects from medical treatment can all irreparably damage patients. Consequences can be painful, debilitating, and even fatal, so solutions must enhance the healing process and improve patients’ prognoses. Medical implant technology has developed vastly over the years, and one of manufacturing’s most disruptive technologies is set to transform how patients are treated.
Medical implant developers require technologies that can deliver speed, individualization, and the ability to produce complex designs. 3D printing, paired with bio-compatible materials such as titanium, is demonstrating its potential as the medical industry’s preferred manufacturing technology for life-changing solutions.
In the past, surgeons replaced areas of the body such as skull bones with metal mesh, which tended to be weak and imprecise. With 3D printing, doctors and designers use medical imaging to create a customized implant, shaped precisely 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.
Sandviken, Sweden, is home to one cutting-edge titanium powder plant where 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 custom 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 prosthesis fitting process involves several visits to create a device that complies to a patient’s needs, slowing the time between their life-changing surgeries and when they receive their devices.
“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 explains. “Long waiting times and a lack of customization can really impact how a patient feels after they’ve undergone a life-changing event or procedure.
“Using computer tomography, it is now possible to optimize 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,” Kissel says.
In summer 2020, Sandvik’s specialist powder plant earned ISO 13485:2016 medical certification for 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.
The future of vision technology in medical manufacturing
Features - Quality
Mitutoyo expert Mark Sawko discusses how vision-based metrology is advancing rapidly, improvements to digital cameras, software techniques that stitch images together, and how to best use modern equipment.
Stitching four images together can create one high-resolution image. Stitching smaller images of a large piece into a single image allows for faster vision measurement without sacrificing accuracy.
PHOTO: MITUTOYO AMERICA CORP
The precision required when manufacturing intricate medical devices requires the right inspection equipment. Mark Sawko, vision product specialist at Mitutoyo America, discusses vision technology advancements for better quality control.
Today’s Medical Developments (TMD): What are some advancements in today’s vision measuring machines?
Mark Sawko (MS): Larger fields of view are a trend. Larger pixel counts and larger complementary metal-oxide semiconductor (CMOS) chips allow users to see more of a part at any time. This makes measurement faster and easier but sacrifices accuracy.
For example, Mitutoyo focuses more on stitching images together using software and hardware. This method takes many high-resolution images and melds them into a single high-resolution image of the entire targeted measurement area without sacrificing accuracy.
TMD: How can you determine which vision measuring machine is best for a process?
MS: It depends on the parts being measured. With such a wide array of vision equipment available... have a sales representative evaluate your parts and processes to determine what best fits your needs. If an on-site visit isn’t possible, sending a part and print to us can work, but it’s not as efficient as having a vision measuring professional look at everything involved.
TMD: How have enhanced resolutions and camera-to- PC-based vision machines advanced today’s systems?
MS: Camera pixel counts are increasing due to advancing technology. If you use the improved resolution from the increased pixel count and increase magnification, the result is better accuracy on even smaller parts. That’s why best practice is to use image stitching to get the best of both worlds – better resolution and better accuracy.
TMD: How does cost come into play when considering investing in a vision measuring machine?
MS: It comes down to, how much can you afford? A bigger budget will deliver better axis scales, optics, cameras, and lighting; however, a lot of high-accuracy measurements can be made with simpler machines. For example, the Mitutoyo QV-Active costs less but delivers 2µm accuracy.
TMD: How does installing a vision measuring machine address improving quality?
MS: Once trained, a lot of vision measurements are automated with automatic edge detection, eliminating human error and measurement fluctuations among operators. Once manufacturers remove human influence, product quality and consistency improve, allowing for tighter process control without investing in multiple, expensive gaging.
By applying statistical analysis, companies can improve manufacturing by monitoring the process and better controlling quality to reduce rejects and scrap in the manufacturing process.
TMD: How are increasing use of robots and cobots accelerating vision measuring machine use?
MS: With robotics, machines can be automatically loaded for around-the-clock measurement operations without the need of an operator. Depending on how many vision measuring machines and robots you have in operation, this obviously increases product throughput without the need for multiple operators who require training.
TMD: How is the Industrial Internet of Things (IIoT) increasing adoption?
MS: More cameras, optics, and semiconductors in more products increase the need for vision measuring machines and systems, since they excel at measuring these types of components quickly and with great accuracy.
TMD: What applications benefit the most from vision measuring machines?
MS: There are so many application possibilities, everything from complex products such as line-produced semiconductors to tiny and complex bone screws and artificial joints. Bone screws might seem simple, but they are very multifaceted, and a vision measuring system can measure profile, head geometry, and thread geometry.
About the author: Elizabeth Engler Modic is the editor of Today’s Medical Developments. She can be reached at emodic@gie.net or 216.393.0264.
Automatic edge detection eliminates human error and measure fluctuations between operators, improving product quality and making precision measurements more consistent.
PHOTO: MITUOTOYO AMERICA CORP.
How to realize additive manufacturing’s full potential
Features - Features
It doesn’t have to be intimidating or complicated, but it’s also not as simple as plugging in a machine and getting immediate results.
During the last three decades, leaders in the medical device industry have been behind some of the most significant advancements in AM, from 3D printing human tissue to fully customized prosthetics.
Yet, many organizations focus on these major innovations instead of looking for incremental improvements, such as making current processes more efficient or consolidating parts – steps that can greatly impact their operations.
Building a sustainable and highly efficient AM production facility requires developing an end-to-end 3D printing strategy within your organization and with an experienced partner.
Additive-first mindset
Every organization’s AM strategy will be different, especially for medical device manufacturers who have significantly more oversight from more regulatory bodies than other industries.
Regardless of the end product, all businesses follow a similar AM roadmap for adoption, and the first step doesn’t involve a costly investment.
Before you can identify what to produce additively, you must have an organization-wide understanding of how the technology will impact your business – implementing 3D printing capabilities means designing for additive first, which can’t be done in a silo. Ensure you have representation from all departments, especially during the first high-level assessment, to bring in new perspectives and get buy-in from leadership throughout the organization.
AM is a complex topic, and you’ll also need to build up competencies to lay the groundwork for AM success. Most organizations find they need to bring in experts and other partners to supplement any knowledge gaps.
Start with biggest challenge
Once you have internal alignment – and before you begin production – assess your portfolio to identify the most feasible applications for 3D printing. It’s tempting to launch AM with a new product, but that makes it tough to measure success and escape pilot mode. Instead, start with narrowing down current applications that would be suitable. Evaluate each application through the lens of technical and financial requirements and advantages.
Technical fit
Industrial 3D printing enables complex structures, functional and part integration, and mass customization – all advantages for medical devices that are accountable to patient-specific needs and anatomies.
When looking for applications that are a technical fit, there are three essential criteria to consider:
Size: 3D printers are typically suited for smaller, complex components. Build chamber sizes can vary depending on the type of AM platform, but applications are not limited geometrically. Looking at your parts by size is a quick way to narrow down your list.
Materials: A range of polymer and metal materials have some clinical history. Don’t eliminate an application based on the material alone but ask if there are parts where you could use similar, if not the same, materials used in conventional manufacturing. Custom materials are available, but it’s best to start with a standard set of materials – especially those approved for medical devices.
Quality requirements: Can 3D printing fulfill the necessary criteria for any part on your list? Here’s where regulations and certifications come into play. Additionally, are there geometries, tolerances, or surfaces that must be replicated through AM?
3D-printed cervical brace
PHOTO: EOS NORTH AMERICA
Economically viable
AM isn’t a replacement for traditional manufacturing. For some applications, conventional processes remain a better option, which is why it’s vital to analyze your portfolio regarding what will create the most value and help make a business case. Use the following criteria to evaluate each product for AM.
Complexity: How complicated is it to manufacture the part traditionally? Is it even possible to manufacture using traditional methods? Do you produce it in small volumes? The more complex a build is, the more cost-effective it is to create via AM compared to traditional manufacturing. The same can be said for small and mid-sized series productions and parts with complex geometries.
Cost-per-part: Comparing AM to traditional methods is never easy. To get a comprehensive cost calculation of AM, you’ll need to consider all design and creation process steps. This analysis includes how AM will benefit everything from data preparation and part production to post-processing and quality inspection.
Value add: Any part produced additively should create value. To determine this, look at it from the perspective of product, operational improvements, and supply chain. Will AM allow you to develop patient-specific customizations? How will you benefit from limitless design capabilities? On the operational and supply chain side, look at ways you can reduce assembly steps or time to market. How beneficial will digital twins and digital inventories be to your value chain?
Once you’ve gone through these steps, assess both areas with equal importance. Look for the product with a high level of suitability to help prioritize where to start.
AM pipeline
Your first venture into 3D printing will take a lot of hard work, but time spent preparing your workforce, identifying the proof of concept, and building a business case for AM will go a long way in making subsequent product transitions easier and quicker. When you look at the pipeline with a qualification perspective in mind, you can create a quality system that can be leveraged for subsequent products without re-inventing the wheel.
A successful AM process is attainable when the right steps are taken. Working with a solutions provider with proven experience and end-to-end expertise can help kick-start your initiative and guide your entire AM journey from set-up to serial production.
Elizabeth Engler Modic
