LP series lasers – available in 355nm, 532nm, and 1,064nm wavelengths – support automation and include track-and-trace or e-pedigree features for medical and pharmaceutical products.
Lasers eliminate inks, chemicals, and solvents which can contaminate medical devices.
LP lasers in 355nm and 532nm wavelengths place ID, serial number, gauge sizes, manufacturing data, and other information on medical devices without marring the product surface so no areas are created that could grow contaminates. This results in a clean, safe, and fast method for marking required information on medical products while reducing or eliminating product damage.
Laser marking on an intravenous (IV) drip dialHuman machine interface (HMI) for machine setupCatheter marking with machine vision verificationMedical device laser-marked
System changeover from one product to another is done with quick input from production systems, eliminating downtime and lost production.
Total joint arthroplasties of the hip and knee are among the most successful surgical procedures of any specialty – with more than 500,000 implant operations performed annually in the United States. With the continued aging of the U.S. population, demand is likely to increase as this cost- effective procedure improves a patient’s quality of life and mobility.
Rising demand for development of orthopedic and cranial implants creates a great opportunity for additive manufacturing (AM), allowing doctors to custom-build devices for each patient’s physiology. With this opportunity comes an increased need for accurate testing of prototypes and finished products, since these medical implants and devices may play a critical role in the human body.
AM solves clear and persistent problems in orthopedics, allowing greater levels of customization. Medical equipment manufacturers are increasingly adopting metal AM technologies – direct metal laser sintering and electron beam melting – into the design and manufacturing of medical devices and implants.
The human body consists of more than 37 trillion cells, (100 billion are brain cells), 206 bones, and 340 joints. If that isn’t complex enough, imagine having to build and inspect an implant to replace one of those parts. The more intricate and complex the structure, the more difficult it can be to inspect, which can be challenge for busy manufacturing plants wanting to remain productive. This is where the power of computed tomography (CT) scanning comes in.
CT scanning is often the best solution for objects with complex shapes, because the non-contact technique doesn’t require line of sight to the region of interest – especially important when it comes to something as intricate as an implant.
While no human body is exactly like another, implants must fit perfectly and be biocompatible. For example, a hip implant requires a very complex structure for bonding to the organic structure – osseointegration. 3D printing enables building these parts, but CT is the only way to look through the entire part, collect dimensional measurements using metrology, and detect flaws – impossible with light or contact metrology.
Today’s industrial CT scanners have advanced functional capabilities that provide valuable data for initial prototyping and optimizing production processes. They can detect potential part failures, even on larger parts, previously not possible because CT scanning techniques produce clear images that complement other methods. These images help manufacturers with needs ranging from comprehensive part fatigue and failure analysis to identification of small cracks and inconsistencies from part to part. Substrate bonding issues, uneven material flow, inclusions, and porosity indications can also be detected through trained interpretation of CT images.
Accuracy inspires confidence
CT scanning builds confidence in testing results by offering new methods for solving challenges in NDT techniques. The scan data makes it fast and easy to quickly identify issues, reducing development time and increasing productivity. Industrial CT scanning of medical devices allows internal structures to be viewed in their functioning position and analyzed without disassembly.
Industrial CT scanning software programs, compatible with other industrial CAD and medical imaging formats, allow advanced measurements to be taken from the CT dataset volume rendering. These measurements help determine clearances between assembled parts or simply a dimension of an individual feature.
Some challenges to traditional NDT inspection techniques, such as density variation, embedded features, organic geometry, dissimilar materials, and variable surface finishes, are detected and quantified by CT with ease. Users scan a device and detect features in less time.
CT scanning resolution delivers clear images that can detect the most minute flaws. Many scanners can provide resolutions down to 5µm to 10µm. Today’s CT software is easier to use, delivering improved workflow design and advanced protocols, making this NDT technique fast and accurate.
Cost-efficient results
CT screening can improve productivity by eliminating issues that could cause problems in post-production. Because parts are not destroyed during testing, it is also very cost-effective. CT scanners cost less than in the past, and many CT manufacturers have buy-back programs or have demo equipment available at reduced prices. Depending on the cost of current inspection requirements or scrap due to destructive tests, customers have been able to show a rapid return on investment in CT equipment.
CT inspection systems come in many different configurations, and a knowledgeable vendor can find the right choice for your quality, production, and budgetary needs.
From the microscopic details of a single part to the global vision that focuses on making the most of your applications, CT inspection offers spectacular views.
About the author: Jeff Urbanski is Key Account Manager with Yxlon, serving customers throughout North America in applying its X-ray and CT systems for a wide variety of NDT applications. For more information contact a specialist with Yxlon at 234.284.7849 or yxlon@yxlon.com.
Slow progress toward European Medical Device Resolution compliance
Departments - 1 Last Look
Peter Rose, managing director of Maetrics in Europe, highlights what manufacturers must develop for a smooth transition into MDR.
Medical Device Regulation (MDR) should be at the top of the agenda for medical device manufacturers. By 2020 the new MDR will be fully in force, and businesses not in compliance will have to pull their products from the market. Anecdotal evidence suggests medical device manufacturers have barely started to address MDR, with many unable to prove they have a compliance roadmap in place.
One possible reason for this lack of action is the expectation that the European Commission (EC) may provide an extension. There is no official confirmation of this, and a series of factors - a lack of available compliance professionals and notified body (NB) capacity - suggest medical device manufacturers would benefit to move early to achieve compliance rather than risk getting caught in bottlenecks later.
Peter Rose
The life sciences industry faces a well-documented skills-gap, including clinical trial and compliance professionals. Research shows that up to 80% of clinical research professionals work freelance for contract research organizations as opposed to in-house. This poses issues for the industry as a lack of skilled resources will be available. Manufacturers who delay complying with the MDR are going to have minimal options for sourcing talent and will most likely need to pay more due to supply and demand.
Additionally, an NB availability crisis is developing in Europe. Because a 20% decline in number of NBs during the last two years, the situation could worsen as scrutiny is applied to NB processes by competent authorities. The remaining NBs will have to tackle growing demand from manufacturers wishing to certify compliance with the new directive and the pressure of the new inspection requirement for NBs. So, manufactures may not be able to move products into the market fast enough because NBs are too burdened to carry out audits.
Maetrics developed a market opportunity value (MOV) model to demonstrate the potential annual revenues achievable for MDR-compliant manufacturers, or conversely, the scale of the market penalty for non-compliance. The $16.5 billion figure is based on the estimate, confirmed by interviews with major medtech businesses operating in Europe, that compliance under-capacity will be 20% of total market value. This result highlights the importance of early compliance to ensure profitability.
With such a complex and undefined horizon, manufacturers should seek the assistance of professionals right away to help build a plan for their compliance with MDR. Acting earlier than their competitors will allow manufacturers to reap first mover advantage, get their products out earlier, and help avoid any delays when the rush to MDR compliance begins.
Wireless devices, implanted deep within the human body, could deliver a drug, monitor patient conditions, or stimulate the brain with electricity or light, thanks to new communications and power-transfer technology developed by Massachusetts Institute of Technology (MIT)researchers and scientists from Brigham and Women’s Hospital.
Radio frequency waves – which can safely pass through human tissues – charged the implants. Without the need for a battery, the devices can be tiny. Researchers tested a prototype about the size of a grain of rice, but they anticipate that it could be made even smaller.
Batteries in current medical devices such as pacemakers occupy most of the space in the product, and they offer limited lifespans. Fadel Adib, an assistant professor in MIT’s Media Lab, envisions much smaller, battery-free devices, and is exploring the possibility of wirelessly powering implantable devices with radio waves emitted by antennas outside the body.
Radio waves tend to dissipate as they pass through the body, becoming too weak to supply enough power. To combat that, researchers devised an In Vivo Networking (IVN) system that relies on an array of antennas that emit radio waves of slightly different frequencies. As the waves travel, they overlap and combine in different ways. At certain points, where the high points of the waves overlap, they can provide enough energy to power an implanted sensor.
Massachusetts Institute of Technology (MIT) researchers have developed technology that could be used to remotely trigger smart pills to deliver drugs.
PHOTO COURTESY OF THE RESEARCHERS
MIT researchers, working with scientists from Brigham and Women’s Hospital, have developed a new way to power and communicate with devices implanted deep within the human body.
PHOTO COURTESY OF THE RESEARCHERS
In this study, researchers tested a prototype about the size of a grain of rice, but they anticipate that it could be made even smaller.
PHOTO COURTESY OF THE RESEARCHERS
“We chose frequencies that are slightly different from each other, and in doing so, we know that at some point these are going to reach their highs at the same time… [to] overcome the energy threshold needed to power the device,” Adib says.
With the new system, researchers don’t need to know the exact location of the sensors in the body, as the power is transmitted across a large area. They can power multiple devices at once. When the sensors receive a burst of power, they also receive a signal telling them to relay information back to the antenna. This signal could also be used to stimulate the release of a drug, a burst of electricity, or a pulse of light.
In tests with pigs, the researchers found they could send power from up to 1m outside the body, to a sensor that was 10cm deep in the body.
If the sensors are located very close to the skin’s surface, they can be powered from up to 38m away.
“There’s currently a tradeoff between how deep you can go and how far you can go outside the body,” Adib says.
Researchers are now working on making the power delivery more efficient and transferring it across greater distances.
University of Minnesota researchers developed a prototype of a 3D-printed device with living cells that could help spinal cord patients restore some function. The size of the device could be custom-printed to fit each patient’s spinal cord and the patient’s own cells would be printed on the guide to avoid rejection in the body.
PHOTO COURTESY OF UNIVERSITY OF MINNESOTA
A 3D-printed device could someday help patients with long-term spinal cord injuries regain some function, according to a team of engineers and medical researchers at the University of Minnesota.
The silicone guide serves as a platform for specialized cells that are then 3D printed on top of it. The guide would be surgically implanted into the injured area of the spinal cord where it would serve as a bridge between living nerve cells above and below the injury area. Researchers hope the device will alleviate pain and allow patients to regain functions such as control of muscles, bowel, and bladder.
“This is the first time anyone has been able to directly 3D print neuronal stem cells derived from adult human cells on a 3D-printed guide and have the cells differentiate into active nerve cells in the lab,” says Michael McAlpine, Ph.D., a co-author of the study and University of Minnesota Benjamin Mayhugh Associate Professor of Mechanical Engineering in the university’s College of Science and Engineering.
Developed during the last two years, the process starts with any kind of cell from an adult, such as a skin cell or blood cell. Using new bioengineering techniques, the researchers reprogram the cells into neuronal stem cells. The engineers print these cells onto a silicone guide – the same 3D-printing technology crafts the guide and cells. The guide keeps the cells alive and allows them to change into neurons. The team developed a prototype guide that would be surgically implanted into the damaged part of the spinal cord and help connect living cells on each side of the injury.
