Unlike consumer-grade devices, Vital Scout is a wireless wearable patch that uses medical-grade ECG sensors to measure stress and recovery rates.
PHOTO COURTESY OF VIVALNK
Healthcare is increasingly moving toward remote patient monitoring (RPM) and telemedicine in order to reduce costs while making care more accessible. This means healthcare developers are looking for solutions combining accurate sensors and quality data to make home healthcare as efficient and productive as possible.
Now, there’s an exciting evolution in medical wearable sensors and platforms that is allowing for more impactful applications of RPM. The emergence of a new category of wearable medical-grade devices, and significantly more accessible cloud platforms to build RPM solutions on, is taking RPM past virtual appointments and patient-reported data. One indicator this evolution has started is the convergence of traditional consumer technology companies into the medical device space, such as Apple with its latest FDA-cleared ECG Watch, allowing for higher quality monitoring available directly to consumers. The first catalyst of this evolution are new sensors available to medical device manufacturers and original equipment manufacturers (OEMs). These new medical devices merge the historically distinct markets of regulated medical devices and consumer wearables. Three key attributes allow these devices to gain more traction in the market: medical-grade data, user-friendly devices, and affordability. These newly enhanced devices overcome healthcare wearability challenges by using form factors that are consumer friendly but packed with medical-grade sensors capable of producing multiple vitals and biometric information. Another important development in RPM is the reliable and secure transport of data from a patient in the home to a remote application at the provider’s site. Managing data at the home involves data communication between the wearable sensor, an intermediate app such as on a mobile phone or router, and then into the cloud. Network reliability, power consumption, and user errors are common issues that need to be dealt with.
A complete RPM solution will need to include wearable sensors, edge processing in the home, reliable transportation of data to the cloud, and ultimately analytics and applications used for patient care and diagnostics. This is a tall order for any single solution provider to deal with and thus limits the pace of medical application innovation. However, a new class of medical sensors and data platforms such as VivaLNK’s IoT Medical Wearable Sensor Platform can reduce the complexities and barriers to RPM application development. By abstracting the device challenges in a remote environment, application development and integration becomes far simpler since it allows the solution provider to focus on the domain of their application instead of the device infrastructure.
VivaLNK’s IoT-enabled medical wearable Sensor Platform includes a range of sensors, edge computing technologies, and an Internet of Health Things (IoHT) data cloud.
PHOTO COURTESY OF VIVALNK
CareTaker is a wireless patient vitals monitoring cuff that demonstrates this evolution in RPM. The form factor of the device and the solution’s ability to track multiple vital signs continuously are a vast improvement compared to traditional devices. When used in the home setting, the accuracy of data reported back to the provider and into the electronic health record (EHR) makes the data viable for use in treatment planning. It is not patient-reported data, but continuous, real-time, highly accurate information about the patient’s state that is sent to the cloud and connects the patient to the provider. This is where the true power of RPM lies.
The decentralization of care is inevitable. As a result, the growth rate of in-hospital devices and equipment will likely pale in comparison to the growth in RPM and devices that can be used in the home for health monitoring. RPM is here, but accelerating time to market is crucial. The advent of new sensors and the ability to access hardware and software in a single platform solves a variety of issues for manufacturers and OEMs so they can focus on the therapeutic expertise of their specific RPM application and more quickly get it to market.
About the author: Jiang Li, founder and CEO of VivaLNK, has a passion for and experience in bringing innovative technology and products into the marketplace, including the world’s first electronic skin technology called eSkin Tattoo in partnership with Google. He can be reached at 408.868.2898 or info@vivalnk.com.
Process monitoring for medical plastic injection molding
Features - Injection molding
Kistler’s piezoelectric sensors and systems measure, analyze cavity pressure during injection molding at Tessy Plastics.
Tessy uses a range of Kistler solutions, including ComoNeo, maXYmos (pictured), load cells, and pressure sensors.
Photos courtesy of Kistler
Custom medical device and consumer component contract manufacturer Tessy Plastics, with several facilities in Central New York, engineers, manufactures, assembles, and distributes a range of products. Using a scientific injection molding (SIM) approach allows Tessy engineers to define and optimize the company’s molding process from start to finish. Ben Passetti, research & development engineer at Tessy, takes the quality of their molded parts seriously.
“Our product portfolio is split 50/50 medical/consumer. We focus primarily on value-added, high-dollar items with very complex manufacturing and tight toler- ances – everything from 720 tons down to micro-molding – so our molding portfolio is large from a versatility standpoint,” Passetti says. “We focus on micro-molding in the medical sector because it is challenging and difficult. We accomplish tight tolerances because of the tooling partners we have.”
Overcoming complexities
Continuous process monitoring and control of the entire production measuring chain are essential in meeting requirements, and Swiss sensors and equipment company Kistler’s cavity pressure systems and sensors handle the task – from measurement through documentation of cavity pressure. Customized monitoring of tolerance limits by piezoelectric sensors results in visible process deviations, detectable at an early stage, minimizing rejects and scrap. Combining Kistler’s process monitoring systems and sensors optimizes process efficiency, offers quality assurance, and gives Tessy a competitive edge.
“There has been a visible shift in the plastic molding market within the past 5 years. Customers are more educated and understand a lot more about the injection molding process than in the past and they are actively searching for more technological, savvy solutions,” Passetti says. “They are more willing to accept risk with applications to gain technological reward in order to advance in this competitive market.”
By combining Kistler process monitoring systems and sensors, Tessy has optimized their process efficiency and quality assurance.
PHOTO COURTESY OF KISTLER
Versatility for success
After reviewing Kistler’s product portfolio, Tessy engineers decided to implement and combine products.
“Tessy has been using several Kistler products,” says Jay Sklenka, field sales engineer at Kistler. “This includes the Kistler ComoNeo, maXYmos, load cells, and pressure sensors. They are also using our amplifiers mounted on the injection molding machines to bring the pressure signals back into the machine controller.”
Understanding how versatility among several components can be integrated to achieve maximum success, Passetti notes that, “Bridging the gap from technology to manufacturing; integrating current technology into our customer’s parts design, is the primary goal of our daily operations.”
Passetti adds that he and his team must ask themselves how they can speed up part production with higher quality and more cost-efficiency for the company and the customer. The answer, Passetti says, is Kistler process monitoring sensors and systems.
“Prior to the implementation of Kistler products, we were seeing process inconsistencies. We had used pressure sensors in the past but never on a micro-scale. We decided to test Kistler’s pressure sensors on a micro-scale to see if we could identify the variation between the machines,” Passetti says. “Once we saw how effective Kistler’s pressure sensors were, we chose to implement them on our machines. They have proven invaluable for seeing the variation between the molding machines, preventing the mold from being overpacked, and detecting short-shots in real-time. From an assembly standpoint, Kistler pressure sensors allow us to detect the force that drives the components back and forth so we can make any necessary adjustments with reliable, visible, sustainable results.”
The maXYmos gives a better understanding of what components look like, ensuring they are fully formed and can move into the production stage with 100% zero-defects. Implementing Kistler’s ComoNeo process monitoring system revealed what was happening in the mold to achieve accuracy and repeatability.
Gaining control
“In one of the first stages of the molding process for our medical components, the parts are inserted with the automation directly into the medical component. Here, we are monitoring the cavity pressure to ensure parts are fully formed and that we do not overpack the mold using a visible envelope/reference curve over the injection profile so that we can monitor the fill,” Passetti says. “Sometimes, we will see a spike in this curve because we are injecting the mold so fast that the machine cannot slow down in time to prevent mold damage. To overcome this issue, we are watching that pressure sensor data on the Kistler process monitoring system, waiting for the curve to start rising, and if it rises too soon, we stop the machine.”
“Later in this molding stage, it gets an actuator placed in it and then a retainer clipped over the entire product. It then goes to a final inspection station, where we use a Kistler sensor and the maXYmos to fire that sled and drive all those components into place. We then measure the forces to actuate and retract the medical assembly so that we get a complete profile of the actuation to determine the pass/fail percentage and the actuation numbers that we need to form a quality assured, repeatable medical assembly,” he adds,
Passetti says they use Kistler process monitoring systems and sensors to glean information from processes, and without this, they would likely struggle to meet the demands of today’s market.
“The presses that we purchase for our medical assembly line now have Kistler amplifiers built directly into them; they are integrated into the human machine interface (HMI) so that the reference curves and data can be transferred directly. We also have a stand-alone ComoNeo unit with its own monitoring system and a maXYmos with its own monitoring unit for other purposes,” Passetti explains.
Since implementing Kistler products, Passetti says the company has experienced success in terms of efficiency, repeatability, quality assurance, and cost-effectiveness.
“We are definitely reducing scrap because we can identify when we are making scrap in real-time,” Passetti says. “Being able to see what is going on directly in the mold – identifying non-conforming parts sooner – reduces scrap and improves our efficiency across the measuring chain.”
Looking at the reduced rate of scrap and increased return on investment (ROI), Passetti notes, “We are definitely satisfied with Kistler solutions. Kistler is continuously working to provide smaller systems and sensors, especially on the micro-scale side, and we are happy with how much easier it allows for integration into our machinery.” Kistler pressure sensors detect the force that drives the components, helping Tessy make adjustments if necessary.Tessy relies on Kistler sensors and cavity pressure systems, from the actual measurement through to the comprehensive documentation of cavity pressure.
Choosing to partner with Kistler has also paved the way for future success and process improvement.
“Our plan is to integrate more Kistler pressure sensors and systems into future molds and to retrofit our existing molds. Process systems and sensor technology from Kistler, integrated into our core processes, helps us stay ahead of the competition from a quality assurance and efficiency standpoint,” Passetti concludes.
The future of the medical tubing sector is highly dynamic because of pressures on organizations to provide high-quality solutions that deliver cost savings throughout the product life cycle. This is mainly driven by the global healthcare market, which continues to demand products and solutions that push the boundaries of what is possible at a highly competitive price point.
For neurovascular and other complicated techniques, catheter manufacturers are being pushed for solutions that cost-effectively deliver complex procedures efficiently. In highly cost-conscious markets, peelable heat-shrink tubing products enable catheter manufacturers to advance efficiencies through streamlining workflows.
Peelable heat-shrink tubing
Peelable heat-shrink tubing (PHST) addresses unmet healthcare needs, such as ultra- small PHST that supports progressively smaller catheter-based procedures. PHST technology reduces total cost of ownership (TCO) because manufacturers don’t have to skive heat-shrink material from the catheter. Removing skiving allows companies to produce more quickly, improve yields, and lower inspection levels while increasing economic safety.
Junkosha’s 2.5:1 PHST solution provides catheter manufacturers with the highest shrink ratio currently possible in a fluorinated ethylene propylene (FEP). Catheter manufacturers save time and money through a reduced number of shrink processes. In addition, thanks to PHST’s take-up, it uses cost-effective, lower tolerance, baseline materials in the manufacturing process, enabling easy reflow into a single, smooth construct.
Applications
According to Robert LaDuca, CEO of medical device tubing and catheter components manufacturer Duke Empirical, high-ratio PHST technology will enable better processes and cost savings in neurovascular catheters which have tapered diameters for the floppy distal segments and proximal sections with larger diameters for pushable support. Catheters are typically braid-reinforced proximally and coil-reinforced distally, so PHST solutions must accommodate the compression required to provide significant bond strength of the materials in a single step.
LaDuca adds that the technology supports tapered cardiovascular devices such as multi-lumen, braid reinforced, peripherally inserted central catheters (PICC) and various next-generation catheters with varying diameters, such as cardiac implant delivery systems where the implant is located in a distal segment of the catheter that is usually larger than the proximal portion of the shaft. Faster, more forceful recovery of the 2.5:1 PHST products reduces or eliminates air entrapment, which can cause bubbles and product defects such as fish eyes, voids, and insufficient strength of bonded layers.
PHOTO COURTESY OF JUNKOSHA
What’s next
Numerous challenges face Junkosha and its supply chain in the U.S. and European markets, including:
Stringent regulation
Need to make procedures less invasive, enable wider variety of operations across harder-to-reach body parts
Increasing healthcare cost
Need to streamline workflows, processes; especially for catheter manufacturers
Although these various challenges differ around the world, they all require one thing: innovations that improve service for patients and provide clinicians and other end-users with technologies that make their lives easier, reduce costs, and save time. Continuous innovation must be at the heart of the healthcare sector’s requirements. Without this, unmet needs will continue.
About the author: Joe Rowan is president and CEO Junkosha USA and Europe. He can be reached at jrowan@junkosha.com or 949.825.6177.
Additive manufacturing: Ceramics
Departments - Medical Infographic
The range of applications, material types expands as ceramic additive manufacturing (AM) processes are continuously researched, validated, and implemented.
Strong compound annual growth rate (CAGR) in end-use part production, application, and hardware revenues
Market share by segment
2018
4% Traditional parts 8% Technical parts 21% General services 34% Specialized services 4% Traditional materials 5% Technical materials 22% High-end hardware 2% Low-cost hardware
2023
4% Traditional parts 14% Technical parts 8% General services 30% Specialized services 3% Traditional materials 7% Technical materials 28% High-end hardware 6% Low-cost hardware
Market
2018 $139 million
2019 $185 million
2020 $268 million
2021 $402 million
2022 $508 million
2023 $745 million
Key companies
3D Ceram Sinto 3D Systems Admatec ExOne HP Johnson Matthey Kwambio Lithoz Nanoe Prodway Tethon 3D Voxeljet Xjet
Forecast
AM adoption to experience an inflection point after 2025.
Source: Smartech Publishing, AM Opportunities in Ceramics 2018
High-throughput precision positioning, indexing for cylindrical machining
Departments - Featured Product
Intelligent laser power modulation (LPM) permits laser power control and rep rate as a function of cutting speed, directly and/or path directly from the MM9 I/O.
LaserLathe application-specific platforms integrate linear and rotary motion; various workholding devices; servo drives; a user-friendly, feature-packed graphic user interface (nuFace GUI); and a digital servo control system.
A 2-axis mechanical motion platform integrates a linear X-axis and theta-axis motion using direct-drive, brushless servomotors with integrated non-contacting, high-resolution encoders. The resulting smooth motion and precise positioning supports laser operations on small diameter and high-precision tubular components. The sealed autonomous mechanical motion platform module can be installed on any horizontal or vertical surface, creating a horizontal motion axis.
Intelligent laser power modulation (LPM) permits laser power control and rep rate as a function of cutting speed, directly and/or path directly from the MM9 I/O.
The LaserLathe also includes tapped mounting hole tooling features for attaching end-user guide systems to control workpieces at user-defined laser-processing points. Modular component attachment enables integration of configured guide bushing, liquid flush, and gas-assist systems.
Elizabeth Engler Modic (Edited by)
