Producing Medical parts with a Metal 3D printerMetal 3D printing is opening new avenues in the medical field, particularly for producing custom implants and prosthetics with high precision. It enables the creation of complex structures, such as porous designs that support bone growth, which are difficult to achieve with traditional manufacturing techniques. Additionally, the use of materials like titanium, known for its strength and biocompatibility, makes 3D printing ideal for medical applications. The technology offers an efficient way to produce both custom and serial parts, supporting advancements in patient care through more personalized solutions. MDE prints medical devices with two One Click Metal systemsThe Italian medical device manufacturer <a href="https://www.mde-rd.com/en/" target="_blank" rel="noopener noreferrer">MDE</a>, based in Brescia, Italy specializes in the production of medical devices and supports clients through the R&amp;D phase and prototyping. The company started with one <a href="https://oneclickmetal.com/boldseries/" target="_blank" rel="noopener noreferrer">3D printing system</a> from One Click Metal to print medical devices and prototypes in stainless steel. Recently they invested in a second system. The second system is dedicated to titanium, and further enlarges MDE‘S capacities to produce high-quality medical-grade components.

The italian company MDE shows how they are using metal 3D printing in their daily business. 

Metal 3D printing in the medical field

A tiny, four-fingered “hand” folded from a single piece of DNA can pick up the virus that causes COVID-19 for highly sensitive rapid detection and can even block viral particles from entering cells to infect them, University of Illinois Urbana-Champaign researchers report. Dubbed the NanoGripper, the nanorobotic hand also could be programmed to interact with other viruses or to recognize cell surface markers for targeted drug delivery, such as for cancer treatment.&nbsp;Led by <a href="https://bioengineering.illinois.edu/people/xingw">Xing Wang</a>, a professor of <a href="https://bioengineering.illinois.edu/">bioengineering</a> and of <a href="https://chemistry.illinois.edu/">chemistry</a> at the U. of I., the researchers describe their advance in the journal <a href="https://www.science.org/doi/10.1126/scirobotics.adi2084">Science Robotics</a>.&nbsp;Inspired by the gripping power of the human hand and bird claws, the researchers designed the NanoGripper with four bendable fingers and a palm, all in one nanostructure folded from a single piece of DNA. Each finger has three joints, like a human finger, and the angle and degree of bending are determined by the design on the DNA scaffold.&nbsp;<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1733792836250-232743.jpg" style="width: 100%px;" class="fr-fic fr-dib">Inspired by the human hand or bird claws, the NanoGripper has four fingers and a palm, all folded from one piece of DNA. Image courtesy of Xing Wang“We wanted to make a soft material, nanoscale robot with grabbing functions that never have been seen before, to interact with cells, viruses and other molecules for biomedical applications,” Wang said. “We are using DNA for its structural properties. It is strong, flexible and programmable. Yet even in the DNA origami field, this is novel in terms of the design principle. We fold one long strand of DNA back and forth to make all of the elements, both the static and moving pieces, in one step.”The fingers contain regions called DNA aptamers that are specially programmed to bind to molecular targets — the spike protein of the virus that causes COVID-19, for this first application ­— and trigger the fingers to bend to wrap around the target. On the opposite side, where the wrist would be, the NanoGripper can attach to a surface or other larger complex for biomedical applications such as sensing or drug delivery.&nbsp;To create a sensor to detect the COVID-19 virus, Wang’s team partnered with a group led by Illinois electrical and computer engineering professor <a href="https://ece.illinois.edu/about/directory/faculty/bcunning">Brian Cunningham</a>, who specializes in biosensing. They coupled the NanoGripper with a photonic crystal sensor platform to create a rapid, 30-minute COVID-19 test matching the sensitivity of the gold-standard qPCR molecular tests used by hospitals, which are more accurate than at-home tests but take much longer. &nbsp;&nbsp;“Our test is very fast and simple since we detect the intact virus directly,” Cunningham said. “When the virus is held in the NanoGripper’s hand, a fluorescent molecule is triggered to release light when illuminated by an LED or laser. When a large number of fluorescent molecules are concentrated upon a single virus, it becomes bright enough in our detection system to count each virus individually.”&nbsp;<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1733792872784-232744.jpg" style="width: 100%px;" class="fr-fic fr-dib">The NanoGripper can be designed to detect a number of viruses or other molecules, or even for targeted drug delivery for cancer treatment, the researchers say. Pictured, from left: researcher Wei Hong, graduate student Linh Le, postdoctoral researcher Mengxi Zheng, Professor Xing Wang, Professor Brian Cunningham, graduate student Skye Shepherd, research fellow Tingjie Song and postdoctoral researcher Saurabh Umrao.In addition to diagnostics, the NanoGripper could have applications in preventive medicine by blocking viruses from entering and infecting cells, Wang said. The researchers found that when NanoGrippers were added to cell cultures that were then exposed to COVID-19, multiple grippers would wrap around the outside of the viruses. This blocked the viral spike proteins from interacting with receptors on the cells’ surface, preventing infection.&nbsp;“It would be very difficult to apply it after a person is infected, but there’s a way we could use it as a preventive therapeutic,” Wang said. “We could make an anti-viral nasal spray compound. The nose is the hot spot for respiratory viruses, like COVID or influenza. A nasal spray with the NanoGripper could prevent inhaled viruses from interacting with the cells in the nose.”&nbsp;<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1733792895626-232746.png" style="width: 100%px;" class="fr-fic fr-dib">An artistic rendering of the NanoGripper’s applications. Sites on the gripper’s fingers recognize the spike protein of a virus, inset, and trigger fluorescent tags to emit light. When coupled with a sensor, individual viruses can be detected for a rapid COVID test, foreground. Alternately, the NanoGrippers can block viruses from entering cells by wrapping around the spike proteins, top right.The NanoGripper could easily be engineered to target other viruses, such as influenza, HIV or hepatitis B, Wang said. In addition, Wang envisions using the NaoGripper for targeted drug delivery. For example, the fingers could be programmed to identify specific cancer markers, and grippers could carry cancer-fighting treatments directly to the target cells.“This approach has bigger potential than the few examples we demonstrated in this work,” Wang said. “There are some adjustments we would have to make with the 3D structure, the stability and the targeting aptamers or nanobodies, but we’ve developed several techniques to do this in the lab. Of course it would require a lot of testing, but the potential applications for cancer treatment and the sensitivity achieved for diagnostic applications showcase the power of soft nanorobotics.” &nbsp;<hr>The National Institutes of Health and the National Science Foundation supported this work. Wang and Cunningham are affiliated with the <a href="https://www.igb.illinois.edu/">Carl R. Woese Institute for Genomic Biology</a> and the&nbsp;<a href="https://hmntl.illinois.edu/">Holonyak Micro and Nanotechnology Lab</a> at the U. of I.&nbsp;

Illinois researchers developed a nanorobotic hand made of DNA that can grab viruses for detection or inhibition. In this artist’s rendering, three “NanoGripper” hands wrap around a COVID-19 virus. Image courtesy of Xing Wang

A tiny, four-fingered “hand” folded from a single piece of DNA can pick up the virus that causes COVID-19 for highly sensitive rapid detection and can even block viral particles from entering cells to infect them, University of Illinois Urbana-Champaign researchers report.

Nanorobot hand made of DNA grabs viruses for diagnostics and blocks cell entry

Photonic Integrated Circuits (PICs) are optical microchips that combine multiple optical functions to create an optical circuit. These chips can generate, manipulate, and detect light. Today, PICs are the backbone of high-speed internet as these chips offer high-speed optical connectivity with minimal energy consumption. There has been a growing interest in research and commercial applications for PICs for various markets, including medical technology (MedTech), as they offer compact optical solutions at a low cost when mass-produced.&nbsp;<h2 dir="ltr">Benefits for MedTech</h2>The most significant benefits of PICs for the development and deployment of innovative MedTech systems in healthcare include:<ul><li dir="ltr">High Sensitivity and Reliability: PIC-based biosensors exhibit high sensitivity and reliability. These features enable the deployment in areas such as point-of-care diagnostics, where accurate and rapid results are required for effective patient management.</li><li dir="ltr">Compactness and Miniaturization: PICs enable the development of compact and miniaturized devices, which is particularly advantageous for wearable health devices and lab-on-chip applications. This miniaturization results from the integration of complex optical functions into small form factor chips, which is key for the development of advanced diagnostic and monitoring technologies that are more user-friendly and more accessible.</li><li dir="ltr">Cost-Effectiveness: The integration of photonic components onto a single chip and ability to manufacture them on a large scale, significantly reduces the cost of a chip. Thus, use of PICs makes advanced medical technologies more affordable for widespread use.</li><li dir="ltr">Accelerated Performance: PICs offer improved performance characteristics such as low propagation losses, high power handling, and efficient integration of active components. These features are vital for the development, deployment and operation of high-performance imaging and sensing solutions in healthcare. The latter are enabling more precise diagnostics and better patient outcomes.</li><li dir="ltr">Versatility in Applications: PICs are very versatile and can be used in a wide range of MedTech applications, from biosensing and imaging to environmental monitoring in healthcare-related settings. This adaptability makes PICs capable of addressing diverse medical challenges.</li></ul>Overall, PICs are transforming MedTech based on innovative solutions that enhance the accuracy, efficiency, and accessibility of healthcare technologies. Their ability to integrate multiple functions into single microsystems and devices makes them suitable for a wide range of advanced medical diagnostics and treatment applications.<a href="https://www.wevolver.com/article/global-photonics-engineering-contest?utm_source=photon+delta&utm_medium=articles&utm_campaign=photonics"><img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1733744077828-photon+delta+-+NOW+LIVE+%281920+x+500+px%29.png" style="width: 100%px;" class="fr-fic fr-dib"></a><h2 dir="ltr">PIC-Enabled Transformative Applications in MedTech</h2>Some of the most prominent MedTech applications that are enabled by PICs include:<h3 dir="ltr">Advanced Diagnostics</h3>PICs are enhancing diagnostic capabilities through technologies like Optical Coherence Tomography (OCT), which is a contactless imaging technique that is used for examining living tissue. OCT is a very useful tool for medical diagnostics thanks to its non-invasive imaging capabilities, which enable high-resolution images of biological tissues. PICs can be used to miniaturize OCT systems, making them more accessible and portable for widespread clinical use. For instance, one of the popular applications of OCT is the detection of tumors or eye disorders. Existing OCT equipment is however costly and bulky in size, which prevents the adoption and use of the technology outside hospitals. PICs can alleviate this limitation based on a significant reduction of the size and cost of the devices. Specifically, PICs enable the development of handheld OCT probes, which are based on lasers and detectors that are directly integrated onto the photonic chip.&nbsp;<h3 dir="ltr">Wearable Health Devices</h3>The miniaturization and integration capabilities of PICs make them ideal for the development and integration of wearable health devices. These devices can continuously monitor vital signs such as heart rate, oxygen levels, and glucose levels with high precision. The compact nature of PICs allows for the development of lightweight and comfortable wearables that provide real-time health monitoring. Commercial companies have demonstrated &nbsp;PIC-enabled systems for spectroscopic breath analysis. It can reveal diseases or metabolic disorders based on the detection of trace gases like methane and nitric oxide. In this direction, laser-based absorption spectroscopy is used to combine high sensitivity and high temporal resolution. The miniaturization and mass production offered by PICs can adopt this spectroscopic technique into handheld devices. In this context, commercial companies are attempting to demonstrate a sensor that can be mounted in a smartwatch to enable the monitoring of a range of different biomarkers.&nbsp;<h3 dir="ltr">Point of Care (PoC) Diagnostics</h3>As already outlined, PIC-enabled biosensors can be very efficient in detecting pathogens based on the measurement of changes in the refractive index of their waveguides. The main advantage of such methods is that the resulting measurements can be very accurate. Moreover, based on such devices it is possible to detect different pathogens using a single chip with only a single sample. As a prominent example, <a href="https://www.phix.com/">PHIX</a> provides the packaging for a PoC diagnostics biosensing platform, which is enabled by a PIC that comprises Vertical-Cavity Surface-Emitting Lasers (VCSELs) and photodiodes. The latter are integrated within a Printed Circuit Board (PCB), along with protective layers. This packaging leads to a cost-effective disposable cartridge that can be integrated within a portable diagnostics device.As another example, <a href="https://bialoom.com/">Bialoom</a> integrates PICs in their proprietary silicon plasmo-photonic biosensor technology, which combines silicon photonics and plasmonics. This technology is used to create biochips embedded in disposable cartridges, designed for rapid and sensitive detection of biomarkers from blood samples. The primary application of Biabloom’s biochips is the diagnosis and treatment of severe infections, which provides a point-of-care diagnostic solution that enables quick and evidence-based medical decisions.<h3 dir="ltr">Optical Sensors in Minimally Invasive Surgeries&nbsp;</h3>Minimally invasive surgeries require precision and real-time feedback. PICs enable the development of sophisticated optical sensors that provide surgeons with critical information during procedures. For example, application-specific photonic integrated circuits (ASPICs) can offer haptic feedback to surgeons, which enhances their ability to perform delicate operations with greater accuracy.<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1733744489308-robot+1.jpg" style="width: 100%px;" class="fr-fic fr-dib">The above-listed applications illustrate that the integration of PICs into MedTech goes beyond mere technological improvements. It enables a paradigm shift that is enabled by a combination of hardware, software and process related innovations (e.g., innovations in diagnostic operations). PIC-enabled solutions are more efficient, cost-effective, and scalable, which enables innovative healthcare solution integration.&nbsp;<h2 dir="ltr">Industry Leaders Insights on the Future of PIC-based MedTech&nbsp;</h2>Recent research initiatives have demonstrated the future of integrating PIC microsystems within MedTech devices and applications. For instance, Maarten Buijs, the CEO of <a href="https://www.surfixdx.com/">Surfix Diagnostics</a> envisions that <a href="https://www.phix.com/markets/medical-devices/">future photonic biochips will integrate both light sources and signal detectors to enable the next generation of point of care devices</a>.&nbsp;In the near future, PICs could be widely used to provide rapid laboratory testing results from simple samples (e.g., urine), which will boost timely diagnostics and more effective treatments. Likewise, PICs will reduce the cost of complexity of blood tests, which could transfer laboratory-level diagnostics at the point of care. As a prominent example, <a href="https://siphoxhealth.com/">SiPhox Health</a> has already developed a silicon photonic chip for <a href="https://www.prnewswire.com/news-releases/siphox-health-introduces-worlds-first-lab-quality-home-blood-testing-platform-at-ces-301714545.html">home-based blood testing</a>, which enables an innovative approach to providing high-quality blood test results quickly and efficiently at home. The company’s solution can measure up to fifty biomarkers from home, which enables patients to gain insights on their heart health, check for inflammation, and access information about the functioning of their thyroid, metabolism, and hormones.There are also PICs applications in biological research beyond PoC diagnostics. As a prominent example, <a href="https://www.imec-int.com/en/articles/integrated-photonics-guiding-light-next-gen-medtech-tools">IMEC highlights the use of silicon nitride-based photonic platforms in medical applications</a>. These platforms could get a boost by the integration of III-V light sources into photonic circuits, which will enable medical tools such as fluorescence microscopy used in DNA sequencing and biological research. Relevant research focuses on the use of photonics on chips to create light interference patterns for very high-resolution <a href="https://www.olympus-lifescience.com/en/microscope-resource/primer/lightandcolor/fluoroexcitation/">fluorescent excitation</a>.&nbsp;Overall, recent advances in PICs and their integration in MedTech applications demonstrate the potential of this technology to transform healthcare. Nowadays, almost 27 years after the development of the<a href="https://www.sciencedirect.com/science/article/abs/pii/S0925400597802547">&nbsp;first SiN PIC-based sensing devices</a>, there is a growing number of PIC applications that are already transforming diagnostic tools, enhancing wearable devices, and improving surgical outcomes. Most importantly, the precision, size, cost-effectiveness and non-invasive operations advantage of the technology make it an enabler for a whole range of novel healthcare applications that are hardly possible nowadays. In the years to come, it is highly likely that PICs enable innovative applications beyond what is available today, which will further revolutionize healthcare delivery.<hr><h2>The Global Photonics Engineering Contest is now live!</h2>The Global Photonics Engineering Contest invites engineers, innovators, and startups to push the boundaries of Photonic Integrated Circuits (PIC) and create applications that address complex engineering challenges and push the boundaries of the industry. Whether you’re in semiconductors, data &amp; telecom, medtech, or agritech, we want to see your breakthrough idea that can harness the power of PICs to change the world.<a href="https://www.wevolver.com/article/global-photonics-engineering-contest?utm_source=photon+delta&utm_medium=articles&utm_campaign=photonics"><img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1733741315174-Untitled+%281920+x+500+px%29+%281%29.png" style="width: 100%px;" class="fr-fic fr-dib"></a><ul><li dir="ltr">Prize: €50,000 worth of services from the PhotonDelta ecosystem to to make your idea market-ready + a chance to receive up to €2 million in pre-seed funding.</li><li dir="ltr">Audience: Open to all engineers, researchers, OEMs, hardware manufacturers, startups/scale-ups, research teams, and students working on innovative PIC applications.</li><li dir="ltr">Early Bird Opportunity:&nbsp;All submissions received by 31st December 2024, will receive personalized feedback from PhotonDelta engineers.</li><li dir="ltr">End date: March 3rd 2025</li></ul><a href="https://www.wevolver.com/article/global-photonics-engineering-contest?utm_source=photon+delta&utm_medium=articles&utm_campaign=photonics" class="button-main-action">ENTER THE CHALLENGE NOW</a><hr>

There has been a growing interest in research and commercial applications for PICs for various markets, including medical technology (MedTech), as they offer compact optical solutions at a low cost when mass-produced. 


Unlocking the Power of Photonic Integrated Circuits in MedTech

Artificial intelligence (AI) is rapidly transforming healthcare by leveraging machine learning techniques to analyze medical images, patient data, and genetic information with unprecedented speed and accuracy, significantly improving early disease detection and enhancing diagnostic precision.


AI-Powered Health Diagnostics

<a href="https://www.cdc.gov/chronic-disease/about/index.html/" target="_blank">Six in 10</a> Americans are living with at least one chronic disease, and four in 10 Americans have two or more chronic diseases. Some of those diseases, such as hypothyroidism and inflammatory diseases, require individuals to carefully track certain blood tests in order to manage their conditions. Unfortunately, that usually means an onerous cycle of scheduling appointments, traveling to hospitals, and waiting for lab results.Now SiPhox Health is working to help patients and their doctors manage diseases from the comfort of their home with a new kind of blood test based on a silicon photonic chip. The system is the size of a coffee maker and can produce precise readings for 20 different biomarkers.The chip-based device is not yet FDA-cleared, so it is currently only being used for research purposes, but SiPhox also provides mail-in blood testing to thousands of people with chronic diseases, both directly and through other health care and wellness businesses, using approved technology. The company hopes its new system can soon deliver faster results to every home that needs it.“A lot of blood tests aren’t done because they're too inconvenient,” SiPhox founder and former MIT researcher Michael Dubrovsky says. “People skip scheduled blood tests, and physicians don’t always prescribe blood tests because they know it’s inconvenient. That requires them to base their decisions on symptoms, and that’s not optimal for many of these chronic diseases.”Dubrovsky and SiPhox co-founder Diedrik Vermeulen met at MIT while researching photonic chip and laser technology. They see SiPhox’s technology as the latest in a long trend toward smaller and more scalable devices as they are condensed onto integrated chips.“Biolabs typically do blood testing with these large instruments that are full of optics, lasers, lenses, mirrors, and all these very expensive features,” Vermeulen says. “We don’t change any of the main features. We leave all the optics the same, but we miniaturize it onto our chips and make it so scalable that you can ship it to homes. It’s like how computers used to be the size of a room and you could only find them in high-end universities — now they’re all on a chip. We’re doing the same for blood testing.”<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1731976955976-MIT-SiPhox-03-press.jpg" style="width: 100%px;" class="fr-fic fr-dib">"We can offer a new way for people to access health care in their home," Vermeulen says. Pictured is an example of the package sent to clients. Image: Courtesy of SiPhox Health<h2>Photonic chips with electric properties</h2>Dubrovsky and Vermeulen met through the MIT ecosystem in 2019. Vermeulen had worked in MIT’s Silicon Photonics Group within the Research Laboratory of Electronics and Dubrovsky was working in the MIT Materials for Micro and Nano Systems group.The two quickly bonded over a new way to approach optical chips.“We had this idea of doing optical chips more like a printed circuit board,” Vermeulen explains. “Electrical chips incorporate a lot of chips on one circuit board, but optical chips typically do everything with a single chip. We wanted to combine optical chips into a new kind of circuit board.”The founders met regularly in the Martin Trust Center for MIT Entrepreneurship to refine their approach. In February of 2020, they started filing patents and receiving guidance from MIT professors. They also entered the START.nano program, which helps early-stage companies accelerate their innovations by giving them access to MIT.nano’s laboratories and equipment.The same lasers that are used to mass produce traditional silicon chips can be used to manufacture SiPhox’s integrated photonic silicon chips. Each 1-millimeter chip contains lenses, polarizers, modulators, splitters, and other optical components you’d see in a traditional lab-based system, but SiPhox’s chips are cheap enough to be single-use.Just as the founders were deciding on the first application for their new chip, the Covid-19 pandemic hit. They took that as a sign.“We decided to focus on biosensing, with one of our chips being disposable and the other one being reusable,” Vermeulen says.The founders worked to detect infectious disease with their chips but realized the technology was better suited for high-fidelity blood testing.“I worked a lot on tunable lasers at MIT, and we use a slightly different approach to lasers at SiPhox,” Vermeulen says. “We applied all of the lessons we learned at MIT to design something from scratch.”SiPhox’s chip testing system works with third-party arm patches that people already use to collect blood samples at home. Dubrovsky likens the system to a Nespresso machine in which users simply place a pod into the machine and press a button. Each of SiPhox’s disposable cartridges contains an array of photonic immunoassay sensors that can be used to detect specific proteins or hormones.The system includes a dashboard that can be viewed by a physician or the patient themselves to get biomarker data at home. The dashboard also provides historic data and educational content about the biomarkers measured. SiPhox also uses large language models to parse third-party blood test data, allowing users to track traditional blood tests in the same dashboard.Because the approach makes use of semiconductor lasers and silicon chips, the founders say a single traditional chip manufacturing facility, or fab, could produce 1 billion of SiPhox’s chips every month.“Our technology is very scalable because it’s all on a chip,” Vermeulen says. “There are only two ways to really scale something: You can do injection molding; that’s how you produce billions of plastic cups, for instance. But if you want to scale something very complex, you have to put it on a silicon chip.”<h2>A platform for health</h2>The founders believe their technology could enable a world where tracking biomarkers is as easy as brushing your teeth. That would have huge implications for the tens of millions of Americans who need to get regular blood tests to manage chronic diseases.“For people with inflammatory diseases, tracking inflammation levels is very important because they can develop resistance to their medicine,” Dubrovsky says. “Once they experience symptoms of a flare-up, it’s very hard to reverse. And these symptoms can be horrible, so catching it early is really important.”To gain FDA clearance, SiPhox plans to begin studies in coming months, but its system’s accuracy has already been validated by third parties, and the company’s Burlington, Massachusetts, facility is capable of manufacturing about 10,000 of its cartridges per month.Once SiPhox gains FDA clearance, it plans to partner with health care systems, health insurers, employers, and mail-in blood testing companies to help people everywhere track their health.“We can offer a new way for people to access health care in their home,” Vermeulen says. “Once they have our blood testing device, whether for a chronic disease or something else, anytime they want telehealth-enabled by blood testing, they can use our device, similar to how Apple users have access to third-party apps from many different service providers. Siphox users will have access to curated third-party services built on top of the core blood testing capability.”

SiPhox Health is working to help patients and their doctors manage diseases from the comfort of their home with a new kind of blood test based on a silicon photonic chip. Image: Courtesy of SiPhox Health

The startup SiPhox, founded by two former MIT researchers, has developed an integrated photonic chip for high-quality, home-based blood testing.

Bringing lab testing to the home

Did you know that injection molding is transforming the medical device industry? This advanced process empowers designers to create high-quality and cost-effective products, ranging from common medical items to highly regulated devices. As products move through various stages of development—from initial prototyping to full-scale production—they must consistently meet stringent compliance, safety, and functionality standards. This ensures that each medical device aligns with critical industry requirements at every step.If you’re considering taking the next step in medical injection molding, this article will guide you through 4 key considerations in medical injection molding, from understanding device classifications and regulations to selecting suitable materials and preparing your design.<h2 dir="ltr">Key Considerations in Medical Injection Molding</h2><h3 dir="ltr">1. Regulatory Compliance: Meeting Corresponding Standards</h3>&nbsp;Food and Drug Administration (FDA) guidelines in the U.S. mandate rigorous tracking and documentation at every production stage to guarantee the traceability of each component. Meanwhile, Medical Device Regulation (MDR) standards in the EU emphasize consistent product safety across the device’s entire lifecycle, pushing manufacturers to follow stringent standards.Medical devices are divided into three classifications, by both FDA and MDR, based on associated risk, each with specific regulatory requirements:Class I Medical Devices: These low-risk devices pose minimal harm to users, often including items like bandages, gloves, and hand-held surgical instruments. Regulatory requirements are relatively basic, focusing mainly on general safety and quality.Class II Medical Devices: Moderate-risk devices, such as syringes, infusion pumps, and diagnostic equipment, require additional regulatory controls. These may involve special labeling, performance standards, and post-market supervision.Class III Medical Devices: High-risk devices, including pacemakers, defibrillators, and implants, require the highest level of regulatory supervision. This includes rigorous premarket approval, extensive testing, and clinical trials to confirm safety and effectiveness.For instance, a diagnostic device used for detecting infectious diseases needs each plastic component to withstand various sterilization processes without degrading or releasing harmful substances. Even minor contamination could compromise the device’s accuracy or pose risks to patients, underscoring the importance of these strict regulatory standards. Ensuring regulatory compliance is essential in medical injection molding, as incorrect categorization or non-compliance can lead to delays, increased costs, and a longer time to market.<h3 dir="ltr">2. Certifications: Guaranteeing Quality and Safety</h3>Certification is a standard, ensuring the products meet or exceed industry requirements. Key certifications in the medical industry include:ISO 13485: This certification ensures a quality management system is in place, maintaining consistency across production batches. For example, if producing IV systems or ventilators, ISO 13485 certification is critical.ISO 10993: For parts that come in direct contact with bodily fluids or tissues, ISO 10993 ensures biocompatibility. This certification is essential when manufacturing parts such as catheter tips or implantable device housings, where material safety directly impacts patient health.ISO 14644: This cleanroom certification is crucial for preventing contamination. A cleanroom-certified facility, for instance, can safely produce surgical device components that require a sterile environment, ensuring they meet hospital and surgical standards.<h3 dir="ltr">3. Material Selection: Biocompatibility and Durability</h3>Choosing materials for medical applications involves considerations beyond standard injection molding. Examples include:<ul><li dir="ltr">Polycarbonate (PC): Due to its strength and transparency, often used for housing devices requiring internal visibility, such as blood analyzers.</li><li dir="ltr">Polyethylene (PE):&nbsp;Known for chemical resistance and flexibility, PE is used in IV bags and tubing, ensuring durability and low moisture absorption.</li><li dir="ltr">Polypropylene (PP): With strong impact resistance and sterilization stability, PP is used in syringes and medical containers, offering long-term reliability.</li><li dir="ltr">Polystyrene (PS):&nbsp;Widely used for disposable labware, PS offers rigidity, transparency, and easy sterilization, making it suitable for laboratory applications.</li><li dir="ltr">Polyether Ether Ketone (PEEK):&nbsp;Widely used in implantable devices due to its strength, stability under sterilization, and biocompatibility.</li><li dir="ltr">Thermoplastic Elastomer (TPE):&nbsp;Its flexibility makes it suitable for soft-touch surgical instrument handles that withstand repeated sterilization.</li></ul>Every material choice has specific trade-offs. For instance, while PE and PP are cost-effective and chemically resistant, they might lack the strength needed for parts exposed to high-stress environments. Therefore, understanding these nuances helps in material selection, optimizing for both performance and cost.<a href="https://www.rpworld.com/en/resources/blog/what-materials-work-best-for-your-medical-device-development.html">&nbsp;Click Here</a> to explore more material choices.<h3 dir="ltr">4. Prototyping to Production: Ensuring a Smooth Transition</h3>Transitioning from prototypes to full-scale production isn’t always straightforward. During prototyping, designs may feature thinner walls or more complex geometries than standard injection molding processes can easily reproduce at scale. For example, a prototype with sharp corners that’s achievable created by the vacuum casting process, but requires design optimization, such as adding radii, and adding draft angle for efficient injection molding without sacrificing quality.When scaling up, an experienced injection molding partner with expertise and capabilities can help optimize these designs for manufacturability without compromising on quality. At RPWORLD, we assist clients in this crucial transition, helping optimize part design, select the most suitable materials, finishing options and more to support efficient and regulatory-compliant production.<h2 dir="ltr">How RPWORLD Injection Molding Accelerates Your Medical Development</h2>At RPWORLD, we integrate material expertise, one-stop manufacturing services, in-depth DFM analysis and ISO-certified process to help bring medical devices to market faster. Our services cover the entire lifecycle—from prototyping to mass production—tailoring to meet the unique needs of each medical device.Our Injection Molding Services Include:<ul><li dir="ltr">20+ years of experience in medical device injection molding, from prototyping to end-use production.</li><li dir="ltr">Mold flow analysis, and in-house tools design and fabrication.</li><li dir="ltr">Design for Manufacturing (DFM) guidance, including design optimization, material selection, finishing selection and more to avoid costly rework and save time up to 80%.</li><li dir="ltr">A wide variety of post-processing options to perfect your parts.</li><li dir="ltr">State-of-the-art quality inspection equipment and stringent quality control including real-time process monitoring to ensure consistency.</li></ul>

Photo by National Cancer Institute on Unsplash

If you’re considering taking the next step in medical injection molding, this article will guide you through 4 key considerations in medical injection molding, from understanding device classifications and regulations to selecting suitable materials and preparing your design.

From Prototype to Production - 4 Critical Considerations for Safe and Compliant Medical Injection Molding

This article was discussed in our <a href="https://www.wevolver.com/profile/the.next.byte" rel="noopener noreferrer">Next Byte podcast</a>.&nbsp;<iframe height="200px" width="100%" frameborder="no" scrolling="no" seamless="" src="https://player.simplecast.com/6b08d0cb-2606-44e8-be73-1dd17a7d2839?dark=false" class="fr-draggable" data-gtm-yt-inspected-24="true" data-lf-form-tracking-inspected-kn9eq4roawkarlvp="true" data-lf-yt-playback-inspected-kn9eq4roawkarlvp="true" data-lf-vimeo-playback-inspected-kn9eq4roawkarlvp="true"></iframe> The full article will continue below.<hr> <iframe width="640" height="360" src="https://www.youtube.com/embed/k7oJjazQAe4?&amp;wmode=opaque&amp;rel=0&amp;enablejsapi=1&amp;origin=https://www.wevolver.com" frameborder="0" allowfullscreen="" class="fr-draggable" data-gtm-yt-inspected-24="true" data-lf-form-tracking-inspected-kn9eq4roawkarlvp="true" data-lf-yt-playback-inspected-kn9eq4roawkarlvp="true" data-lf-vimeo-playback-inspected-kn9eq4roawkarlvp="true">&nbsp;</iframe>As we age, it becomes more difficult to remember where things are—whether it’s recalling where we left the keys or where we parked the car. This spatial memory deteriorates further with the onset of dementia, a condition that someone in the world develops every three seconds, according to Alzheimer’s Disease International.<img src="https://images.wevolver.com/eyJidWNrZXQiOiJ3ZXZvbHZlci1wcm9qZWN0LWltYWdlcyIsImtleSI6ImZyb2FsYS8xNzMxMDI1MjMwNTYyLTI5YzA1YzhlLmpwZyIsImVkaXRzIjp7InJlc2l6ZSI6eyJ3aWR0aCI6OTUwLCJmaXQiOiJjb3ZlciJ9fX0=" style="width: 100%px;" class="fr-fic fr-dib">© Alzheimer’s Disease International<blockquote>We are addressing a serious concern for those affected by dementia.<footer>- Friedhelm Hummel</footer></blockquote>Researchers at two EPFL labs have joined forces to give a boost to spatial memory by creating a unique experimental setup that combines non-invasive deep-brain stimulation, virtual reality training, and fMRI imaging—all housed within Campus Biotech in Geneva. Published in Science Advances, the study demonstrates that targeted, painless electric impusles to the hippocampus and adjacent structures, a deep brain region implied in memory and spatial navigation, can improve the brain’s ability to recall locations and navigate more effectively.“By finding ways to improve spatial memory without surgery or medication, we are addressing a serious concern for a large and growing population: the elderly, as well as brain trauma patients and those affected by dementia,” says Friedhelm Hummel, head of the <a href="https://www.epfl.ch/labs/hummel-lab/">Hummel Lab</a>.The study is the result of a collaboration between the Hummel Lab and Olaf Blanke’s Laboratory of Cognitive Neuroscience (<a href="https://www.epfl.ch/labs/lnco/">LCNO</a>), both at EPFL’s Neuro X institute. By combining Hummel’s expertise in non-invasive brain stimulation with Blanke’s cognitive research of spatial navigation in virtual reality environments, the researchers developed a unique neuro-technological setup.<h2>A one-of-a-kind combination of neuro-technologies</h2>The experiment begins with researchers placing four harmless electrodes on the heads of healthy individuals to stimulate the hippocampus and adjacent structures. This non-invasive technique, <a href="https://actu.epfl.ch/news/non-invasive-deep-brain-stimulation-enhances-motor/">called transcranial temporal interference electric stimulation</a> (tTIS), sends targeted pulses without causing any discomfort for the participant.<blockquote>This leads us to believe that by stimulating the hippocampus, we temporarily increased brain plasticity.<footer>Elena Beanato</footer></blockquote>Next, volunteers are immersed in a virtual world using VR goggles. <a href="https://infoscience.epfl.ch/server/api/core/bitstreams/3f433490-92a4-461e-be04-fc02dea934b0/content">Building on previous research</a> by co-first-author Hyuk-June Moon, the scientists task the participants with navigating through a series of locations and remembering key landmarks. This immersive virtual setting allows researchers to precisely measure how well participants can recall and navigate spatial information whilst receiving tTIS.<img src="https://images.wevolver.com/eyJidWNrZXQiOiJ3ZXZvbHZlci1wcm9qZWN0LWltYWdlcyIsImtleSI6ImZyb2FsYS8xNzMxMDI1Mjc2NjI5LTkyYmZiNzhiLmpwZyIsImVkaXRzIjp7InJlc2l6ZSI6eyJ3aWR0aCI6OTUwLCJmaXQiOiJjb3ZlciJ9fX0=" style="width: 100%px;" class="fr-fic fr-dib">Full experimental setup at Campus Biotech, combining non-invasive brain stimulation, virtual reality and fMRI. © 2024 EPFL“When stimulation was applied, we observed a clear improvement of the participants’ recall time—the time it took to start moving toward where they remembered the object to be,” says Elena Beanato, the other first author of the study. “This leads us to believe that by stimulating the hippocampus, we temporarily increased brain plasticity, which, when combined with training in a virtual environment, leads to better spatial navigation.”The entire experiment was conducted within an fMRI scanner. This provided researchers with real-time images of brain activity, allowing them to monitor how the hippocampus and surrounding regions responded to tTIS during the spatial navigation tasks. The fMRI data revealed changes in neural activity associated with the observed behavioral changes, specifically in the regions responsible for memory and navigation, giving the researchers deeper insight into how non-invasive stimulation modulates brain function.This integration of advanced technologies at EPFL's Neuro X Institute, makes Campus Biotech one of the few places where all three experimental techniques can be combined in a single study.<blockquote>“In the long term, we envision using this approach to develop targeted therapies for patients suffering from cognitive impairments.<footer>- Olaf Blanke</footer></blockquote>“The alliance of tTIS, virtual reality, and fMRI offers a highly controlled and innovative approach to studying the brain’s response to stimulation and its impact on cognitive functions,” adds Olaf Blanke. “In the long term, we envision using this approach to develop targeted therapies for patients suffering from cognitive impairments, offering a non-invasive way to enhance memory and spatial abilities.”<hr>ReferencesBeanato, E., Moon, H.-J., Windel, F., Vassiliadis, P., Wessel, M. J., Popa, T., Menoud, P., Neufeld, E., De Falco, E., Gauthier, B., Steiner, M., Blanke, O., &amp; Hummel, F. C. (2024). Noninvasive modulation of the hippocampal-entorhinal complex during spatial navigation in humans. Science Advances. DOI: <a href="https://doi.org/10.1126/sciadv.ado4103" target="_blank" rel="noopener">10.1126/sciadv.ado4103</a>

EPFL researchers have combined virtual reality, non-invasive brain stimulation and advanced brain imaging techniques to improve spatial navigation in healthy participants. The study is a first step in addressing dementia in an aging population without medication or surgery.

Neurotechnology boosts memory without surgery

<section id="isPasted">Imagine you have a virtual copy of your own body. This digital twin, an accurate computer model, can help doctors better understand your health, personalize treatments, and intervene earlier to prevent more significant problems. What sounds like science fiction now is becoming more and more of a reality, and in the (distant) future, it could revolutionize healthcare.Source: <a href="https://www.catharinaziekenhuis.nl/actueel/" target="_blank" rel="noreferrer">Catharina Ziekenhuis Eindhoven</a> / Geert Piek</section><section tabindex="-1">A digital twin is actually a kind of digital version of yourself, based on data from your body, but also on information from many other people. This technology is already being used in sectors such as industry and urban planning, where these virtual copies can be used to predict how machines or traffic systems will behave, for example.Now, this technique is also increasingly finding its way into healthcare.<h2 id="isPasted">What does this mean for the patient of the future?</h2>Lukas Dekker, cardiologist-electrophysiologist at the Catharina Hospital and professor at Eindhoven University of Technology (TU/e), explains: “In the future, we will be able to provide tailor-made care with the help of a digital twin.”“This means that we are better able to determine the best treatment for each patient, instead of giving everyone the same standard of care. This not only makes healthcare more personalized but also more efficient and affordable. We move away from the idea of&nbsp;one size fits all.”A digital twin is not a simple model that doctors use to try out surgeries in advance but a smart collection of data that uses real-time information to simulate and predict your health. “We combine medical scans, data on how your body moves and how it responds to treatments. This allows us to calculate, for example, how your heart functions,” says Dekker.<h3>Saving lives</h3>This opens the door to new possibilities. Let's say you've had a heart attack. With a digital twin, doctors would be able to predict who has an increased risk of cardiac arrhythmias after such an attack. That can save lives.Carlijn Buck, PhD candidate in cardiovascular biomechanics, is working on&nbsp;<a href="https://www.catharinaziekenhuis.nl/kan-data-voorspellen-wie-na-een-infarct-hartritmestoornissen-ontwikkelt/" target="_blank" rel="noreferrer">the development of digital twins of heart patients within the COMBAT-VT project</a>. “It's still a long way off to make a complete digital copy of the body, but the first versions of digital twins of the heart have already been created,” she says. “The next step is for such a model to adapt as new data comes in, and then quickly predict whether something will go wrong.”This means that doctors can predict your health better and better without you having to go to the hospital constantly. “In the future, more and more devices you wear – such as smart watches or heart monitors – will pass on data to your doctor.”“They can then monitor your health remotely and intervene if necessary,” explains Dekker. “When something is measured, you don't just want the data in question to be analyzed, but also to be analyzed in a certain context. After all, one person differs significantly from another, whether that is due to age, weight, or medical history.”<h3 id="isPasted">No unnecessary burden on healthcare</h3>One of the most significant advantages of a digital twin is that it helps doctors estimate when you need what type of medical care. “Some patients may need to be checked more quickly than others. With a digital twin, we can better assess this in the future and offer tailored care,” says Dekker.This also means that the healthcare system is not unnecessarily burdened. “Not every patient needs a complicated model,” Buck explains. “For some patients, a simple risk model is sufficient, based on data such as age and weight. But if there is a high risk, we can create a more detailed model to get a better understanding.”She explains that this requires more complicated data, such as an MRI scan of the heart. This means more impact for the patient, a more labor-intensive job for the medical engineer who assembles the twin, and higher healthcare costs. “So if you don't need such a detailed model, you shouldn't do it.”<h3>Human side remains crucial</h3>Creating&nbsp;a digital twin is an intensive process in which technicians and doctors work closely together. The technician builds the twins while the doctor determines how they will be used in practice. “For example, in the case&nbsp;<a href="https://www.catharinaziekenhuis.nl/behandelingen/ablatie/" target="_blank" rel="noreferrer">of ablation</a>, a procedure to treat cardiac arrhythmias, the model could help determine when and how the heart can best be treated,” says Buck.But, she emphasizes, a digital twin does not replace the doctor. “The model doesn't tell you how you feel or how you view surgery. It can't take the context into account; it's only useful for what it's made for. It is, therefore, a tool for the doctor to provide the best possible care. The human side and the overall context remain crucial, and that’s why we will still need a doctor.”<h3>Enormous possibilities</h3>Although the technology is still in the early stages of development, the possibilities of digital twins are enormous. The combination of data, technology and medical expertise ensures that we can provide more and more tailor-made care in the future.The COMBAT-VT project falls under the umbrella of the&nbsp;<a href="https://www.tue.nl/en/research/research-groups/eaisi/eaisi-business-operations/eindhoven-medtech-innovation-center/" target="_blank">Eindhoven MedTech Innovation Center (e/MTIC),</a> a large regional partnership in the field of medical technology between TU/e, Philips, and the Catharina Hospital, Maxima Medical Center, and Kempenhaeghe. A crucial collaboration for this research is combining input from healthcare with technological developments. </section>

Lukas Dekker and Carlijn Buck in consultation with their digital twin. Photo: Catharina Ziekenhuis Eindhoven

Researchers Lukas Dekker and Carlijn Buck of TU/e and the Catharina Hospital are investigating how they can provide better-tailored care to heart patients through smart modeling, thanks to a digital twin of each patient.

Digital twins will help to tailor healthcare more in the future

<section id="isPasted">In the 2010s, at-home 3D printing become a widespread craze but as years passed the buzz has quieted. While some of the media excitement may have tempered, 3D printing applications continued to flourish in more technical industries, and the technology has become an intrinsic part of manufacturing and producing products from hearing aids, dentistry parts or surgical instruments and inhalers. As part of 3D printing’s resurgence, it is now transforming the life sciences industry and revolutionizing Medtech in unexpected ways.</section><section><h2>Using 3D Printed Microneedles to Tackle Skin Cancer</h2>Our customer <a href="https://www.imcomet.com/" target="_blank" rel="noopener">IMcoMET Medtech</a> is a biotech startup in the field of skin cancer treatment. Immunotherapy is now turning to the use of micro-scale tools to change the way we treat skin cancer, &nbsp;IMcoMET MedTech has developed technology like the <a href="https://bmf3d.com/resource/skin-cancer-treatment-device-manufactured-with-micro-3d-printing/" target="_blank" rel="noopener">microneedle-Duo (M-Duo)</a> which allows the microenvironment of the tumor and all of its components to be physically removed, to then be replaced with healthy tissue.<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1730078578343-imcomet-image.jpg" style="width: 100%px;" class="fr-fic fr-dib"><section id="isPasted">This small scale of design and alternative approach to tumor aspiration wouldn’t be possible without 3D printing technology from Boston Micro Fabrication, which printed the parts needed to assemble the device on its open-source, micro 3D printing platform. The technology used 3D printed components such as the caps/lid that hold the needles in place. BMF was able to print these high-precision pieces, bridging the gap between classic technology (SLA 3D and nano 3D printing). BMF is able to manufacture these parts due to the high-precision capabilities of its devices – with 100µm channels and spacing requirements of the part down to 20-40 µm.</section><section><h2>Shaping COVID-19 Testing with High-Resolution Molding</h2>Researchers at&nbsp;<a href="https://www.berkeley.edu/" target="_blank" rel="noopener">UC Berkeley</a> were looking for an alternative method to produce molds for multiplex&nbsp;<a href="https://bmf3d.com/resource/3d-printing-molds-uc-berkeley/" target="_blank" rel="noopener">microfluidic</a> devices that can be used in the fight against COVID-19. These devices are equipped with a sensor and can be used to perform traditional antibody testing for patients who are infected. As a means to reduce the spread of viruses, there is a pressing need to detect infection at a very early stage through viral RNA analysis.Christos Adamopoulos, PhD Candidate and Asmaysinh Gharia, Researcher at UC Berkeley were very impressed with the ultra-high resolution that BMF’s technology can achieve. The accuracy and precision of these 3D printed molds is especially important as the microfluidic multiplex devices currently use 100µm channels and they wanted to make channels on an even smaller scale with a higher density.After running through tests with BMF on their 10-micron resolution <a href="https://bmf3d.com/10%CE%BCm-series-printers/" target="_blank" rel="noopener">microArch S140 3D</a> printer, they discovered it was possible to produce features and channels down to 50µm and still have the layers align accurately. They can now fit eight channels instead of five onto the same footprint and can scale up device complexity without increasing the production scale.<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1730078636789-1730078636789.png" class="fr-fic fr-dib"><h2 id="isPasted">Increasing High Quality Precision in Medtech</h2>Medical devices place extremely high demands on the reliability of their components. &nbsp;With applications including surgical power tools, ventilators, and heart pumps, precision bearings are among the critical components on which the safety of treated patients often directly depends. The need for precision and selection fitting components for the device is of the utmost importance.<a href="https://www.rndrmedical.com/" target="_blank" rel="noopener">RNDR Medical</a> is a team of talented and experienced medical device engineers, designers, technicians and executives focused on the advancement of medical technologies. In their recent partnership with BMF, they were able to launch a <a href="https://bmf3d.com/resource/micro-3d-printing-for-disposable-medical-devices/" target="_blank" rel="noopener">novel single-use scope for endourology</a> that is utilized for direct visualization and navigation to enable diagnosis and treatment of urinary tract disorders, such as kidney stones and urothelial carcinoma, as well as pyeloscopy procedures enabling therapeutic access to the renal pelvis and kidneys.<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1730078665670-disposable-tip-rndr-1.png" style="width: 100%px;" class="fr-fic fr-dib"><section id="isPasted">Anthony Appling, Principal, Co-owner, and Keith Wells, Design Engineering Lead were seeking a manufacturing solution since the device requires a high degree of precision while being sealed to prevent fluid exposure. While searching for a solution to navigate the long and expensive wait times of micro molding, they came across Boston Micro Fabrication’s Projection Micro Stereolithography (PµSL) micro 3D printing technology.By partnering with BMF, the RNDR team was able to cut production time in half. BMF’s microscale 3D printers also enabled the company’s medical device engineers to evaluate and iterate designs in a matter of days and weeks vs months. As RNDR Medical can attest, BMF 3D printers are well-suited for visualization systems, therapy and diagnostic catheters, and delivery systems across medical device markets.</section><section><h2>Enhanced efficiency in Medtech devices</h2>According to the Centers for Medicare and Medicaid Services, annual US healthcare spending on medical devices is projected to reach around $300 billion to $400 billion — 5-6% of $6.8 trillion in total healthcare spend — by 2030. &nbsp;3D printing is already becoming a critical player in the production and manufacturing process as companies and research institutes continue to utilize its applications.Last year, the <a href="https://www.unict.it/en" target="_blank" rel="noopener">University of Catania</a> designed <a href="https://bmf3d.com/resource/micro-3d-printing-for-micro-optofluidics/" target="_blank" rel="noopener">micro-optofluidic devices</a> suitable for an enhanced optical investigation device. Lorena Saitta, PhD in the Polymers and Composites was looking for a one-step manufacturing process that could guarantee optical transparency and tailored surface chemistry without the need for further assembly. The device also needed appropriate surface roughness to avoid flow instability and minimize the risk of fluid leakage at assembly points.Saitta turned to 3D printing to manufacture the micro-optofluidic device in one piece. Using the <a href="https://bmf3d.com/10%CE%BCm-series-printers/" target="_blank" rel="noopener">microArch S140,</a> team was able to print the device with integrated inlets, outlets, and insertions for micro-optical fibers. The microArch S140 was also able to manufacture the micro-optofluidic device in one piece, eliminating concerns over fluid leakage. Projection Micro Stereolithography has opened new frontiers in the manufacturing of micro-optofluidic devices” says Lorena Saitta, PhD, University of Catania.</section><section><h2>Expanding MedTech Applications</h2>Use cases are increasingly proving that 3D printing is growing to be more intertwined with the advancement of technology in healthcare and the life sciences. Beyond applications in use today, BMF is continuing to innovate through its partnership with the University of Nottingham. The Centre for Additive Manufacturing, a multidisciplinary research group at The University of Nottingham, is developing a toolkit that will act as an instruction manual to improve the pathway from research all the way through to development and clinical adoption; identifying how medical technology companies can develop personalized and tailored medical devices. This project aims to help to unlock a bottleneck that prevents the bringing of new innovative engineering to the NHS.Whether it’s by creating micro-scale tools that deliver immunotherapy and have the potential to change the way we treat skin cancer, to producing high accuracy and precision printing molds for early detection COVID-19 tests or looking away from traditional manufacturing to additive manufacturing to combat extended production times, micro 3D printing is pushing the boundaries of innovation. The benefit of utilizing 3D continues to be recognized by companies as a creative, high-quality solution and will continue to play a critical role in new innovations to come.</section></section></section>

3D printing applications continued to flourish in more technical industries, and the technology has become an intrinsic part of manufacturing and producing products from hearing aids, dentistry parts or surgical instruments and inhalers.

The top ways high precision 3D printing is changing the medical and life sciences landscape

Two new kinds of on-skin electronics allow users to build and customize them directly on the body – with potential applications in biometric sensing, medical monitoring, interactive prosthetic makeup and more.<a href="https://www.hybridbody.human.cornell.edu/#/skinlink/">SkinLink</a>, developed by the&nbsp;<a href="https://www.hybridbody.human.cornell.edu/">Hybrid Body Lab</a> led by&nbsp;<a href="https://www.human.cornell.edu/people/hk932">Cindy Hsin-Liu Kao</a>, assistant professor of human centered design in the College of Human Ecology, is an on-skin electronic interface that can be fabricated right on the body, providing flexibility in design depending on the intended use. And&nbsp;<a href="https://www.hybridbody.human.cornell.edu/#/ecskin/">ECSkin</a> is an electrochromic display interface that also can be fabricated in situ, and features modular design through tiles that can be arranged as desired.Some of the potential applications for SkinLink include vital-sign and posture monitoring, proximity sensing and body art.“Both of these projects are modular prototyping toolkits, to enable much more intricate on-skin circuitry prototyping,” Kao said. “And users are able to build the circuitry directly on the skin surface.”Doctoral student and lab member Pin-Sung Ku is lead author of “<a href="https://dl.acm.org/doi/10.1145/3596241">SkinLink:&nbsp;On-body Construction and Prototyping of Reconfigurable Epidermal Interfaces</a>,” which was presented in early October at UbiComp/ISWC ’24, the Association for Computing Machinery’s international joint conference on pervasive and ubiquitous computing.The work earned a Distinguished Paper Award from the journal, Proceedings of the ACM on Interactive, Mobile, Wearable and Ubiquitous Technologies, where it was originally published in June 2023.<a href="https://dl.acm.org/doi/10.1145/3659613">ECSkin: Tessellating Electrochromic Films for Reconfigurable On-skin Displays</a>, which published May 15, 2024, in the same journal and for which Ku is also lead author, was also presented at the conference. Kao is senior author for both papers.SkinLink represents a step forward from&nbsp;<a href="https://news.cornell.edu/stories/2022/11/skinkit-offers-versatile-wearable-skin-computing">SkinKit, which the lab developed</a> and presented at UbiComp in 2021. The earlier iteration featured slim and flexible printed circuit boards in temporary tattoo form, but the boards had predefined behaviors and larger surface areas, making customizability a challenge.“There were several issues we didn’t address in SkinKit, such as how to allow users to program the modules the way they want to,” Ku said. “For SkinKit, everything was pre-programmed; users had to attach things in a certain order. With SkinLink, there is more customizability of the functions they like.”With SkinKit, for example, the circuitry had to be built before applying it to the body; with SkinLink, users can put one module on the body, then another, for more customizability.&nbsp;The SkinLink toolkit consists of functional circuit modules, made of flexible printed circuit boards, and flexible, custom-designed wiring (called trace modules, or traces) that connect the sensor and actuator modules to the microcontroller board.That’s a key difference from SkinKit: Smaller circuit boards are connect via flexible wiring, allowing for greater freedom of motion without sacrificing connectivity.&nbsp; “The circuit boards are somewhat rigid,” Ku said, “but we created the traces to be elastic, stretchable and flexible, so as not to hinder body movement.”The on-body fabrication process starts with selecting and programming the circuit board and trace modules. The microcontroller board can be repeatedly programmed during this step, to fine-tune the circuit functions. The boards can be temporarily placed on the body and customized, before final placement.The researchers conducted A/B testing of SkinLink, comparing its usability with SkinKit in a 14-person study, and found that SkinLink enables a more flexible wiring process than SkinKit, along with unrestricted circuit arrangement and superior wearability. Compared to the SkinKit, the SkinLink interface has a much smaller footprint, better stretchability, easier fabricating and more seamless wear.SkinKit, Kao said, offered a “low floor” – a term coined by computer scientist Ben Shneiderman, meaning that people with little or no experience can quickly get started designing and prototyping wearable tech. SkinLink takes it a couple of steps further, she said.“Another goal is what we call ‘high ceilings and wide walls,’” she said. “High ceilings means increasing the complexity of the prototypes; wide walls refers to the vast array of things that could be designed. That’s what I think SkinLink really does.”Kao said she sees both SkinLink and ECSkin as “enabling technologies,” with a variety of potential uses. Some of the studies with SkinLink involved artists, wearable tech researchers, and psychology researchers for physiology sensing; she also envisions applications beyond humans.&nbsp;“Being able to use this as a functional technology for physiological sensing or artistic practice is one application,” she said. “Our work has focused on skin interfaces for humans, but I think there could also be potential for designing ‘skin’ interfaces for other living beings, such as animals, and sensing for agricultural purposes, even on plants. We are interested in bringing SkinLink to broader disciplines to support on-skin prototyping.”

An ECSkin on-body display, composed of modular electrochromic films, is flexible and soft, and easily conforms to complex body parts such as the wrist. Hybrid Body Lab/Provided

Two new kinds of on-skin electronics allow users to build and customize them directly on the body – with potential applications in biometric sensing, medical monitoring, interactive prosthetic makeup and more.

On-body electronics can monitor health, support creative expression

<section id="isPasted"><a href="https://www.rndrmedical.com/">RNDR Medical</a> is a team of talented and experienced medical device engineers, designers, technicians and executives focused on the advancement of medical technologies. The experts at the Louisville, Kentucky (USA) company have over 100 years of combined experience and offer a full suite of engineering services to best-in-class FDA registered clean room manufacturing. Professional accolades include the invention of multi-million-unit product lines, over 100 patents with multiple pending, dozens of successful products launched, and bringing RNDR innovation to clinical domains ranging from endoscopy, cardiology, urology, peripheral vascular, and laparoscopy.</section><section><h2>The Challenge</h2>One specific product RNDR Medical developed and will soon be launching is a novel single use scope for endourology that is utilized for direct visualization and navigation to enable diagnosis and treatment of disorders in the urinary tract, such as kidney stones and urothelial carcinoma, as well as pyeloscopy procedures enabling therapeutic access to the renal pelvis and kidneys. The ureteroscope features a digital high-definition camera and illumination that enable direct visualization of the anatomy as well as fluid irrigation for maintaining a clear image. &nbsp;A working channel allows passage of therapeutic tools through the ureteroscope, such as lithotripsy fibers and retrieval baskets, for the treatment of kidney stones.A key component of this device is the distal tip, which houses the camera chip and illumination source as well as directing fluid paths for irrigation and providing the link from the working channel to the exterior anatomical environment. &nbsp;These elements must be contained within the distal tip with a high degree of precision while being sealed to prevent fluid ingress into the device, all within a .130” diameter profile. &nbsp;Additionally, the exterior geometry of this tip component must be atraumatic to the anatomy as it is the forward facing, advancing part of the device. &nbsp;Containing all these design elements within such a small profile requires a component with complex 3D geometry, tight tolerances, and wall thickness traditionally only achievable through niche micro molding. &nbsp;Finally, mature component volumes are in the tens of thousands per year, which would result in a longer ROI for expensive micro molding.<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1729490241116-rndr-bmf-parts-2.jpg" style="width: 100%px;" class="fr-fic fr-dib">Micro 3D printed distal tip, Micromolded distal tip<h2 id="isPasted">An Alternative to Micro Molding</h2>Anthony Appling, Principal, Co-owner and Keith Wells, Design Engineering Lead were looking for an alternative to the expense and long wait times of micro molding when they came across Boston Micro Fabrication’s Projection Micro Stereolithography (PµSL) micro 3D printing technology. Capable of achieving resolution of 2µm~25µm and tolerance of +/- 10µm~25µm, BMF’s microArch series of micro-precision 3D printers seemed to be a potential solution.During the early phase design of the device BMF printers allowed for very quick iterative development of the distal tip component at scale. &nbsp;This greatly expedited the development schedule as traditional methods would have required the expense of micro machining to achieve the iterative development necessary for good design, followed by the investment and long lead time of micro molding – with potentially the need for multiple tools to properly test multiple optimal tip geometries in the correct material. &nbsp;The speed and flexibility of the BMF system was highly beneficial to their engineering team to hone in on an optimal design with minimal time and expense.Further, Appling and Wells realized that the BMF material held up well to their test battery for the component such that additive manufacturing became a feasible solution not just for design development but for potential initial production volumes as well. &nbsp;“BMF 3D printing technology is critical to the fast, iterative development of precision components, enabling the advantages of additive manufacturing at-scale from prototype to production,” said Appling.Finally, the volume flexibility and manufacturing scalability of the BMF system is very attractive for product development through manufacturing. &nbsp;In RNDR’s case they can yield up to 500 units of tip components from a single build cycle.In terms of measurable results, RNDR Medical credits BMF technology with cutting development time by as much as a half. BMF microscale 3D printers also enabled the company’s medical device engineers to evaluate and iterate designs in a matter of days and weeks vs months. The geometric accuracy and material integrity of these 3D printed parts inspired confidence, and the 3D printed distal tips withstood pre-clinical evaluation in a simulated use environment.<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1729490280774-rndr-end-part-1.png" style="width: 100%px;" class="fr-fic fr-dib">Disposable scope tip<h2 id="isPasted">The Future</h2>As the company looks ahead, it’s envisioning using micro 3D printing as a bridge technology for initial commercialization and large-scale production. To determine suitability, an evaluation of available 3D materials will be especially important. At a time when demand for minimally invasive medicine is growing, there is also a need for highly functioning disposable catheters and scopes with feature-rich characteristics at the end of smaller-diameter catheters. As with the examples described in this case study show, multiple design features will need to be contained within smaller profiles.For medical device engineers, the challenge of packing more features into less space can quickly exceed the limits of multi-axis machining and molding, where draft and uniform wall thickness must be maintained. With microscale 3D printing, however, engineers can maximize the entire volume of a component for functionality without traditional concerns about design for manufacturing (DFM). As RNDR Medical can attest, BMF 3D printers are well-suited for visualization systems, therapy and diagnostic catheters, and delivery systems across medical device markets.</section>

RNDR Medical is set to launch a novel single-use scope for endourology, designed for direct visualization and navigation to diagnose and treat urinary tract disorders like kidney stones and urothelial carcinoma, as well as facilitating pyeloscopy procedures.

Micro 3D Printing for Disposable Medical Devices

Neural spheroids — 3D clusters of brain cells — are emerging as essential tools for understanding neural networks and studying neurological diseases in the lab. EPFL’s e-Flower, a flower-shaped 3D microelectrode array (MEA), allows researchers to monitor the electrical activity of these spheroids in a way that was previously impossible. This breakthrough, <a href="https://www.science.org/doi/10.1126/sciadv.adp8054" target="_blank" rel="noopener">published in Science Advances</a>, lays the groundwork for more sophisticated research on brain organoids, which are complex, miniaturized models of brain tissues.<blockquote>Our flexible technology makes it possible to get accurate recordings without damaging the 3D neural models.<footer>Stéphanie P. Lacour</footer></blockquote>“The e-Flower lets us record neural activity from much more of the surface of neural spheroids in real-time — something that wasn’t possible with earlier tools. Our flexible technology makes it possible to get accurate recordings without damaging the 3D neural models, giving us a better understanding of how their complex circuits work,” says Stéphanie P. Lacour, lead author of the paper and head of the Laboratory for Soft Bioelectronic Interfaces (<a href="https://www.epfl.ch/labs/lsbi/">LSBI</a>) at the Neuro X Institute.<h2>Why neural spheroids?</h2>“We focused on neural spheroids for this study because they provide a straightforward and accessible model,” says Eleonora Martinelli, one of the lead researchers on the project.<img src="https://s3-us-west-1.amazonaws.com/wevolver-project-images/froala%2F1729211190818-9f9374f8.jpg" style="width: 100%px;" class="fr-fic fr-dib">Eleonora Martinelli says the goal is to apply the e-Flower to brain organoids. © 2024 EPFL / Alain HerzogNeural spheroids are three-dimensional clusters of neurons that replicate some of the key functions of brain tissue. They are simpler than organoids, which contain multiple cell types and more closely mimic the brain. The LSBI team at Campus Biotech worked in collaboration with Luc Stoppini and Adrien Roux at the&nbsp;<a href="https://www.hesge.ch/hepia/en/group/bioengineering" target="_blank" rel="noopener">Tissue Engineering Laboratory</a> (HEPIA-HESGE), researchers with long-standing experience with neural spheroids electrophysiology.“Spheroids are relatively easy to produce and manipulate in the lab, which makes them ideal for early-stage testing,” Martinelli continues. “However, our goal is to eventually apply the e-Flower to brain organoids, which more accurately model brain development and disorders.”“Organoids represent an exciting interface both for neuroscience research and next-generation neurotechnology,” says Stéphanie Lacour. “They bridge the gap between simplified in vitro models and the complexities of the human brain. Our work with the e-Flower is a critical step toward being able to explore these 3D models.”<h2>The serendipity behind the innovation</h2><blockquote>What was originally a problem for one project became the solution for another.<footer>Eleonora Martinelli</footer></blockquote>Interestingly, the e-Flower was born out of an unexpected discovery. Outman Akouissi, a collaborator on the project, encountered a challenge while working on soft implants for peripheral nerves: the hydrogels he used caused his devices to curl unpredictably when exposed to water. What started as a frustration turned into a breakthrough when Akouissi and Martinelli realized this curling mechanism could be harnessed for a completely different application — wrapping around neural spheroids.“This was a perfect example of how serendipity can lead to innovation,” says Martinelli. “What was originally a problem for one project became the solution for another.”<h2>A new approach to neural electrophysiology</h2>The device consists of four flexible petals equipped with platinum electrodes, which curl around the spheroid when exposed to the liquid that supports the cell structure. This actuation is driven by the swelling of a soft hydrogel, making the device both gentle on the tissue and easy to use.Designed to be compatible with existing electrophysiological systems, the e-Flower offers a plug-and-play solution for researchers, avoiding the need for complex external actuators or harmful solvents.Once the technology is applied to organoids, the ability to record electrical activity from all sides will provide a much more comprehensive understanding of brain processes. Researchers hope this will lead to new insights into neurodevelopment, brain injury recovery, and neurological diseases.<hr>ReferencesMartinelli, E., Akouissi, O., Liebi, L., Furfaro, I., Maulà, D., Savoia, N., Remy, A., Nikles, L., Roux, A., Stoppini, L., Lacour, S.P. "The e-Flower: A Hydrogel-Actuated 3D MEA for Brain Spheroid Electrophysiology." Science Advances, 2023. DOI:<a href="https://www.science.org/doi/10.1126/sciadv.adp8054" target="_blank" rel="noopener">10.1126/sciadv.adp8054</a>

EPFL researchers have developed a novel neural recording device called the "e-Flower" that gently wraps organoids in soft petals.

e-Flower records neuronal activity with electronic petals

In this episode, we explore the versatile knee exoskeleton designed to enhance safety during lifting by using a novel design that improves the freedom of movement and safety in comparison to current state of the art.

Podcast: Wear This Exoskeleton & Save Your Knees!

In this episode, we explore the first healthcare device powered by body heat, made possible with liquid-based metals and discover how this innovative technology is paving the way for sustainable and energy-efficient medical devices, revolutionizing the future of healthcare.

Podcast: Powering Medical Devices With Body Heat

In 2023, more than 100,000 Americans died from opioid overdoses. The most effective way to save someone who has overdosed is to administer a drug called naloxone, but a first responder or bystander can’t always reach the person who has overdosed in time.Researchers at MIT and Brigham and Women’s Hospital have developed a new device that they hope will help to eliminate those delays and potentially save the lives of people who overdose. The device, about the size of a stick of gum, can be implanted under the skin, where it monitors heart rate, breathing rate, and other vital signs. When it determines that an overdose has occurred, it rapidly pumps out a dose of naloxone.<iframe width="640" height="360" src="https://www.youtube.com/embed/_ZObB_mONE0?&amp;wmode=opaque&amp;rel=0&amp;enablejsapi=1&amp;origin=https://www.wevolver.com" frameborder="0" allowfullscreen="" class="fr-draggable" data-lf-form-tracking-inspected-kn9eq4roawkarlvp="true" data-lf-yt-playback-inspected-kn9eq4roawkarlvp="true" data-lf-vimeo-playback-inspected-kn9eq4roawkarlvp="true"></iframe>In a study&nbsp;<a href="https://doi.org/10.1016/j.device.2024.100517" target="_blank">appearing today in the journal&nbsp;Device</a>, the researchers showed that the device can successfully reverse overdoses in animals. With further development, the researchers envision that this approach could provide a new option for helping to prevent overdose deaths in high-risk populations, such as people who have already survived an overdose.“This could really address a significant unmet need in the population that suffers from substance abuse and opiate dependency to help mitigate overdoses, with the initial focus on the high-risk population,” says Giovanni Traverso,&nbsp;an associate professor of mechanical engineering at MIT, a gastroenterologist at Brigham and Women’s Hospital, and the senior author of the study.The paper’s lead authors are Hen-Wei Huang, a former MIT visiting scientist and currently an assistant professor of electrical and electronic engineering at Nanyang Technological University in Singapore; Peter Chai, an associate professor of emergency medicine physician at Brigham and Women’s Hospital; SeungHo Lee, a research scientist at MIT’s Koch Institute for Integrative Cancer Research; Tom Kerssemakers and Ali Imani, former master’s students at Brigham and Women’s Hospital; and Jack Chen, a doctoral student in mechanical engineering at MIT.<h2>An implantable device</h2>Naloxone is an opioid antagonist, meaning that it can bind to opioid receptors and block the effects of other opioids, including heroin and fentanyl. The drug, which is given by injection or as a nasal spray, can restore normal breathing within just a few minutes of being administered.However, many people are alone when they overdose, and may not receive assistance in time to save their lives. Additionally, with a new wave of synthetic, more potent opioids sweeping the U.S., opioid overdoses can be more rapid in onset and unpredictable. To try to overcome that, some researchers are developing wearable devices that could detect an overdose and administer naloxone, but none of those have yet proven successful. The MIT/BWH team set out to design an implantable device that would be less bulky, provide direct injection of naloxone into the subcutaneous tissue, and eliminate the need for the patient to remember to wear it.The device that the researchers came up with includes sensors that can detect heart rate, breathing rate, blood pressure, and oxygen saturation. In an animal study, the researchers used the sensors to measure all of these signals and determine exactly how they change during an overdose of fentanyl. This resulted in a unique algorithm that increases the sensitivity of the device to accurately detect opioid overdose and distinguish it from other conditions where breathing is decreased, such as sleep apnea.This study showed that fentanyl first leads to a drop in heart rate, followed quickly by a slowdown of breathing. By measuring how these signals changed, the researchers were able to calculate the point at which naloxone administration should be triggered.“The most challenging aspect of developing an engineering solution to prevent overdose mortality is simultaneously addressing patient adherence and willingness to adopt new technology, combating stigma, minimizing false positive detections, and ensuring the rapid delivery of antidotes,” says Huang. “Our proposed solution tackles these unmet needs by developing a miniaturized robotic implant equipped with multisensing modalities, continuous monitoring capabilities, on-board decision making, and an innovative micropumping mechanism.”The device also includes a small reservoir that can carry up to 10 milligrams of naloxone. When an overdose is detected, it triggers a pump that ejects the naloxone, which is released within about 10 seconds.In their animal studies, the researchers found that this drug administration could reverse the effects of an overdose 96 percent of the time.“We created a closed-loop system that can sense the onset of the opiate overdose and then release the antidote, and then you see that recovery,” Traverso says.<h2>Preventing overdoses</h2>The researchers envision that this technology could be used to help people who are at the highest risk of overdose, beginning with people who have had a previous overdose. They now plan to investigate how to make the device as user-friendly as possible, studying factors such as the optimal location for implantation.“A key pillar of addressing the opioid epidemic is providing naloxone to individuals at key moments of risk. Our vision for this device is for it to integrate into the cascade of harm-reduction strategies to efficiently and safely deliver naloxone, preventing death from opioid overdose and providing the opportunity to support individuals with opioid use disorder,” says Chai.The researchers hope to be able to test the device in humans within the next three to five years. They are now working on miniaturizing the device further and optimizing the on-board battery, which currently can provide power for about two weeks.

A new device, which can be implanted under the skin, rapidly releases naloxone to reverse an opioid overdose. Credit: Courtesy of the researchers, edited by MIT News

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