In his final year of medical school, Matt Kesinger realized that a clinical examination was never going to be good enough for early stroke detection, and he began to develop the technological solution that would become Forest Devices’ ALPHASTROKE.
The process of material selection often begins by evaluating the characteristics of a given polymer family, and comparing and contrasting them with the characteristics of other polymer families. This evaluation is done in concert with a thorough review of the performance requirements of the device.
Medical device interconnectivity has obvious benefits, but it also introduces new cyber-attack vectors for hackers to insert malware, compromise connected technologies, steal patient data, or even jeopardize patient health. The current state of medical device cyber readiness and compliance requires an immediate, industrywide call to action
Many OEMs will utilize multi-cavitation tooling to reduce piece part prices while preparing to increase the production volume of a micromolded component. While this may be a cost effective approach for simple thermoplastic parts, it may not be the best technique for micromolded parts, especially those made of bioabsorbable or high dollar value materials. This article discusses overcoming expenses such as material waste, and mold and automation issues, and presents four key areas for cost savings in bioabsorbable products.
The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.
Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.
Rapid technology advances in medical microelectronics, driven by increased service life, miniaturization, lack of redundancy and functional integration, requires a rigorous development, manufacturing and monitoring methodology to assure reliability. Such an approach must be relevant throughout the product lifecycle and, for every component in a system hierarchy. It must also be effective and efficient. This article discusses a smart end-to-end solution for capacitor reliability that can yield better, more dependable medical electronic devices.
As a part of a fast-track effort to bring the exoskeleton from science fiction to real-world use, Proto Labs will provide custom-machined aluminum-joint housings for a futuristic brain-machine robotics system that would help paraplegics walk again. The plan is to have a working model ready for a user by the time of the powered exoskeleton race at Cybathlon, an international competition in Zurich in October.
Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.
Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.
Scientists from Colorado State University (CSU) have demonstrated that hemophobic surfaces significantly reduce platelet adhesion and activation, a process that can lead to life-threatening blood clots.
SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced recently it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new DSG (Dynamic Surgical Guidance) integration module to be used in combination with Zavation’s spinal fusion system to make its pedicle screws “smart.”
Royal Philips, a leader in integrated image-guided therapy solutions, recently announced the development of an industry-first augmented-reality surgical navigation technology that is designed to help surgeons perform image-guided open and minimally-invasive spine surgery.
New technology from the Georgia Institute of Technology targets vagus nerve stimulation (VNS) to improve its therapeutic benefit as a treatment for chronic inflammatory disease.
ResMed (NYSE: RMD) announced today at the 35th annual J.P. Morgan Healthcare Conference that the U.S. Food and Drug Administration has cleared ResMed's AirMini, the world's smallest continuous positive airway pressure (CPAP) device.
Researchers in Switzerland have produced real-life evidence that implanted devices could one day be powered by solar energy. Study participants who wore solar power measurement devices throughout their regular daily activities generated the energy required to power the average contemporary pacemaker, regardless of the weather, season, or age.
A team of Israeli scientists has further developed its breathalyzer technology, and a recent clinical study demonstrated an 86 percent success rate identifying 17 different diseases. The researchers’ nanoarray uses data collected from over 1,400 subjects to establish “breathprints” for diseases like cancer and multiple sclerosis, and then relies upon artificial intelligence (AI) technology to make a diagnosis.
A multidisciplinary team of scientists from Texas has developed an implantable drug delivery device that uses nanochannels to regulate dosage of drugs over time. Researchers say the implant is “drug agnostic” and could potentially be paired with a variety of pharmaceutical treatments for a host of diseases or ailments, such as cancer therapies, HIV drug cocktails, immunotherapy, or cortisone injections for joint pain.
A recent advance in bioelectronic medicine may be able to stop internal or external bleeding by stimulating certain nerves in the brain using a “neural tourniquet.” Researchers from the Feinstein Institute for Medical Research (FIMR) believe the treatment could be used in battlefield medicine, emergency care, surgery, or post-partum treatments to treat or prevent hemorrhaging.
For the first time, scientists have generated lasers from the interaction of light and water waves. This "water-wave" laser can find future application in optofluidic devices and "lab-on-a-chip” devices for studying cell biology and delivering drugs at the nanoscale.