Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.
This article, focused on the opportunities for innovation in cancer diagnostics, is the last in a four-part series exploring the role of medtech innovation as it pertains to the distinct stages of cancer care.
A combination of human-centric design and new sensor, analytics, and data transmission technologies may soon make inhalation devices easier to use, more consistent, and more useful for patients and healthcare providers.
Injection molding is a parts manufacturing process used for a wide range of products including medical devices, children’s toys, household appliances, and automobile parts. Sometimes a second molded part is added as a grip, handle, cover, or sleeve to cover vibration resistance, slippery surfaces, poor ergonomics, and cosmetic concerns. Instead of trying to assemble two different molded parts together, manufacturers can use a rapid overmolding process as an alternative solution. This article touches on three key elements to consider when designing injection molded parts with rapid overmolding.
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.
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.
Using fiber optics, University of Central Florida (UCF) researchers have developed a technique to monitor, in real time, the formation of dangerous blood clots during cardiovascular procedures.
The Juvenile Diabetes Research Fund (JDRF) has invested in a long-lasting continuous glucose monitor (CGM) that uses engineered live cells to replenish and maintain the stability of the implant’s optical biosensor over time.
Medtronic's newest addition to its growing minimally-invasive surgery portfolio is the single-handed, powered Signia surgical stapler, which has the ability to sense human tissue thickness and automatically adjust stapling speed to achieve consistent staple lines.
Verb Surgical — the joint venture between Johnson & Johnson’s Ethicon and Alphabet’s Verily Life Sciences— says it has successfully demonstrated their first digital surgery prototype to senior company executives, one year after announcing their collaboration.
Novel needle technology developed at the University of Adelaide (UA) uses a tiny fiber optic camera and infrared light to guide neurosurgeons through dangerous procedures. Computer software connected to the needle can recognize blood vessels and alert the surgeon, preventing a potentially life-threatening bleed.
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.